Molecular Profile Detail

Profile Name ERBB2 T798M
Gene Variant Detail

ERBB2 T798M (gain of function)

Relevant Treatment Approaches HER inhibitor (Pan) HER2 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
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 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 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) 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 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 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 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 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 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 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 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) 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 sensitive 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 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 resistant HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) G776delinsVC were resistant to Tucatinib (ARRY-380) in culture (PMID: 30527195). 30527195
ERBB2 G776delinsVC non-small cell lung carcinoma no benefit 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 resistant 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 non-small cell lung carcinoma no benefit HER2 Inhibitor Neratinib Phase II 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 non-small cell lung 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 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 non-small cell lung 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 non-small cell lung 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 adenocarcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in 1 partial response and 1 stable disease in 2 patients with lung adenocarcinoma harboring ERBB2 (HER2) G776delinsVC (PMID: 30149884; NCT02979821). 30149884
ERBB2 G776delinsVC non-small cell lung 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 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 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 Advanced Solid Tumor sensitive 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 sensitive 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 sensitive 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 lung adenocarcinoma predicted - sensitive 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 non-small cell lung 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 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 non-small cell lung 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 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 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 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 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 - 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 breast cancer sensitive 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 Advanced Solid Tumor predicted - sensitive 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 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 R678Q Advanced Solid Tumor predicted - sensitive 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 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 gastroesophageal junction adenocarcinoma predicted - resistant HER2 Inhibitor Neratinib Phase II 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 colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 endometrial cancer no benefit HER2 Inhibitor Neratinib Phase II 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 L726F breast cancer resistant Lapatinib Preclinical Actionable In a preclinical study, breast cancer cells expressing ERBB2 (HER2) L726F demonstrated resistance to Tykerb (lapatinib) in both culture and xenograft models (PMID: 25435280). 25435280
ERBB2 L726F Advanced Solid Tumor decreased response Lapatinib Preclinical Actionable In a preclinical study, transformed cells over expressing ERBB2 (HER2) L726F demonstrated reduced sensitivity to Tykerb (lapatinib) in culture (PMID: 18413839). 18413839
ERBB2 L726F Advanced Solid Tumor sensitive HER2 Inhibitor XL647 Preclinical - Cell culture Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) L726F in culture (PMID: 18413839). 18413839
ERBB2 V842I colorectal cancer resistant Cetuximab Preclinical Actionable In a preclinical study, colorectal cancer cell lines over expressing ERBB2 (HER2) V842I were resistant to Erbitux (cetuximab) in culture (PMID: 26243863). 26243863
ERBB2 V842I breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) V842I demonstrated growth inhibition when treated with Nerlynx (neratinib) (PMID: 23220880). 23220880
ERBB2 V842I colorectal cancer conflicting HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cell lines over expressing ERBB2 (HER2) V842I in culture (PMID: 26243863). 26243863
ERBB2 V842I colorectal cancer conflicting HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 2 patients and progressive disease in 1 patient with colorectal cancer harboring ERBB2 (HER2) V842I (PMID: 29420467; NCT01953926). 29420467
ERBB2 V842I breast cancer sensitive Trastuzumab Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 V842I reverted to normal morphology in culture upon Herceptin (trastuzumab) treatment (PMID: 23220880). 23220880
ERBB2 V842I endometrial cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 endometrial cancer harboring ERBB2 (HER2) V842I (PMID: 29420467; NCT01953926). 29420467
ERBB2 V842I 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) V842I in culture (PMID: 26243863). 26243863
ERBB2 V842I colon cancer resistant Trastuzumab Preclinical Actionable In a preclinical study, transformed mouse colon epithelial cells over expressing ERBB2 (HER2) V842I were resistant to Herceptin (trastuzumab) in culture (PMID: 26243863). 26243863
ERBB2 V842I breast cancer sensitive Lapatinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 V842I demonstrated growth inhibition when treated with Tykerb (lapatinib) (PMID: 23220880). 23220880
ERBB2 V842I colorectal cancer resistant Panitumumab Preclinical Actionable In a preclinical study, colorectal cancer cell lines over expressing ERBB2 (HER2) V842I were resistant to Vectibix (panitumumab) in culture (PMID: 26243863). 26243863
ERBB2 V842I colorectal cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of colorectal cancer cell lines over expressing ERBB2 (HER2) V842I in culture (PMID: 26243863). 26243863
ERBB2 V777L ERBB2 V842I colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 S310F ERBB2 V842I 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, resulting in a clinical benefit rate of 31% (5/16), with 1 complete response, 1 partial response, and 3 patients achieving stable disease for 24 weeks or more, which included a patient harboring ERBB2 (HER2) S310F and V842I (PMID: 28679771). 28679771
ERBB2 amp ERBB2 L866M 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 amp ERBB2 L866M 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 amp ERBB2 L866M colorectal cancer resistant 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 amp ERBB2 L866M colorectal cancer sensitive 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 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 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 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 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 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 L755A non-small cell lung carcinoma no benefit HER2 Inhibitor Neratinib Phase II 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 L786V non-small cell lung carcinoma no benefit HER2 Inhibitor Neratinib Phase II 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 non-small cell lung cancer harboring ERBB2 (HER2) L786V (PMID: 29420467; NCT01953926). 29420467
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 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 G309A breast cancer sensitive 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 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 T862A Advanced Solid Tumor decreased response 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 V839G Advanced Solid Tumor sensitive HER2 Inhibitor XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) V839G in culture (PMID: 18413839). 18413839
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 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 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 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) 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 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 Tucatinib (ARRY-380) in culture (PMID: 30527195). 30527195
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 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 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) 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 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 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 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 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 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 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 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 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 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 predicted - sensitive 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 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 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 D277G ERBB2 S310F urinary bladder cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 K831N colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 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 L755S ERBB2 R1153* ERBB2 V777L urinary bladder cancer no benefit HER2 Inhibitor Neratinib Phase II 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) L755S, R1153*, and V777L (PMID: 29420467; NCT01953926). 29420467
ERBB2 E717K Advanced Solid Tumor decreased response 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 XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) E717K in culture (PMID: 18413839). 18413839
ERBB2 T798I Advanced Solid Tumor sensitive HER2 Inhibitor XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) T798I in culture (PMID: 18413839). 18413839
ERBB2 T798I lung cancer resistant 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 resistant 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 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 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 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_P780dup (also referred to as P780_Y781insGSP) in culture (PMID: 28363995). 28363995
ERBB2 G778_P780dup non-small cell lung 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 decreased response 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 breast cancer resistant 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 breast cancer resistant 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 breast cancer 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, resulting in a clinical benefit rate of 31% (5/16), which included patients with ERBB2 G778_P780dup (1 complete response (referred to as V777_G778insGSP) and 1 patient with stable disease for more than 24 weeks (referred to as P780_Y781insGSP) (PMID: 28679771). 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 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 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 lung adenocarcinoma sensitive HER inhibitor (Pan) Dacomitinib Phase II 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 non-small cell lung carcinoma no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival over 17 months in 2 patient with non-small cell lung cancer harboring ERBB2 (HER2) G778_P780dup (PMID: 29420467; NCT01953926). 29420467
ERBB2 G778_P780dup lung adenocarcinoma predicted - sensitive 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 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 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 Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II 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 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 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) P780_Y781insGSP demonstrated decreased response to Nerlynx (neratinib) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 G778_P780dup Advanced Solid Tumor resistant 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 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 Tucatinib (ARRY-380) compared to Poziotinib (HM781-36B) in culture (PMID: 30527195). 30527195
ERBB2 amp ERBB2 S310F lung adenocarcinoma predicted - sensitive 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 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 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 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 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 S310F Advanced Solid Tumor sensitive Lapatinib Preclinical Actionable In a preclinical study, Tykerb (lapatinib) inhibited proliferation of transformed cells expressing ERBB2 S310F in culture (PMID: 22908275). 22908275
ERBB2 S310F biliary tract cancer no benefit HER2 Inhibitor Neratinib Phase II 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 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 colon cancer sensitive 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 cervical cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II 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) D769N (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310F endometrial cancer no benefit HER2 Inhibitor Neratinib Phase II 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 non-small cell lung carcinoma predicted - resistant HER2 Inhibitor Neratinib Phase II 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 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 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 colorectal cancer conflicting HER2 Inhibitor Neratinib Phase II 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 Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II 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 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 gastroesophageal junction adenocarcinoma no benefit HER2 Inhibitor Neratinib Phase II 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 urinary bladder cancer no benefit HER2 Inhibitor Neratinib Phase II 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 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 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 S310F urinary bladder cancer sensitive Lapatinib Preclinical 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 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 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
CDH1 R63* ERBB2 L869Q breast cancer predicted - sensitive 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 L768S breast cancer sensitive Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) L768S were sensitive to Herceptin (trastuzumab) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
ERBB2 L768S breast cancer sensitive Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) L768S were sensitive to Tykerb (lapatinib) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
ERBB2 L768S breast cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, transformed human breast cells expressing ERBB2 (HER2) L768S were sensitive to Nerlynx (neratinib) in culture, resulting in decreased colony formation (PMID: 27697991). 27697991
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 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 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 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 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 - 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 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 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 G776_V777insVGC non-small cell lung carcinoma predicted - resistant HER2 Inhibitor Neratinib Phase II 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 L755_E757delinsS Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II 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 D769H Her2-receptor negative breast cancer no benefit HER2 Inhibitor Neratinib Phase II 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 breast cancer sensitive 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 colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 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 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 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 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 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 Advanced Solid Tumor sensitive 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 predicted - resistant 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 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 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 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 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 Advanced Solid Tumor predicted - sensitive 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 positive KRAS wild-type colorectal cancer sensitive Lapatinib + Trastuzumab Phase II Actionable In a Phase II clinical trial, 30% (8/27) of patients with ERBB2 (HER2)-positive KRAS wild-type colorectal cancer achieved an objective response and 44% (12/27) of patients had stable disease when treated with the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) (PMID: 27108243). 27108243
ERBB2 pos PTEN mut Her2-receptor positive breast cancer predicted - sensitive Buparlisib + Trastuzumab Phase I Actionable In a Phase I clinical trial, the combination of Buparlisib (BKM120) and Herceptin (trastuzumab) was well tolerated and resulted in some preliminary efficacy in patients with ERBB2 (HER2)-positive breast cancer harboring PIK3CA activating mutations and/or PTEN mutations that had progressed on Herceptin (trastuzumab)-based therapy (PMID: 24470511). 24470511
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 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 pos PTEN loss Her2-receptor positive breast cancer no benefit Palbociclib + Pictilisib Preclinical Actionable In a preclinical study, the combination of Ibrance (palbociclib) and Pictilisib (GDC-0941) did not improve growth inhibition compared to single drug treatment in ERBB2 (HER2)-positive breast cancer cell lines harboring PTEN loss in culture (PMID: 27020857). 27020857
ERBB2 pos PTEN loss Her2-receptor positive breast cancer decreased response Trastuzumab Phase I Actionable In a retrospective analysis, ERBB2 (HER2)-positive breast cancer patients with PTEN loss demonstrated a decreased median progression-free survival of 6.0 months, compared to 9.0 months for patients without PI3K pathway activation following treatment with a Herceptin (trastuzumab) containing regimen (PMID: 21676217). 21676217
ERBB2 positive Her2-receptor positive breast cancer sensitive Cyclophosphamide + Doxorubicin + Paclitaxel + Trastuzumab Guideline Actionable Sequential therapy, Adriamycin (doxorubicin) and Cytoxan (cyclophosphamide), followed by Taxol (paclitaxel) plus Herceptin (trastuzumab), is included in the guidelines as adjuvant therapy for patients with hormone receptor-negative (ER and PR), ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Trastuzumab + Tucatinib Phase Ib/II Actionable In a Phase Ib clinical trial, the combination of Tucatinib (ARRY-380) and Herceptin (trastuzumab) demonstrated clinical activity in central nervous system (CNS) metastases in patients with ERBB2 (HER2)-positive metastatic breast cancer, with 100% (3/3) patients achieving CNS stable disease as best response (San Antonio Breast Cancer Symposium 2015, Abstract P4-14-19). detail...
