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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 N813D lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a Phase II trial, Gilotrif (afatinib) treatment resulted in partial response in a patient with lung adenocarcinoma harboring ERBB2 (HER2) N813D (PMID: 30149884; NCT02979821). 30149884
ERBB2 D769Y Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) D769Y were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 D769Y breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 D769Y reverted to normal morphology in culture upon Tykerb (lapatinib) treatment (PMID: 23220880). 23220880
ERBB2 D769Y gastroesophageal junction adenocarcinoma predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.9 months in a patient with gastroesophageal cancer harboring ERBB2 (HER2) D769Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 D769Y breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 D769Y reverted to normal morphology in culture upon Herceptin (trastuzumab) treatment (PMID: 23220880). 23220880
ERBB2 D769Y Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). 31588020
ERBB2 D769Y malignant peripheral nerve sheath tumor predicted - sensitive HER2 (ERBB2) Antibody Lapatinib Case Reports/Case Series Actionable In a clinical case study, Tykerb (lapatinib) treatment resulted in clinical improvements, partial tumor size reduction, and metabolic response in a patient with neurofibroma/schwannoma hybrid nerve sheath tumor harboring ERBB2 (HER2) D769Y (PMID: 32017710). 32017710
ERBB2 D769Y Advanced Solid Tumor sensitive Osimertinib Preclinical - Cell culture Actionable In a preclinical study, Tagrisso (osimertinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). 31588020
ERBB2 D769Y urinary bladder cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.4 months in a patient with bladder cancer harboring both ERBB2 (HER2) D769Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 D769Y Advanced Solid Tumor sensitive Nazartinib Preclinical - Cell culture Actionable In a preclinical study, Nazartinib (EGF816) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). 31588020
ERBB2 D769Y breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) D769Y reverted to normal morphology in culture upon Nerlynx (neratinib) treatment (PMID: 23220880). 23220880
ERBB2 D769Y Advanced Solid Tumor sensitive HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). 31588020
ERBB2 D769Y Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). 31588020
ERBB2 D769Y Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) D769Y were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 D769Y Advanced Solid Tumor sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). 31588020
ERBB2 D769Y Advanced Solid Tumor sensitive HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). 31588020
ERBB2 D769Y Advanced Solid Tumor sensitive HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769Y in culture (PMID: 31588020). 31588020
ERBB2 D769Y ERBB2 amp Her2-receptor positive breast cancer resistant HER2 (ERBB2) Antibody Trastuzumab Preclinical - Pdx Actionable In a preclinical study, a breast cancer patient-derived xenograft (PDX) model with ERBB2 (HER2) amplification and ERBB2 D769Y was refractory to treatment with Herceptin (trastuzumab) (PMID: 30301790). 30301790
ERBB2 D769Y ERBB2 amp Her2-receptor positive breast cancer resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Pdx Actionable In a preclinical study, a breast cancer patient-derived xenograft (PDX) model with ERBB2 (HER2) amplification and ERBB2 D769Y was refractory to treatment with Tykerb (lapatinib) (PMID: 30301790). 30301790
ERBB2 D769Y ERBB2 amp Her2-receptor positive breast cancer sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including stable disease in a patient harboring ERBB2 (HER2) D769Y, and Nerlynx (neratinib) inhibited tumor growth in a breast cancer patient-derived xenograft (PDX) model with ERBB2 (HER2) amplification and ERBB2 (HER2) D769Y (PMID: 30301790). 30301790
ERBB2 T862A Advanced Solid Tumor decreased response HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, higher dose of Tykerb (lapatinib) inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) N862A in culture (PMID: 22046346). 22046346
ERBB2 T862A Advanced Solid Tumor sensitive HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, AEE788 inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) T862A in culture (PMID: 22046346). 22046346
ERBB2 G776delinsVC Advanced Solid Tumor conflicting HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor conflicting HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC Advanced Solid Tumor resistant Nazartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Nazartinib (EGF816) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC Advanced Solid Tumor resistant HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Tarloxotinib (TRLX) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC Advanced Solid Tumor conflicting HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Pyrotinib in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC Advanced Solid Tumor conflicting HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor conflicting HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor conflicting HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC lung non-small cell carcinoma conflicting HER inhibitor (Pan) Afatinib Preclinical - Cell line xenograft Actionable In a preclinical study, Gilotrif (afatinib) inhibited proliferation and induced cell-cycle arrest and apoptosis of a non-small cell lung cancer (NSCLC) cell line harboring ERBB2 (HER2) G776delinsVC in culture and inhibited tumor growth in NSCLC cell line xenografts carrying ERBB2 (HER2) G776delinsVC (PMID: 26545934). 26545934
ERBB2 G776delinsVC lung non-small cell carcinoma conflicting HER inhibitor (Pan) Afatinib Clinical Study Actionable In a retrospective analysis, Gilotrif (afatinib) treatment resulted in an objective response rate of 0% (0/3) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor conflicting Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Tagrisso (osimertinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC Advanced Solid Tumor conflicting Osimertinib Preclinical - Cell culture Actionable In a preclinical study, Tagrisso (osimertinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Tykerb (lapatinib) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Nerlynx (neratinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC lung non-small cell carcinoma no benefit HER inhibitor (Pan) Dacomitinib Clinical Study Actionable In a retrospective analysis, Vizimpro (dacomitinib) treatment resulted in an objective response rate of 0% (0/2) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). 30527195
ERBB2 G776delinsVC lung non-small cell carcinoma resistant Gefitinib Preclinical Actionable In a preclinical study, non-small cell lung cancer cells harboring ERBB2 (HER2) G776delinsVC demonstrated resistance to treatment with Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 G776delinsVC lung non-small cell carcinoma no benefit HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, Kadcyla (ado-trastuzumab emtansine) treatment demonstrated limited efficacy in patients with relapsed non-small cell lung cancer harboring ERBB2 (Her2) mutations, resulting in progressive disease in a patient harboring ERBB2 (HER2) G776delinsVC (PMID: 29313813). 29313813
ERBB2 G776delinsVC Advanced Solid Tumor resistant HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Tukysa (tucatinib) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC lung non-small cell carcinoma no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 8.5 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) G776delinsVC (PMID: 29420467; NCT01953926). 29420467
ERBB2 G776delinsVC lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) G776delinsVC did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 G776delinsVC Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 29686424). 29686424
ERBB2 G776delinsVC Advanced Solid Tumor decreased response Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC demonstrated decreased response to Tarceva (erlotinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor predicted - sensitive Luminespib Preclinical - Cell culture Actionable In a preclinical study, Luminespib (AUY922) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC breast cancer sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited Erbb2 (Her2) phosphorylation and viability of breast cancer cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Clinical Study - Cohort Actionable In a retrospective study, Gilotrif (afatinib) treatment resulted in an objective response rate (ORR) of 15.6% (5/32) and a disease control rate of 68.8% (22/32) in patients with lung adenocarcinoma harboring ERBB2 (HER2) mutations, patients harboring G776delinsVC (n=5) or G778_P780dup (n=5) achieved longer median progression-free survival (7.6 mo) than those with Y772_A775dup (n=14, 1.2 mo) or missense mutations (n=8, 3.6 mo), with an ORR of 40% (4/10) and a DCR of 100% (10/10) (PMID: 32162827). 32162827
ERBB2 G776delinsVC Advanced Solid Tumor sensitive AZ5104 Preclinical - Cell culture Actionable In a preclinical study, AZ5104 inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC lung adenocarcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall responses of partial response in 44% (8/18) and stable disease in 39% (7/18), and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations, and a subset of patients specifically harboring ERBB2 (HER2) G776delinsVC had a 100% (2/2) partial response rate (PMID: 29989854; NCT02675829). 29989854
ERBB2 G776delinsVC Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC Advanced Solid Tumor resistant HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Imbruvica (ibrutinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, a patient with non-small cell lung cancer harboring ERBB2 G776delinsVC demonstrated a partial response and an ongoing progression-free survival when treated with Pyrotinib (PMID: 30596880; NCT02535507). 30596880
ERBB2 G776delinsVC breast cancer sensitive HER inhibitor (Pan) HER2 (ERBB2) Antibody Ado-trastuzumab emtansine + Poziotinib Preclinical - Cell culture Actionable In a preclinical study, addition of Poziotinib (HM781-36B) enhanced growth inhibition by Kadcyla (ado-trastuzumab emtansine) treatment in breast cancer cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVC lung cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 26545934). 26545934
ERBB2 G776delinsVC lung non-small cell carcinoma no benefit HER2 (ERBB2) Antibody Lapatinib Clinical Study Actionable In a retrospective analysis, Tykerb (lapatinib) treatment resulted in an objective response rate of 0% (0/1) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). 30527195
ERBB2 G776delinsVC Advanced Solid Tumor predicted - sensitive Ganetespib Preclinical - Cell culture Actionable In a preclinical study, Ganetespib inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Case Reports/Case Series Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a partial response in one patient and stable disease in another patient with lung adenocarcinoma harboring ERBB2 (HER2) G776delinsVC (PMID: 30149884; NCT02979821). 30149884
ERBB2 G776delinsVC lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Clinical Study Actionable In a retrospective analysis, Poziotinib (HM781-36B) treatment resulted in an objective response rate of 50% (1/2) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). 30527195
ERBB2 G776delinsVC lung non-small cell carcinoma no benefit Erlotinib Clinical Study Actionable In a retrospective analysis, Tarceva (erlotinib) treatment resulted in an objective response rate of 0% (0/1) in non-small cell lung cancer patients harboring ERBB2 (HER2) G776delinsVC (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Vizimpro (dacomitinib) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor predicted - sensitive Ganetespib Preclinical - Cell culture Actionable In a preclinical study, Ganetespib inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor predicted - sensitive Luminespib Preclinical - Cell culture Actionable In a preclinical study, Luminespib (AUY922) inhibited growth of transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Nerlynx (neratinib) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, ERBB2 (HER2) C805S was identified as a secondary mutation in transformed cells expressing ERBB2 (HER2) G776delinsVC that acquired resistance to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Pyrotinib in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Tykerb (lapatinib) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant AZ5104 Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to AZ5104 in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Tucatinib (ARRY-380) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Tagrisso (osimertinib) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Tarceva (erlotinib) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC ERBB2 C805S Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC and an acquired ERBB2 (HER2) C805S were resistant to Gilotrif (afatinib) in culture (PMID: 30527195). 30527195
ERBB2 P780_Y781insGSP lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, Kadcyla (ado-trastuzumab emtansine) treatment demonstrated limited efficacy in patients with relapsed non-small cell lung cancer harboring ERBB2 (Her2) mutations, resulting in stable disease in a patient harboring ERBB2 (HER2) P780_Y781insGSP (PMID: 29313813). 29313813
ERBB2 P780_Y781insGSP lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, a patient with non-small cell lung cancer harboring ERBB2 P780_Y781insGSP demonstrated stable disease and progression-free survival for more than one year when treated with Pyrotinib (PMID: 30596880; NCT02535507). 30596880
ERBB2 V773M Advanced Solid Tumor sensitive HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited survival of transformed cells expressing ERBB2 (HER2) V773M in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V773M were resistant to Tagrisso (osimertinib) in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V773M were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) V773M in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V773M in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor resistant Nazartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V773M were resistant to Nazartinib (EGF816) in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V773M were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor sensitive HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V773M in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor sensitive HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V773M in culture (PMID: 31588020). 31588020
ERBB2 V773M Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) V773M in culture (PMID: 31588020). 31588020
ERBB2 exon20 lung non-small cell carcinoma no benefit HER inhibitor (Pan) Afatinib Phase II Actionable In a Phase II trial, Gilotrif (afatinib) monotherapy was tolerated but did not result in clinical benefit in patients with advanced non-small cell lung cancer harboring ERBB2 (HER2) exon 20 mutations who had not received tyrosine kinase inhibitor therapy, with no patient (0/18) achieved objective response and 61.1% (11/18) of patients achieved stable disease as best response (PMID: 32738416). 32738416
ERBB2 exon20 lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Phase II Actionable In a Phase II trial, non-small cell lung cancer patients harboring an ERBB2 exon 20 mutation demonstrated an objective response rate of 53.3% (8/15) and a median progression-free survival of 6.4 months when treated with Pyrotinib (PMID: 30596880; NCT02535507). 30596880
ERBB2 G778_S779insCPG Advanced Solid Tumor sensitive HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G778_S779insCPG in culture (PMID: 28363995). 28363995
ERBB2 G778_S779insCPG lung adenocarcinoma no benefit HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall responses of partial response in 44% (8/18) and stable disease in 39% (7/18), and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations, but one patient specifically harboring a G778_S779insCPG mutation did not have a partial response (PMID: 29989854; NCT02675829). 29989854
ERBB2 G309A breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 G309A reverted to normal morphology in culture upon Herceptin (trastuzumab) treatment (PMID: 23220880). 23220880
ERBB2 G309A breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) G309A demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 G309A breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 G309A demonstrated growth inhibition when treated with Tykerb (lapatinib) (PMID: 23220880). 23220880
ERBB2 V697L endometrial cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.6 months in a patient with endometrial cancer harboring ERBB2 (HER2) V697L (PMID: 29420467; NCT01953926). 29420467
ERBB2 V697L Advanced Solid Tumor predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial, a patient with cancer of unknown primary involving the head and neck that harbored ERBB2 (HER2) V697L demonstrated a response to treatment with Nerlynx (neratinib) that lasted 13 months (PMID: 29247016). 29247016
ERBB2 V697L triple-receptor negative breast cancer sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial, a triple-negative breast cancer patient harboring ERBB2 V697L demonstrated a response to treatment with Nerlynx (neratinib) (PMID: 29247016). 29247016
ERBB2 G776_V777insVC ERBB2 over exp lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, a non-small cell lung cancer patient with ERBB2 overexpression (IHC 3+) and harboring ERBB2 G776_V777insVC demonstrated a partial response when treated with Kadcyla (ado-trastuzumab emtansine), with a duration of response of 7.3 months, a progression-free survival of 8.5 months, and an overall survival of 20.2 months (PMID: 30206164; NCT02289833). 30206164
ERBB2 L755_E757delinsS Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 9.0 months in a patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) L755_E757delinsS (PMID: 29420467; NCT01953926). 29420467
ERBB2 G776delinsLC Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsLC were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsLC Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsLC were resistant to Tagrisso (osimertinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsLC Advanced Solid Tumor resistant HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsLC were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsLC Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsLC in culture (PMID: 31588020). 31588020
ERBB2 G776delinsLC lung cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) G776delinsLC in culture (PMID: 26545934). 26545934
ERBB2 G776delinsLC Advanced Solid Tumor resistant Nazartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsLC were resistant to Nazartinib (EGF816) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsLC Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsLC were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsLC Advanced Solid Tumor sensitive HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsLC in culture (PMID: 31588020). 31588020
ERBB2 G776delinsLC Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsLC in culture (PMID: 31588020). 31588020
ERBB2 G776delinsLC lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) G776delinsLC did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 G776delinsLC Advanced Solid Tumor sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsLC in culture (PMID: 31588020). 31588020
ERBB2 G776delinsLC Advanced Solid Tumor resistant HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsLC were resistant to Imbruvica (ibrutinib) in culture (PMID: 31588020). 31588020
ERBB2 over exp breast cancer sensitive HER2 Inhibitor KU004 Preclinical Actionable In a preclinical study, KU004 inhibited growth and induced apoptosis in breast cancer cell lines over expressing ERBB2 in culture (PMID: 26437915). 26437915
ERBB2 over exp carcinoma predicted - sensitive HER2 (ERBB2) Antibody Margetuximab Phase I Actionable In a Phase I trial, Margetuximab (MGAH22) treatment resulted in partial responses in 12% (7/60) and stable disease in 50% (30/60) of patients with ERBB2 (HER2)-positive breast or gastric cancer, or other carcinomas that overexpress Erbb2 (Her2) (PMID: 28119295). 28119295
ERBB2 over exp stomach cancer sensitive HER inhibitor (Pan) Dacomitinib Phase II Actionable In a Phase II trial, Vizimpro (dacomitinib) resulted in a 7.4% (2/27) response rate and 40.7% (11/27) disease control rate when treating advanced gastric cancer patients with ERBB2 (HER2) over expression (J Clin Oncol 30, 2012 (suppl 4; abstr 54)). detail...
ERBB2 over exp stomach cancer sensitive HER inhibitor (Pan) Dacomitinib Preclinical Actionable In a preclinical study, ERBB2 (HER2) over expressing gastric cancer cells were sensitive to Vizimpro (dacomitinib), resulting in inhibition of ERBB2 (HER2)/ERBB3 (HER3) heterodimers (PMID: 22135232). 22135232
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Immune Cell Therapy HER2 CAR-T cells Preclinical - Cell line xenograft Actionable In a preclinical study, ERBB2 (HER2)-specific CAR-T cells induced cell death in ERBB2 (HER2)-over expressing gastric cancer cell lines in culture, and inhibited tumor growth and improved survival in a ERBB2 (HER2)-over expressing gastric cancer cell line xenograft model (PMID: 28284008). 28284008
ERBB2 over exp stomach cancer sensitive HER2 Inhibitor Epertinib Phase I Actionable In a Phase I trial, S-222611 resulted in a complete response in a gastric-esophageal junction cancer patient overexpressing ERBB2 (HER2) and a partial response in a gastric cancer patient also overexpressing ERBB2 (HER2) (J Clin Oncol 33, 2015 (suppl; abstr 2511)). detail...
ERBB2 over exp stomach cancer sensitive CDX-3379 Preclinical Actionable In a preclinical study, CDX-3379 (KTN3379) inhibited tumor growth by 43% in N87 gastric cancer xenograft model, which has been demonstrated to have ERBB2 (HER2) amplification and overexpression (AACR; 2015. Abstract nr 1558, PMID: 18441328). detail... 18441328
ERBB2 over exp gastroesophageal adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab-anns FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, the Herceptin (trastuzumab) biosimilar Kanjinti (Trastuzumab-anns) demonstrated structure, function, and pharmacokinetic profile comparable to Herceptin (trastuzumab) (PMID: 28341959), thus supporting the extrapolation of data from the Phase III trial that supported the approval of Herceptin (trastuzumab) in Erbb2 (Her2) overexpressing gastrioesophageal adenocarcinoma (PMID: 20728210; NCT01041404) for approval of Kanjinti (Trastuzumab-anns) (FDA.gov). 20728210 detail... 28341959 detail... detail...