ERBB2 positive salivary gland cancer predicted - sensitive DS-8201a Phase I Actionable In a Phase I trial, treatment with DS-8201a resulted in a partial response in 50% (2/4) of evaluable patients with salivary gland cancer and ERBB2 (HER2) expression (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 409P; NCT02564900). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Docetaxel + Pertuzumab + Trastuzumab FDA approved 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 metastatic breast cancer (PMID: 23801166). 23801166
ERBB2 positive Advanced Solid Tumor predicted - sensitive HER2 Inhibitor AC480 Phase I Actionable In a Phase I clinical trial, AC480 (BMS-599626) treatment demonstrated preliminary clinical activity, resulting in stable disease as best response in 25% (11/44) of patients with advanced solid tumors, including patients expressing EGFR and/or ERBB2, with 2 patients achieving stable disease for greater than 6 months (PMID: 21576284). 21576284
ERBB2 positive breast cancer sensitive XMT-1522 Preclinical - Pdx & cell culture Actionable In a preclinical study, XMT-1522 inhibited growth of Erbb2 (Her2)-positive breast cancer cells in culter, resulted in tumor regression in both cell line and patient-derived xenograft models (Cancer Res 2016;76(4 Suppl): Abstract nr P4-14-28). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Oxaliplatin + Trastuzumab Preclinical Actionable In a preclinical study, the combination of Herceptin (trastuzumab) and Eloxatin (oxaliplatin) resulted in growth inhibition of ERBB2 (HER2)-positive breast cancer cells in culture (PMID: 24300914). 24300914
ERBB2 positive Her2-receptor positive breast cancer sensitive Lapatinib + MK2206 Phase I Actionable In a Phase I trial, Tykerb (lapatinib) and MK2206 combination treatment resulted in stable disease for more than 6 months in 40% (2/5) of patients with ERBB2 (HER2)-positive breast cancer (PMID: 27026198). 27026198
ERBB2 positive Her2-receptor positive breast cancer sensitive Buparlisib + Trastuzumab Phase I Actionable In a Phase I clinical trial, the combination of Buparlisib (BKM120) and Herceptin (trastuzumab) was well tolerated in patients with ERBB2 (HER2)-positive advanced or metastatic breast cancer that had progressed on Herceptin (trastuzumab) (PMID: 24470511). 24470511
ERBB2 positive Her2-receptor positive breast cancer sensitive HER inhibitor (Pan) Afatinib + Trastuzumab Phase I Actionable In a Phase I clinical trial, ERBB2 (HER2)-positive breast cancer patients treated with Gilotrif (afatinib), in combination with Herceptin (trastuzumab), demonstrated an overall objective response rate of 11% (2/18) while 28% (5/18) attained a best response of stable disease (PMID: 25370464). 25370464
ERBB2 positive stomach cancer sensitive 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 ductal carcinoma in situ predicted - sensitive HER2-pulsed DC1 vaccine Phase Ib/II Actionable In a Phase I/Ib clinical trial, vaccination with a HER2-peptide pulsed dendritic cell vaccine was well-tolerated and resulted in immune response in patients with ERBB2 (HER2)-positive ductal carcinoma in situ (DCIS), and resulted in pathologic complete response rate of 28% (12/42), compared to 8.3% (1/12) in patients with invasive breast cancer (PMID: 27965306). 27965306
ERBB2 positive Her2-receptor positive breast cancer sensitive MM-302 Phase I Actionable In a Phase I study, MM-302 demonstrated safety in patients with ERBB2 (HER2) positive breast cancer (Cancer Res 2012;72(24 Suppl):Abstract nr P5-18-09) detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Carboplatin + Docetaxel + Pertuzumab + Trastuzumab Guideline Actionable Taxotere (docetaxel), Paraplatin (carboplatin), and Herceptin (trastuzumab) plus Perjeta (pertuzumab) therapy, 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 stomach cancer predicted - sensitive 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 Neratinib Phase II Actionable In a Phase II clinical trial, Nerlynx (neratinib) demonstrated safety and efficacy as a monotherapy in patients with ERBB2 (HER2)-positive breast cancer (PMID: 23953056). 23953056
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 Inhibitor Neratinib FDA approved Actionable In a Phase III trial that supported FDA approval, ERBB2 (HER2)-positive 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
ERBB2 positive stomach cancer sensitive Oxaliplatin + Trastuzumab Preclinical Actionable In a preclinical study, the combination of Herceptin (trastuzumab) and Eloxatin (oxaliplatin) resulted in growth inhibition of ERBB2 (HER2)-positive gastric cancer cells in culture (PMID: 24300914). 24300914
ERBB2 positive gastroesophageal junction adenocarcinoma predicted - sensitive HER inhibitor (Pan) 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 Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine + Docetaxel Phase Ib/II Actionable In a Phase Ib/II trial, Kadcyla (trastuzumab emtansine) and Taxotere (docetaxel) combination treatment resulted in median progression-free survival of 13.8 months and objective response in 80.0% (20/25) of patients with ERBB2 (HER2)-positive metastatic breast cancer (PMID: 27052654). 27052654
ERBB2 positive ovarian cancer sensitive ARX-788 Preclinical - Cell line xenograft Actionable In a preclinical study, an ERBB2 (HER2)-positive ovarian cancer 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 GBR1302 Case Reports/Case Series Actionable In a Phase I trial, GBR 1302 treatment resulted in prolonged (more than 4 months) stable disease in a patient with ERBB2 (HER2) positive (IHC 2+) breast adenocarcinoma (Annals of Oncology, Volume 29, Issue suppl_8, October 2018, mdy288.020; NCT02829372). detail...
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Ibrutinib Preclinical - Cell line xenograft Actionable In a preclinical study, Imbruvica (ibrutinib) inhibited Her family receptor signaling, resulted in apoptosis and growth inhibition in ERBB2 (HER2)-positive breast cancer cell lines in culture and in cell line xenograft models (PMID: 27256378). 27256378
ERBB2 positive Her2-receptor positive breast cancer sensitive Everolimus + Trastuzumab + Vinorelbine Phase III Actionable In a Phase III trial (BOLERO-3), the combination of Afinitor (everolimus), Herceptin (trastuzumab), and Navelbine (vinorelbine) increased progression-free survival in patients with Herceptin (trastuzumab)-resistant, ERBB2 (HER2)-positive, advanced breast cancer who had prior taxane treatment (PMID: 24742739; NCT01007942). 24742739
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 Inhibitor Capecitabine + Neratinib Phase II Actionable In a Phase II trial, Nerlynx (neratinib) and Xeloda (capecitabine) combination therapy resulted in an overall 12-month survival rate of 63% (23/37) in patients with Erbb2 (Her2)-positive breast cancer brain metastases (J Clin Oncol 35, 2017 (suppl; abstr 1005)). detail...
ERBB2 positive colorectal cancer no benefit ZW25 Phase I Actionable In a Phase I trial, ZW25 treatment resulted in disease progression in a patient with ERBB2 (HER2)-positive colorectal cancer (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 255P; NCT02892123). detail...
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in a median progression-free survival of 4.04 months, and a disease control rate of 75.49% (77/102; 20 partial responses) in heavily-treated Erbb2 (Her2)-positive breast cancer patients (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 237O; NCT02418689). detail...
ERBB2 positive Advanced Solid Tumor predicted - sensitive ZW25 Phase I Actionable In a Phase I trial, ZW25 treatment resulted in partial response in 14% (2/14) and stable disease in 21% (3/14) of patients with ERBB2 (HER2)-positive tumors, including breast, gastric, esophageal, colorectal, and adnexal cancers (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 255P; NCT02892123). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 BATs Preclinical - Cell culture Actionable In a preclinical study, HER2 BATs demonstrated enhanced toxicity comparing to unarmed T-cells against Erbb2 (Her2)-positive breast cancer cells in culture (PMID: 11359672). 11359672
ERBB2 positive gastroesophageal junction adenocarcinoma no benefit Ado-trastuzumab emtansine Phase III Actionable In a Phase III trial, Kadcyla (trastuzumab emtansine) did not demonstrated efficacy benefit over Taxol (paclitaxel) on median overall survival (7.9 vs 8.6 months) in patients with previously treated ERBB2 (HER2)-positive locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (J Clin Oncol 34, 2016 (suppl 4S; abstr 5)). detail...
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive ZW25 Phase I Actionable In a Phase I trial, ZW25 treatment resulted in partial response in 28.6% (2/7) and stable disease in 28.6% (2/7) of patients with ERBB2 (HER2)-positive breast cancers (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 255P; NCT02892123). detail...
ERBB2 positive gastric adenocarcinoma predicted - sensitive HER inhibitor (Pan) 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 Her2-receptor positive breast cancer sensitive Capecitabine + Trastuzumab Phase II Actionable In Phase II clinical trials, the combination of Xeloda (capecitabine) and Herceptin (trastuzumab) demonstrated efficacy with a manageable toxicity profile in heavily pretreated patients with ERBB2 (HER2)-positive advanced breast cancer and earlier Herceptin (trastuzumab) exposure (PMID: 17679724). 17679724
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 Inhibitor Pyrotinib Phase I Actionable In a Phase I trial, Pyrotinib treatment resulted in an objective response rate of 50% (18/36, all partial responses), and a clinical benefit rate of 61.1% (22/36), and a median progression-free survival of 35.4 weeks in patients with ERBB2 (HER2)-positive breast cancer (PMID: 28498781, NCT01937689). detail... 28498781
ERBB2 positive Her2-receptor positive breast cancer sensitive MYL-1401O + Paclitaxel Phase III Actionable In a Phase III trial, MYL-1401O demonstrated safety and efficacy comparable to Herceptin (trastuzumab) when given in combination with Taxol (paclitaxel), resulted in an objective response rate of 69.6% in ERBB2 (HER2)-positive breast cancer patients (J Clin Oncol 34, 2016 (suppl; abstr LBA503)). detail...
ERBB2 positive transitional cell carcinoma no benefit lapuleucel-T Phase II Actionable In a Phase II trial, Neuvenge (lapuleucel-T) treatment did not result in statistically significant improvement of overall survival (37.0 vs 22.2 months, HR = 0.96) or disease recurrence-free survival (11.9 vs 10.1 months, HR = 0.99) compared to standard of care in ERBB2 (HER2) positive urothelial cancer patients (J Clin Oncol 34, 2016 (suppl; abstr 4513)). detail...
ERBB2 positive breast adenocarcinoma sensitive DS-8201a Preclinical - Cell culture Actionable In a preclinical study, DS-8201 inhibited growth of an ERBB2 (HER2)-positive breast adenocarcinoma cell line in culture (PMID: 27026201). 27026201
ERBB2 positive Her2-receptor positive breast cancer sensitive Oxaliplatin + Trastuzumab + TS-1 Phase II Actionable In a Phase II clinical trial, the combination of TS-1 (S-1) and Herceptin (trastuzumab) demonstrated safety and efficacy in patients with ERBB2 (HER2)-positive metastatic breast cancer, with an overall response rate of 53.6% (15/28), and a clinical benefit rate of 75.0% (21/28) (PMID: 24982373). 24982373
ERBB2 positive Her2-receptor positive breast cancer sensitive CT-P6 Phase III Actionable In a Phase III trial, CT-P6 demonstrated equivalence to reference Herceptin (trastuzumab) in patients with ERBB2 (HER2)-positive breast cancer, with 46.8% (116/248) of patients treated with CT-P6 achieving pathologic complete response compared to 50.4% (129/256) with Herceptin (trastuzumab) treatment (PMID: 28592386). 28592386
ERBB2 positive Her2-receptor positive breast cancer sensitive Entinostat + Lapatinib Phase I Actionable In a Phase I trial, Entinostat and Tykerb (lapatinib) combination treatment resulted in complete response in 7% (1/15) and stable disease in 27% (4/15) of ERBB2 (HER2) positive breast cancer patients (J Clin Oncol 34, 2016 (suppl; abstr 609)). detail...