ERBB2 over exp pancreatic cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 22% (2/9, all partial response) and stable disease lasting over 120 days in 11% (1/9) of patients with pancreatic cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp stomach cancer sensitive HER2 Inhibitor TAK-285 Preclinical Actionable In a preclinical study, the N87 gastric cancer cell line, which has been demonstrated to have ERBB2 (HER2) amplification and over expression, was sensitive to TAK-285, inhibiting phosphorylation of ERBB2 (HER2) and ERBB3 (HER3) (PMID: 25594012, PMID: 18441328). 18441328 25594012
ERBB2 over exp stomach cancer sensitive HER2 Inhibitor TAK-285 Preclinical - Cell line xenograft Actionable In a preclinical study, TAK-285 inhibited tumor growth in gastric cancer cell line xenograft models over expressing ERBB2 (HER2) (PMID: 23983820). 23983820
ERBB2 over exp estrogen-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a clinical case study, Pyrotinib treatment resulted in stable disease for 4 months in a patient with advanced metastatic ER-positive, ERBB2 (HER2)-overexpressing breast cancer (PMID: 32547945). 32547945
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Capecitabine + Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with Xeloda (capecitabine) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp gastric adenocarcinoma predicted - sensitive HER2 (ERBB2) Antibody Capecitabine + Lapatinib + Oxaliplatin Phase II Actionable In a Phase II trial, Tykerb (lapatinib), Xeloda (capecitabine), and Eloxatin (oxaliplatin) combination treatment resulted in a disease control rate of 81.3% (26/32, 7 complete response, 15 partial response, 4 stable disease) in patients with Erbb2 (Her2)-positive (defined as IHC3+ or IHC 2+ with ERBB2 amplification) gastric adenocarcinoma (PMID: 29409051; NCT02015169). 29409051
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody HER2 Inhibitor Trastuzumab + Varlitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Varlitinib (ARRY-334543), in combination with Herceptin (trastuzumab), resulted in a 91% tumor growth inhibition and tumor regression in human cell line xenograft models of gastric cancer overexpressing ERBB2 (HER2) (Cancer Res January 15, 2009 69; 2150). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 Inhibitor Capecitabine + Neratinib FDA approved Actionable In a Phase III (NALA) trial that supported FDA approval, combination of Nerlynx (neratinib) and Xeloda (capecitabine) reduced risk of disease progression or death (HR=0.76, p=0.006), improved 12-month PFS (28.8%, 88/307 vs 14.8%, 46/314) compared to lapatinib and capecitabine combination in patients with metastatic ERBB2 (HER2)-positive (amp/over exp) breast cancer who had 2 or more prior ERBB2 (HER2)-targeted therapies (J Clin Oncol 37, no. 15_suppl (May 20, 2019) 1002-1002; NCT01808573). detail...
ERBB2 over exp gastric adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable Herceptin (trastuzumab) in combination with fluoropyrimidine and cisplatin (category 1) or other platinum agents (category 2A), but not anthracyclines, is included in guidelines as first-line therapy for Erbb2 (Her2)-overexpressing metastatic gastric adenocarcinoma patients (NCCN.org) detail...
ERBB2 over exp gastric adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ToGA) that supported FDA approval, patients with either gastric or gastroesophageal junction adenocarcinoma with ERBB2 (HER2) overexpression or ERBB2 (HER2) amplification had increased overall survival (13.8 mo vs 11.1 mo) when treated with Herceptin (trastuzumab) in combination with chemotherapy compared to chemotherapy alone (PMID: 20728210; NCT01041404). 20728210 detail... detail...
ERBB2 over exp gastroesophageal junction adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable Herceptin (trastuzumab), in combination with fluoropyrimidine and cisplatin, or other chemotherapy agents, but not anthracyclines, is included in guidelines for Erbb2 (Her2)-overexpressing metastatic esophagogastric junction adenocarcinoma patients (NCCN.org) detail...
ERBB2 over exp gastroesophageal junction adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ToGA) that supported FDA approval, patients with either gastric cancer or gastroesophageal junction adenocarcinoma with ERBB2 (HER2) overexpression or ERBB2 (HER2) amplification had increased overall survival (13.8 mo vs 11.1 mo) when treated with Herceptin (trastuzumab) in combination with chemotherapy compared to chemotherapy alone (PMID: 20728210; NCT01041404). 20728210 detail... detail...
ERBB2 over exp Her2-receptor positive breast cancer predicted - sensitive HER2 (ERBB2) Antibody Entinostat + Lapatinib + Trastuzumab Phase I Actionable In a Phase Ib trial, combination treatment consisted of Entinostat, Tykerb (lapatinib) and Herceptin (trastuzumab) resulted in complete response in 9.5% (2/21), partial response in 14.3% (3/21), and stable disease in 38.1% (8/21) of patients with ERBB2 (HER2)-positive breast cancer that progressed through Herceptin (trastuzumab) treatment (PMID: 31097774; NCT01434303). 31097774
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 Inhibitor Neratinib Guideline Actionable Nerlynx (neratinib) is included in guidelines for patients with high-risk ERBB2 (HER2)-positive early breast cancer (PMID: 31236598; ESMO.org). 31236598 detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 Inhibitor Neratinib FDA approved Actionable In a Phase III trial that supported FDA approval, ERBB2 (HER2)-positive (overexpressing and/or amplification) breast cancer patients previously treated with Herceptin (trastuzumab) demonstrated a significantly greater two year invasive disease-free survival rate (93.9%) when treated with Nerlynx (neratinib) compared to the rate (91.6%) in those patients treated with placebo (PMID: 26874901; NCT00878709). 26874901 detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Docetaxel + Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with Taxotere (docetaxel) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp pancreatic carcinoma predicted - sensitive HER2 (ERBB2) Immune Cell Therapy HER2 CAR-T cells Phase I Actionable In a Phase I trial, treatment with ERBB2 (HER2)-specific CAR-T cells demonstrated safety and preliminary activity in patients with biliary tract or pancreatic carcinoma with ERBB2 (HER2) over expression, resulting in partial response in one of 11 patients and stable disease in 5, and a median progression free survival of 4.8 months (PMID: 28710747; NCT01935843). 28710747
ERBB2 over exp pancreatic carcinoma sensitive HER2 (ERBB2) Antibody ADC ST8176AA1 Preclinical - Pdx Actionable In a preclinical study, ADC ST8176AA1 treatment inhibited tumor growth in patient-derived xenograft (PDX) models of pancreatic carcinoma overexpressing ERBB2 (HER2) (PMID: 32039017). 32039017
ERBB2 over exp stomach cancer sensitive HER2 Inhibitor Varlitinib Preclinical - Cell line xenograft Actionable In a preclinical study, Varlitinib (ARRY-334543) resulted in a 74% tumor growth inhibition and tumor regression in 88% (7/8) of human cell line xenograft models of gastric cancer overexpressing ERBB2 (HER2) (Cancer Res January 15, 2009 69; 2150). detail...
ERBB2 over exp stomach cancer predicted - sensitive HER2 (ERBB2) Antibody MM-302 Preclinical Actionable In a preclinical study, ERBB2 (HER2) over expressing gastric cancer xenograft models demonstrated anti-tumor activity when treated with MM-302 (Cancer Res December 15, 2010 70; P3-14-09). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab FDA approved - On Companion Diagnostic Actionable Herceptin (trastuzumab) is FDA approved as an adjuvant treatment for ERBB2 (HER2)-overexpressing (or amplification) breast cancer patients and for metastatic ERBB2 (HER2)-overexpressing (or amplification) breast cancer patients as indicated by an FDA approved companion diagnostic (FDA.gov). detail... detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with a taxane, such as Taxotere (docetaxel) or Taxol (paclitaxel), is included in guidelines as neoadjuvant therapy for patients with ERBB2 (HER2)-positive early breast cancer or as first-line therapy for patients with ERBB2 (HER2)-positive advanced breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). detail... 31236598 30032243
ERBB2 over exp breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab-anns FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, the Herceptin (trastuzumab) biosimilar Kanjinti (Trastuzumab-anns) demonstrated structure, function, and pharmacokinetic profile comparable to Herceptin (trastuzumab) (PMID: 28341959), thus supporting the extrapolation of data from the Phase III trial that supported the approval of Herceptin (trastuzumab) in Erbb2 (Her2) overexpressing breast cancer (PMID: 23602601; NCT00567190) for approval of Kanjinti (Trastuzumab-anns) (FDA.gov). 23602601 detail... 28341959 detail... detail...
ERBB2 over exp gastric adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab-anns FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, the Herceptin (trastuzumab) biosimilar Kanjinti (Trastuzumab-anns) demonstrated structure, function, and pharmacokinetic profile comparable to Herceptin (trastuzumab) (PMID: 28341959), thus supporting the extrapolation of data from the Phase III trial that supported the approval of Herceptin (trastuzumab) in Erbb2 (Her2) overexpressing gastric adenocarcinoma (PMID: 20728210; NCT01041404) for approval of Kanjinti (Trastuzumab-anns) (FDA.gov). 20728210 28341959 detail... detail... detail...
ERBB2 over exp urinary bladder cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 33% (3/9, 1 complete response, 1 partial response) and stable disease lasting over 120 days in 22% (2/9) of patients with bladder cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp Her2-receptor positive breast cancer predicted - sensitive HER2 (ERBB2) Antibody Entinostat + Lapatinib Phase I Actionable In a Phase Ib trial, Entinostat and Tykerb (lapatinib) combination therapy resulted in complete response in 7.1% (1/14) and stable disease in 28.6% (4/14) of patients with ERBB2 (HER2)-positive breast cancer that progressed through Herceptin (trastuzumab) treatment (PMID: 31097774; NCT01434303). 31097774
ERBB2 over exp biliary tract cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 29% (2/7, all partial response) and stable disease lasting over 120 days in 38% (3/7) of patients with biliary cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody M802 Preclinical - Cell culture Actionable In a preclinical study, M802 inhibited growth of a gastric cancer cell line expressing high levels of ERBB2 (HER2) in culture, and inhibited tumor growth in xenograft models (PMID: 31412896). 31412896
ERBB2 over exp cholangiocarcinoma predicted - sensitive HER2 (ERBB2) Immune Cell Therapy HER2 CAR-T cells Phase I Actionable In a Phase I trial, a patient with perihilar cholangiocarcinoma over expressing ERBB2 achieved a partial response and progression-free survival for 4.5 months following treatment with ERBB2 (HER2)-specific CAR-T cells (PMID: 28710747, NCT01935843). 28710747
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Docetaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf FDA approved Actionable In a Phase III trial (FeDeriCa) that supported FDA approval, Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) demonstrated pharmacokinetics, safety, and efficacy comparable to i.v. pertuzumab and trastuzumab (H+P) (Cancer Res 2020;80(4 Suppl):Abstract nr PD4-07; NCT03493854), warranted the extrapolation of data from a Phase III trial supporting the approval of H+P plus docetaxel in Erbb2 (Her2)-positive metastatic breast cancer (PMID: 23602601; NCT00567190) for approval of Phesgo (FDA.gov). detail... detail... 23602601 detail...
ERBB2 over exp gastric adenocarcinoma sensitive VS-5584 Preclinical - Cell line xenograft Actionable In a preclinical study, VS-5584 inhibited tumor growth in human gastric cancer cell line xenograft models overexpressing ERBB2 (HER2) (PMID: 23270925). 23270925
ERBB2 over exp salivary gland cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 80% (4/5, all partial response) of patients with salivary gland cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp stomach cancer predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab deruxtecan Phase II Actionable In a Phase II trial (DESTINY-Gastric01), Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51%, 61/119 vs 14%, 8/56, p<0.0001) and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.01) compared to chemotherapy in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma with high Erbb2 (Her2) expression (IHC 3+ or IHC 2+ plus ISH +), whose disease progressed after 2 or more prior therapies (PMID: 32469182; NCT03329690). 32469182
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab deruxtecan Guideline Actionable Enhertu (fam-trastuzumab deruxtecan-nxki) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive ADXS31-164 Preclinical Actionable In a preclinical study, ADXS31-164 prevented development of spontaneous mammary tumors in Erbb2 (Her2)-over expressing transgenic animal models (PMID: 20725099). 20725099
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib + Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with Tykerb (lapatinib) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib + Trastuzumab Guideline Actionable The combination of Herceptin (trastuzumab) and Tykerb (lapatinib) is included in guidelines for patients with ERBB2 (HER2)-positive advanced breast cancer who progressed on Herceptin (trastuzumab)-based therapy, however, the combination therapy is not recommended as neoadjuvant therapy for ERBB2 (HER2)-positive patients with early breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). detail... 30032243 31236598
ERBB2 over exp ovarian cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 13% (1/8, all partial response) of patients with ovarian cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Docetaxel + Pertuzumab + Trastuzumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (CLEOPATRA) that supported FDA approval, treatment with Perjeta (pertuzumab), combined with Herceptin (trastuzumab) and Taxotere (docetaxel), improved median progression free survival to 18.5 months compared to 12.4 months with placebo plus Herceptin (trastuzumab) and Taxotere (docetaxel) in patients with ERBB2 (HER2)-positive (overexpression and amplification) metastatic breast cancer (PMID: 23602601; NCT00567190). detail... 23602601 detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Docetaxel + Pertuzumab + Trastuzumab Guideline Actionable Perjeta (pertuzumab), Herceptin (trastuzumab), and Taxotere (docetaxel) therapy is included in the guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp breast cancer sensitive HER2 (ERBB2) Antibody M802 Preclinical - Cell culture Actionable In a preclinical study, treatment with M802 increased apoptosis and inhibited growth of breast cancer cell lines expressing high levels of ERBB2 (HER2) in culture (PMID: 31412896). 31412896
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody MBS301 Preclinical - Cell line xenograft Actionable In a preclinical study, MBS301 inhibited proliferation of a gastric cancer cell line expressing high levels of ERBB2 (HER2) in culture, and inhibited tumor growth in xenograft models (PMID: 30081724). 30081724
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, Tykerb (lapatinib) inhibited growth of HER2-over expressing breast carcinoma cell lines in culture (PMID: 27450453). 27450453
ERBB2 over exp colorectal cancer resistant Cetuximab Preclinical - Cell line xenograft Actionable In a preclinical study, ERBB2 (HER2) over expression was associated with resistance to Erbitux (cetuximab) treatment in a human cell line xenograft model of colorectal cancer (PMID: 26296355). 26296355
ERBB2 over exp colorectal cancer resistant Cetuximab Clinical Study - Cohort Actionable In a retrospective analysis, patients with metastatic KRAS exon 2 wild-type colorectal cancer harboring ERBB2 (HER2) amplification or overexpression (n=79) demonstrated poorer objective response rate (31.2 vs 46.9, p=0.031) and progression-free survival (5.7 vs 7 months, p=0.087) to anti-EGFR treatment (Vectibix (panitumumab) or Erbitux (cetuximab), as monotherapy or combined with chemotherapy) when compared to ERBB2 (HER2)-negative patients (n=113) (PMID: 30952821). 30952821
ERBB2 over exp breast cancer sensitive HER2 (ERBB2) Antibody ZW49 Preclinical - Pdx Actionable In a preclinical study, ZW49 treatment induced tumor regression in a patient-derived xenograft (PDX) model of breast cancer overexpressing ERBB2 (HER2) (Cancer Res 2019;79(4 Suppl):Abstract nr P6-17-13). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 Inhibitor CUDC-101 Phase I Actionable In a Phase I clinical trial, a breast cancer patient with ERBB2 (HER2) over expression that had progressed on Herceptin (trastuzumab) demonstrated stable disease for more than 12 weeks following treatment with CUDC-101 (PMID: 25107918). 25107918
ERBB2 over exp lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 13% (2/16, all partial response) and stable disease lasting over 120 days in 13% (2/16) of patients with non-small cell lung cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp gastroesophageal junction adenocarcinoma sensitive HER2 Inhibitor Epertinib Phase I Actionable In a Phase I trial, S-222611 resulted in a complete response in a gastric-esophageal junction cancer patient over expressing ERBB2 (HER2) and a partial response in a gastric cancer patient also over expressing ERBB2 (HER2) (J Clin Oncol 33, 2015 (suppl; abstr 2511)). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody HER2 Inhibitor Capecitabine + Trastuzumab + Tucatinib Guideline Actionable Tukysa (tucatinib), Herceptin (trastuzumab), and Xeloda (capecitabine) combination therapy is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody HER2 Inhibitor Capecitabine + Trastuzumab + Tucatinib FDA approved Actionable In a Phase II trial (HER2CLIMB) that supported FDA approval, addition of Tukysa (tucatinib) to Herceptin (trastuzumab) and Xeloda (capecitabine) significantly improved progression-free survival at 1 year (PFS1) compared to placebo (33.1% vs 12.3%, HR=0.54, p<0.001) in patients with metastatic ERBB2 (HER2)-positive breast cancer who received prior HER2-targeted therapy, PFS1 was significantly improved (24.9% vs 0%, HR=0.48, p<0.001) in patients with brain metastasis (PMID: 31825569; NCT02614794). detail... 31825569
ERBB2 over exp esophagus adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable Herceptin (trastuzumab), in combination with first-line chemotherapy with fluoropyrimidine and cisplatin or other chemotherapy agents, but not anthracyclines, is included in guidelines for Erbb2 (Her2)-overexpressing metastatic esophageal adenocarcinoma patients (NCCN.org) detail...
ERBB2 over exp breast cancer sensitive HER2 (ERBB2) Antibody MM-302 + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, combination of MM-302 and Herceptin (trastuzumab) synergistically inhibited tumor growth in cell line xenograft models of Erbb2 (Her2)-over expressing breast cancer (PMID: 26759238). 26759238
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab + Vinorelbine Guideline Actionable Herceptin (trastuzumab) combined with Navelbine (vinorelbine) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab + Vinorelbine Guideline Actionable The combination of Herceptin (trastuzumab) and Navelbine (vinorelbine) is included in guidelines as first-line therapy for patients with ERBB2 (HER2)-positive advanced breast cancer (PMID: 30032243; ESMO.org). 30032243 detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Guideline Actionable The combination of Herceptin (trastuzumab) and Perjeta (pertuzumab) with a taxane, such as Taxotere (docetaxel) or Taxol (palictaxel), is included in guidelines for patients with ERBB2 (HER2)-positive early breast cancer patients or advanced breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). 31236598 detail... 30032243
ERBB2 over exp breast cancer sensitive HER2 Inhibitor AV-412 Preclinical - Cell line xenograft Actionable In a preclinical study, AV-412 inhibited growth of ERBB2 (HER2)-over expressing breast cancer cell lines in culture, and inhibited tumor growth in a ERBB2 (HER2)-over expressing breast cancer cell line xenograft model (PMID: 17888033). 17888033
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody MM-111 + Paclitaxel + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, MM-111, in combination with Herceptin (trastuzumab) and Taxol (paclitaxel), resulted in a synergistic effect thereby inhibiting ErbB2 in ERBB2 (HER2) over expressing gastric cancer cell line xenograft models (J Clin Oncol 31, 2013 (suppl 4; abstr 48)). detail...
ERBB2 over exp biliary tract cancer predicted - sensitive HER2 (ERBB2) Immune Cell Therapy HER2 CAR-T cells Phase I Actionable In a Phase I trial, treatment with ERBB2 (HER2)-specific CAR-T cells demonstrated safety and preliminary activity in patients with biliary tract or pancreatic carcinoma with ERBB2 (HER2) over expression, resulting in partial response in one of 11 patients and stable disease in 5, and a median progression free survival of 4.8 months (PMID: 28710747; NCT01935843). 28710747
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Pertuzumab/trastuzumab/hyaluronidase-zzxf FDA approved Actionable In a Phase III trial (FeDeriCa) that supported FDA approval, Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) treatment in combination with chemotherapy in the neoadjuvant-adjuvant setting demonstrated safety and total pathological complete response rate (59.7% vs 59.5%) comparable to intravenous Perjeta (pertuzumab) and Herceptin (trastuzumab) plus chemotherapy in patients with ERBB2 (HER2)-positive early breast cancer (Cancer Res 2020;80(4 Suppl):Abstract nr PD4-07; NCT03493854). detail... detail...
ERBB2 over exp Her2-receptor positive breast cancer predicted - sensitive HER2 (ERBB2) Antibody Margetuximab Phase Ib/II Actionable In Phase I clinical trial, Margetuximab (MGAH22) displayed safety and had initial efficacy in patients with ERBB2 (HER2) positive breast cancer (J Clin Oncol 31, 2013 (suppl; abstr 3004)). detail...
ERBB2 over exp lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Phase II Actionable In a Phase II trial, Kadcyla (ado-trastuzumab emtansine) treatment in non-small cell lung cancer patients who were ERBB2 positive (defined as IHC 2+ or IHC 3+) resulted in an objective response rate of 20% (4/20), with 4 partial responses, a median progression-free survival (PFS) of 2.7 mo, and a median overall survival (OS) of 15.3 mo in patients who were IHC 3+ (n=20) while patients who were IHC 2+ (n=29) had a median PFS of 2.6 mo, a median OS of 12.2 mo, and no responses (PMID: 30206164; NCT02289833). 30206164
ERBB2 over exp lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, Kadcyla (ado-trastuzumab emtansine) treatment demonstrated limited efficacy in patients with relapsed non-small cell lung cancer harboring ERBB2 (Her2) overexpression (n=5) or amplification (n=3), resulting in stable disease as best response in 37.5% (3/8) of the patients (PMID: 29313813). 29313813
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Paclitaxel + Pertuzumab + Trastuzumab Guideline Actionable Perjeta (pertuzumab), Herceptin (trastuzumab), and Taxol (paclitaxel) therapy is included in the guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2) receptor-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab-anns Phase III Actionable In a Phase III (LILAC) trial, Kanjinti (Trastuzumab-anns) treatment demonstrated safety and efficacy similar to Herceptin (trastuzumab) in neoadjuvant and adjuvant settings, resulted in a complete response in 48% (172/358) of patients with Erbb2 (Her2)-positive breast cancer, compared to 41% (137/338) in Herceptin (trastuzumab)-treated patients (PMID: 29880292; NCT01901146). 29880292
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trazimera Preclinical Actionable In a preclinical study, PF-05280014 inhibited growth of ERBB2 (HER2)-over expressing breast cancer cells with activity comparable to Herceptin (trastuzumab) in culture (PMID: 25001079). 25001079
ERBB2 over exp uterine cancer no benefit HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in no objective response (0/7) in patients with uterine cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody trastuzumab and hyaluronidase-oysk injection FDA approved - On Companion Diagnostic Actionable In a Phase III trial (HannaH) that supported FDA approval, Herceptin Hylecta (trastuzumab and hyaluronidase-oysk injection) treatment demonstrated safety and efficacy profile comparable to intravenous trastuzumab treatment, resulted in pathologic complete response in 45.4% (118/260) of patients with ERBB2 (HER2)-positive (IHC 3+ or ISH positive) breast cancer (PMID: 22884505; NCT00950300). detail... detail... 22884505
ERBB2 over exp stomach cancer sensitive HER2 Inhibitor BMS-690514 Preclinical Actionable In a preclinical study, BMS-690514 inhibited tumor growth in a gastric cancer xenograft model with ERBB2 (HER2) amplification and overexpression (PMID: 21531814). 21531814
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Preclinical - Cell line xenograft Actionable In a preclinical study, Kadcyla (trastuzumab emtansine) inhibited tumor growth in human cell line xenograft models of gastric cancer with ERBB2 (HER2) amplification and over expression (PMID: 21458915). 21458915
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, Tykerb (lapatinib) inhibited growth of HER2-amplified and HER2-over expressing gastric cancer cell lines in culture (PMID: 18774637). 18774637
ERBB2 over exp colorectal cancer decreased response Panitumumab Clinical Study - Cohort Actionable In a retrospective analysis, patients with metastatic KRAS exon 2 wild-type colorectal cancer harboring ERBB2 (HER2) amplification or overexpression (n=79) demonstrated poorer objective response rate (31.2 vs 46.9, p=0.031) and progression-free survival (5.7 vs 7 months, p=0.087) to anti-EGFR treatment (Vectibix (panitumumab) or Erbitux (cetuximab), as monotherapy or combined with chemotherapy) when compared to ERBB2 (HER2)-negative patients (n=113) (PMID: 30952821). 30952821
ERBB2 over exp Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 26% (30/114, 2 complete response, 28 partial response) and stable disease lasting over 120 days in 14% (16/114) of patients with advanced solid tumors harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody MM-302 + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, combination of MM-302 and Herceptin (trastuzumab) resulted in improved tumor growth inhibition in cell line xenograft models of Erbb2 (Her2)-over expressing gastric cancer (PMID: 26759238). 26759238
ERBB2 over exp stomach cancer sensitive HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, Tukysa (tucatinib) inhibited proliferation of an ERBB2 (HER2) over expressing gastric cancer cell line in culture (Cancer Res April 15, 2010 70:3610). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Capecitabine + Lapatinib Guideline Actionable Tykerb (lapatinib) combined with Xeloda (capecitabine) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Carboplatin + Paclitaxel + Trastuzumab Guideline Actionable Herceptin combined with Paraplatin (carboplatin) and Taxol (paclitaxel) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp colorectal cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 38% (14/37, all partial response) and stable disease lasting over 120 days in 11% (4/37) of patients with colorectal cancer harboring ERBB2 (HER2) amplification or overexpression, with a median duration of response of 11 months (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp Her2-receptor positive breast cancer sensitive NAX014 Preclinical Actionable In a preclinical study, NAX014 induced cellular senescence, prevented tumor growth, and decreased tumor volume in a Her2 positive breast cancer mouse model (PMID: 26168818). 26168818
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 Inhibitor TAK-285 Preclinical - Cell line xenograft Actionable In a preclinical study, TAK-285 inhibited growth of breast cancer cell line harboring ERBB2 (HER2) over expression in culture and in cell line xenograft models (PMID: 23983820). 23983820
ERBB2 over exp salivary gland carcinoma predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II (MyPathway) trial, Perjeta (pertuzumab) and Herceptin (trastuzumab) combination therapy resulted in an objective response rate of 60% (9/15, 1 complete response, 8 partial responses) and a clinical benefit rate of 67% (10/15) in patients with advanced salivary gland carcinoma harboring ERBB2 (HER2) amplification or overexpression, with a median progression- free survival of 8.6 months, and a median overall survival of 20.4 months (PMID: 32067683; NCT02091141). 32067683
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine FDA approved - On Companion Diagnostic Actionable In a Phase III trial (EMILIA) that supported FDA approval, treatment with Kadclya (trastuzumab emtansine) improved median progression free survival (9.6 mo vs 6.4 mo) and overall survival (30.9 mo vs 25.1 mo) compared to Tykerb (lapatinib) combined with Xeloda (capecitabine) in patients with metastatic ERBB2 (HER2)-positive breast cancer (PMID: 24879797, PMID: 23020162; NCT00829166). 24879797 detail... detail... 23020162
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Guideline Actionable Kadcyla (ado-trastuzumab emtansine) is included in the guidelines for patients with ERBB2 (HER2)-positive advanced breast cancer who progressed through one line of Herceptin (trastuzumab)-based therapy or ERBB2 (HER2)-positive patients with early breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). 31236598 detail... 30032243
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KATHERINE) that supported FDA approval, treatment with Kadclya (trastuzumab emtansine) resulted in improved invasive disease-free survival (HR=0.50, p<0.001) compared to Herceptin (trastuzumab) in patients with ERBB2 (HER2)-positive early breast cancer who had residual invasive disease after taxane and trastuzumab-based neoadjuvant therapy (PMID: 30516102; NCT01772472). detail... detail... 30516102
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Guideline Actionable Kadcyla (ado-trastuzumab emtansine) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp stomach cancer sensitive HER2 Inhibitor KU004 Preclinical Actionable In a preclinical study, KU004 inhibited growth and induced apoptosis in gastric cancer cell lines over expressing ERBB2 in culture and suppressed growth in a dose dependent manner in xenograft models (PMID: 26437915). 26437915
ERBB2 over exp gastroesophageal junction adenocarcinoma predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab deruxtecan Phase II Actionable In a Phase II trial (DESTINY-Gastric01), Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51%, 61/119 vs 14%, 8/56, p<0.0001) and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.01) compared to chemotherapy in patients with advanced gastric cancer or gastroesophageal junction adenocarcinoma with high Erbb2 (Her2) expression (IHC 3+ or IHC 2+ plus ISH +), whose disease progressed after 2 or more prior therapies (PMID: 32469182; NCT03329690). 32469182
ERBB2 over exp PIK3CA H1047R Her2-receptor positive breast cancer resistant HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Preclinical Actionable In a preclinical study, a mouse breast cancer model with ERBB2 (HER2) over-expression that also expressed the PIK3CA H1047R mutation showed resistance to the combination of Heceptin (trastuzumab) and Perjeta (pertuzumab) (PMID: 23940356). 23940356
ERBB2 over exp PIK3CA H1047R Her2-receptor positive breast cancer sensitive Bevacizumab + Buparlisib Preclinical Actionable In a preclinical study, treatment with Buparlisib (BKM120) resulted in decreased tumor growth, but not tumor regression, in mouse models of ERBB2 (HER2)-over expressing breast cancer expressing PIK3CA H1047R (PMID: 23940356). 23940356
ERBB2 over exp PIK3CA H1047R Her2-receptor positive breast cancer resistant HER2 (ERBB2) Antibody Lapatinib + Trastuzumab Preclinical Actionable In a preclinical study, a mouse breast cancer model with mammary ERBB2 (HER2) over-expression that also expressed the PIK3CA H1047R mutation showed resistance to the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) (PMID: 23940356). 23940356
ERBB2 over exp PIK3CA H1047R Her2-receptor positive breast cancer resistant HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, mouse breast cancer models over expressing ERBB2 (HER2) and expressing PIK3CA H1047R were resistant to Herceptin (trastuzumab) (PMID: 23940356). 23940356
ERBB2 over exp PIK3CA H1047R Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Buparlisib + Trastuzumab Preclinical Actionable In a preclinical study, the combination of Herceptin (trastuzumab) and Buparlisib (BKM120) inhibited tumor growth in mouse ERBB2 (HER2)-over expressing breast cancer models expressing PIK3CA H1047R, with moderate efficacy over Buparlisib (BKM120) alone (PMID: 23940356). 23940356
ERBB2 over exp PIK3CA H1047R Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Buparlisib + Pertuzumab + Trastuzumab Preclinical Actionable In a preclinical study, the combination of Buparlisib (BKM120), Herceptin (trastuzumab), and Perjeta (pertuzumab) inhibited tumor growth in mouse models of ERBB2 (HER2)-over expressing breast cancer expressing PIK3CA H1047R, with improved efficacy over Buparlisib (BKM120) alone (PMID: 23940356). 23940356
ERBB2 over exp PIK3CA H1047R Her2-receptor positive breast cancer no benefit HER2 (ERBB2) Antibody Buparlisib + Lapatinib + Trastuzumab Preclinical Actionable In a preclinical study, the combination of Buparlisib (BKM120), Herceptin (trastuzumab), and Tykerb (lapatinib) inhibited tumor growth in mouse models of ERBB2 (HER2)-over expressing breast cancer expressing PIK3CA H1047R, but efficacy was not significantly improved over Buparlisib (BKM120) alone (PMID: 23940356). 23940356
ERBB2 over exp PIK3CA H1047R stomach cancer predicted - resistant HER2 (ERBB2) Antibody Trastuzumab Clinical Study - Cohort Actionable In a clinical study (AMNESIA-1), assessment of pre-treatment tumor samples from ERBB2 (HER2)-positive gastric or gastroesophageal cancer patients (defined as HER2 IHC 3+ or HER2 IHC 2+/ISH+) identified PIK3CA mutations in 15% (3/20) of patients demonstrating primary resistance to Herceptin (trastuzumab), including 1 patient harboring PIK3CA H1047R (PMID: 29208673). 29208673
ERBB2 over exp PIK3CA H1047R SRC over exp urinary bladder cancer no benefit Ponatinib Preclinical - Pdx Actionable In a preclinical study, treatment with Iclusig (ponatinib) was not effective in inhibiting tumor growth in a patient-derived xenograft (PDX) model of bladder cancer with SRC over expression, which also over expressed ERBB2 (HER2) and harbored PIK3CA H1047R (PMID: 26270481). 26270481
ERBB2 over exp PIK3CA H1047R SRC over exp urinary bladder cancer no benefit HER2 (ERBB2) Antibody Lapatinib Preclinical - Pdx Actionable In a preclinical study, treatment with Tykerb (lapatinib) was not effective in inhibiting tumor growth in a patient-derived xenograft (PDX) model of bladder cancer with ERBB2 (HER2) over expression, which also over expressed SRC and harbored PIK3CA H1047R (PMID: 26270481). 26270481
ERBB2 amp ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Preclinical - Cell line xenograft Actionable In a preclinical study, Kadcyla (trastuzumab emtansine) inhibited tumor growth in human cell line xenograft models of gastric cancer with ERBB2 (HER2) amplification and over expression (PMID: 21458915). 21458915
ERBB2 amp ERBB2 over exp stomach cancer sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell line xenograft Actionable In a preclinical study, Gilotrif (afatinib) induced tumor regression in a gastric cancer cell line xenograft model with HER2 (ERBB2) amplification and over expression (PMID: 23578997). 23578997
ERBB2 amp ERBB2 over exp lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, a non-small cell lung cancer patient with ERBB2 overexpression (IHC 3+) and ERBB2 amplification demonstrated a partial response when treated with Kadcyla (ado-trastuzumab emtansine), with a duration of response of 8.3 months, a progression-free survival of 9.6 months, and an overall survival of 21.6 months (PMID: 30206164; NCT02289833). 30206164
ERBB2 over exp PIK3CA mut Her2-receptor positive breast cancer sensitive PKI-179 Preclinical - Cell line xenograft Actionable In a preclinical study, PKI-179 inhibited growth of breast cancer cells harboring PIK3CA mutations and ERBB2 (HER2) over expression in culture and cell line xenograft models (PMID: 20797855). 20797855
ERBB2 over exp PIK3CA mut breast cancer sensitive HER2 (ERBB2) Antibody Miransertib + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, a breast cancer xenograft model with ERBB2 (HER2) over expression and harboring a PIK3CA mutation was sensitive to the combination treatment of Miransertib (ARQ092) and Herceptin (trastuzumab), demonstrating greater inhibition of tumor growth when compared to treatment with either agent alone (PMID: 26469692). 26469692
ERBB2 over exp PIK3CA mut breast cancer sensitive Miransertib + Paclitaxel Preclinical - Cell line xenograft Actionable In a preclinical study, a breast cancer xenograft model with ERBB2 (HER2) over expression and harboring a PIK3CA mutation was sensitive to the combination treatment of Miransertib (ARQ092) and Taxol (paclitaxel), demonstrating greater inhibition of tumor growth when compared to treatment with either agent alone (PMID: 26469692). 26469692
ERBB2 over exp PIK3CA N345T stomach cancer predicted - resistant HER2 (ERBB2) Antibody Trastuzumab Clinical Study - Cohort Actionable In a clinical study (AMNESIA-1), assessment of pre-treatment tumor samples from ERBB2 (HER2)-positive gastric or gastroesophageal cancer patients (defined as HER2 IHC 3+ or HER2 IHC 2+/ISH+) identified PIK3CA mutations in 15% (3/20) of patients demonstrating primary resistance to Herceptin (trastuzumab), including 1 patient harboring PIK3CA N345T (PMID: 29208673). 29208673
ERBB2 over exp PIK3CA H1047L stomach cancer predicted - resistant HER2 (ERBB2) Antibody Trastuzumab Clinical Study - Cohort Actionable In a clinical study (AMNESIA-1), assessment of pre-treatment tumor samples from ERBB2 (HER2)-positive gastric or gastroesophageal cancer patients (defined as HER2 IHC 3+ or HER2 IHC 2+/ISH+) identified PIK3CA mutations in 15% (3/20) of patients demonstrating primary resistance to Herceptin (trastuzumab), including 1 patient harboring PIK3CA H1047L (PMID: 29208673). 29208673
ERBB2 over exp PIK3CA act mut Her2-receptor positive breast cancer decreased response HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). 30720867
ERBB2 over exp PIK3CA E542X Her2-receptor positive breast cancer decreased response HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). 30720867
ERBB2 over exp PIK3CA E545X Her2-receptor positive breast cancer decreased response HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). 30720867
ERBB2 over exp PIK3CA H1047X Her2-receptor positive breast cancer decreased response HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, the presence of PIK3CA activating mutations including E542X, E545X, and H1047X correlated with shorter progression-free survival (2.66 months) compared to PIK3CA wild-type or other mutations (4.24 month, HR=1.68, p=0.033) in patients with metastatic Erbb2 (Her2)-positive (amplification or overexpression) breast cancer treated with Poziotinib (HM781-36B) (PMID: 30720867, NCT02418689). 30720867
ERBB2 amp ERBB2 over exp ERBB2 rearrange lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, a non-small cell lung cancer patient with ERBB2 overexpression (IHC 3+), ERBB2 amplification, and an ERBB2 rearrangement demonstrated a partial response when treated with Kadcyla (ado-trastuzumab emtansine), with a duration of response of 10.8 months, a progression-free survival of 12.2 months, and an overall survival of 12.9 months (PMID: 30206164; NCT02289833). 30206164
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S were resistant to Tukysa (tucatinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor predicted - sensitive Luminespib Preclinical - Cell culture Actionable In a preclinical study, Luminespib (AUY922) inhibited growth of transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells co-expressing ERBB2 (HER2) C805S and ERBB2 (HER2) Y772_A775dup (also referred to as A775_G776insYVMA) demonstrated resistance to Vizimpro (dacomitinib) in culture (PMID: 28363995). 28363995
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, ERBB2 (HER2) C805S was identified as a secondary mutation in transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) that acquired resistance to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells co-expressing ERBB2 (HER2) Y772_A775dup (also referred to as A775_G776insYVMA) and ERBB2 (HER2) C805S demonstrated resistance to Nerlynx (neratinib) in culture (PMID: 28363995). 28363995
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells co-expressing ERBB2 (HER2) Y772_A775dup (also referred to as A775_G776insYVMA) and ERBB2 (HER2) C805S demonstrated resistance to Gilotrif (afatinib) in culture (PMID: 28363995). 28363995
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor predicted - sensitive Ganetespib Preclinical - Cell culture Actionable In a preclinical study, Ganetespib inhibited growth of transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S were resistant to Tykerb (lapatinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant AZ5104 Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S were resistant to AZ5104 in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S were resistant to Tarceva (erlotinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S were resistant to Tagrisso (osimertinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup ERBB2 C805S Advanced Solid Tumor resistant HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) and an acquired ERBB2 (HER2) C805S were resistant to Pyrotinib in culture (PMID: 30527195). 30527195
ERBB2 M774delinsWLV ERBB2 C805S Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells co-expressing ERBB2 (HER2) M774delinsWLV and ERBB2 (HER2) C805S demonstrated resistance to Gilotrif (afatinib) in culture (PMID: 28363995). 28363995
ERBB2 M774delinsWLV ERBB2 C805S Advanced Solid Tumor resistant HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells co-expressing ERBB2 (HER2) M774delinsWLV and ERBB2 (HER2) C805S demonstrated resistance to Nerlynx (neratinib) in culture (PMID: 28363995). 28363995
ERBB2 M774delinsWLV ERBB2 C805S Advanced Solid Tumor resistant HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, acquisition of ERBB2 (HER2) C805S in transformed cells expressing ERBB2 (HER2) M774delinsWLV conferred resistance to Vizimpro (dacomitinib) in culture (PMID: 28363995). 28363995
ERBB2 Q709L Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L demonstrated decreased cell proliferation and reduced survival when treated with Herceptin (trastuzumab) in culture (PMID: 30449325). 30449325
ERBB2 Q709L Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L demonstrated decreased cell proliferation and reduced survival when treated with Tykerb (lapatinib) in culture (PMID: 30449325). 30449325
ERBB2 Q709L Advanced Solid Tumor predicted - sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). 30449325
ERBB2 Q709L Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L demonstrated decreased cell proliferation and reduced survival when treated with Perjeta (pertuzumab) in culture (PMID: 30449325). 30449325
ERBB2 Q709L Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 Q709L Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 Q709L Advanced Solid Tumor predicted - resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Q709L demonstrated resistance to treatment with Erbitux (cetuximab) in culture (PMID: 30449325). 30449325
ERBB2 G776delinsIC lung non-small cell carcinoma no benefit HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, a patient with non-small cell lung cancer harboring ERBB2 G776delinsIC did not respond to treatment with Pyrotinib and developed progressive disease (PMID: 30596880; NCT02535507). 30596880
ERBB2 G778_S779insLPS Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_S779insLPS in culture (PMID: 31588020). 31588020
ERBB2 G778_S779insLPS Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_S779insLPS in culture (PMID: 31588020). 31588020
ERBB2 G778_S779insLPS Advanced Solid Tumor sensitive HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited survival of transformed cells expressing ERBB2 (HER2) G778_S779insLPS in culture (PMID: 31588020). 31588020
ERBB2 G778_S779insLPS Advanced Solid Tumor sensitive HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_S779insLPS in culture (PMID: 31588020). 31588020
ERBB2 G778_S779insLPS Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_S779insLPS were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 G778_S779insLPS Advanced Solid Tumor sensitive HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_S779insLPS in culture (PMID: 31588020). 31588020
ERBB2 G778_S779insLPS Advanced Solid Tumor sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_S779insLPS in culture (PMID: 31588020). 31588020
ERBB2 G778_S779insLPS Advanced Solid Tumor resistant Nazartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_S779insLPS were resistant to Nazartinib (EGF816) in culture (PMID: 31588020). 31588020
ERBB2 G778_S779insLPS Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_S779insLPS were resistant to Tagrisso (osimertinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_S779insLPS Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_S779insLPS were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 mutant lung squamous cell carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Phase III Actionable In a Phase III trial (LUX-Lung 8), secondary analysis demonstrated favorable outcomes with Gilotrif (afatinib) treatment compared to Tarceva (erlotinib) in lung squamous cell carcinoma patients with ERBB (HER) family mutations, and ERBB2 (HER2) mutations predicted an OS (HR=0.06, p=0.02) and PFS (HR=0.06, p=0.02) benefit for Gilotrif (afatinib) over Tarceva (erlotinib) treatment (PMID: 29902295; NCT01523587). 29902295
ERBB2 mutant ovarian cancer no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, no clinical benefit, and a median progression-free survival of 2.1 months in patients with ovarian cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant Her2-receptor negative breast cancer sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an object response rate of 24% (6/25), a clinical benefit rate of 40% (10/25), and a median progression-free survival of 3.5 months in patients with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant lung non-small cell carcinoma no benefit HER inhibitor (Pan) Afatinib Guideline Actionable Gilotrif (afatinib) is not recommended as a monotherapy in guidelines for non-small cell lung cancer patients with ERBB2 mutations (NCCN.org). detail...