ERBB2 positive esophageal cancer predicted - sensitive HER inhibitor (Pan) 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 Advanced Solid Tumor predicted - sensitive HER2 Inhibitor S-222611 Phase I Actionable In a Phase I clinical trial, S-222611 demonstrated safety and some efficacy in patients with advanced solid tumors expressing EGFR or ERBB2 (HER2), with an overall clinical benefit rate of 27% (7/33) (PMID: 25434923). detail... 25434923
ERBB2 positive breast cancer sensitive Withacnistin Preclinical Actionable In a preclinical study, withacnistin induced tumor regression in transgenic mouse models of Erbb2 (Her2)-driven breast cancer (PMID: 24983364). 24983364
ERBB2 positive Her2-receptor positive breast cancer sensitive Lapatinib + Trastuzumab Phase II Actionable In a Phase II trial, Tykerb (lapatinib) and Herceptin (trastuzumab) combination treatment resulted in complete response in the breast in 10.6% (7/66) and minimal residual disease in 16.7% (11/66) of ERBB2-positive breast cancer patients 11 days after receiving the treatment (European Breast Cancer Conference; Mar 2016; Abstract #6LBA). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Lapatinib + Trastuzumab Clinical Study - Meta-analysis Actionable In a meta-analysis of six randomized clinical trials, Tykerb (lapatinib) and Herceptin (trastuzumab) combination treatment resulted in 13% absolute improvement in pathologic complete response rate in ERBB2 (HER2)-positive breast cancer patients compared to Herceptin (trastuzumab) single treatment (PMID: 27140927). 27140927
ERBB2 positive ovarian cancer sensitive PRS-343 Preclinical - Cell line xenograft Actionable In a preclinical study, PRS-343 induced localized immune activation in cell line xenograft models of Erbb2 (Her2)-positive ovarian cancer, resulted in significant tumor growth inhibition (Eur J Cancer, Dec 2016, 69 (Suppl. 1): S99, abstract 301). detail...
ERBB2 positive uterine corpus serous adenocarcinoma sensitive SYD985 Preclinical - Cell line xenograft Actionable In a preclinical study, SYD895 induced cell death in ERBB2 (HER2)-expressing primary uterine serous carcinoma (USC) cell lines in culture, including cell lines with both high and low levels of ERBB2 (HER2) expression, and inhibited tumor growth and improved survival in ERBB2 (HER2)-expressing USC primary cell line xenografts (PMID: 27256376). 27256376
ERBB2 positive gastric adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Phase II Actionable In a Phase II clinical trial, monotherapy with Gilotrif (afatinib) resulted in a moderate clinical benefit in ERBB2 (HER2)-positive patients with either gastroesophageal junction adenocarcinoma, metastatic esophageal cancer, or gastric adenocarcinoma, demonstrating a tumor reduction in 25% (5/20) according to RECIST, an objective partial response in 10% (2/20), a median progression-free survival of 2 months, and a median overall survival of 7 months (PMID: 30463996; NCT01522768). 30463996
ERBB2 positive sarcoma predicted - sensitive HER2 CAR-T cells Phase Ib/II Actionable In a Phase I/II trial, treatment with ERBB2 (HER2)-specific CAR-T cells resulted in stable disease for 12 weeks to 14 months in 4/17 evaluable patients with ERBB2 (HER2)-positive sarcomas and a median overall survival of 10.3 months (PMID: 25800760; NCT00902044). 25800760
ERBB2 positive inflammatory breast carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Phase II Actionable In a Phase II clinical trial, treatment with Gilotrif (afatinib) resulted in a clinical benefit rate of 35% (9/26) in patients with ERBB2 (HER2)-positive inflammatory breast cancer, with 8 confirmed partial responses and 1 patient achieving stable disease for greater than 6 months (PMID: 27923043). 27923043
ERBB2 positive Her2-receptor positive breast cancer sensitive Sunitinib + Trastuzumab Phase II Actionable In a Phase II trial, Sutent (sunitinib), in combination with Herceptin (trastuzumab), demonstrated safety and efficacy in ERBB2 (HER2) positive advanced breast cancer patients (PMID: 24606768). 24606768
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive Metformin Phase III Actionable In a Phase III trial, ERBB2 (HER2) positive breast cancer patients with diabetes demonstrated a greater disease free survival and overall survival when treated with Glucophage (metformin) compared to ERBB2 (HER2) positive breast cancer patients with diabetes not treated with Glucophage (metformin) (PMID: 28375706). 28375706
ERBB2 positive Her2-receptor positive breast cancer sensitive 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-negative, ERBB2 (HER2) receptor-positive breast cancer (NCCN.org). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Trodusquemine Preclinical - Cell line xenograft Actionable In a preclinical study, Trodusquemine (MSI-1436) inhibited tumor growth and metastasis in a ERBB2 (HER2)-positive human breast cancer cell line xenograft model (PMID: 24845231). 24845231
ERBB2 positive colorectal cancer predicted - sensitive DS-8201a Phase I Actionable In a Phase I trial, treatment with DS-8201a resulted in an objective response rate of 25% (3/12) and disease control rate of 83.3% (10/12) in evaluable patients with Erbbe (Her2)-expressing colorectal cancer (Annals of Oncology (2018) 29 (suppl_8): viii150-viii204; NCT02564900). detail...
ERBB2 positive stomach carcinoma sensitive HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, Tucatinib (ARRY-380) inhibited tumor growth in a ERBB2 (HER2)-positive gastric carcinoma cell line xenograft model (Cancer Res April 15, 2012 72:852). detail...
ERBB2 positive stomach cancer sensitive DS-8201a Preclinical - Pdx & cell culture Actionable In a preclinical study, DS-8201 inhibited growth of a ERBB2 (HER2)-positive gastric carcinoma cell line in culture and in xenograft models, and induced tumor regression in a patient-derived xenograft (PDX) model of ERBB2 (HER2)-positive gastric cancer (PMID: 27026201). 27026201
ERBB2 positive Advanced Solid Tumor predicted - sensitive DS-8201a Phase I Actionable In a Phase I trial, treatment with DS-8201a was well-tolerated and resulted in an overall response rate (ORR) of 38% (19/50) and disease control rate (DCR) of 90% (45/50) in patients with ERBB2 (HER2)-expressing solid tumors, and an ORR of 29% (4/14) and DCR of 93% (13/14) in patients with low ERBB2 (HER2) expression (J Clin Oncol 35, 2017 (suppl; abstr 108)). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Carboplatin + Docetaxel + Trastuzumab Guideline Actionable Taxotere (docetaxel), Paraplatin (carboplatin), and Herceptin (trastuzumab) therapy is included in the guidelines as adjuvant therapy for patients with hormone receptor-negative (ER and PR), ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 positive breast cancer sensitive DS-8201a Preclinical - Pdx & cell culture Actionable In a preclinical study, DS-8201 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 stomach cancer predicted - sensitive ZW25 Phase I Actionable In a Phase I trial, ZW25 treatment resulted in stable disease in 20% (1/5) of patients with ERBB2 (HER2)-positive gastric or esophageal cancers (Ann Oncol 2017, Vol 28, Suppl 5, Abstract #255P; NCT02892123). detail...
ERBB2 positive esophageal cancer predicted - sensitive ZW25 Phase I Actionable In a Phase I trial, ZW25 treatment resulted in stable disease in 20% (1/5) of patients with ERBB2 (HER2)-positive gastric or esophageal cancers (Ann Oncol 2017, Vol 28, Suppl 5, Abstract #255P; NCT02892123). detail...
ERBB2 positive ovarian carcinoma sensitive SYD985 Preclinical - Cell culture Actionable In a preclinical study, SYD985 decreased survival of a ERBB2 (HER2)-positive ovarian carcinoma cell line in culture (PMID: 25589493). 25589493
ERBB2 positive pancreatic cancer sensitive DS-8201a Preclinical - Cell line xenograft Actionable In a preclinical study, DS-8201a inhibited tumor growth in a pancreatic cancer cell line xenograft model with low ERBB2 (HER2) expression (PMID: 27026201). 27026201
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Capecitabine + Trastuzumab + Tucatinib Phase Ib/II Actionable In a Phase Ib trial, the combination of Tucatinib (ARRY-380), 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 esophageal cancer predicted - sensitive HER inhibitor (Pan) Afatinib Phase II Actionable In a Phase II clinical trial, monotherapy with Gilotrif (afatinib) resulted in a moderate clinical benefit in ERBB2 (HER2)-positive patients with either gastroesophageal junction adenocarcinoma, metastatic esophageal cancer, or gastric adenocarcinoma, demonstrating a tumor reduction in 25% (5/20) according to RECIST, an objective partial response in 10% (2/20), a median progression-free survival of 2 months, and a median overall survival of 7 months (PMID: 30463996; NCT01522768). 30463996
ERBB2 positive Her2-receptor positive breast cancer sensitive 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 predicted - sensitive HER2 Vaccine Phase II Actionable In Phase II clinical trials, ERBB2 (HER2) vaccines demonstrated safety and some efficacy in the adjuvant setting in ERBB2 (HER2)-positive breast cancer patients (PMID: 23585514). 23585514
ERBB2 positive gastroesophageal adenocarcinoma predicted - sensitive GBR1302 Case Reports/Case Series Actionable In a Phase I trial, GBR 1302 treatment resulted in prolonged (more than 4 months) stable disease in a patient with ERBB2 (HER2) positive (IHC 3+) gastroesophageal adenocarcinoma (Annals of Oncology, Volume 29, Issue suppl_8, October 2018, mdy288.020; NCT02829372). detail...
ERBB2 positive glioblastoma multiforme sensitive HER2 CAR-T cells Phase I Actionable In a Phase I trial, glioblastoma patients positive for ERBB2 (HER2) demonstrated antitumor activity when treated with ERBB2 (HER2)-CAR-T cell therapy including one patient with a partial response and seven patients with stable disease ranging from 8 weeks to 29 months (PMID: 28426845). 28426845
ERBB2 positive Advanced Solid Tumor predicted - sensitive GBR1302 Phase I Actionable In a Phase I trial, GBR 1302 treatment resulted in no radiological response, only prolonged (more than 4 months) stable disease in 10.5% (2/19) of patients with ERBB2 (HER2) positive advanced solid tumors (Annals of Oncology, Volume 29, Issue suppl_8, October 2018, mdy288.020; NCT02829372). detail...
ERBB2 positive stomach cancer sensitive MI130004 Preclinical - Cell line xenograft Actionable In a preclinical study, MI130004 inhibited proliferation of ERBB2 (HER2)-positive gastric cancer cells in culture, and led to decreased tumor volume and improved survival in cell line xenograft models (PMID: 29440297). 29440297
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 Inhibitor Neratinib + Paclitaxel Phase II Actionable In a Phase II trial, Nerlynx (neratinib) plus Taxol (paclitaxel) demonstrated similar efficacy to Herceptin (trastuzumab) plus Taxol (paclitaxel), with an median progression-free survival of 12.9 months, however, potentially decreased CNS metastasis risk, with an incidence of 8.3% (20/242) compared to 17.3% (41/237) in the Herceptin (trastuzumab) plus Taxol (paclitaxel) group (PMID: 27078022). 27078022
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive 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 predicted - sensitive MGAH22 Phase I Actionable In a Phase I trial, Margetuximab (MGAH22) treatment resulted in tumor reduction in 78% (18/23) of patients with ERBB2 (HER2)-positive breast cancer (PMID: 28119295). 28119295
ERBB2 positive stomach cancer sensitive HER2 Vaccine Preclinical - Patient cell culture Actionable In a preclinical study, ERBB2 (HER2)-specific cytotoxic T-cell lines generated from gastric cancer patients demonstrated activity against autologous ERBB2 (HER2)-expressing gastric cancer cells in culture (PMID: 9754653). 9754653
ERBB2 positive ovarian cancer sensitive MI130004 Preclinical - Cell line xenograft Actionable In a preclinical study, MI130004 inhibited proliferation of ERBB2 (HER2)-positive ovarian cancer cells in culture, and led to decreased tumor volume, reduced ERBB2 (HER2) expression, and improved survival in cell line xenograft models (PMID: 29440297). 29440297
ERBB2 positive Her2-receptor positive breast cancer sensitive CDX-3379 Preclinical Actionable In a preclinical study, CDX-3379 (KTN3379) inhibited tumor growth in xenograft models of ERBB2 (HER2)-positive breast cancer (PMID: 26880266). 26880266
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 Inhibitor Varlitinib Phase I Actionable In a Phase I expansion trial, 36% (5/14) of metastatic breast cancer patients positive for ERBB2 (HER2) demonstrated stable disease for up to 16 weeks when treated with Varlitinib (ARRY-334543) (Cancer Res May 1, 2009 69; 3603). detail...