ERBB2 mutant cervical cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate of 20% (1/5), a clinical benefit rate of 60% (3/5), and a median progression-free survival of 20.1 months in patients with cervical cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant lung non-small cell carcinoma sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate of 3.8% (1/26), a clinical benefit rate of 42.3% (11/26), and a median progression-free survival of 5.5 months in patients with non-small cell lung cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant lung non-small cell carcinoma sensitive HER2 Inhibitor Neratinib Phase I Actionable In a Phase I study, Nerlynx (neratinib) administered with temsirolimus was tolerable and demonstrated antitumor activity in ERBB2-mutant non-small-cell lung cancer (PMID: 24323026). 24323026
ERBB2 mutant lung non-small cell carcinoma sensitive HER2 Inhibitor AV-412 Preclinical Actionable In a preclinical study, non-small cell lung cancer cells harboring an ERBB2 (HER2) mutation demonstrated sensitivity to AV-412, resulting in decreased phosphorylation of Erbb2, Akt, and Erk (PMID: 19459856). 19459856
ERBB2 mutant endometrial cancer no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 28.6% (2/7), and a median progression-free survival of 2.6 months in patients with endometrial cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant colorectal cancer no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 8.3% (1/12), and a median progression-free survival of 1.8 months in patients with colorectal cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant invasive bladder transitional cell carcinoma predicted - sensitive Cisplatin + Gemcitabine + Sorafenib Phase II Actionable In a Phase II trial, ERBB2 (HER2) mutations were only detected in patients with muscle-invasive urothelial bladder cancer that responded to Nexavar (sorafenib), Platinol (cisplatin) and Gemzar (gemcitabine) combination therapy (J Clin Oncol 35, 2017 (suppl 6S; abstract 345)). detail...
ERBB2 mutant lung cancer sensitive HER2 Inhibitor Neratinib Phase I Actionable In a Phase I clinical trial, Nerlynx (neratinib) administered with Torisel (temsirolimus) was tolerable and demonstrated antitumor activity in ERBB2 (HER2)-mutant non-small-cell lung cancer (PMID: 24323026). 24323026
ERBB2 mutant biliary tract cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate at 8 weeks of 22.2% (2/9), a clinical benefit rate of 33.3% (3/9), and a median progression-free survival of 2.8 months in patients with biliary tract cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant gastroesophageal junction adenocarcinoma no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 20% (1/5), and a median progression-free survival of 1.7 months in patients with gastroesophageal cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mutant Her2-receptor positive breast cancer sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial, Nerlynx (neratinib) treatment resulted in complete response in 12.5% (3/24) and partial response in 20.8% (5/24) of ERBB2 (HER2) mutant but not amplified breast cancer patients (Cancer Res 2017;77(4 Suppl):Abstract nr PD2-08). detail...
ERBB2 mutant lung non-small cell carcinoma sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Guideline Actionable Kadcyla (trastuzumab emtansine) is included in guidelines for non-small cell lung cancer patients with ERBB2 (HER2) mutations (NCCN.org). detail...
ERBB2 mutant lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab + Vinorelbine Case Reports/Case Series Actionable In a clinical study, treatment with Herceptin (trastuzumab) in combination with chemotherapy resulted in an objective response rate of 67% (4/6) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies (PMID: 28167203). 28167203
ERBB2 mutant lung non-small cell carcinoma no benefit HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable Herceptin (trastuzumab) is not recommended as a monotherapy in guidelines for non-small cell lung cancer patients with ERBB2 mutations (NCCN.org). detail...
ERBB2 mutant lung non-small cell carcinoma sensitive HER2 Inhibitor Pyrotinib Phase II Actionable In a Phase II trial, Pyrotinib treatment in non-small cell lung cancer patients harboring an ERBB2 (HER2) mutation resulted in a partial response in 54.5% (6/11) of patients and stable disease in 27.3% (3/11) of patients, and a PFS of 6.2 months (Journal of Thoracic Oncology, Vol. 12, Issue 1, S359). detail...
ERBB2 mutant lung adenocarcinoma sensitive HER inhibitor (Pan) Afatinib Phase II Actionable In a Phase II trial, treatment with Gilotrif (afatinib) resulted in objective response in 3 lung adenocarcinoma patients harboring ERBB2 (HER2) mutations (PMID: 22325357). 22325357
ERBB2 mutant breast cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial, Nerlynx (neratinib) demonstrated activity in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, with treatment resulting in a clinical benefit rate of 31% (5/16; 1 complete response, 1 partial response, and 3 patients achieving stable disease for 24 weeks or more) and a median progression-free survival of 16 weeks (PMID: 28679771). 28679771
ERBB2 mutant urinary bladder cancer no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 18.8% (3/16), and a median progression-free survival of 1.8 months in patients with bladder cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 mut PIK3CA mut breast cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), 6 of 7 patients with ERBB2 (HER2)-mutant breast cancer who progressed on Nerlynx (neratinib) harbored either a PIK3CA (n=5) or PIK3R1 (n=1) mutation (PMID: 31978326). 31978326
ERBB2 L755A lung non-small cell carcinoma no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.6 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) L755A (PMID: 29420467; NCT01953926). 29420467
ERBB2 G776_V777insYVMA Advanced Solid Tumor sensitive HER inhibitor (Pan) Canertinib Preclinical Actionable In a preclinical study, Canertinib inhibited Erbb2 (Her2) phosphorylation and cell growth in transformed human cell lines expressing ERBB2 (HER2) G776_V777insYVMA (PMID: 16843263). 16843263
ERBB2 D277G ERBB2 S310F urinary bladder cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with bladder cancer harboring both ERBB2 (HER2) D277G and S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 V839G Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) V839G in culture (PMID: 18413839). 18413839
ERBB2 V773A Advanced Solid Tumor decreased response HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, higher dose of Tykerb (lapatinib) inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) V773A in culture (PMID: 22046346). 22046346
ERBB2 V773A Advanced Solid Tumor sensitive HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, AEE788 inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) V773A in culture (PMID: 22046346). 22046346
ERBB2 negative Her2-receptor negative breast cancer predicted - sensitive Exemestane + Seribantumab Phase II Actionable In a Phase II trial, Seribantumab (MM-12) and Aromasin (exemestane) combination treatment resulted in a 74% decrease in risk of progression (HR 0.26) and a a 59% decrease in risk of death (HR 0.436) compared to exemestane alone in ERBB2-negative, hormone receptor positive breast cancer patients (AACR Precision Medicine Series: Targeting the Vulnerabilities of Cancer, May 2016, Abstract # A14). detail...
ERBB2 negative Her2-receptor negative breast cancer no benefit Docetaxel + Ramucirumab Phase III Actionable In a Phase III trial, Cyramze (ramucirumab) in combination with Taxotere (docetaxel) did not improve clinical outcomes in ERBB2 (HER2)-negative breast cancer patients (PMID: 25185099). 25185099
ERBB2 negative Her2-receptor negative breast cancer predicted - sensitive Sorafenib + Vinorelbine Phase Ib/II Actionable In a Phase I/II trial, combination of Navelbine (vinorelbine) and Nexavar (sorafenib) resulted in a response rate of 30% (8/27), median progression free survival of 5.7 months, and a clinical benefit rate (absence of disease progression at 6 months) of 48% (13/27) in patients with ERBB2 (HER2)-negative metastatic breast cancer (PMID: 27992451). 27992451
ERBB2 neg ERBB2 pos Her2-receptor negative breast cancer sensitive LY411575 + Paclitaxel Preclinical Actionable In a preclinical study, circulating tumor cells (CTC) from patients with ERBB2 (HER2)-negative breast cancer were demonstrated to contain both ERBB2 (HER2)-positive and ERBB2 (HER2)-negative subpopulations, and the combination of LY411575 and Taxol (paclitaxel) resulted in increased tumor growth inhibition in CTC-derived xenograft models compared to either agent alone (PMID: 27556950). 27556950
ERBB2 neg ERBB2 pos Her2-receptor negative breast cancer sensitive Paclitaxel + RO4929097 Preclinical Actionable In a preclinical study, circulating tumor cells (CTC) from patients with ERBB2 (HER2)-negative breast cancer were demonstrated to contain both ERBB2 (HER2)-positive and ERBB2 (HER2)-negative subpopulations, and the combination of RO4929097 and Taxol (paclitaxel) resulted in increased tumor growth inhibition in CTC-derived xenograft models compared to either agent alone (PMID: 27556950). 27556950
ERBB2 T798M breast cancer sensitive HER2 (ERBB2) Antibody Cetuximab + Lapatinib Preclinical - Cell line xenograft Actionable In preclinical studies, the combination of Erbitux (cetuximab) and Tykerb (lapatinib) inhibited cell growth of a human breast cancer cell line harboring ERBB2 T798M and synergized to inhibit tumor growth in xenograft models (PMID: 23948973). 23948973
ERBB2 T798M Advanced Solid Tumor sensitive WZ4002 Preclinical Actionable In a preclinical study, WZ4002 inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) T798M in culture (PMID: 22046346). 22046346
ERBB2 T798M breast cancer resistant Cetuximab Preclinical Actionable In a preclinical study, breast cancer cells expressing the ERBB2 (HER2) T798M mutant were resistant to Erbitux (cetuximab)(PMID: 23948973). 23948973
ERBB2 T798M breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, human breast cancer cell lines and cell line xenografts expressing ERBB2 T798M demonstrated sensitivity to the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) (PMID: 23948973). 23948973
ERBB2 T798M Her2-receptor positive breast cancer resistant HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, ERBB2 (HER2)-receptor positive breast cancer cells expressing ERBB2 (HER2) T798M were resistant to Tykerb (lapatinib) in both culture and xenograft models (PMID: 23948973). 23948973
ERBB2 T798M breast cancer sensitive XL147 Preclinical Actionable In a preclinical study, breast cancer cell lines expressing ERBB2 (HER2) T798M demonstrated sensitivity to XL147 (SAR245408) in cell culture (PMID: 23948973). 23948973
ERBB2 T798M breast cancer sensitive Buparlisib Preclinical Actionable In a preclinical study, human breast cancer cells expressing the ERBB2 (HER2) T798M mutation demonstrated sensitivity to BKM120 (PMID: 23948973). 23948973
ERBB2 T798M breast cancer resistant CI-1040 Preclinical Actionable In a preclinical study, breast cancer cells expressing ERBB2 T798M demonstrated resistance to CI-1040 (PMID: 23948973). 23948973
ERBB2 T798M breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab + XL147 Preclinical Actionable In a preclinical study, breast cancer cells expressing ERBB2 (HER2) T798M were sensitive to the combination of Herceptin (trastuzumab) and XL147 (PMID: 23948973). 23948973
ERBB2 T798M Advanced Solid Tumor sensitive EKI-785 Preclinical Actionable In a preclinical study, EKI-285 (CL-387785) inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) T798M in culture (PMID: 22046346). 22046346
ERBB2 T798M Advanced Solid Tumor resistant HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, transformed cell lines expressing ERBB2 (HER2) T798M demonstrated resistance when treated with AEE788 in culture (PMID: 22046346). 22046346
ERBB2 T798M Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cell lines expressing ERBB2 (HER2) T798M demonstrated resistance when treated with Tykerb (lapatinib) in culture (PMID: 22046346). 22046346
ERBB2 T798M breast cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, breast cancer cells expressing ERBB2(HER2) T798M were sensitive to Gilotrif (afatinib) (PMID: 23948973). 23948973
ERBB2 T798M ERBB2 amp breast cancer resistant HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, a human ERBB2-amplified breast cancer cell line expressing ERBB2 (HER2) T798M was resistant to Herceptin (trastuzumab) in culture and in xenograft models (PMID: 23948973). 23948973
ERBB2 V777L Advanced Solid Tumor sensitive HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). 31588020
ERBB2 V777L Advanced Solid Tumor sensitive Nazartinib Preclinical - Cell culture Actionable In a preclinical study, Nazartinib (EGF816) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). 31588020
ERBB2 V777L breast cancer predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab + Vinorelbine Case Reports/Case Series Actionable In a clinical case study, the combination of Navelbine (vinorelbine) and Herceptin (trastuzumab) resulted in a partial response with tumor regression in a breast cancer patient harboring ERBB2 (HER2) V777L (PMID: 31118664). 31118664
ERBB2 V777L breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) V777L demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 V777L colorectal cancer resistant Panitumumab Preclinical Actionable In a preclinical study, colorectal cancer cells over expressing ERBB2 (HER2) V777L were resistant to Vectibix (panitumumab) in culture (PMID: 26243863). 26243863
ERBB2 V777L Advanced Solid Tumor conflicting HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, Tykerb (lapatinib) inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) V777L in culture (PMID: 22046346). 22046346
ERBB2 V777L Advanced Solid Tumor conflicting HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V777L were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 V777L biliary tract cancer conflicting HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 3.6 months in one patient, and progressive disease with a progression-free survival of 0.8 months in another patient with biliary tract cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L colorectal cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) V777L in culture (PMID: 26243863). 26243863
ERBB2 V777L urinary bladder cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 6.9 months in a patients with bladder cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L colon cancer resistant HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, transformed mouse colon epithelial cells over expressing ERBB2 (HER2) V777L were resistant to Herceptin (trastuzumab) in culture (PMID: 26243863). 26243863
ERBB2 V777L Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response in one patient, and progressive disease in 4 patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L Advanced Solid Tumor sensitive HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). 31588020
ERBB2 V777L colorectal cancer conflicting HER2 Inhibitor Neratinib Preclinical - Cell line xenograft Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) V777L in culture and suppressed tumor growth in cell line xenograft models (PMID: 26243863). 26243863
ERBB2 V777L colorectal cancer conflicting HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.4 months in a patient with colorectal cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L gastroesophageal junction adenocarcinoma predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.1 months in a patient with gastroesophageal cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a retrospective study, Gilotrif (afatinib) treatment resulted in a partial response in a patient with lung adenocarcinoma harboring ERBB2 (HER2) V777L (PMID: 32162827). 32162827
ERBB2 V777L colon cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) V777L in culture (PMID: 26243863). 26243863
ERBB2 V777L breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 V777L demonstrated growth inhibition when treated with Tykerb (lapatinib) (PMID: 23220880). 23220880
ERBB2 V777L endometrial cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 6.9 months in a patient with endometrial cancer harboring ERBB2 (HER2) V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, a non-small cell lung cancer patient harboring ERBB2 (HER2) V777L who had received prior platinum-based chemotherapy demonstrated a partial response when treated with Pyrotinib (PMID: 32614698; NCT02834936). 32614698
ERBB2 V777L Advanced Solid Tumor sensitive HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). 31588020
ERBB2 V777L colorectal cancer sensitive HER2 (ERBB2) Antibody HER2 Inhibitor Neratinib + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, Herceptin (trastuzumab) and Nerlynx (neratinib) combination treatment inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) V777L in culture and suppressed tumor growth in cell line xenograft models (PMID: 26243863). 26243863
ERBB2 V777L Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). 31588020
ERBB2 V777L Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V777L were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 V777L Advanced Solid Tumor sensitive HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, transformed cell lines expressing ERBB2 (HER2) V777L demonstrated growth inhibition when treated with AEE788 in culture (PMID: 22046346). 22046346
ERBB2 V777L Advanced Solid Tumor sensitive Osimertinib Preclinical - Cell culture Actionable In a preclinical study, Tagrisso (osimertinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). 31588020
ERBB2 V777L colorectal cancer resistant Cetuximab Preclinical - Pdx Actionable In a preclinical study, human colorectal cancer cells over expressing ERBB2 (HER2) V777L were resistant to Erbitux (cetuximab) in culture and in patient-derived xenograft models (PMID: 26243863). 26243863
ERBB2 V777L Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). 31588020
ERBB2 V777L breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 V777L reverted to normal morphology in culture upon Herceptin (trastuzumab) treatment (PMID: 23220880). 23220880
ERBB2 V777L Advanced Solid Tumor sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) V777L in culture (PMID: 31588020). 31588020
ERBB2 L755S ERBB2 V777L ERBB2 R1153* urinary bladder cancer no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with bladder cancer harboring ERBB2 (HER2) L755S, R1153*, and V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L ERBB2 V842I colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.8 months in a patient with colorectal cancer harboring ERBB2 (HER2) V777L and V842I (PMID: 29420467; NCT01953926). 29420467
ERBB2 V777L ERBB2 amp Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including partial response in a patient harboring ERBB2 (HER2) V777L (PMID: 30301790). 30301790
ERBB2 V777L PIK3CA H1047R breast cancer resistant HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, a breast cancer cell line harboring ERBB2 (HER2) V777L and PIK3CA H1047R demonstrated resistance to Nerlynx (neratinib) in culture (PMID: 31978326). 31978326
ERBB2 V777L PIK3CA H1047R breast cancer sensitive HER2 Inhibitor Everolimus + Neratinib Preclinical - Cell culture Actionable In a preclinical study, Afinitor (everolimus) and Nerlynx (neratinib) worked synergistically to inhibit viability of a breast cancer cell line harboring ERBB2 (HER2) V777L and PIK3CA H1047R in culture (PMID: 31978326). 31978326
ERBB2 H878Y Advanced Solid Tumor sensitive HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, transformed cell lines expressing ERBB2 (HER2) H878Y demonstrated growth inhibition when treated with AEE788 in culture (PMID: 22046346). 22046346
ERBB2 H878Y Advanced Solid Tumor sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, Tykerb (lapatinib) inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) H878Y in culture (PMID: 22046346). 22046346
ERBB2 D769H Advanced Solid Tumor sensitive HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 D769H Her2-receptor negative breast cancer no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.5 months in a patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) D769H (PMID: 29420467; NCT01953926). 29420467
ERBB2 D769H Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 D769H breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 D769H demonstrated growth inhibition when treated with Tykerb (lapatinib) (PMID: 23220880). 23220880
ERBB2 D769H Advanced Solid Tumor sensitive Nazartinib Preclinical - Cell culture Actionable In a preclinical study, Nazartinib (EGF816) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 D769H Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 D769H breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 D769H reverted to normal morphology in culture upon Herceptin (trastuzumab) treatment (PMID: 23220880). 23220880
ERBB2 D769H colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.9 months in a patient with colorectal cancer harboring ERBB2 (HER2) D769H (PMID: 29420467; NCT01953926). 29420467
ERBB2 D769H breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) D769H demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 D769H Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) D769H were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 D769H Advanced Solid Tumor sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 D769H Advanced Solid Tumor sensitive HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 D769H Advanced Solid Tumor sensitive HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 D769H Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) D769H were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 D769H Advanced Solid Tumor sensitive Osimertinib Preclinical - Cell culture Actionable In a preclinical study, Tagrisso (osimertinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 V604_E619del breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, Tykerb (lapatinib) inhibited Erbb2 signaling and viability of transformed breast epithelial cells expressing ERBB2 (HER2) V604_E619del in culture (PMID: 31135266). 31135266
ERBB2 V604_E619del breast cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited Erbb2 signaling and viability of transformed breast epithelial cells expressing ERBB2 (HER2) V604_E619del in culture (PMID: 31135266). 31135266
ERBB2 T733I Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) T733I in culture (PMID: 18413839). 18413839
ERBB2 T733I biliary tract cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.7 months in a patient with biliary tract cancer harboring ERBB2 (HER2) T733I (PMID: 29420467; NCT01953926). 29420467
ERBB2 T733I Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) T733I demonstrated resistance to treatment with Tykerb (lapatinib) (PMID: 18413839). 18413839
ERBB2 G776_V777insVGC lung non-small cell carcinoma predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 1 patient and progressive disease in 2 patients with non-small cell lung cancer harboring ERBB2 (HER2) G776_V777insVGC (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F gastroesophageal junction adenocarcinoma predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.9 months in a patient with gastroesophageal cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F colorectal cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) S310F in culture (PMID: 26243863). 26243863
ERBB2 S310F cervical cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response in 1 patient, stable disease in 1 patient, and progressive disease in 1 patient with cervical cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F gallbladder cancer predicted - sensitive HER2 (ERBB2) Antibody Capecitabine + Lapatinib Case Reports/Case Series Actionable In a clinical case study, Tykerb (lapatinib) in combination with Xeloda (capecitabine) resulted in rapid clinical improvement and decrease of tumor size after 2 cycles of treatment in a patient with metastatic gallbladder cancer harboring ERBB2 (HER2) S310F (PMID: 31558980). 31558980
ERBB2 S310F urinary bladder cancer no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 4 patients and progressive disease in 1 patient with bladder cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F endometrial cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 2.6 months in a patient with endometrial cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F breast cancer resistant HER2 (ERBB2) Antibody Pertuzumab Preclinical - Cell culture Actionable In a preclinical study, ligand-activated breast cancer cells expressing ERBB2 (HER2) S310F demonstrated resistance to treatment with Perjeta (pertuzumab) in culture compared to cells expressing wild-type ERBB2 (HER2) (PMID: 31920346). 31920346
ERBB2 S310F colon cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) S310F in culture (PMID: 26243863). 26243863
ERBB2 S310F salivary gland carcinoma predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Case Reports/Case Series Actionable In a Phase II (MyPathway) trial, Perjeta (pertuzumab) and Herceptin (trastuzumab) combination therapy resulted in stable disease in a patient with advanced salivary gland carcinoma harboring ERBB2 (HER2) S310F, with a progression-free survival of 11 months (PMID: 32067683; NCT02091141). 32067683
ERBB2 S310F urinary bladder cancer no benefit HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, a bladder cancer cell line harboring ERBB2 S310F did not demonstrate decreased viability when treated with Herception (trastuzumab) in culture (PMID: 31635022). 31635022
ERBB2 S310F Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in complete response with a progression-free survival of 14.6 months in one patient, and stable disease with a progression-free survival of 3.7 months in another patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F urinary bladder cancer sensitive Gefitinib Preclinical - Cell culture Actionable In a preclinical study, a bladder cancer cell line harboring ERBB2 S310F demonstrated decreased viability when treated with Iressa (gefitinib) in culture (PMID: 31635022). 31635022
ERBB2 S310F biliary tract cancer conflicting HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response in one and progressive disease in another patient with biliary tract cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F urinary bladder cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, Tykerb (lapatinib) inhibited foci formation of bladder cancer cells over expressing ERBB2 (HER2) S310F in culture (PMID: 24971884). 24971884
ERBB2 S310F lung non-small cell carcinoma predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.9 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F colon cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) S310F in culture (PMID: 26243863). 26243863
ERBB2 S310F colorectal cancer resistant Panitumumab Preclinical Actionable In a preclinical study, colorectal cancer cells over expressing ERBB2 (HER2) S310F were resistant to Vectibix (panitumumab) in culture (PMID: 26243863). 26243863
ERBB2 S310F Advanced Solid Tumor sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, Tykerb (lapatinib) inhibited proliferation of transformed cells expressing ERBB2 S310F in culture (PMID: 22908275). 22908275
ERBB2 S310F colorectal cancer conflicting HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with colorectal cancer harboring ERBB2 (HER2) S310F (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F colorectal cancer conflicting HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) S310F in culture (PMID: 26243863). 26243863
ERBB2 S310F urinary bladder cancer no benefit HER2 (ERBB2) Antibody Pertuzumab Preclinical - Cell culture Actionable In a preclinical study, a bladder cancer cell line harboring ERBB2 S310F did not demonstrate decreased viability when treated with Perjeta (pertuzumab) in culture (PMID: 31635022). 31635022
ERBB2 S310F urinary bladder cancer decreased response Selumetinib Preclinical Actionable In a preclinical study, bladder cancer cells over expressing ERBB2 (HER2) S310F demonstrated reduced sensitivity to Selumetinib (AZD6244) in culture (PMID: 24971884). 24971884
ERBB2 S310F breast cancer resistant HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, ligand-activated breast cancer cells expressing ERBB2 (HER2) S310F demonstrated resistance to treatment with Herceptin (trastuzumab) in culture (PMID: 31920346). 31920346
ERBB2 S310F urinary bladder cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited foci formation of bladder cancer cells over expressing ERBB2 (HER2) S310F in culture (PMID: 24971884). 24971884
ERBB2 S310F colorectal cancer resistant Cetuximab Preclinical Actionable In a preclinical study, colorectal cancer cells over expressing ERBB2 (HER2) S310F were resistant to Erbitux (cetuximab) in culture (PMID: 26243863). 26243863
ERBB2 S310F urinary bladder cancer sensitive Cetuximab Preclinical - Cell culture Actionable In a preclinical study, a bladder cancer cell line harboring ERBB2 S310F demonstrated decreased viability when treated with Erbitux (cetuximab) in culture (PMID: 31635022). 31635022
ERBB2 S310F Advanced Solid Tumor sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) decreased cell survival of transformed human cells expressing ERBB2 (HER2) S310F (PMID: 22908275). 22908275
ERBB2 D277H ERBB2 S310F urinary bladder cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited foci formation of bladder cancer cells over expressing both ERBB2 (HER2) D277H and S310F in culture (PMID: 24971884). 24971884
ERBB2 D277H ERBB2 S310F urinary bladder cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, Tykerb (lapatinib) inhibited foci formation of bladder cancer cells over expressing both ERBB2 (HER2) D277H and S310F in culture (PMID: 24971884). 24971884
ERBB2 D277H ERBB2 S310F urinary bladder cancer decreased response Selumetinib Preclinical Actionable In a preclinical study, bladder cancer cells over expressing both ERBB2 (HER2) D277H and S310F demonstrated reduced sensitivity to Selumetinib (AZD6244) in culture (PMID: 24971884). 24971884
ERBB2 S310F ERBB2 V842I breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial, Nerlynx (neratinib) treatment resulted in a clinical benefit rate of 31% (5/16) in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, with 1 patient harboring ERBB2 (HER2) S310F and V842R achieved stable disease over 6 months (PMID: 28679771; NCT01670877). 28679771
ERBB2 S310F ERBB2 V842I cervical cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), a heavily pretreated cervical cancer patient co-harboring ERBB2 (HER2) S310F and ERBB2 (HER2) V842I demonstrated a partial response when treated with Nerlynx (neratinib) (PMID: 32723675; NCT01953926). 32723675
ERBB2 S310F ERBB2 G660D ampulla of Vater carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical case study, Gilotrif (afatinib) treatment resulted in stable disease with slight lymph node metastasis reduction in a patient with ampulla of Vater carcinoma harboring ERBB2 S310F and G660D, but the disease eventually progressed after 4 months (PMID: 29146616). 29146616
ERBB2 S310F ERBB2 amp lung adenocarcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall responses of partial response in 44% (8/18) and stable disease in 39% (7/18), and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations; a patient harboring ERBB2 (HER2) S310F and ERBB2 (HER2) amplification had a partial response (PMID: 29989854; NCT02675829). 29989854
ERBB2 L313I ERBB2 amp Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including partial response in a patient harboring ERBB2 (HER2) L313I (PMID: 30301790). 30301790
ERBB2 R188C cancer no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R188C did not demonstrate sensitivity to growth inhibition by Iressa (gefitinib) in culture (PMID: 32366937). 32366937
ERBB2 R188C cancer sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of transformed cells expressing ERBB2 (HER2) R188C in culture (PMID: 32366937). 32366937
ERBB2 R188C cancer sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of transformed cells expressing ERBB2 (HER2) R188C in culture (PMID: 32366937). 32366937
ERBB2 R188C cancer no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R188C did not demonstrate sensitivity to growth inhibition by Tarceva (erlotinib) in culture (PMID: 32366937). 32366937
ERBB2 R188C cancer sensitive HER inhibitor (Pan) Canertinib Preclinical - Cell culture Actionable In a preclinical study, Canertinib (CI-1033) inhibited growth of transformed cells expressing ERBB2 (HER2) R188C in culture (PMID: 32366937). 32366937
ERBB2 R188C cancer sensitive HER2 Inhibitor Pelitinib Preclinical - Cell culture Actionable In a preclinical study, Pelitinib inhibited growth of transformed cells expressing ERBB2 (HER2) R188C in culture (PMID: 32366937). 32366937
ERBB2 R188C cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) R188C in culture (PMID: 32366937). 32366937
ERBB2 Y772_A775dup Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in complete response in one patient, and stable disease in 2 patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) Y772_A775dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 Y772_A775dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Case Reports/Case Series Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in one partial response, stable disease in one patient, and progressive disease in three patients with lung adenocarcinoma harboring ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) (PMID: 30149884; NCT02979821). 30149884
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) demonstrated decreased response to Gilotrif (afatinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup urinary bladder cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patients with bladder cancer harboring ERBB2 (HER2) Y722_A775dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 Y772_A775dup lung non-small cell carcinoma no benefit Erlotinib Clinical Study Actionable In a retrospective analysis, Tarceva (erlotinib) treatment resulted in an objective response rate of 0% (0/1) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (reported as (A775_G776insYVMA) (PMID: 30527195). 30527195
ERBB2 Y772_A775dup lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) Y772_A775dup (also referred to as A775_G776insYVMA) did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 Y772_A775dup lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Clinical Study Actionable In a retrospective analysis, Poziotinib (HM781-36B) treatment resulted in an objective response rate of 33% (1/3) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (reported as (A775_G776insYVMA) (PMID: 30527195). 30527195
ERBB2 Y772_A775dup lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a confirmed objective response rate of 42% (5/12) in patients with non-small cell lung cancer harboring ERBB2 (HER2) Y772_A775dup (n=9) or ERBB2 (HER2) G778_P780dup (n=3), with a median progression-free survival of 5.6 months (PMID: 31588020; NCT03066206). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) were resistant to Tukysa (tucatinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Tarloxotinib (TRLX) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Phase II Actionable In a Phase II trial, Pyrotinib treatment resulted in an objective response rate of 27.3% (12/44) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (also reported as A775_G776insYVMA or M774_A775insAYVM) who had received prior platinum-based chemotherapy (PMID: 32614698; NCT02834936). 32614698
ERBB2 Y772_A775dup lung adenocarcinoma no benefit HER inhibitor (Pan) Afatinib Clinical Study - Cohort Actionable In a retrospective study, Gilotrif (afatinib) treatment resulted in an objective response rate (ORR) of 15.6% (5/32) and a disease control rate of 68.8% (22/32) in patients with lung adenocarcinoma harboring ERBB2 (HER2) mutations, ORR (0%, 0/14), DCR (35.7%, 5/14), and median progression-free survival (1.2 mo) were significantly lower in patients with Y772_A775dup than those with other exon 20 insertions (40%, 4/10; 100%, 10/10; 7.6 mo) or missense mutations (13%, 1/8; 75%, 6/8; 3.6 mo) (PMID: 32162827). 32162827
ERBB2 Y772_A775dup lung adenocarcinoma no benefit HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical study, a lung adenocarcinoma patient harboring ERBB2 Y772_A775dup (also referred to as A775_G776insYVMA and E740_A741insAYVM) achieved a partial response for 5 months following treatment with pulse Gilotrif (afatinib), however, a second patient harboring ERBB2 Y772_A775dup treated with pulse Gilotrif (afatinib) demonstrated progressive disease (PMID: 26964772). 26964772
ERBB2 Y772_A775dup lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Clinical Study Actionable In a retrospective analysis, Gilotrif (afatinib) treatment resulted in an objective response rate of 16% (5/31) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (reported as (A775_G776insYVMA) (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor resistant Nazartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Nazartinib (EGF816) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor resistant AZ5104 Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) were resistant to AZ5104 in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) Y772_A775dup in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited ERBB2 (HER2) phosphorylation and growth of a transformed cell line expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) in culture (PMID: 29686424). 29686424
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup lung non-small cell carcinoma no benefit HER inhibitor (Pan) Dacomitinib Clinical Study Actionable In a retrospective analysis, Vizimpro (dacomitinib) treatment resulted in an objective response rate of 0% (0/13) in non-small cell lung cancer patients harboring ERBB2 (HER2) Y772_A775dup (reported as (A775_G776insYVMA) (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) were resistant to Tykerb (lapatinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup lung non-small cell carcinoma sensitive HER inhibitor (Pan) HER2 (ERBB2) Antibody Ado-trastuzumab emtansine + Poziotinib Preclinical - Pdx Actionable In a preclinical study, Poziotinib (HM781-36B) and Kadcyla (ado-trastuzumab emtansine) combination treatment resulted in sustained tumor regression in patient-derived xenograft models of non-small cell lung cancer harboring ERBB2 (HER2) Y772_A775dup (PMID: 31588020). 31588020
ERBB2 Y772_A775dup lung cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) Y772_A775dup (also referred to as A775_G776insYVMA) in culture (PMID: 26545934). 26545934
ERBB2 Y772_A775dup Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Nerlynx (neratinib) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) Y772_A775dup (also referred to as ERBB2 A775_G776insYVMA) in culture (PMID: 28363995). 28363995
ERBB2 Y772_A775dup Advanced Solid Tumor resistant Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) were resistant to Tarceva (erlotinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor predicted - sensitive Ganetespib Preclinical - Cell culture Actionable In a preclinical study, Ganetespib inhibited growth of transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as reported as A775_G776insYVMA) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Tagrisso (osimertinib) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) were resistant to Tagrisso (osimertinib) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup breast cancer sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited viability of breast cancer cells expressing ERBB2 (HER2) Y772_A775dup in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor conflicting HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited growth of transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor conflicting HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y722_A755dup were resistant to Pyrotinib in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor predicted - sensitive Luminespib Preclinical - Cell culture Actionable In a preclinical study, Luminespib (AUY922) inhibited growth of transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as reported as A775_G776insYVMA) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Imbruvica (ibrutinib) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) demonstrated decreased response to Vizimpro (dacomitinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup Advanced Solid Tumor resistant HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) Y772_A775dup were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup lung non-small cell carcinoma no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 5 patients and progressive disease in 4 patients with non-small cell lung cancer harboring ERBB2 (HER2) Y772_A775dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 Y772_A775dup lung cancer sensitive HER inhibitor (Pan) Poziotinib Preclinical Actionable In a preclinical study, Poziotinib (HM781-36B) induced regression of lung tumors in mouse models harboring ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA), with no signs of progression at 12 weeks (PMID: 29686424). 29686424
ERBB2 Y772_A775dup breast cancer sensitive HER inhibitor (Pan) HER2 (ERBB2) Antibody Ado-trastuzumab emtansine + Poziotinib Preclinical - Cell culture Actionable In a preclinical study, addition of Poziotinib (HM781-36B) enhanced growth inhibition by Kadcyla (ado-trastuzumab emtansine) treatment in breast cancer cells expressing ERBB2 (HER2) Y772_A775dup in culture (PMID: 31588020). 31588020
ERBB2 Y772_A775dup ERBB2 amp Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including stable disease in a patient harboring ERBB2 (HER2) Y772_A775dup (PMID: 30301790). 30301790
ERBB2 D769N Advanced Solid Tumor sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). 31588020
ERBB2 D769N Advanced Solid Tumor sensitive Nazartinib Preclinical - Cell culture Actionable In a preclinical study, Nazartinib (EGF816) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). 31588020
ERBB2 D769N Advanced Solid Tumor sensitive Osimertinib Preclinical - Cell culture Actionable In a preclinical study, Tagrisso (osimertinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). 31588020
ERBB2 D769N Advanced Solid Tumor sensitive HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). 31588020
ERBB2 D769N Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). 31588020
ERBB2 D769N Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). 31588020
ERBB2 D769N Advanced Solid Tumor sensitive HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). 31588020
ERBB2 D769N Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) D769N were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 D769N Advanced Solid Tumor sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, Tykerb (lapatinib) inhibited growth of transformed cells expressing ERBB2 (HER2) D769H in culture (PMID: 31588020). 31588020
ERBB2 D769N Advanced Solid Tumor sensitive HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited survival of transformed cells expressing ERBB2 (HER2) D769N in culture (PMID: 31588020). 31588020
ERBB2 D769N cervical cancer no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 3.5 months in a patient with cervical cancer harboring ERBB2 (HER2) D769N (PMID: 29420467; NCT01953926). 29420467
ERBB2 E812K Advanced Solid Tumor decreased response HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cells over expressing ERBB2 (HER2) E812K demonstrated reduced sensitivity to Tykerb (lapatinib) in culture (PMID: 18413839). 18413839
ERBB2 E812K lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Case Reports/Case Series Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in stable disease in a patient with lung adenocarcinoma harboring ERBB2 (HER2) E812K (PMID: 30149884; NCT02979821). 30149884
ERBB2 E812K Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) E812K in culture (PMID: 18413839). 18413839
ERBB2 K753E breast cancer resistant HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) K753E were resistant to Herceptin (trastuzumab) in culture (PMID: 27697991). 27697991
ERBB2 K753E breast cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) K753 were sensitive to Nerlynx (neratinib) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