ERBB2 positive stomach cancer predicted - sensitive MGAH22 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 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 ovarian cancer sensitive Hertuzumab-vc-MMAE 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 carcinoma sensitive SYD985 Preclinical - Cell culture Actionable In a preclinical study, SYD985 decreased survival of a ERBB2 (HER2)-positive gastric carcinoma cell line in culture (PMID: 25589493). 25589493
ERBB2 positive breast cancer predicted - sensitive SYD985 Phase I Actionable In a Phase I trial, SYD985 treatment resulted in an overall response of 33% (33/99) and a median progression-free survival of 9.4 months in patients with ERBB2 (HER2)-positive (50) or ERBB2 (HER2)-low (49) metastatic breast cancer (Journal of Clinical Oncology 36, no. 15_suppl (May 20 2018) 1014-1014; NCT02277717). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Entinostat + Lapatinib + Trastuzumab Phase I Actionable In a Phase I trial, combination treatment consisted of Entinostat, Tykerb (lapatinib) and Herceptin (trastuzumab) resulted in complete response in 9% (2/22), partial response in 14% (3/22), and stable disease in 27% (6/22) of ERBB2 (HER2) positive breast cancer patients (J Clin Oncol 34, 2016 (suppl; abstr 609)). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine + Docetaxel + Pertuzumab Phase Ib/II Actionable In a Phase Ib/II trial, Kadcyla (trastuzumab emtansine), Taxotere (docetaxel) and Perjeta (pertuzumab) combination treatment resulted in pathologic complete response in 60.3% (44/73) of patients with ERBB2 (HER2)-positive locally advanced breast cancer (PMID: 27052654). 27052654
ERBB2 positive Her2-receptor positive breast cancer sensitive HER2 Inhibitor Tucatinib Phase I Actionable In a Phase I trial, treatment with Tucatinib (ARRY-380) 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 Her2-receptor positive breast cancer sensitive Hertuzumab-vc-MMAE Preclinical - Cell culture Actionable In a preclinical study, Hertuzumab-vc-MMAE decreased viability of ERBB2 (HER2)-positive breast cancer cell lines in culture (PMID: 27509865). 27509865
ERBB2 positive Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine FDA approved 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). 23020162 24879797
ERBB2 positive Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine Phase III Actionable In a Phase III trial, Kadclya (trastuzumab emtansine) demonstrated improved median progression free survival and overall survival compared to Tykerb (lapatinib) and Xeloda (capecitabine) combination treatment in patients with ERBB2 (HER2) positive breast cancer, regardless of the expression level of Erbb2 (Her2), Egfr, and Her3, or PIK3CA mutation status (PMID: 26920887). 26920887
ERBB2 positive gastroesophageal junction adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Phase II Actionable In a Phase II clinical trial, monotherapy with Gilotrif (afatinib) resulted in a moderate clinical benefit in ERBB2 (HER2)-positive patients with either gastroesophageal junction adenocarcinoma, metastatic esophageal cancer, or gastric adenocarcinoma, demonstrating a tumor reduction in 25% (5/20) according to RECIST, an objective partial response in 10% (2/20), a median progression-free survival of 2 months, and a median overall survival of 7 months (PMID: 30463996; NCT01522768). 30463996
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Ado-trastuzumab emtansine + Tucatinib Phase Ib/II Actionable In a Phase Ib clinical trial, treatment with the combination of Tucatinib (ARRY-380) and Trastuzumab emtansine (T-DM1) resulted in partial response in 33% (11/33) and stable disease in 48% (16/33) and a clinical benefit rate of 58% (19/33) in patients with ERBB2 (HER2)-positive metastatic breast cancer (San Antonio Breast Cancer Symposium 2015, Abstract P4-14-20). detail...
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Ado-trastuzumab emtansine + Tucatinib Phase Ib/II Actionable In a Phase Ib trial, the combination of Tucatinib (ARRY-380) and Trastuzumab emtansine (T-DM1) demonstrated clinical activity in CNS metastases in patients with ERBB2 (HER2)-positive metastatic breast cancer, with 12.5% (1/8) evaluable patients achieving CNS complete response, 25% (2/8) partial CNS response, and 62.5% (5/8) CNS stable disease (San Antonio Breast Cancer Symposium 2015, Abstract P4-14-19). detail...
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Ado-trastuzumab emtansine + Tucatinib Phase Ib/II Actionable In a Phase Ib clinical trial, treatment with the combination of Tucatinib (ARRY-380) and Trastuzumab emtansine (T-DM1) resulted in an overall response rate of 47% (15/52) and median progression-free survival of 6.5 months in patients with ERBB2 (HER2)-positive metastatic breast cancer, including patients with CNS metastasis (J Clin Oncol 34, 2016 (suppl; abstr 513)). detail...
ERBB2 positive breast cancer sensitive ARX-788 Preclinical - Cell line xenograft Actionable In a preclinical study, an ERBB2 (HER2)-positive breast cancer 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 gastroesophageal junction adenocarcinoma no benefit MM-111 + Paclitaxel + Trastuzumab Phase II Actionable In a Phase II trial, Taxol (paclitaxel) and Herceptin (trastuzumab) treatment in combination with MM-111 did not improve progression free survival (9.6 weeks) and median overall survival (32.1 weeks) compared to without MM-111 (23.3 weeks, 56.1 weeks) in ERBB2 positive gastroesophageal junction cancer patients (J Clin Oncol 34, 2016 (suppl; abstr 4043)). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive Lapatinib + Palbociclib Preclinical Actionable In a preclinical study, the combination of Tykerb (lapatinib) and Ibrance (palbociclib) worked additively to suppress growth of ERBB2 (HER2)-positive breast cancer cell lines in culture (PMID: 25221644). 25221644
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive SB3 Phase III Actionable In a Phase III trial, SB3 treatment demonstrated safety, immunogenicity, and survival result similar to Herceptin (trastuzumab), resulted in event-free-survival rates of 92.2% and 91.6%, respectively, in patients with Erbb2 (Her2)-positive breast cancer (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 153PD; NCT02149524). detail...
ERBB2 positive breast carcinoma sensitive SYD985 Preclinical - Pdx & cell culture Actionable In a preclinical study, SYD985 decreased survival of ERBB2 (HER2)-positive breast carcinoma cell lines in culture, and inhibited tumor growth and induced tumor remission in cell line and patient-derived xenograft models of ERBB2 (HER2)-positive breast carcinoma, including models with low ERBB2 (HER2) expression (PMID: 25589493). 25589493
ERBB2 positive breast cancer sensitive MI130004 Preclinical - Cell line xenograft Actionable In a preclinical study, MI130004 inhibited proliferation of ERBB2 (HER2)-receptor positive breast cancer cells in culture, and led to decreased tumor volume and improved survival in cell line xenograft models (PMID: 29440297). 29440297
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive HER2 Inhibitor Capecitabine + Tucatinib Phase Ib/II Actionable In a Phase Ib trial, the combination of Tucatinib (ARRY-380) with other agents demonstrated clinical activity in central nervous system (CNS) metastases in patients with ERBB2 (HER2)-positive metastatic breast cancer, with 1/1 evaluable patient treated with Tucatinib (ARRY-380) and Capecitabine achieving CNS partial response (San Antonio Breast Cancer Symposium 2015, Abstract P4-14-19). detail...
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive ABP 980 Phase III Actionable In a Phase III trial, ABP 980 treatment demonstrated safety and efficacy similar to Herceptin (trastuzumab), with pathologic complete response rates of 48% and 40.5%, respectively, in patients with Erbb2 (Her2)-positive breast cancer (Ann Oncol 2017, Vol 28, Suppl 5, Abstract # 151PD; NCT01901146). detail...
ERBB2 positive breast cancer sensitive ADCT-502 Preclinical - Pdx Actionable In a preclinical study, ADCT-502 demonstrated anti-tumor activity in ERBB2 (HER2)-expressing breast cancer cell line and patient-derived xenograft (PDX) models, including PDX models expressing low levels of ERBB2 (HER2) (Eur J Cancer, 2016, Vol. 69, Supp1, S28). detail...
ERBB2 positive stomach cancer sensitive Lapatinib + Paclitaxel Phase III Actionable In a Phase III trial, second-line treatment using Tykerb (lapatinib) with paclitaxel demonstrated some efficacy in patients with HER2-positive advanced gastric cancer (PMID: 24868024). 24868024
ERBB2 positive breast cancer sensitive HER2 Inhibitor Ado-trastuzumab emtansine + Tucatinib Phase Ib/II Actionable In a Phase Ib/II trial, ERBB2 (HER2)-positive breast cancer patients demonstrated an objective response rate of 47% (16/34), including one complete response and fifteen partial responses, and a progression-free survival of 8.2 months when treated with a combination of Tucatinib (ARRY-380) and Kadcyla (trastuzumab emtansine) compared to 6.5 months with Herceptin (trastuzumab) and Perjeta (pertuzumab) treatment (PMID: 29955792; NCT01983501). 29955792
ERBB2 positive Her2-receptor positive breast cancer sensitive 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 gastric adenosquamous carcinoma no benefit Ado-trastuzumab emtansine Phase III Actionable In a Phase III trial, Kadcyla (trastuzumab emtansine) did not demonstrated efficacy benefit over Taxol (paclitaxel) on median overall survival (7.9 vs 8.6 months) in patients with previously treated ERBB2 (HER2)-positive locally advanced or metastatic gastric/gastroesophageal junction adenocarcinoma (J Clin Oncol 34, 2016 (suppl 4S; abstr 5)). detail...
ERBB2 pos PTEN dec exp Her2-receptor positive breast cancer decreased response Trastuzumab Clinical Study - Cohort Actionable In a clinical study, ERBB2 (HER2)-positive breast cancer patients with PI3K pathway activation resulting from low PTEN expression and/or PIK3CA activating mutations demonstrated decreased progression-free survival following treatment with Herceptin (trastuzumab) compared to patients without PI3K pathway activation (PMID: 17936563). 17936563
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 non-small cell lung carcinoma no benefit HER2 Inhibitor Neratinib Phase II 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 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 sensitive EKI-285 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 Advanced Solid Tumor resistant Lapatinib Preclinical 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 neg MET pos gastric adenocarcinoma no benefit Fluorouracil + Leucovorin + Onartuzumab + Oxaliplatin Phase III Actionable In a Phase III trial, addition of Onartuzumab to the mFOLFOX6 chemotherapy did not improve overall survival (HR=0.82, p=0.24), progression free survival (HR=0.90, p=0.43), or objective response rate (46.1% vs 40.6%) compared to placebo in patients with Erbb2 (Her2)-negative, Met-positive gastroesophageal adenocarcinoma (PMID: 27918764). 27918764
ERBB2 neg MET pos gastroesophageal junction adenocarcinoma no benefit Onartuzumab Phase III Actionable In a Phase III trial, addition of Onartuzumab to mFOLFOX6 did not improve clinical outcome compared to mFOLFOX6 alone in MET-positive, ERBB2 (HER2)-positive gastric/gastroesophageal junction adenocarcinoma patients (J Clin Oncol 33, 2015 (suppl; abstr 4012)). detail...
ERBB2 neg MET pos gastric adenocarcinoma no benefit Rilotumumab Phase III Actionable In a Phase III trial, addition of Rilotumumab to chemotherapy consisted of epirubicin, cisplatin and capecitabine (ECX) resulted in statistically significantly worse overall survival (9.6 vs 11.5 months) compared to ECX alone in MET-positive, ERBB2 (HER2)-positive gastric/gastroesophageal junction adenocarcinoma patients (J Clin Oncol 33, 2015 (suppl; abstr 4000)). detail...
ERBB2 neg MET pos gastric adenocarcinoma no benefit Onartuzumab Phase III Actionable In a Phase III trial, addition of Onartuzumab to mFOLFOX6 did not improve clinical outcome compared to mFOLFOX6 alone in MET-positive, ERBB2 (HER2)-positive gastric/gastroesophageal junction adenocarcinoma patients (J Clin Oncol 33, 2015 (suppl; abstr 4012)). detail...