ERBB2 K753E breast cancer resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) K753E were resistant to Tykerb (lapatinib) in culture (PMID: 27697991). 27697991
ERBB2 wild-type Advanced Solid Tumor sensitive Osimertinib Preclinical Actionable In a preclinical study, Tagrisso (osimertinib) treatment resulted in antitumor efficacy in cells overexpressing wild-type ERBB2 (HER2), demonstrating inhibition of ERBB2 (HER2) phosphorylation and cell growth in culture and tumor regression in mouse models overexpressing wild-type ERBB2, with an 80% reduction in tumor volume (PMID: 29298799). 29298799
ERBB2 wild-type Advanced Solid Tumor sensitive HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, AEE788 inhibited proliferation of transformed cell lines expressing wild-type ERBB2 (HER2) in culture (PMID: 22046346). 22046346
ERBB2 wild-type Advanced Solid Tumor sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, Tykerb (lapatinib) inhibited proliferation of transformed cell lines expressing wild-type ERBB2 (HER2) in culture (PMID: 22046346). 22046346
ERBB2 L866M colorectal cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) L866M in culture (PMID: 26243863). 26243863
ERBB2 L866M colorectal cancer resistant Panitumumab Preclinical Actionable In a preclinical study, colorectal cancer cells over expressing ERBB2 (HER2) L866M were resistant to Vectibix (panitumumab) in culture (PMID: 26243863). 26243863
ERBB2 L866M colon cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) L866M in culture (PMID: 26243863). 26243863
ERBB2 L866M colon cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) L866M in culture (PMID: 26243863). 26243863
ERBB2 L866M colorectal cancer resistant Cetuximab Preclinical Actionable In a preclinical study, colorectal cancer cells over expressing ERBB2 (HER2) L866M were resistant to Erbitux (cetuximab) in culture (PMID: 26243863). 26243863
ERBB2 L866M colorectal cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) L866M in culture (PMID: 26243863). 26243863
ERBB2 L866M ERBB2 amp colorectal cancer resistant Cetuximab Preclinical Actionable In a preclinical study, xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) L866M and ERBB2 (HER2) amplification were resistant to Erbitux (cetuximab) (PMID: 26243863). 26243863
ERBB2 L866M ERBB2 amp colorectal cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) treatment resulted in stable tumor size in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) L866M and ERBB2 (HER2) amplification (PMID: 26243863). 26243863
ERBB2 L866M ERBB2 amp colorectal cancer resistant HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) had no effect on tumor growth in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) L866M and ERBB2 (HER2) amplification (PMID: 26243863). 26243863
ERBB2 L866M ERBB2 amp colorectal cancer sensitive HER2 (ERBB2) Antibody HER2 Inhibitor Neratinib + Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) and Nerlynx (neratinib) combination treatment resulted in sustained tumor regression in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) L866M and ERBB2 (HER2) amplification (PMID: 26243863). 26243863
ERBB2 V659E lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Capecitabine + Lapatinib Case Reports/Case Series Actionable In a clinical case study, treatment with the combination of Tykerb (lapatinib) and Xeloda (capecitabine) resulted in eight months of progression-free survival followed by disease progression in a non-small cell lung cancer patient harboring ERBB2 (HER2) V659E (PMID: 32478891). 32478891
ERBB2 V659E lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in two patients with non-small cell lung cancer harboring ERBB2 (HER2) V659E (PMID: 29420467; NCT01953926). 29420467
ERBB2 V659E Advanced Solid Tumor predicted - resistant HER2 (ERBB2) Antibody Pertuzumab Preclinical - Cell culture Actionable In a preclinical study, treatment with Perjeta (pertuzumab) led to induced growth of cells expressing ERBB2 (HER2) V659E in culture (PMID: 30449325). 30449325
ERBB2 V659E biliary tract cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 11.1 months in a patient with biliary tract cancer harboring ERBB2 (HER2) V659E (PMID: 29420467; NCT01953926). 29420467
ERBB2 V659E lung non-small cell carcinoma predicted - sensitive Icotinib Case Reports/Case Series Actionable In a clinical case study, a patient with non-small cell lung cancer harboring ERBB2 (HER2) V659E achieved six months of progression-free survival with Icotinib treatment, prior to disease progression (PMID: 32478891). 32478891
ERBB2 V659E Advanced Solid Tumor predicted - sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). 30449325
ERBB2 V659E Advanced Solid Tumor predicted - resistant Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 V659E Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E demonstrated decreased cell proliferation and reduced survival when treated with Herceptin (trastuzumab) in culture (PMID: 30449325). 30449325
ERBB2 V659E breast cancer sensitive 23814 + Tivozanib Preclinical Actionable In a preclinical study, the combination of 23814 and Tivozanib (AV-951) inhibited tumor growth in several transgenic mouse models of breast cancer expressing ERBB2 (HER2) V659E, including those with resistance to VEGFR inhibitors (PMID: 25995436). 25995436
ERBB2 V659E lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) V659E did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 V659E lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical case study, Gilotrif (afatinib) treatment resulted in eight months of progression-free survival followed by disease progression in a non-small cell lung cancer patient harboring ERBB2 (HER2) V659E previously treated with the combination of Tykerb (lapatinib) and Xeloda (capecitabine) (PMID: 32478891). 32478891
ERBB2 V659E Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E demonstrated decreased cell proliferation and reduced survival when treated with Tykerb (lapatinib) in culture (PMID: 30449325). 30449325
ERBB2 V659E lung non-small cell carcinoma no benefit Anlotinib Case Reports/Case Series Actionable In a clinical case study, Anlotinib (AL-3818) treatment resulted in disease progression after seven months in a non-small cell lung cancer patient harboring ERBB2 (HER2) V659E that progressed in response to multiple prior therapies (PMID: 32478891). 32478891
ERBB2 V659E lung cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) V659E in culture (PMID: 26545934). 26545934
ERBB2 V659E Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 V659E Advanced Solid Tumor predicted - resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E demonstrated resistance to treatment with Erbitux (cetuximab) in culture (PMID: 30449325). 30449325
ERBB2 V659E Advanced Solid Tumor predicted - sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) V659E demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 V659E lung adenocarcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall responses of partial response in 44% (8/18) and stable disease in 39% (7/18), and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations, and a subset of patients specifically harboring ERBB2 (HER2) V659E had a 50% (1/2) partial response rate (PMID: 29989854; NCT02675829). 29989854
ERBB2 V659E lung non-small cell carcinoma no benefit HER inhibitor (Pan) Afatinib + Rivoceranib Case Reports/Case Series Actionable In a clinical case study, Gilotrif (afatinib) and Apatinib (YN968D1) combination treatment resulted in disease progression within one month in a non-small cell lung cancer patient harboring ERBB2 (HER2) V659E that progressed in response to prior therapies (PMID: 32478891). 32478891
ERBB2 L785F Advanced Solid Tumor decreased response HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cells over expressing ERBB2 (HER2) L785F demonstrated reduced sensitivity to Tykerb (lapatinib) in culture (PMID: 18413839). 18413839
ERBB2 L785F Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) L785F in culture (PMID: 18413839). 18413839
ERBB2 G660R Advanced Solid Tumor predicted - resistant HER2 (ERBB2) Antibody Pertuzumab Preclinical - Cell culture Actionable In a preclinical study, treatment with Perjeta (pertuzumab) in transformed cells expressing ERBB2 (HER2) G660R was not effective in inhibiting cell proliferation and survival as compared to other activating ERBB2 (HER2) mutations in culture (PMID: 30449325). 30449325
ERBB2 G660R Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 G660R Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R demonstrated decreased cell proliferation and reduced survival when treated with Tykerb (lapatinib) in culture (PMID: 30449325). 30449325
ERBB2 G660R Advanced Solid Tumor predicted - resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R demonstrated resistance to treatment with Erbitux (cetuximab) in culture (PMID: 30449325). 30449325
ERBB2 G660R Advanced Solid Tumor predicted - sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 G660R Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R demonstrated decreased cell proliferation and reduced survival when treated with Herceptin (trastuzumab) in culture (PMID: 30449325). 30449325
ERBB2 G660R Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 G660R Advanced Solid Tumor predicted - sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660R demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). 30449325
ERBB2 G776C lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, a patient with non-small cell lung cancer harboring ERBB2 G776C demonstrated a partial response when treated with Pyrotinib (PMID: 30596880; NCT02535507). 30596880
ERBB2 R678Q colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.6 months in a patient with colorectal cancer harboring ERBB2 (HER2) R678Q (PMID: 29420467; NCT01953926). 29420467
ERBB2 R678Q breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 R678Q demonstrated growth inhibition when treated with Tykerb (lapatinib) (PMID: 23220880). 23220880
ERBB2 R678Q cervical cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), a heavily pretreated cervical cancer patient harboring ERBB2 (HER2) R678Q demonstrated stable disease when treated with Nerlynx (neratinib) (PMID: 32723675; NCT01953926). 32723675
ERBB2 R678Q Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q demonstrated decreased cell proliferation and reduced survival when treated with Tykerb (lapatinib) in culture (PMID: 30449325). 30449325
ERBB2 R678Q breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) R678Q demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 R678Q Advanced Solid Tumor predicted - resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q demonstrated resistance to treatment with Erbitux (cetuximab) in culture (PMID: 30449325). 30449325
ERBB2 R678Q Advanced Solid Tumor predicted - sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 R678Q Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 R678Q Advanced Solid Tumor predicted - sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). 30449325
ERBB2 R678Q Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q demonstrated decreased cell proliferation and reduced survival when treated with Herceptin (trastuzumab) in culture (PMID: 30449325). 30449325
ERBB2 R678Q endometrial cancer no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 5.5 months in a patient with endometrial cancer harboring ERBB2 (HER2) R678Q (PMID: 29420467; NCT01953926). 29420467
ERBB2 R678Q gastroesophageal junction adenocarcinoma predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with gastroesophageal cancer harboring ERBB2 (HER2) R678Q (PMID: 29420467; NCT01953926). 29420467
ERBB2 R678Q Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) R678Q did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 G776V cervical cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), a heavily pretreated cervical cancer patient harboring ERBB2 (HER2) G776V demonstrated stable disease when treated with Nerlynx (neratinib) (PMID: 32723675; NCT01953926). 32723675
ERBB2 G776V Advanced Solid Tumor sensitive HER2 Inhibitor AP32788 Preclinical - Cell culture Actionable In a preclinical study, AP32788 inhibited growth of transformed cell lines over expressing ERBB2 (HER2) G776V in culture (AACR, Cancer Res: April 2016; Volume 57, Abstract #2644). detail...
ERBB2 G776V PIK3CA H1047R ovarian cancer sensitive HER2 Inhibitor Everolimus + Neratinib Preclinical - Cell culture Actionable In a preclinical study, the addition of Afinitor (everolimus) to treatment with Nerlynx (neratinib) inhibited viability of an ovarian cancer cell line harboring ERBB2 (HER2) G776V and expressing PIK3CA H1047R in culture (PMID: 31978326). 31978326
ERBB2 G776V PIK3CA H1047R ovarian cancer resistant HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, expression of PIK3CA H1047R conferred resistance to Nerlynx (neratinib) in an ovarian cancer cell line harboring ERBB2 (HER2) G776V in culture (PMID: 31978326). 31978326
ERBB2 E719G Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) E719G in culture (PMID: 18413839). 18413839
ERBB2 E719G Advanced Solid Tumor decreased response HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cells over expressing ERBB2 (HER2) E719G demonstrated reduced sensitivity to Tykerb (lapatinib) in culture (PMID: 18413839). 18413839
ERBB2 exon 20 ins Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in complete response in 1, partial response in 1, and stable disease in 3 of the 5 patients with Erbb2 (Her2)-receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) exon 20 insertion mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Carboplatin + Paclitaxel + Trastuzumab Case Reports/Case Series Actionable In a clinical study, treatment with the combination of Herceptin (trastuzumab), Paraplatin (carboplatin), and Taxol (paclitaxel) in non-small cell lung cancer patients harboring an ERBB2 exon 20 insertion (n=2) resulted in a partial response in one patient and stable disease in the other patient (PMID: 23610105). 23610105
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab + Vinorelbine Case Reports/Case Series Actionable In a clinical study, treatment with the combination of Herceptin (trastuzumab) and Navelbine (vinorelbine) in non-small cell lung cancer patients harboring an ERBB2 exon 20 insertion (n=8) resulted in a partial response in 5 patients and stable disease in 2 patients (PMID: 23610105). 23610105
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical study, targeted therapy with Gilotrif (afatinib) or Herceptin (trastuzumab) resulted in an objective response rate of 44% (4/9) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies, all four responders harbored ERBB2 (HER2) exon 20 insertions (PMID: 28167203). 28167203
ERBB2 exon 20 ins lung non-small cell carcinoma no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 10 and progressive disease in 5 of the 15 patients with non-small cell lung cancer harboring ERBB2 (HER2) exon 20 insertion mutations (PMID: 29420467; NCT01953926). 29420467
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Clinical Study - Cohort Actionable In a clinical study, Poziotinib (HM781-36B) treatment resulted in an objective response rate (ORR) of 27.6% (8/29), a disease control rate of 69%, a median progression-free survival of 5.6 months, and an overall survival of 9.5 months in patients with advanced non-small cell lung cancer harboring EGFR or ERBB2 (HER2) exon 20 insertion mutations, ORR was 50% in patients harboring ERBB2 (HER2) mutations (Annals of Oncology (2020) 31 (suppl_4): S882). detail...
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial (ZENITH20-2), Poziotinib (HM781-36B) demonstrated a manageable safety profile, resulted in an objective response rate of 35.1% (26/74) in evaluable patients with advanced non-small cell lung cancer harboring ERBB2 (HER2) exon 20 insertion mutations, with a median duration of response of 5.1 months, a disease control rate of 70%, and a median progression-free survival of 5.5 months (Annals of Oncology (2020) 31 (suppl_4): S1188; NCT03318939). detail...
ERBB2 exon 20 ins Advanced Solid Tumor sensitive HER2 Inhibitor AP32788 Preclinical - Pdx & cell culture Actionable In a preclinical study, AP32788 inhibited growth of transformed cell lines over expressing ERBB2 (HER2) exon 20 insertions in culture, and induced tumor regression in PDX models (AACR, Cancer Res: April 2016; Volume 57, Abstract #2644). detail...
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab Case Reports/Case Series Actionable In a clinical study, Herceptin (trastuzumab) treatment in a non-small cell lung cancer patient harboring an ERBB2 exon 20 insertion resulted in a partial response (PMID: 23610105). 23610105
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab Case Reports/Case Series Actionable In a clinical study, targeted therapy with Gilotrif (afatinib) or Herceptin (trastuzumab) resulted in an objective response rate of 44% (4/9) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies, all four responders harbored ERBB2 (HER2) exon 20 insertions (PMID: 28167203). 28167203
ERBB2 exon 20 ins lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical study, treatment with pulse Gilotrif (afatinib) resulted in an objective response rate of 33.3% (1/3) in lung adenocarcinoma patients with ERBB2 (HER2) exon 20 insertion mutations (PMID: 26964772). 26964772
ERBB2 exon 20 ins lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Docetaxel + Trastuzumab Case Reports/Case Series Actionable In a clinical study, treatment with the combination of Herceptin (trastuzumab) and Taxotere (docetaxel) in a non-small cell lung cancer patient harboring an ERBB2 exon 20 insertion resulted in a partial response (PMID: 23610105). 23610105
ERBB2 exon 20 ins lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Dacomitinib Phase II Actionable In a Phase II trial, Vizimpro (dacomitinib) treatment resulted in an overall response rate of 25% (3/26) in patients with lung adenocarcinoma harboring ERBB2 (HER2) exon 20 mutations, including exon 20 insertions, indels, and missense mutations (23, 2, 1, respectively) (PMID: 25899785; NCT00818441). 25899785
ERBB2 L841V Her2-receptor negative breast cancer no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 2.8 months in a patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) L841V (PMID: 29420467; NCT01953926). 29420467
ERBB2 L841V colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.8 months in a patient with colorectal cancer harboring ERBB2 (HER2) L841V (PMID: 29420467; NCT01953926). 29420467
ERBB2 L1157R cancer no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L1157R did not demonstrate sensitivity to growth inhibition by Tarceva (erlotinib) in culture (PMID: 32366937). 32366937
ERBB2 L1157R cancer sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of transformed cells expressing ERBB2 (HER2) L1157R in culture (PMID: 32366937). 32366937
ERBB2 L1157R cancer no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L1157R did not demonstrate sensitivity to growth inhibition by Iressa (gefitinib) in culture (PMID: 32366937). 32366937
ERBB2 L1157R cancer sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of transformed cells expressing ERBB2 (HER2) L1157R in culture (PMID: 32366937). 32366937
ERBB2 L1157R cancer sensitive HER inhibitor (Pan) Canertinib Preclinical - Cell culture Actionable In a preclinical study, Canertinib (CI-1033) inhibited growth of transformed cells expressing ERBB2 (HER2) L1157R in culture (PMID: 32366937). 32366937
ERBB2 L1157R cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) L1157R in culture (PMID: 32366937). 32366937
ERBB2 L1157R cancer sensitive HER2 Inhibitor Pelitinib Preclinical - Cell culture Actionable In a preclinical study, Pelitinib inhibited growth of transformed cells expressing ERBB2 (HER2) L1157R in culture (PMID: 32366937). 32366937
ERBB2 M774delinsWLV lung adenocarcinoma sensitive HER inhibitor (Pan) Dacomitinib Case Reports/Case Series Actionable In a Phase II trial, a lung adenocarcinoma patient harboring ERBB2 (HER2) M774delinsWLV demonstrated a partial response to treatment with Vizimpro (dacomitinib) (PMID: 25899785; NCT00818441). 25899785
ERBB2 M774delinsWLV Advanced Solid Tumor sensitive HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited growth of transformed cells expressing ERBB2 (HER2) M774delinsWLV in culture (PMID: 28363995). 28363995
ERBB2 R456C ERBB2 amp Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a clinical study, Nerlynx (neratinib) treatment resulted in partial response in 2 of 6 and disease stabilization in 4 of 6 breast cancer patients with ERBB2 (HER2) amplification and an ERBB2 (HER2) mutation, including stable disease in a patient harboring ERBB2 (HER2) R456C (PMID: 30301790). 30301790
ERBB2 L663P Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 L663P Advanced Solid Tumor predicted - sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). 30449325
ERBB2 L663P Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P demonstrated decreased cell proliferation and reduced survival when treated with Perjeta (pertuzumab) in culture (PMID: 30449325). 30449325
ERBB2 L663P Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 L663P Advanced Solid Tumor predicted - sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 L663P Advanced Solid Tumor predicted - resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P demonstrated resistance to treatment with Erbitux (cetuximab) in culture (PMID: 30449325). 30449325
ERBB2 L663P Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P demonstrated decreased cell proliferation and reduced survival when treated with Tykerb (lapatinib) in culture (PMID: 30449325). 30449325
ERBB2 L663P Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L663P demonstrated decreased cell proliferation and reduced survival when treated with Herceptin (trastuzumab) in culture (PMID: 30449325). 30449325
ERBB2 dec exp breast cancer predicted - sensitive HER2 (ERBB2) Antibody MP0274 Preclinical - Pdx Actionable In a preclinical study, MP0274 induced apoptosis in breast cancer cells with low level Erbb2 (Her2) expression in culture and inhibited tumor growth in patient-derived xenograft (PDX) models (Cancer Res 2013;73(24 Suppl): Abstract nr P4-12-30). detail...
ERBB2 G776delinsVV Advanced Solid Tumor resistant HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Imbruvica (ibrutinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Tagrisso (osimertinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor resistant HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Nerlynx (neratinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor sensitive Nazartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Nazartinib (EGF816) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor resistant HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Pyrotinib in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsVV in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor resistant HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVV were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 G776delinsVV Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G776delinsVV in culture (PMID: 29686424). 29686424
ERBB2 G776delinsVV Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) G776delinsVV in culture (PMID: 31588020). 31588020
ERBB2 P780L Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) P780L in culture (PMID: 18413839). 18413839
ERBB2 P780L Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) P780L demonstrated resistance to treatment with Tykerb (lapatinib) (PMID: 18413839). 18413839
ERBB2 A775_G776insYVMA lung non-small cell carcinoma sensitive HER inhibitor (Pan) Afatinib Preclinical - Pdx & cell culture Actionable In a preclinical study, treatment with Gilotrif (afatinib) resulted in decreased cell viability of patient-derived non-small cell lung cancer organoids harboring ERBB2 A775_G776insYVMA and tumor growth inhibition and tumor regression in patient derived xenograft (PDX) models, but to a lesser degree than treatment with Pyrotinib (PMID: 30596880; NCT02535507). 30596880
ERBB2 A775_G776insYVMA Advanced Solid Tumor sensitive JQ1 + Osimertinib Preclinical Actionable In a preclinical study, transgenic mouse models expressing ERBB2 (HER2) A775_G776insYVMA demonstrated greater tumor regression when treated with the combination of JQ1 and Tagrisso (osimertinib) compared to treatment with either agent alone, which resulted in little to no regression (PMID: 29298799). 29298799
ERBB2 A775_G776insYVMA lung non-small cell carcinoma sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, Kadcyla (ado-trastuzumab emtansine) treatment demonstrated limited efficacy in patients with relapsed non-small cell lung cancer harboring ERBB2 (Her2) mutations, resulting in a partial response in 20% (1/5) and stable disease in 60% (3/5) of patients harboring ERBB2 (HER2) A775_G776insYVMA (PMID: 29313813). 29313813
ERBB2 A775_G776insYVMA lung non-small cell carcinoma sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Preclinical - Pdx Actionable In a preclinical study, treatment with Kadcyla (ado-trastuzumab emtansine) resulted in tumor growth inhibition and tumor regression of patient derived xenograft (PDX) models harboring ERBB2 A775_G776insYVMA, but to a lesser degree than treatment with Pyrotinib (PMID: 30596880; NCT02535507). 30596880
ERBB2 A775_G776insYVMA lung adenocarcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall responses of partial response in 44% (8/18) and stable disease in 39% (7/18), and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations, and a subset of patients specifically harboring ERBB2 (HER2) A775_G776insYVMA mutation had a 60% (3/5) partial response rate (PMID: 29989854; NCT02675829). 29989854
ERBB2 A775_G776insYVMA lung non-small cell carcinoma sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, ten patients with non-small cell lung cancer harboring ERBB2 A775_G776insYVMA demonstrated an objective response rate of 50% (5/10) and a progression-free survival of 4.1 months when treated with Pyrotinib, and preclinical analysis showed Pyrotinib treatment led to reduced cell viability in patient-derived organoids and tumor growth inhibition and regression in patient derived xenograft (PDX) models (PMID: 30596880; NCT02535507). 30596880
ERBB2 A775_G776insYVMA PIK3CA R425L lung non-small cell carcinoma predicted - resistant HER2 (ERBB2) Antibody Trastuzumab Case Reports/Case Series Actionable In a clinical study, the PIK3CA R425L mutation was identified as a potential resistance mechanism in a non-small cell lung carcinoma patient harboring ERBB2 (HER2) A775_G776insYVMA, that progressed during Herceptin (trastuzumab) treatment (PMID: 28167203). 28167203
ERBB2 D821N Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) D821N in culture (PMID: 18413839). 18413839
CDH1 R63* ERBB2 L869Q breast cancer predicted - sensitive HER2 (ERBB2) Antibody Capecitabine + Lapatinib Case Reports/Case Series Actionable In a clinical case study, treatment with the combination of Tykerb (lapatinib) and Xeloda (capecitabine) resulted in prolonged response and reduction in liver metastasis in a metastatic breast cancer patient harboring ERBB2 L869Q and CDH1 R63* mutations (PMID: 26487584). 26487584
ERBB2 T798I lung cancer resistant HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed lung cancer cells over expressing ERBB2 (HER2) T798I were resistant to Tykerb (lapatinib) in culture (PMID: 25238247). 25238247
ERBB2 T798I Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) T798I in culture (PMID: 18413839). 18413839
ERBB2 T798I Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cells over expressing ERBB2 (HER2) T798I were resistant to Tykerb (lapatinib) in culture (PMID: 25238247). 25238247
ERBB2 act mut Advanced Solid Tumor sensitive HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) activation loop mutations demonstrated sensitivity to AEE788 in culture (PMID: 22046346). 22046346
ERBB2 act mut lung non-small cell carcinoma predicted - resistant Osimertinib Case Reports/Case Series Actionable In a retrospective analysis, activating ERBB2 (HER2) mutations were identified in 3 of 100 patients with non-small cell lung cancer at treatment discontinuation of Tagrisso (osimertinib) (PMID: 31839416). 31839416
ERBB2 act mut Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 11% (4/36) of patients with advanced solid tumors harboring ERBB2 (HER2) activating mutations but not amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 act mut lung adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab deruxtecan Phase II Actionable In a Phase II trial (DESTINY-Lung01), Enhertu (trastuzumab deruxtecan) treatment resulted in an objective response rate of 61.9% (26/42) and a median progression free survival of 14 months in patients with metastatic non-small cell lung carcinoma harboring ERBB2 activating mutations (J Clin Oncol 38: 2020 (suppl; abstr 9504); NCT03505710). detail...
ERBB2 act mut breast cancer sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II clinical trial, Nerlynx (neratinib) treatment resulted in clinical benefit in 36% (5/14) of metastatic breast cancer patients harboring ERBB2 (HER2) activating mutations, with 1 complete response, 1 partial response, and 2 patients achieving stable disease for greater than 6 months, and a median progression-free survival of 5 months (J Clin Oncol 34, 2016 (suppl; abstr 516)). detail...
ERBB2 act mut lung non-small cell carcinoma decreased response Atezolizumab Clinical Study - Cohort Actionable In a clinical study, immunotherapies including Tecentriq (atezolizumab) (n=5), Opdivo (nivolumab) (n=17), Keytruda (pembrolizumab) (n=36), and Camrelizumab (SHR-1210) (n=20) resulted in significantly shorter median progression-free survival (51.0 vs 70.5 days, HR=2.47, p=0.0037) in non-small cell lung cancer patients harboring EGFR (n=7) or ERBB2 (HER2) (n=7) activating mutations compared to wild-type patients (PMID: 31085721). 31085721
ERBB2 act mut lung adenocarcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Phase II Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall response rates of 44% (8/18) and 39% (7/18) partial response and stable disease, respectively, and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations (PMID: 29989854; NCT02675829). 29989854
ERBB2 act mut cervical cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), heavily pretreated cervical cancer patients harboring an ERBB2 (HER2) mutation demonstrated an objective response rate of 25% (4/16), including 1 complete response and 3 partial responses, a median progression-free survival of 7.0 months, a median overall survival of 16.8 months, and a clinical benefit rate of 43.8% (7/16) when treated with Nerlynx (neratinib) (PMID: 32723675; NCT01953926). 32723675
ERBB2 act mut lung non-small cell carcinoma decreased response Nivolumab Clinical Study - Cohort Actionable In a clinical study, immunotherapies including Tecentriq (atezolizumab) (n=5), Opdivo (nivolumab) (n=17), Keytruda (pembrolizumab) (n=36), and Camrelizumab (SHR-1210) (n=20) resulted in significantly shorter median progression-free survival (51.0 vs 70.5 days, HR=2.47, p=0.0037) in non-small cell lung cancer patients harboring EGFR (n=7) or ERBB2 (HER2) (n=7) activating mutations compared to wild-type patients (PMID: 31085721). 31085721
ERBB2 act mut lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Phase II Actionable In a Phase II trial, Pyrotinib treatment resulted in an objective response rate of 30% (18/60), with 55% (33/60) demonstrating stable disease, median duration of response of 6.9 mo, and median progression-free survival of 6.9 mo, and median overall survival of 14.4 mo in non-small cell lung cancer patients harboring ERBB2 (HER2) activating mutations, including exon 20 insertions and mutations occurring at L755, G776, and V777, who had received prior platinum-based chemotherapy (PMID: 32614698; NCT02834936). 32614698
ERBB2 act mut biliary tract cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Case Reports/Case Series Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in an objective response in a patient with biliary cancer harboring an ERBB2 (HER2) activating mutation, but no amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 act mut estrogen-receptor positive breast cancer predicted - sensitive Vistusertib Phase I Actionable In a Phase I trial, Vistusertib (AZD2014) demonstrated safety and preliminary efficacy in patients with advanced solid tumors, including a patient with ER-positive breast cancer harboring an ERBB2 activating mutation (PMID: 25805799). 25805799
ERBB2 act mut lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in partial response in 21% (3/14) and stable disease lasting over 120 days in 21% (3/14) of patients with non-small cell lung cancer harboring ERBB2 (HER2) activating mutations but not amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 act mut lung non-small cell carcinoma decreased response Pembrolizumab Clinical Study - Cohort Actionable In a clinical study, immunotherapies including Tecentriq (atezolizumab) (n=5), Opdivo (nivolumab) (n=17), Keytruda (pembrolizumab) (n=36), and Camrelizumab (SHR-1210) (n=20) resulted in significantly shorter median progression-free survival (51.0 vs 70.5 days, HR=2.47, p=0.0037) in non-small cell lung cancer patients harboring EGFR (n=7) or ERBB2 (HER2) (n=7) activating mutations compared to wild-type patients (PMID: 31085721). 31085721
ERBB2 act mut lung non-small cell carcinoma decreased response Camrelizumab Clinical Study - Cohort Actionable In a clinical study, immunotherapies including Tecentriq (atezolizumab) (n=5), Opdivo (nivolumab) (n=17), Keytruda (pembrolizumab) (n=36), and Camrelizumab (SHR-1210) (n=20) resulted in significantly shorter median progression-free survival (51.0 vs 70.5 days, HR=2.47, p=0.0037) in non-small cell lung cancer patients harboring EGFR (n=7) or ERBB2 (HER2) (n=7) activating mutations compared to wild-type patients (PMID: 31085721). 31085721
ERBB2 act mut PIK3CA act mut breast cancer sensitive VS-5584 Preclinical Actionable In a preclinical study, breast cancer cells with mutations in both ERBB2 (HER2) and PIK3CA were more sensitive to VS-5584 (PMID: 23270925). 23270925
ERBB2 act mut STK11 loss breast cancer sensitive AZD8055 Preclinical Actionable In a preclinical study, AZD8055 inhibited tumor growth in a mouse model of spontaneous breast cancer harboring an ERBB2 (HER2) activating mutation and loss of STK11 (LKB1), which was enhanced by the addition of 2-DG (2-deoxyglucose) (PMID: 25436981). 25436981
ERBB2 G292R urinary bladder cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with bladder cancer harboring both ERBB2 (HER2) G292R (PMID: 29420467; NCT01953926). 29420467
ERBB2 S653C urinary bladder cancer decreased response Selumetinib Preclinical Actionable In a preclinical study, bladder cancer cells over expressing ERBB2 (HER2) S653C demonstrated reduced sensitivity to Selumetinib (AZD6244) in culture (PMID: 24971884). 24971884
ERBB2 S653C urinary bladder cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited foci formation of bladder cancer cells over expressing ERBB2 (HER2) S653C in culture (PMID: 24971884). 24971884
ERBB2 S653C urinary bladder cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, Tykerb (lapatinib) inhibited foci formation of bladder cancer cells over expressing ERBB2 (HER2) S653C in culture (PMID: 24971884). 24971884
ERBB2 L755_T759del breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, breast cancer cells expressing ERBB2 (HER2) L755_T759del were sensitive to treatment with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 L755_T759del breast cancer sensitive Gefitinib Preclinical Actionable In a preclinical study, breast cancer cells expressing ERBB2 (HER2) L755_T759del were sensitive to treatment with Iressa (gefitinib) (PMID: 23220880). 23220880
ERBB2 L755_T759del breast cancer resistant HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, breast cancer cells expressing ERBB2 (HER2) L755_T759del were resistant to treatment with Tykerb (lapatinib), resulting in decreased growth inhibition (PMID: 23220880). 23220880
ERBB2 S783P Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cells over expressing ERBB2 (HER2) S783P were resistant to Tykerb (lapatinib) in culture (PMID: 18413839). 18413839
ERBB2 S783P Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) S783P in culture (PMID: 18413839). 18413839
ERBB2 Y803N Advanced Solid Tumor decreased response HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cells over expressing ERBB2 (HER2) Y803N demonstrated reduced sensitivity to Tykerb (lapatinib) in culture (PMID: 18413839). 18413839
ERBB2 Y803N Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) Y803N in culture (PMID: 18413839). 18413839
ERBB2 P489L cancer sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of transformed cells expressing ERBB2 (HER2) P489L in culture (PMID: 32366937). 32366937
ERBB2 P489L cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) P489L in culture (PMID: 32366937). 32366937
ERBB2 P489L cancer sensitive HER inhibitor (Pan) Canertinib Preclinical - Cell culture Actionable In a preclinical study, Canertinib (CI-1033) inhibited growth of transformed cells expressing ERBB2 (HER2) P489L in culture (PMID: 32366937). 32366937
ERBB2 P489L cancer sensitive HER2 Inhibitor Pelitinib Preclinical - Cell culture Actionable In a preclinical study, Pelitinib inhibited growth of transformed cells expressing ERBB2 (HER2) P489L in culture (PMID: 32366937). 32366937
ERBB2 P489L cancer sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of transformed cells expressing ERBB2 (HER2) P489L in culture (PMID: 32366937). 32366937
ERBB2 P489L cancer no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) P489L did not demonstrate sensitivity to growth inhibition by Tarceva (erlotinib) in culture (PMID: 32366937). 32366937
ERBB2 P489L cancer no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) P489L did not demonstrate sensitivity to growth inhibition by Iressa (gefitinib) in culture (PMID: 32366937). 32366937
ERBB2 L915M Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical - Cell culture Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) L915M in culture (PMID: 18413839). 18413839
ERBB2 G660D Advanced Solid Tumor predicted - sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D demonstrated decreased cell proliferation and reduced survival when treated with Gilotrif (afatinib) in culture (PMID: 30449325). 30449325
ERBB2 G660D lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells cells expressing ERBB2 (HER2) G660D did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 G660D Advanced Solid Tumor sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D treated with Herceptin (trastuzumab) demonstrated decreased proliferation, reduced survival, and inhibition of colony formation in culture, and in mouse models led to improved survival compared to control models with wild-type ERBB2 (HER2) (PMID: 30449325). 30449325
ERBB2 G660D Advanced Solid Tumor no benefit Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D did not benefit from treatment with Tarceva (erlotinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 G660D Advanced Solid Tumor predicted - resistant HER2 (ERBB2) Antibody Pertuzumab Preclinical - Cell culture Actionable In a preclinical study, treatment with Perjeta (pertuzumab) led to induced growth and colony formation of cells expressing ERBB2 (HER2) G660D in culture (PMID: 30449325). 30449325
ERBB2 G660D Advanced Solid Tumor predicted - resistant Cetuximab Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D demonstrated resistance to treatment with Erbitux (cetuximab) in culture (PMID: 30449325). 30449325
ERBB2 G660D Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D demonstrated decreased cell proliferation and reduced survival when treated with Tykerb (lapatinib) in culture (PMID: 30449325). 30449325
ERBB2 G660D Advanced Solid Tumor predicted - sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D demonstrated decreased cell proliferation and reduced survival when treated with Nerlynx (neratinib) in culture (PMID: 30449325). 30449325
ERBB2 G660D lung cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) G660D in culture (PMID: 26545934). 26545934
ERBB2 G660D lung cancer sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical study, a patient with lung cancer harboring a germline mutation, ERBB2 (HER2) G660D, demonstrated improved symptoms within 30 days of Gilotrif (afatinib) treatment, as well as a 21% reduction in tumor volume in 12 weeks and a durable response that lasted for more than 15 weeks (PMID: 30449325). 30449325
ERBB2 G660D lung cancer sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical case study, Gilotrif (afatinib) treatment resulted in partial response in the lung lesion and stable bone metastasis for over 16 months in a patient with familial lung cancer harboring germline ERBB2 G660D mutation (PMID: 29146616). 29146616
ERBB2 G660D Advanced Solid Tumor no benefit Gefitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G660D did not benefit from treatment with Iressa (gefitinib) in culture when compared to Erbb2 (Her2) inhibitors (PMID: 30449325). 30449325
ERBB2 L755P Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) L755P in culture (PMID: 31588020). 31588020
ERBB2 L755P Advanced Solid Tumor resistant HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Nerlynx (neratinib) in culture (PMID: 31588020). 31588020
ERBB2 L755P Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). 31588020
ERBB2 L755P Advanced Solid Tumor resistant HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 L755P lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Case Reports/Case Series Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in stable disease lasted more than 7 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) L755P (PMID: 31588020; NCT03066206). 31588020
ERBB2 L755P Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 L755P lung adenocarcinoma no benefit HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall responses of partial response in 44% (8/18) and stable disease in 39% (7/18), and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations, but a subset of patients specifically harboring ERBB2 L755P (2/2) did not demonstrate a partial response (PMID: 29989854; NCT02675829). 29989854
ERBB2 L755P Advanced Solid Tumor resistant HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Imbruvica (ibrutinib) in culture (PMID: 31588020). 31588020
ERBB2 L755P Advanced Solid Tumor sensitive WZ4002 Preclinical Actionable In a preclinical study, WZ4002 inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) L755P in culture (PMID: 22046346). 22046346
ERBB2 L755P Advanced Solid Tumor resistant HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Pyrotinib in culture (PMID: 31588020). 31588020
ERBB2 L755P Advanced Solid Tumor sensitive EKI-785 Preclinical Actionable In a preclinical study, EKI-285 (CL-387785) inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) L755P in culture (PMID: 22046346). 22046346
ERBB2 L755P lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, Pyrotinib treatment resulted in an objective response rate of 25% (1/4) in non-small cell lung cancer patients harboring ERBB2 (HER2) L755P who had received prior platinum-based chemotherapy (PMID: 32614698; NCT02834936). 32614698
ERBB2 L755P lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, a patient with non-small cell lung cancer harboring ERBB2 L755P demonstrated a partial response when treated with Pyrotinib (PMID: 30596880; NCT02535507). 30596880
ERBB2 L755P lung non-small cell carcinoma no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 14.8 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) L755P (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755P Advanced Solid Tumor resistant Nazartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Nazartinib (EGF816) in culture (PMID: 31588020). 31588020
ERBB2 L755P Advanced Solid Tumor resistant Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Tagrisso (osimertinib) in culture (PMID: 31588020). 31588020
ERBB2 L755P Advanced Solid Tumor resistant HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, transformed cell lines expressing ERBB2 (HER2) L755P demonstrated resistance when treated with AEE788 in culture (PMID: 22046346). 22046346