ERBB2 neg MET pos gastroesophageal junction adenocarcinoma no benefit Rilotumumab Phase III Actionable In a Phase III trial, addition of Rilotumumab to chemotherapy consisted of epirubicin, cisplatin and capecitabine (ECX) resulted in statistically significantly worse overall survival (9.6 vs 11.5 months) compared to ECX alone in MET-positive, ERBB2 (HER2)-positive gastric/gastroesophageal junction adenocarcinoma patients (J Clin Oncol 33, 2015 (suppl; abstr 4000)). detail...
ERBB2 neg MET pos esophagus adenocarcinoma no benefit Fluorouracil + Leucovorin + Onartuzumab + Oxaliplatin Phase III Actionable In a Phase III trial, addition of Onartuzumab to the mFOLFOX6 chemotherapy did not improve overall survival (HR=0.82, p=0.24), progression free survival (HR=0.90, p=0.43), or objective response rate (46.1% vs 40.6%) compared to placebo in patients with Erbb2 (Her2)-negative, Met-positive gastroesophageal adenocarcinoma (PMID: 27918764). 27918764
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 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 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 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 V697L Advanced Solid Tumor predicted - sensitive HER2 Inhibitor Neratinib Phase II 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 endometrial cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 amp ERBB2 L755S Her2-receptor positive breast cancer resistant Lapatinib + Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, breast cancer cell lines with ERBB2 (HER2) amplification and expressing ERBB2 L755S demonstrated decreased inhibition proliferation compared to cells expressing wild-type ERBB2 (HER2) following treatment with Herceptin (trastuzumab) and Tykerb (lapatinib) (PMID: 30301790). 30301790
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer resistant Lapatinib + Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, expression of ERBB2 (HER2) L755S conferred resistance to Tykerb (lapatinib) plus Herceptin (trastuzumab) combination therapy in ESR1-positive/ERBB2 (HER2)-positive breast cancer cells with ERBB2 amplification in culture (PMID: 28487443). 28487443
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell line xenograft Actionable In a preclinical study, Gilotrif (afatinib) inhibited growth of ESR1-positive/ERBB2 (HER2)-positive breast cancer cell lines with ERBB2 amplification and harboring ERBB2 L755S in culture, and inhibited tumor growth in xenograft models (PMID: 28487443). 28487443
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer resistant Lapatinib Preclinical - Cell culture Actionable In a preclinical study, breast cancer cell lines with ERBB2 (HER2) amplification and expressing ERBB2 L755S demonstrated decreased inhibition of ERBB2 (HER2) signaling and proliferation compared to cells expressing wild-type ERBB2 (HER2) following treatment with Tykerb (lapatinib) (PMID: 30301790). 30301790
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer resistant Lapatinib Preclinical - Cell line xenograft Actionable In a preclinical study, ERBB2 (HER2) L755S was associated with reactivation of ERBB2 (HER2) signaling and acquired resistance to Tykerb (lapatinib) in ESR1-positive/ERBB2 (HER2)-positive breast cancer cell lines with ERBB2 amplification in culture and in xenograft models (PMID: 28487443). 28487443
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer resistant Pertuzumab + Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, expression of ERBB2 (HER2) L755S conferred resistance to Perjeta (pertuzumab) plus Herceptin (trastuzumab) combination therapy in ESR1-positive/ERBB2 (HER2)-positive breast cancer cells with ERBB2 amplification in culture (PMID: 28487443). 28487443
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer decreased response Ado-trastuzumab emtansine Preclinical - Cell culture Actionable In a preclinical study, expression of ERBB2 (HER2) L755S resulted in decreased sensitivity to treatment with Kadcyla (trastuzumab emtansine) in ESR1-positive/ERBB2 (HER2)-positive breast cancer cells with ERBB2 amplification in culture (PMID: 28487443). 28487443
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of ESR1-positive/ERBB2 (HER2)-positive breast cancer cell lines with ERBB2 amplification and harboring ERBB2 L755S in culture (PMID: 28487443). 28487443
ERBB2 amp ERBB2 L755S 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) L755S, and breast cancer cell lines with ERBB2 (HER2) amplification and expressing ERBB2 (HER2) L755S demonstrated sensitivity to Nerlynx (neratinib) in culture (PMID: 30301790). 30301790
ERBB2 amp ERBB2 L755S Her2-receptor positive breast cancer decreased response Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, breast cancer cell lines with ERBB2 (HER2) amplification and expressing ERBB2 L755S demonstrated decreased inhibition proliferation compared to cells expressing wild-type ERBB2 (HER2) following treatment with Herceptin (trastuzumab) (PMID: 30301790). 30301790
ERBB2 L755S 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) L755S in culture (PMID: 26243863). 26243863
ERBB2 L755S colon cancer 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, resulting in a clinical benefit rate of 31% (5/16), with 1 complete response, 1 partial response in a patient with ERBB2 (HER2) L755S, and 3 patients achieving stable disease for 24 weeks or more (PMID: 28679771). 28679771
ERBB2 L755S biliary tract cancer no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease in one and stable disease in another patient with biliary tract cancer harboring ERBB2 (HER2) L755S (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755S colorectal cancer resistant Cetuximab Preclinical Actionable In a preclinical study, colorectal cancer cells over expressing ERBB2 (HER2) L755S were resistant to Erbitux (cetuximab) in culture (PMID: 26243863). 26243863
ERBB2 L755S colorectal cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) inhibited growth of colorectal cancer cells over expressing ERBB2 (HER2) L755S in culture (PMID: 26243863). 26243863
ERBB2 L755S Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in complete response in 1 patient, partial response in 1 patient, stable disease in 2 patients, and progressive disease in 4 patients with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) L755S (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755S non-small cell lung carcinoma predicted - sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 12.7 months in a patient with non-small cell lung cancer harboring ERBB2 (HER2) L755S (PMID: 29420467; NCT01953926). 29420467
ERBB2 L755S colon cancer sensitive Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) inhibited colony formation in transformed mouse colon epithelial cells over expressing ERBB2 (HER2) L755S in culture (PMID: 26243863). 26243863
ERBB2 L755S Advanced Solid Tumor sensitive HER2 Inhibitor XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) L755S in culture (PMID: 18413839). 18413839
ERBB2 L755S Advanced Solid Tumor resistant Lapatinib Preclinical - Cell culture Actionable In a preclinical study, transformed cells expressing ERBB2 L755S demonstrated resistance when treated with Tykerb (lapatinib) in culture (PMID: 22046346). 23220880 22046346
ERBB2 L755S Her2-receptor positive breast cancer resistant Lapatinib Preclinical - Cell culture Actionable In a preclinical study, expression of ERBB2 (HER2) L755S conferred resistance to Tykerb (lapatinib) in ERBB2 (HER2)-positive breast cancer cell lines in culture (PMID: 28487443). 28487443
ERBB2 L755S 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) L755S in culture (PMID: 26243863). 26243863
ERBB2 L755S colorectal cancer resistant Panitumumab Preclinical Actionable In a preclinical study, colorectal cancer cells over expressing ERBB2 (HER2) L755S were resistant to Vectibix (panitumumab) in culture (PMID: 26243863). 26243863
ERBB2 L755S Advanced Solid Tumor sensitive WZ4002 Preclinical Actionable In a preclinical study, WZ4002 inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) L755S in culture (PMID: 22046346). 22046346
ERBB2 L755S Advanced Solid Tumor sensitive EKI-285 Preclinical Actionable In a preclinical study, EKI-285 (CL-387785) inhibited proliferation of transformed cell lines expressing ERBB2 (HER2) L755S in culture (PMID: 22046346). 22046346
ERBB2 L755S Advanced Solid Tumor resistant HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, transformed cell lines expressing ERBB2 (HER2) L755S demonstrated resistance to AEE788 in culture, except at very high doses (PMID: 22046346). 22046346
ERBB2 L755S breast cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, treatment with Nerlynx (neratinib) resulted in growth inhibition in transformed human breast cell lines expressing ERBB2 (HER2) L755S in culture (PMID: 23220880). 23220880
APC Q1429fs BRAF N581S ERBB2 L755S rectum adenocarcinoma no benefit Fluorouracil + Leucovorin + Trastuzumab Case Reports/Case Series Actionable In a clinical case study, a rectal adenocarcinoma patient harboring APC Q1429fs, BRAF N581S, and ERBB2 L755S did not respond to Herceptin (trastuzumab) treatment in combination with Fluorouracil and Wellcovorin (leucovorin) (PMID: 27626067). 27626067
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 adenocarcinoma predicted - sensitive 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 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 amp ERBB2 R456C 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 K753E breast cancer resistant 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 K753E breast cancer resistant 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 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 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 - sensitive 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 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 - 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 non-small cell lung carcinoma no benefit HER2 Inhibitor Neratinib Phase II 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 - sensitive 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 biliary tract cancer no benefit HER2 Inhibitor Neratinib Phase II 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 adenocarcinoma predicted - sensitive 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 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 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 Advanced Solid Tumor predicted - resistant 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 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 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 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 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 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 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 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 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 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 L869R breast cancer resistant Lapatinib Preclinical - Cell line xenograft Actionable In a preclinical study, transformed breast cancer cells over expressing ERBB2 (HER2) L869R were resistant to Tykerb (lapatinib) in culture, formed tumors and metastasized readily in xenograft animal models (PMID: 27900369). 27900369
ERBB2 L869R lung adenocarcinoma predicted - resistant Lapatinib Case Reports/Case Series Actionable In a clinical case study, ERBB2 (HER2) L869R was identified in the lymph node metastasis from a lung adenocarcinoma patient that progressed on Tykerb (lapatinib) therapy (PMID: 27900369). 27900369
ERBB2 L869R breast cancer sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, Nerlynx (neratinib) inhibited ERBB2 (HER2) phosphorylation and growth of transformed breast epithelial cells expressing ERBB2 (HER2) L869R in culture (PMID: 28274957). 28274957
ERBB2 L869R breast cancer 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, resulting in a clinical benefit rate of 31% (5/16), with 1 complete response, 1 partial response, and 3 patients achieving stable disease for 24 weeks or more, which included a patient harboring ERBB2 (HER2) L869R (PMID: 28679771). 28679771
ERBB2 L869R breast cancer sensitive HER inhibitor (Pan) Afatinib Preclinical - Cell culture Actionable In a preclinical study, Gilotrif (afatinib) inhibited ERBB2 (HER2) phosphorylation and growth of transformed breast epithelial cells expressing ERBB2 (HER2) L869R in culture (PMID: 28274957). 28274957
ERBB2 L869R Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in partial response with a progression-free survival of 3.6 months in a patient with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) L869R (PMID: 29420467; NCT01953926). 29420467
ERBB2 H878Y Advanced Solid Tumor sensitive 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 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 L726I breast cancer resistant Gefitinib Preclinical Actionable In a preclinical study, an ERBB2 (HER2) L726I mutation was detected in a murine breast cancer cell line that acquired resistance to Iressa (gefitinib) in culture (PMID: 17638894). 17638894
ERBB2 G292R urinary bladder cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 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 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 L785F Advanced Solid Tumor sensitive HER2 Inhibitor XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) L785F in culture (PMID: 18413839). 18413839
ERBB2 L785F Advanced Solid Tumor decreased response 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 D769N cervical cancer no benefit HER2 Inhibitor Neratinib Phase II 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 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 gastroesophageal junction adenocarcinoma predicted - resistant HER2 Inhibitor Neratinib Phase II 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 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 urinary bladder cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 breast cancer sensitive 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 amp ERBB2 D769Y Her2-receptor positive breast cancer resistant 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 amp ERBB2 D769Y 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 amp ERBB2 D769Y Her2-receptor positive breast cancer resistant 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 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 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 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 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 P780L Advanced Solid Tumor sensitive HER2 Inhibitor XL647 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 Lapatinib Preclinical Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) P780L demonstrated resistance to treatment with Tykerb (lapatinib) (PMID: 18413839). 18413839
ERBB2 N813D lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Phase II 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 R896C breast cancer sensitive Lapatinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 R896C reverted to normal morphology in culture upon Tykerb (lapatinib) treatment (PMID: 23220880). 23220880
ERBB2 R896C breast cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 (HER2) R896C reverted to normal morphology in culture upon Nerlynx (neratinib) treatment (PMID: 23220880). 23220880
ERBB2 R896C breast cancer sensitive Trastuzumab Preclinical Actionable In a preclinical study, transformed human breast cell lines expressing ERBB2 R896C reverted to normal morphology in culture upon Herceptin (trastuzumab) treatment (PMID: 23220880). 23220880
ERBB2 amp ERBB2 T798M breast cancer resistant 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 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 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 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 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 Advanced Solid Tumor resistant 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 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 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 Her2-receptor positive breast cancer resistant 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 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 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 Advanced Solid Tumor sensitive EKI-285 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 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 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 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 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 non-small cell lung 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 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 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 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 non-small cell lung carcinoma sensitive 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 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 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 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 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 non-small cell lung 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 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 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 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 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 non-small cell lung carcinoma predicted - sensitive Trastuzumab 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 non-small cell lung carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical study, treatment with Gilotrif (afatinib) resulted in an objective response rate of 33% (2/6) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies (PMID: 28167203). 28167203
ERBB2 mutant non-small cell lung 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 non-small cell lung 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 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 R784G colorectal cancer predicted - resistant Cetuximab Case Reports/Case Series Actionable In a clinical study, ERBB2 R784G was identified in all 11 colorectal cancer patients who were resistant to Erbitux (cetuximab) treatment, and was associated with decreased survival rate (PMID: 30549033). 30549033
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 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 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 adenocarcinoma predicted - sensitive 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 non-small cell lung carcinoma predicted - sensitive 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 biliary tract cancer predicted - sensitive 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 Advanced Solid Tumor predicted - sensitive 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 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 G778A colorectal cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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) G778A (PMID: 29420467; NCT01953926). 29420467
ERBB2 N857S Advanced Solid Tumor decreased response 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 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 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 Phase II 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 breast cancer sensitive 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 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 biliary tract cancer no benefit HER2 Inhibitor Neratinib Phase II 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 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 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 gastroesophageal junction adenocarcinoma predicted - resistant HER2 Inhibitor Neratinib Phase II 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 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 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 endometrial cancer no benefit HER2 Inhibitor Neratinib Phase II 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 colon cancer resistant 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 Phase II 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 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 colorectal cancer sensitive 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 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 urinary bladder cancer no benefit HER2 Inhibitor Neratinib Phase II 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 breast cancer sensitive 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 amp ERBB2 V777L 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 L841V Her2-receptor negative breast cancer no benefit HER2 Inhibitor Neratinib Phase II 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 Phase II 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 M774delinsWLV lung adenocarcinoma sensitive HER inhibitor (Pan) Dacomitinib Phase II 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 Y803N Advanced Solid Tumor sensitive HER2 Inhibitor XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) Y803N in culture (PMID: 18413839). 18413839
ERBB2 Y803N Advanced Solid Tumor decreased response 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 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 amp ERBB2 Y772_A775dup 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 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 decreased response 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 non-small cell lung 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 non-small cell lung 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 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 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 Tucatinib (ARRY-380) in culture (PMID: 30527195). 30527195
ERBB2 Y772_A775dup urinary bladder cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 Advanced Solid Tumor sensitive 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 decreased response 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 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 non-small cell lung 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 non-small cell lung 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 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 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 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 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 Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II 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 Advanced Solid Tumor sensitive 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 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 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 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 non-small cell lung 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 lung adenocarcinoma predicted - sensitive HER inhibitor (Pan) Poziotinib Phase II Actionable In a Phase II trial, Poziotinib (HM781-36B) treatment resulted in 1 partial response, 1 stable disease, and 1 progressive disease in 3 patients with lung adenocarcinoma harboring ERBB2 (HER2) Y772_A775dup (reported as A775_G776insYVMA) (PMID: 30149884; NCT02979821). 30149884
ERBB2 Y772_A775dup lung adenocarcinoma conflicting 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 S310Y gastroesophageal junction adenocarcinoma predicted - resistant HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 0.8 month in a patient with gastroesophageal cancer harboring ERBB2 (HER2) S310Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310Y urinary bladder cancer no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease in 2 patients and progressive disease in 2 patients with bladder cancer harboring ERBB2 (HER2) S310Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310Y colorectal cancer sensitive Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) delayed tumor growth in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) S310Y (PMID: 26243863). 26243863
ERBB2 S310Y cervical cancer predicted - resistant HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in progressive disease with a progression-free survival of 0.5 month in a patient with cervical cancer harboring ERBB2 (HER2) S310Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310Y lung squamous cell carcinoma predicted - sensitive HER inhibitor (Pan) Afatinib Case Reports/Case Series Actionable In a clinical case study, Gilotrif (afatinib) treatment resulted in stable disease over 8-months in a patient with advanced squamous cell lung carcinoma harboring ERBB2 (HER2) S310Y (PMID: 30584328). 30584328
ERBB2 S310Y colorectal cancer resistant Cetuximab Preclinical Actionable In a preclinical study, xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) S310Y were resistant to Erbitux (cetuximab) (PMID: 26243863). 26243863
ERBB2 S310Y colorectal cancer sensitive Lapatinib Preclinical Actionable In a preclinical study, Tykerb (lapatinib) delayed tumor growth in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) S310Y (PMID: 26243863). 26243863
ERBB2 S310Y endometrial cancer no benefit HER2 Inhibitor Neratinib Phase II Actionable In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in stable disease with a progression-free survival of 9.6 months in a patient with endometrial cancer harboring ERBB2 (HER2) S310Y (PMID: 29420467; NCT01953926). 29420467
ERBB2 S310Y colorectal cancer sensitive HER2 Inhibitor Neratinib + Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) and Nerlynx (neratinib) combination treatment resulted in tumor regression in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) S310Y (PMID: 26243863). 26243863
ERBB2 S310Y colorectal cancer sensitive HER2 Inhibitor Neratinib Preclinical Actionable In a preclinical study, Nerlynx (neratinib) delayed tumor growth in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) S310Y (PMID: 26243863). 26243863
ERBB2 S310Y colorectal cancer sensitive Lapatinib + Trastuzumab Preclinical Actionable In a preclinical study, Herceptin (trastuzumab) and Tykerb (lapatinib) combination treatment resulted in tumor regression in xenograft models of patient derived colorectal cancer cells harboring ERBB2 (HER2) S310Y (PMID: 26243863). 26243863
ERBB2 E812K Advanced Solid Tumor decreased response 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 Phase II 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 XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) E812K in culture (PMID: 18413839). 18413839
ERBB2 L915M Advanced Solid Tumor sensitive HER2 Inhibitor XL647 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 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 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 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 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 V773A Advanced Solid Tumor decreased response 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 P761del endometrial cancer predicted - resistant HER2 Inhibitor Neratinib Phase II 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 V773L breast cancer sensitive 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 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 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 over exp MET amp stomach cancer predicted - resistant Trastuzumab Clinical Study - Cohort Actionable In a clinical study (AMNESIA-1), assessment of pre-treatment tissue from ERBB2 (HER2)-positive gastric or gastroesophageal cancer patients (defined as HER2 IHC 3+ or HER2 IHC 2+/ISH+) identified MET amplification in 1 patient demonstrating primary resistance to Herceptin (trastuzumab) (PMID: 29208673). 29208673
BRAF V600E ERBB2 over exp KRAS A146V stomach cancer predicted - resistant 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 KRAS A146V and BRAF V600E in 1 patient demonstrating primary resistance to Herceptin (trastuzumab) (PMID: 29208673). 29208673
ERBB2 over exp KRAS G13D stomach cancer predicted - resistant 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 KRAS G13D in 1 patient demonstrating primary resistance to Herceptin (trastuzumab) (PMID: 29208673). 29208673
ERBB2 over exp MET amp MET R988C stomach cancer predicted - resistant Trastuzumab Clinical Study - Cohort Actionable n a clinical study (AMNESIA-1), assessment of pre-treatment tumor samples from ERBB2 (HER2)-positive (defined as HER2 IHC 3+ or HER2 IHC 2+/ISH+) gastric or gastroesophageal cancer patients identified MET R988C and amplification of MET in 1 patient demonstrating primary resistance to Herceptin (trastuzumab) (PMID: 29208673). 29208673
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 stomach cancer sensitive 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 Her2-receptor positive breast cancer predicted - sensitive MGAH22 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 stomach cancer sensitive HER2 Inhibitor S-222611 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 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 Ado-trastuzumab emtansine FDA approved 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 23020162
ERBB2 over exp uterine cancer no benefit 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 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 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 gastric adenocarcinoma sensitive Trastuzumab Guideline Actionable Herceptin (trastuzumab), in combination with fluoropyrimidine and cisplatin, or other chemotherapy agents, 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 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 colorectal cancer predicted - sensitive 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 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 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 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 ovarian cancer predicted - sensitive 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 stomach cancer sensitive 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 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 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 gastroesophageal junction adenocarcinoma sensitive HER2 Inhibitor S-222611 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 stomach cancer predicted - sensitive 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 stomach cancer sensitive 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 cholangiocarcinoma predicted - sensitive 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 gastric adenocarcinoma predicted - sensitive 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 carcinoma predicted - sensitive MGAH22 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 Advanced Solid Tumor predicted - sensitive 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 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 Her2-receptor positive breast cancer sensitive trastuzumab and hyaluronidase-oysk injection FDA approved 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). 22884505
ERBB2 over exp breast cancer sensitive 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 stomach cancer sensitive HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, Tucatinib (ARRY-380) 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 urinary bladder cancer predicted - sensitive 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 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 salivary gland cancer predicted - sensitive 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 Her2-receptor positive breast cancer sensitive PF-05280014 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 stomach cancer sensitive 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 gastroesophageal junction adenocarcinoma sensitive 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 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 pancreatic cancer predicted - sensitive 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 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 stomach cancer sensitive 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 biliary tract cancer predicted - sensitive 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 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 stomach cancer sensitive 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 pancreatic carcinoma predicted - sensitive 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 breast cancer sensitive 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 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 esophagus adenocarcinoma sensitive 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 esophageal adenocarcinoma patients (NCCN.org) detail...