ERBB2 L755P Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cell lines expressing ERBB2 (HER2) L755P demonstrated resistance when treated with Tykerb (lapatinib) in culture (PMID: 22046346). 22046346
ERBB2 L755P Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) L755P were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 L755P Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) L755P in culture (PMID: 31588020). 31588020
ERBB2 V773L breast cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) V773L were sensitive to Nerlynx (nerlatinib) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
ERBB2 V773L breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) V773L were sensitive to Tykerb (lapatinib) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
ERBB2 V773L breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) V773L were sensitive to Herceptin (trastuzumab) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
ERBB2 K831N colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.7 months in a patient with colorectal cancer harboring ERBB2 (HER2) K831N (PMID: 29420467; NCT01953926). 29420467
ERBB2 P761del endometrial cancer predicted - resistant HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 1.9 months in a patient with endometrial cancer harboring ERBB2 (HER2) P761del (PMID: 29420467; NCT01953926). 29420467
ERBB2 G778_P780dup breast cancer resistant HER2 (ERBB2) Antibody Trastuzumab Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 P780_Y781insGSP demonstrated resistance when treated with Herceptin (trastuzumab) (PMID: 23220880). 23220880
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall responses of partial response in 44% (8/18) and stable disease in 39% (7/18), and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations, and a subset of patients specifically harboring ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) had a 33% (1/3) partial response rate (PMID: 29989854; NCT02675829). 29989854
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a clinical study, three lung adenocarcinoma patients harboring ERBB2 (HER2) G778_P780dup (also reported as V777_G778insGSP) demonstrated a clinical benefit when treated with Pyrotinib, including a patient with three months of stable disease who had progressed on several prior lines of therapy, a patient with an ongoing partial response of six months, and a patient with an ongoing partial response of eight months who had prior disease progression with Gilotrif (afatinib) (PMID: 32036069). 32036069
ERBB2 G778_P780dup Advanced Solid Tumor decreased response Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) P780_Y781insGSP were resistant to Tagrisso (osimertinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor decreased response Osimertinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) demonstrated decreased response to Tagrisso (osimertinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup breast cancer sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial, Nerlynx (neratinib) treatment resulted in a clinical benefit rate of 31% (5/16) in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, with 1 complete response (referred to as V777_G778insGSP) and 1 stable disease for more than 24 weeks (referred to as P780_Y781insGSP) in 3 patients harboring ERBB2 G778_P780dup (PMID: 28679771; NCT01670877). 28679771
ERBB2 G778_P780dup breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) P780_Y781insGSP reverted to normal morphology in culture upon Nerlynx (neratinib) treatment (PMID: 23220880). 23220880
ERBB2 G778_P780dup lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Clinical Study Actionable In a retrospective analysis, Gilotrif (afatinib) treatment resulted in an objective response rate of 25% (1/4) in non-small cell lung cancer patients harboring ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited growth of a transformed cell line expressing ERBB2 (HER2) G778_P780dup (reported P780insGSP) in culture (PMID: 29686424). 29686424
ERBB2 G778_P780dup Advanced Solid Tumor sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited survival of transformed cells expressing ERBB2 (HER2) P780_Y781insGSP in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Gilotrif (afatinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) demonstrated decreased response to Gilotrif (afatinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Case Reports/Case Series Actionable In a clinical case study, Poziotinib (HM781-36B) treatment resulted in stable disease lasting nine months in a metastatic lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) with prior disease progression following an initial partial response to Gilotrif (afatinib) (PMID: 32036069). 32036069
ERBB2 G778_P780dup breast cancer sensitive HER inhibitor (Pan) HER2 (ERBB2) Antibody Ado-trastuzumab emtansine + Poziotinib Preclinical - Cell culture Actionable In a preclinical study, addition of Poziotinib (HM781-36B) enhanced growth inhibition by Kadcyla (ado-trastuzumab emtansine) treatment in breast cancer cells expressing ERBB2 (HER2) G778_P780dup in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Clinical Study - Cohort Actionable In a retrospective study, Gilotrif (afatinib) treatment resulted in an objective response rate (ORR) of 15.6% (5/32) and a disease control rate of 68.8% (22/32) in patients with lung adenocarcinoma harboring ERBB2 (HER2) mutations, patients harboring G776delinsVC (n=5) or G778_P780dup (n=5) achieved longer median progression-free survival (7.6 mo) than those with Y772_A775dup (n=14, 1.2 mo) or missense mutations (n=8, 3.6 mo), with an ORR of 40% (4/10) and a DCR of 100% (10/10) (PMID: 32162827). 32162827
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical case study, a patient with metastatic lung adenocarcinoma harboring ERBB2 (HER2) G778_P780dup (also referred to as V777_G778insGSP) demonstrated tumor shrinkage and clinical response for 7 months following treatment with Gilotrif (afatinib) (PMID: 28363995). 28363995
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical study, five lung adenocarcinoma patients each harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) demonstrated a clinical benefit from treatment with Gilotrif (afatinib), including one patient with a partial response lasting nine months, a second patient demonstrating a 51% reduction in primary tumor size after one month with a partial response lasting eight months, and three patients with stable disease ranging from 6 to 9 months (PMID: 32036069). 32036069
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical study, a lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also referred to as V747_G748insGSP and G748_P750dup), demonstrated a 13% regression of target lesions and stable disease for 11 months following treatment with pulse Gilotrif (afatinib) (PMID: 26964772). 26964772
ERBB2 G778_P780dup breast cancer sensitive HER inhibitor (Pan) Poziotinib Preclinical - Cell culture Actionable In a preclinical study, Poziotinib (HM781-36B) inhibited viability of breast cancer cells expressing ERBB2 (HER2) G778_P780dup in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup breast cancer resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, breast epithelial cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) were resistant to Tykerb (lapatinib) treatment in cell culture (PMID: 31980423). 31980423
ERBB2 G778_P780dup breast cancer resistant HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 P780_Y781insGSP demonstrated resistance when treated with Tykerb (lapatinib) (PMID: 23220880). 23220880
ERBB2 G778_P780dup Advanced Solid Tumor resistant Nazartinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Nazartinib (EGF816) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor sensitive HER2 Inhibitor Pyrotinib Preclinical - Cell culture Actionable In a preclinical study, Pyrotinib inhibited survival of transformed cells expressing ERBB2 (HER2) G778_P780dup in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor sensitive HER2 Inhibitor Tarloxotinib Preclinical - Cell culture Actionable In a preclinical study, Tarloxotinib (TRLX) inhibited survival of transformed cells expressing ERBB2 (HER2) G778_P780dup in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup lung cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited Erbb2 (Her2) phosphorylation and downstream signaling in bronchial epithelial cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) in culture (PMID: 26545934). 26545934
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Imbruvica (ibrutinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor resistant AZ5104 Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) were resistant to AZ5104 in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor decreased response HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) demonstrated decreased response to Tukysa (tucatinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) P780_Y781insGSP demonstrated decreased response to Nerlynx (neratinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) in culture (PMID: 28363995). 28363995
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Nerlynx (neratinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup lung adenocarcinoma sensitive HER inhibitor (Pan) Dacomitinib Case Reports/Case Series Actionable In a Phase II trial, two lung adenocarcinoma patients harboring ERBB2 (HER2) G778_780dup (reported as P780_Y781insGSP) demonstrated partial response to treatment with Vizimpro (dacomitinib) (PMID: 25899785; NCT00818441). 25899785
ERBB2 G778_P780dup Her2-receptor positive breast cancer predicted - resistant HER2 (ERBB2) Antibody Lapatinib Case Reports/Case Series Actionable In a clinical case study, ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) was identified in a patient with ERBB2 (HER2)-positive breast cancer at the time of disease progression while on Tykerb (lapatinib) treatment (PMID: 31980423). 31980423
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib + Cisplatin + Pemetrexed Disodium Case Reports/Case Series Actionable In a clinical case study, the combination of Gilotrif (afatinib), Platinol (cisplatin), and Alimta (Pemetrexed Disodium) followed by the combination of Gilotrif (afatinib) and Alimta (Pemetrexed Disodium) resulted in an ongoing partial response over 19 months in a patient with lung adenocarcinoma harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) (PMID: 32036069). 32036069
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, Vizimpro (dacomitinib) inhibited growth of transformed cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) in culture (PMID: 28363995). 28363995
ERBB2 G778_P780dup Advanced Solid Tumor conflicting HER inhibitor (Pan) Dacomitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Vizimpro (dacomitinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup lung non-small cell carcinoma no benefit HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival over 17 months in 2 patients with non-small cell lung cancer harboring ERBB2 (HER2) G778_P780dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 G778_P780dup Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Case Reports/Case Series Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 3.5 months in one patient, and stable disease with a progression-free survival of 20.0 months in another patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) G778_P780dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 G778_P780dup lung non-small cell carcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a Phase II trial, Pyrotinib treatment resulted in an objective response rate of 60% (3/5) in non-small cell lung cancer patients harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) who had received prior platinum-based chemotherapy (PMID: 32614698; NCT02834936). 32614698
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) were resistant to Tykerb (lapatinib) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P80dup were resistant to Tykerb (lapatinib) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup Advanced Solid Tumor resistant HER2 Inhibitor Sapitinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup were resistant to Sapitinib (AZD8931) in culture (PMID: 31588020). 31588020
ERBB2 G778_P780dup lung non-small cell carcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a confirmed objective response rate of 42% (5/12) in patients with non-small cell lung cancer harboring ERBB2 (HER2) Y772_A775dup (n=9) or ERBB2 (HER2) G778_P780dup (n=3), with a median progression-free survival of 5.6 months (PMID: 31588020; NCT03066206). 31588020
ERBB2 G778_P780dup breast cancer predicted - sensitive HER2 (ERBB2) Antibody Lapatinib + Perifosine Preclinical - Cell culture Actionable In a preclinical study, addition of Perifosine restored sensitivity to Tykerb (lapatinib) in breast epithelial cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP in culture (PMID: 31980423). 31980423
ERBB2 G778_P780dup lung cancer no benefit Gefitinib Preclinical Actionable In a preclinical study, bronchial epithelial cells expressing ERBB2 (HER2) G778_P780dup (also referred to as P780_Y781insGSP) did not demonstrate sensitivity to Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 G778_P780dup Advanced Solid Tumor resistant Erlotinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G778_P780dup (reported as P780_Y781insGSP) were resistant to Tarceva (erlotinib) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup PIK3CA H1047R breast cancer decreased response HER2 Inhibitor Neratinib Preclinical - Pdx Actionable In a preclinical study, Nerlynx (neratinib) resulted in a moderate delay of tumor growth in a breast cancer patient-derived xenograft model harboring ERBB2 (HER2) G778_P780dup and PIK3CA H1074R (PMID: 31978326). 31978326
ERBB2 G778_P780dup ERBB2 amp lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Dacomitinib Case Reports/Case Series Actionable In a clinical case study, a patient with metastatic lung adenocarcinoma harboring ERBB2 (HER2) G778_P780dup (also reported as P780_Y781insGSP) demonstrated an ongoing partial response following four months of Vizimpro (dacomitinib) treatment (PMID: 32036069). 32036069
ERBB2 G778_P780dup ERBB2 amp lung adenocarcinoma predicted - sensitive HER2 Inhibitor Pyrotinib Case Reports/Case Series Actionable In a clinical case study, Pyrotinib treatment resulted in 11 months of stable disease in a lung adenocarcinoma patient harboring ERBB2 (HER2) G778_P780dup (also reported as V777_G778insGSP) and ERBB2 (HER2) amplification (PMID: 32036069). 32036069
ERBB2 N857S Advanced Solid Tumor sensitive HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, AEE788 inhibited proliferation of transformed cell lines expressing ERBB2(HER2) N857S in culture (PMID: 22046346). 22046346
ERBB2 N857S Advanced Solid Tumor decreased response HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, higher dose of Tykerb (lapatinib) inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) N857S in culture (PMID: 22046346). 22046346
ERBB2 E717K Advanced Solid Tumor decreased response HER2 (ERBB2) Antibody Lapatinib Preclinical Actionable In a preclinical study, transformed cells over expressing ERBB2 (HER2) E717K demonstrated reduced sensitivity to Tykerb (lapatinib) in culture (PMID: 18413839). 18413839
ERBB2 E717K Advanced Solid Tumor sensitive HER2 Inhibitor Tesevatinib Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) E717K in culture (PMID: 18413839). 18413839
ERBB2 positive Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Margetuximab + MGD013 Phase I Actionable In a Phase I trial, MGD013 and Margetuximab (MGAH22) combination treatment resulted in a partial response in 50% (3/6) and stable disease in 33.3% (2/6) of patients with ERBB2 (HER2)-positive advanced solid tumors (J Clin Oncol 38: 2020 (suppl; abstr 3004); NCT03219268). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab deruxtecan FDA approved Actionable In a Phase II trial (DESTINY-Breast01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment resulted in an objective response rate of 60.9% (112/184) in patients with unresectable or metastatic ERBB2 (HER2)-positive breast cancer who have received two or more prior anti-HER2 therapies, with a median response duration of 14.8 months and a median progression-free survival of 16.4 months (PMID: 31825192; NCT03248492). 31825192
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab deruxtecan Preclinical - Pdx & cell culture Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) inhibited growth of ERBB2 (HER2)-positive breast cancer cell lines in culture and xenograft models, and demonstrated antitumor activity in patient-derived xenograft (PDX) models of ERBB2 (HER2)-positive breast cancer, including models with low ERBB2 (HER2) expression (PMID: 27026201). 27026201
ERBB2 positive gastroesophageal junction adenocarcinoma predicted - sensitive HER inhibitor (Pan) HER2 (ERBB2) Antibody Afatinib + Trastuzumab Phase II Actionable In a Phase II clinical trial, the combination therapy of Gilotrif (afatinib) and Herceptin (trastuzumab) in ERBB2 (HER2)-positive patients with either gastroesophageal junction adenocarcinoma, metastatic esophageal cancer, or gastric adenocarcinoma resulted in a partial response in 8% (1/12) and disease control for 4 months or more in 17% (2/12) (PMID: 30463996; NCT01522768). 30463996
ERBB2 positive salivary gland cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable ERBB2 (HER2)-targeted therapy, including Herceptin (trastuzumab) is included in guidelines for patients with ERBB2 (HER2)-positive salivary gland tumors with distant metastases (NCCN.org). detail...
ERBB2 positive stomach cancer predicted - sensitive HER2 (ERBB2) Antibody MEDI4276 Phase I Actionable In a Phase I trial, MEDI4276 treatment resulted in complete response in 1 patient with breast cancer, partial response in 1 patient with breast cancer, and stable disease in 12 patients with Erbb2 (Her2)-positive breast or gastric cancer (Annals of Oncology, Volume 29, Issue suppl_3, 1 March 2018, abstract 470; NCT02576548). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 Inhibitor Tucatinib Phase I Actionable In a Phase I trial, treatment with Tukysa (tucatinib) resulted in a response rate of 14% (3/22; all partial responses (PR)) and a clinical benefit rate (PR plus stable disease for greater than or equal to 24 weeks) of 27% (6/22) in Erbb2 (Her2)-positive breast cancer patients (PMID: 28053022). 28053022
ERBB2 positive stomach carcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab Duocarmazine Preclinical - Cell culture Actionable In a preclinical study, Trastuzumab Duocarmazine (SYD985) decreased survival of a ERBB2 (HER2)-positive gastric carcinoma cell line in culture (PMID: 25589493). 25589493
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER2 (ERBB2) Antibody HER2 Inhibitor Capecitabine + Trastuzumab + Tucatinib Phase Ib/II Actionable In a Phase Ib trial, the combination of Tukysa (tucatinib), Herceptin (trastuzumab), and Capecitabine demonstrated clinical activity in CNS metastases in patients with ERBB2 (HER2)-positive metastatic breast cancer, with 50% (1/2) of evaluable patients achieving CNS partial response and 50% (1/2) achieving CNS stable disease (San Antonio Breast Cancer Symposium 2015, Abstract P4-14-19). detail...
ERBB2 positive ovarian cancer sensitive HER2 (ERBB2) Antibody Disitamab vedotin Preclinical - Cell line xenograft Actionable In a preclinical study, treatment with Hertuzumab-vc-MMAE decreased viability of ERBB2 (HER2)-positive ovarian cancer cell lines in culture and inhibited tumor growth in ERBB2 (HER2)-positive ovarian cancer cell line xenograft models (PMID: 27509865). 27509865
ERBB2 positive stomach cancer sensitive HER2 (ERBB2) Antibody ARX-788 Preclinical - Cell line xenograft Actionable In a preclinical study, ERBB2 (HER2)-positive ovarian xenograft model was sensitive to treatment with ARX-788, resulting in tumor regression (Cancer Res 2015;75(15 Suppl):Abstract nr 639). detail...
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER2 (ERBB2) Antibody Abemaciclib + Fulvestrant + Trastuzumab Phase II Actionable In a Phase II trial, the combination therapy of Verzenio (abemaciclib), Herceptin (trastuzumab), and Faslodex (fulvestrant) in patients with ERBB2 (HER2)-receptor positive breast cancer (n=79) resulted in safety and a greater progression-free survival (PFS) compared to patients treated with standard of care chemotherapy plus Herceptin (trastuzumab) (n=79), demonstrating a PFS of 8.3 months versus 5.7 months (p=0.051), respectively (PMID: 32353342; NCT02675231). 32353342
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Cyclophosphamide + Doxorubicin + Paclitaxel + Pertuzumab + Trastuzumab Guideline Actionable Sequential therapy, Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide), followed by Taxol (paclitaxel) plus Herceptin (trastuzumab) and Perjeta (pertuzumab), is included in the guidelines as adjuvant therapy for patients with hormone receptor-negative (ER and PR), ERBB2 (HER2)-positive breast cancer who are node positive (NCCN.org). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase III Actionable In a Phase III trial, adjuvant Herceptin (trastuzumab), Perjeta (pertuzumab), plus chemotherapy resulted in improved invasive disease-free survival compared to Herceptin (trastuzumab) plus chemotherapy in patients with Erbb2 (Her2)-positive breast cancer (J Clin Oncol 35, 2017 (suppl; abstr LBA500)). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Copanlisib Preclinical Actionable In a preclinical study, breast cancer cell lines with a PIK3CA activating mutation and/or ERBB2 (HER2)-over expression demonstrated increased sensitivity to inhibition of proliferation by Aliqopa (copanlisib) in culture, compared to ERBB2 (HER2)-negative and wild-type PIK3CA cell lines (PMID: 24170767). 24170767
ERBB2 positive pancreatic cancer sensitive HER2 (ERBB2) Antibody Trastuzumab deruxtecan Preclinical - Cell line xenograft Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) inhibited tumor growth in a pancreatic cancer cell line xenograft model with low ERBB2 (HER2) expression (PMID: 27026201). 27026201
ERBB2 positive gastroesophageal junction adenocarcinoma