ERBB2 over exp biliary tract cancer predicted - sensitive 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 non-small cell lung carcinoma predicted - sensitive 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 Her2-receptor positive breast cancer sensitive 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 amp ERBB2 L313I 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 S783P Advanced Solid Tumor resistant 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 XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) S783P in culture (PMID: 18413839). 18413839
ERBB2 T733I Advanced Solid Tumor sensitive HER2 Inhibitor XL647 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 no benefit HER2 Inhibitor Neratinib Phase II 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 Lapatinib Preclinical Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) T733I demonstrated resistance to treatment with Tykerb (lapatinib) (PMID: 18413839). 18413839
ERBB2 E719G Advanced Solid Tumor decreased response 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 E719G Advanced Solid Tumor sensitive HER2 Inhibitor XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) E719G in culture (PMID: 18413839). 18413839
ERBB2 amp KRAS wild-type colorectal cancer no benefit Panitumumab Clinical Study - Cohort Actionable In a retrospective analysis, 17.6% (3/17) of colorectal cancer patients with wild-type KRAS who did not respond to treatment with either Erbitux (cetuximab) or Vectibix (panitumumab) were found to harbor ERBB2 (HER2) amplifications, while no patients in the KRAS wild-type therapy-responsive cohort were found to have ERBB2 (HER2) amplification or overexpression (n=14) (PMID: 22586653). 22586653
ERBB2 amp KRAS wild-type colorectal cancer no benefit Cetuximab Clinical Study - Cohort Actionable In a retrospective analysis, 17.6% (3/17) of colorectal cancer patients with wild-type KRAS who did not respond to treatment with either Erbitux (cetuximab) or Vectibix (panitumumab) were found to harbor ERBB2 (HER2) amplifications, while no patients in the KRAS wild-type therapy-responsive cohort were found to have ERBB2 (HER2) amplification or overexpression (n=14) (PMID: 22586653). 22586653
ROS1 fusion ERBB2 amp NOTCH1 amp SRC amp STK11 amp non-small cell lung carcinoma predicted - resistant Crizotinib Case Reports/Case Series Actionable In a clinical study, a non-small cell lung carcinoma patient harboring a ROS1 fusion treated with Xalkori (crizotinib) responded, but eventually progressed, and was subsequently found to harbor presumed resistance alterations, including amplification of SRC, ERBB2 (HER2), STK11, and NOTCH1 (PMID: 29636358). 29636358
ERBB2 amp MET amp gastric adenocarcinoma predicted - resistant AMG 337 Case Reports/Case Series Actionable In a clinical case study, a patient with ERBB2 (HER2) and MET co-amplified gastric adenocarcinoma did not respond to AMG 337 therapy (PMID: 26432108). 26432108
ERBB2 amp MET amp gastric adenocarcinoma predicted - resistant Bevacizumab + Capecitabine + Oxaliplatin + Trastuzumab Case Reports/Case Series Actionable In a clinical case study, a patient with ERBB2 (HER2) amplified gastric adenocarcinoma progressed rapidly when treated with Herceptin (trastuzumab) with Xeloda (capecitabine), Eloxatin (oxaliplatin), and Avastin (bevacizumab), and reprofiling of the tumor revealed co-amplification of MET (PMID: 26432108). 26432108
ERBB2 amp MET amp esophageal carcinoma resistant Crizotinib Preclinical - Cell culture Actionable In a preclinical study, a human esophageal carcinoma cell line harboring amplification of ERBB2 (HER2) and MET was resistant to Xalkori (crizotinib) in culture (PMID: 26432108). 26432108
ERBB2 amp MET amp esophageal carcinoma resistant Lapatinib Preclinical Actionable In a preclinical study, a human esophageal carcinoma cell line harboring amplification of ERBB2 and MET was resistant to Tykerb (lapatinib) in culture (PMID: 26432108). 26432108
ERBB2 amp MET amp esophagus adenocarcinoma sensitive Crizotinib + Lapatinib Preclinical - Cell culture Actionable In a preclinical study, the combination of Xalkori (crizotinib) and Tykerb (lapatinib) worked synergistically to inhibit growth of an esophageal adenocarcinoma cell line with ERBB2 (HER2) and MET amplification in culture (PMID: 27595477). 27595477
ERBB2 amp MET amp gastroesophageal junction adenocarcinoma sensitive Crizotinib + Lapatinib Preclinical - Cell culture Actionable In a preclinical study, the combination of Xalkori (crizotinib) and Tykerb (lapatinib) inhibited the growth of gastroesophageal adenocarcinoma cells with ERBB2 (HER2) and MET amplification in culture (PMID: 25350844). 25350844
ERBB2 amp MET amp gastric adenocarcinoma predicted - resistant Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab Case Reports/Case Series Actionable In a clinical case study, a patient with ERBB2 (HER2) and MET co-amplified gastric adenocarcinoma was insensitive to Herceptin (trastuzumab) and FOLFOX combination treatment (PMID: 26432108). 26432108
ERBB2 amp MET amp esophageal carcinoma sensitive Crizotinib + Lapatinib Preclinical - Cell culture Actionable In a preclinical study, a human esophageal carcinoma cell line harboring amplification of ERBB2 (HER2) and MET was sensitive to inhibition by Tykerb (lapatinib) and Xalkori (crizotinib) in culture (PMID: 26432108). 26432108
ERBB2 amp MET amp gastric adenocarcinoma predicted - sensitive Crizotinib + Paclitaxel + Trastuzumab Case Reports/Case Series Actionable In a clinical case study, a patient with ERBB2 (HER2) and MET co-amplified gastric adenocarcinoma had near complete regression of the disease after 2 months of treatment with Herceptin (trastuzumab), Xalkori (crizotinib) and weekly Taxol (paclitaxel) (PMID: 26432108). 26432108
ERBB2 amp FGFR2 amp esophagus adenocarcinoma sensitive AZD4547 + Lapatinib Preclinical - Cell culture Actionable In a preclinical study, the combination of AZD-4547 and Tykerb (lapatinib) worked synergistically to inhibit growth of an esophageal adenocarcinoma cell line with ERBB2 (HER2) and FGFR2 amplification in culture (PMID: 27595477). 27595477
ROS1 fusion ERBB2 amp FGFR3 amp RET amp non-small cell lung carcinoma predicted - resistant Crizotinib Case Reports/Case Series Actionable In a clinical study, a non-small cell lung carcinoma patient harboring a ROS1 fusion treated with Xalkori (crizotinib) responded, but eventually progressed, and was subsequently found to harbor presumed resistance alterations, including amplification of ERBB2 (HER2), FGFR3, and RET (PMID: 29636358). 29636358
ERBB2 amp stomach cancer sensitive HER inhibitor (Pan) Poziotinib Preclinical Actionable In a preclinical study, Poziotinib suppressed cell growth, decreased phosphorylation of downstream signaling molecules, and induced apoptosis of human gastric cancer cells harboring ERBB2 (HER2) amplification (PMID: 21306821). 21306821
ERBB2 amp colorectal cancer resistant Cetuximab Clinical Study Actionable In a clinical study, ERBB2 (HER2) amplification was associated with resistance to Erbitux (cetuximab) in colorectal cancer patients (PMID: 21900593). 21900593
ERBB2 amp colorectal cancer sensitive Cetuximab + Lapatinib Preclinical - Pdx Actionable In a preclinical study, the combination of Erbitux (cetuximab) and Tykerb (lapatinib) induced tumor regression in patient-derived xenograft (PDX) models of colorectal cancer with ERBB2 (HER2) amplification (PMID: 22586653). 22586653
ERBB2 amp 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 amp breast cancer sensitive Torkinib Preclinical - Cell culture Actionable In a preclinical study, ERBB2 (HER2) amplified breast cancer cells treated with Torkinib (PP242) demonstrated some efficacy in culture including reduced phosphorylation of S6 and Akt, apoptosis, and decreased cell growth (PMID: 27197158). 27197158
ERBB2 amp urinary bladder cancer sensitive HER inhibitor (Pan) Afatinib Phase II Actionable In a Phase II clinical trial, patients with ERBB2 (HER2) amplified urothelial carcinoma had improved progression free survival when treated with Gilotrif (afatinib), and median PFS was 6.6 months for patients with ERBB2 or ERBB3 alterations relative to 1.4 months for patients lacking alterations (PMID: 27044931). 27044931
ERBB2 amp colorectal cancer predicted - sensitive 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 amp colorectal cancer resistant Trastuzumab Preclinical Actionable In a preclinical study, colorectal cancer tumorgrafts with ERBB2 (HER2) amplification demonstrated resistance to Herceptin (trastuzumab) treatment in animal models (PMID: 26296355). 26296355
ERBB2 amp Advanced Solid Tumor predicted - sensitive 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 amp Her2-receptor positive breast cancer predicted - sensitive BGB-283 Preclinical - Cell culture Actionable In a preclinical study, BGB-283 inhibited proliferation of ERBB2 (HER2) amplified breast cancer cells in culture (PMID: 26208524). 26208524
ERBB2 amp parotid gland cancer predicted - sensitive Ado-trastuzumab emtansine Phase II Actionable In a Phase II (MATCH) trial, Kadcyla (trastuzumab emtansine) treatment resulted in partial response in a patient with ERBB2 (HER2) amplified salivary duct carcinoma of the parotid gland and a patient with ERBB2 (HER2) amplified squamous cell carcinoma of the parotid gland (J Clin Oncol 36, 2018 (suppl; abstr 100); NCT02465060). detail...
ERBB2 amp Her2-receptor positive breast cancer sensitive CDX-3379 + Trastuzumab Preclinical Actionable In a preclinical study, the combination of Herceptin (trastuzumab) and CDX-3379 (KTN3379) inhibited tumor growth in xenograft models of ERBB2 (HER2)-amplified breast cancer, with increased efficacy compared to KTN3379 alone (PMID: 26880266). 26880266
ERBB2 amp colorectal adenocarcinoma predicted - sensitive Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a clinical case study, a patient with metastatic colorectal adenocarcinoma harboring ERBB2 (HER2) amplification demonstrated clinical benefit with stable disease in the primary tumor for 7 months following treatment with Kadcyla (trastuzumab emtansine) (PMID: 28040715). 28040715
ERBB2 amp Her2-receptor positive breast cancer sensitive Trastuzumab Clinical Study - Meta-analysis Actionable In a meta-analysis, breast cancer patients with >12 copies of ERBB2 (HER2) had a better response to Herceptin (trastuzumab) than patients with 6-12 copies of ERBB2 (HER2) (PMID: 24691421). 24691421
ERBB2 amp biliary tract cancer predicted - sensitive 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 amp stomach cancer predicted - sensitive HER inhibitor (Pan) Afatinib + Trastuzumab Case Reports/Case Series Actionable In a Phase II clinical trial, a gastric cancer patient with ERBB2 (HER2) amplification who progressed on previous therapy demonstrated a 22% regression in a metastatic site when treated with a combination of Gilotrif (afatinib) and Herceptin (trastuzumab) (PMID: 30463996; NCT01522768). 30463996
ERBB2 amp Her2-receptor positive breast cancer sensitive Lapatinib + S63845 Preclinical - Cell culture Actionable In a preclinical study, the combination of Tykerb (lapatinib) and S63845 demonstrated synergy in an ERBB2 (HER2)-amplified breast cancer cell line in culture, resulting in decreased cell viability (PMID: 28768804). 28768804
ERBB2 amp breast cancer sensitive Buparlisib Preclinical - Cell line xenograft Actionable In a preclinical study, a breast cancer cell line xenograft model harboring ERBB2 (HER2) amplification demonstrated tumor regression within the mammary fat pad when treated with Buparlisib (BKM120) (PMID: 28539475). 28539475
ERBB2 amp breast cancer predicted - sensitive HER2 Inhibitor Neratinib + Temsirolimus Phase I Actionable In a Phase I clinical trial, Nerlynx (neratinib) administered with Torisel (temsirolimus) was tolerable and demonstrated antitumor activity in ERBB2 (HER2)-amplified breast cancer resistant to (Herceptin) trastuzumab (PMID: 24323026). 24323026
ERBB2 amp gastric adenocarcinoma no benefit Lapatinib Phase III Actionable In a Phase III clinical trial, the addition of Tykerb (lapatinib) to Xeloda (capecitabine) and Eloxatin (oxaliplatin) combination treatment did not significantly prolong overall survival compared to placebo, but did improve progression-free survival and response rate in gastric adenocarcinoma patients harboring ERBB2 amplification (PMID: 26628478). 26628478
ERBB2 amp gastroesophageal junction adenocarcinoma sensitive Trastuzumab FDA approved 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
ERBB2 amp uterine corpus serous adenocarcinoma sensitive HER2 Inhibitor Neratinib + Taselisib Preclinical - Cell culture Actionable In a preclinical study, the combination of Taselisib (GDC-0032) and Nerlynx (neratinib) resulted in a synergistic effect, demonstrating greater cell growth inhibitory activity in uterine serous carcinoma cells harboring ERBB2 (HER2) amplification compared to either agent alone (PMID: 26333383). 26333383
ERBB2 amp lung cancer predicted - sensitive HER2 Inhibitor TAS0728 Preclinical - Cell culture Actionable In a preclinical study, TAS0728 inhibited Erbb2 downstream signaling and proliferation of ERBB2 (HER2) amplified lung cancer cells in culture (PMID: 30787176). 30787176
ERBB2 amp gastric adenocarcinoma predicted - sensitive 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 amp colorectal cancer sensitive Lapatinib + Pertuzumab Preclinical - Pdx Actionable In a preclinical study, the combination of Perjeta (pertuzumab) and Tykerb (lapatinib) induced tumor regression in patient-derived xenograft (PDX) models of colorectal cancer with ERBB2 (HER2) amplification (PMID: 22586653). 22586653
ERBB2 amp colorectal cancer decreased response Lapatinib Preclinical - Pdx Actionable In a preclinical study, treatment with Tykerb (lapatinib) resulted in initial disease stabilization with subsequent progression, in patient-derived colorectal cancer tumorgraft models with ERBB2 (HER2) amplification (PMID: 26296355). 26296355
ERBB2 amp breast cancer sensitive HER inhibitor (Pan) Afatinib Preclinical Actionable In a preclinical study, Gilotrif (afatinib) inhibited proliferation of breast cancer cell lines with ERBB2 (HER2) amplification in culture (PMID: 26545934). 26545934
ERBB2 amp breast cancer sensitive HER2 Inhibitor Neratinib + Pertuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, breast cancer cell line xenograft models harboring ERBB2 (HER2) amplification were sensitive to the combination of Perjeta (pertuzumab) and Nerlynx (neratinib), resulting in a delay of brain lesion growth and improved survival (PMID: 28539475). 28539475
ERBB2 amp Her2-receptor positive breast cancer sensitive trastuzumab and hyaluronidase-oysk injection Phase III 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). 22884505
ERBB2 amp colorectal cancer sensitive Lapatinib + Trastuzumab Preclinical - Pdx Actionable In a preclinical study, the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) treatment induced tumor regression in patient-derived colorectal cancer tumorgraft models harboring ERBB2 (HER2) amplification (PMID: 26296355). 26296355
ERBB2 amp Advanced Solid Tumor sensitive HER inhibitor (Pan) Afatinib Phase II Actionable In a Phase II trial, Gilotrif (afatinib), demonstrated safety and efficacy in various advanced solid tumor patients with ERBB2 (HER2) amplification (PMID: 23775486). 23775486
ERBB2 amp gastrointestinal system cancer sensitive HER inhibitor (Pan) Dacomitinib Preclinical Actionable In a preclinical study, Vizimpro (dacomitinib) demonstrated significant growth-inhibitory effects in HER2- amplified gastric cancer cells (PMID: 18606718). 18606718
ERBB2 amp breast cancer sensitive CH5132799 Preclinical Actionable In a preclinical study, CH5132799 inhibited proliferation of breast cancer cells with ERBB2 (HER2) amplification in culture (PMID: 21558396). 21558396
ERBB2 amp Her2-receptor positive breast cancer sensitive S63845 + Trastuzumab Preclinical - Pdx & cell culture Actionable In a preclinical study, S63845 and Herceptin (trastuzumab) demonstrated synergy in ERBB2 (HER2)-amplified breast cancer cells in culture and in ERBB2 (HER2)-amplified breast cancer patient-derived xenograft (PDX) models, resulting in enhanced tumor growth inhibition and overall survival compared to either agent alone (PMID: 28768804). 28768804
ERBB2 amp breast cancer decreased response Lapatinib Preclinical - Cell culture Actionable In a preclinical study, ERBB2 (HER2) amplified breast cancer cells treated with Tykerb (lapatinib) demonstrated decreased phosphorylation of Erbb2 (her2) and Akt, however, after 4-8 hours, Akt-driven Rictor showed upregulation, thereby resulting in a decreased treatment response (PMID: 27197158). 27197158
ERBB2 amp breast cancer sensitive LJM716 + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, breast cancer cell line xenograft models harboring ERBB2 (HER2) amplification were sensitive to the combination of Herceptin (trastuzumab) and LJM716, resulting in a delay of brain lesion growth and improved survival (PMID: 28539475). 28539475
ERBB2 amp stomach cancer sensitive Lapatinib + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) treatment induced tumor regression in ERBB2 (HER2)-amplified cell line xenograft models of gastric cancer (PMID: 26296355). 26296355
ERBB2 amp pancreatic cancer predicted - sensitive 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 amp ovarian cancer predicted - sensitive 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 amp Her2-receptor positive breast cancer sensitive HER2 Inhibitor TAS0728 Preclinical - Cell line xenograft Actionable In a preclinical study, TAS0728 inhibited Erbb2 downstream signaling and proliferation of ERBB2 (HER2) amplified breast cancer cell lines in culture, and induced tumor regression in cell line xenograft models (PMID: 30787176). 30787176
ERBB2 amp uterine corpus serous adenocarcinoma sensitive SYD985 Preclinical Actionable In a preclinical study, SYD895 induced cell death in ERBB2 (HER2)-amplified primary uterine serous carcinoma (USC) cell lines in culture and inhibited tumor growth and improved survival in ERBB2 (HER2)-amplified USC primary cell line xenografts (PMID: 27256376). 27256376
ERBB2 amp Her2-receptor positive breast cancer sensitive Palbociclib + Trastuzumab Preclinical Actionable In a preclinical study, the combination of Ibrance (palbociclib) and Herceptin (trastuzumab) worked synergistically to inhibit growth of ERBB2 (HER2)-amplified breast cancer cells in culture (PMID: 19874578). 19874578
ERBB2 amp Advanced Solid Tumor predicted - sensitive Ado-trastuzumab emtansine Phase II Actionable In a Phase II (MATCH) trial, Kadcyla (trastuzumab emtansine) treatment resulted in partial response in 8.1% (3/37) and stable disease in 43% (16/37) of patients with ERBB2 (HER2) amplified non-breast, non-gastric advanced solid tumors, with a 6-month progression-free survival rate of 24.8% (J Clin Oncol 36, 2018 (suppl; abstr 100); NCT02465060). detail...
ERBB2 amp duodenum adenocarcinoma predicted - sensitive Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab Case Reports/Case Series Actionable In a clinical case study, a patient with duodenal adenocarcinoma harboring ERBB2 (HER2) amplification demonstrated a complete pathologic response after treatment with a combination of Herceptin (trastuzumab), Adrucil (fluorouracil), Wellcovorin (leucovorin), and Eloxatin (oxaliplatin) (PMID: 28784859). 28784859
ERBB2 amp stomach cancer sensitive HER2 Inhibitor TAS0728 Preclinical - Cell line xenograft Actionable In a preclinical study, TAS0728 inhibited Erbb2 downstream signaling and proliferation of ERBB2 (HER2) amplified gastric cancer cells in culture, and induced tumor regression in cell line xenograft models (PMID: 30787176). 30787176
ERBB2 amp uterine cancer no benefit 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 amp Her2-receptor positive breast cancer predicted - sensitive KRIBB11 + MK2206 Preclinical - Cell culture Actionable In a preclinical study, MK-2206 and KRIBB11 synergistically inhibited growth of ERBB2 (HER2)-amplified breast cancer cell lines in culture (PMID: 28598816). 28598816
ERBB2 amp stomach cancer predicted - sensitive Fluorouracil + Oxaliplatin + Trastuzumab Case Reports/Case Series Actionable In a Phase II clinical trial, a gastric cancer patient with ERBB2 (HER2) amplification demonstrated a response for 24 months when treated with the combination of Adrucil (fluorouracil), Eloxatin (oxaliplatin), and Herceptin (trastuzumab) (PMID: 30463996; NCT01522768). 30463996
ERBB2 amp breast cancer sensitive HER2 Inhibitor LJM716 + Neratinib Preclinical - Cell line xenograft Actionable In a preclinical study, breast cancer cell line xenograft models harboring ERBB2 (HER2) amplification were sensitive to the combination of LJM716 and Nerlynx (neratinib), resulting in a delay of brain lesion growth and improved survival (PMID: 28539475). 28539475
ERBB2 amp acral lentiginous melanoma sensitive Ado-trastuzumab emtansine Case Reports/Case Series Actionable In a clinical case study, Kadcyla (trastuzumab emtansine) treatment resulted in complete radiographic response that lasted over 28 months in a patient with acral melanoma harboring ERBB2 (HER2) amplification (26-fold) that was resistant to check-point inhibition (PMID: 30093446). 30093446
ERBB2 amp non-small cell lung carcinoma predicted - sensitive 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 amp colorectal cancer no benefit Pertuzumab Preclinical - Pdx Actionable In a preclinical study, Perjeta (pertuzumab) did not inhibit tumor growth in patient-derived xenograft (PDX) models of ERBB2 (HER2)-amplified colorectal cancer (PMID: 22586653). 22586653
ERBB2 amp urinary bladder cancer predicted - sensitive 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 amp esophagus adenocarcinoma no benefit Lapatinib Phase III Actionable In a Phase III clinical trial, the addition of Tykerb (lapatinib) to Xeloda (capecitabine) and Eloxatin (oxaliplatin) combination treatment did not significantly prolong overall survival compared to placebo, but did improve progression-free survival and response rate in esophagus adenocarcinoma patients harboring ERBB2 amplification (PMID: 26628478). 26628478
ERBB2 amp non-small cell lung carcinoma sensitive 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 non-small cell lung cancer (NSCLC) cell lines with ERBB2 (HER2) amplification in culture, and inhibited tumor growth in ERBB2 (HER2)-amplified NSCLC cell line xenograft models (PMID: 26545934). 26545934
ERBB2 amp vulva squamous cell carcinoma sensitive Depatuxizumab mafodotin Preclinical - Cell line xenograft Actionable In a preclinical study, ABT-414 demonstrated cytoxicity against a EGFR-amplified vulvar epidermoid carcinoma cell line in culture and induced tumor regression in EGFR-amplified vulvar epidermoid carcinoma cell line xenograft models (PMID: 26846818). 26846818
ERBB2 amp breast cancer sensitive Pertuzumab + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, breast cancer cell line xenograft models harboring ERBB2 (HER2) amplification were sensitive to the combination of Herceptin (trastuzumab) and Perjeta (pertuzumab), resulting in a delay of brain lesion growth and improved survival (PMID: 28539475). 28539475
ERBB2 amp uterine corpus serous adenocarcinoma sensitive Taselisib Preclinical - Cell culture Actionable In a preclinical study, a uterine serous carcinoma cell line harboring ERBB2 (HER2) amplification demonstrated sensitivity to treatment with Taselisib (GDC-0032) in culture, resulting in inhibition of cell growth (PMID: 26333383). 26333383
ERBB2 amp breast cancer sensitive HER inhibitor (Pan) Dacomitinib Preclinical Actionable In a preclinical study, Vizimpro (dacomitinib) was more effective in preventing proliferation in ERBB2 (HER2) amplified breast cancer cells than in wild-type ERBB2 (HER2) breast cancer cells (PMID: 22761403). 22761403
ERBB2 amp Her2-receptor positive breast cancer sensitive CDX-3379 Preclinical Actionable In a preclinical study, CDX-3379 (KTN3379) inhibited tumor growth in xenograft models of ERBB2 (HER2)-amplified breast cancer (PMID: 26880266). 26880266
ERBB2 amp lung adenocarcinoma no benefit HER inhibitor (Pan) Dacomitinib Phase II Actionable In a Phase II trial, Vizimpro (dacomitinib) treatment resulted in an overall response rate of 0% (0/4) in patients with lung adenocarcinoma harboring ERBB2 (HER2) amplification (PMID: 25899785; NCT00818441). 25899785
ERBB2 amp gastroesophageal junction adenocarcinoma no benefit Lapatinib Phase III Actionable In a Phase III clinical trial, the addition of Tykerb (lapatinib) to Xeloda (capecitabine) and Eloxatin (oxaliplatin) combination treatment did not significantly prolong overall survival compared to placebo, but did improve progression-free survival and response rate in gastroesophageal junction adenocarcinoma patients harboring ERBB2 amplification (PMID: 26628478). 26628478
ERBB2 amp stomach carcinoma no benefit Debio 1347 Preclinical - Cell line xenograft Actionable In a preclinical study, Debio 1347 did not inhibit tumor growth in cell line xenograft models of ERBB2 (HER2) amplified gastric carcinoma (PMID: 26438159). 26438159
ERBB2 amp lung squamous cell carcinoma resistant Gefitinib Preclinical Actionable In a preclinical study, a lung squamous cell carcinoma cell line with ERBB2 (HER2) amplification demonstrated resistance to treatment with Iressa (gefitinib) in culture (PMID: 26545934). 26545934
ERBB2 amp stomach cancer sensitive Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, Herceptin (trastuzumab) inhibited tumor growth in human cell line xenograft models of gastric cancer with ERBB2 (HER2) amplification (PMID: 26296355). 26296355
ERBB2 amp scrotum Paget's disease predicted - sensitive Ado-trastuzumab emtansine Phase II Actionable In a Phase II (MATCH) trial, Kadcyla (trastuzumab emtansine) treatment resulted in partial response in a patient with ERBB2 (HER2) amplified Paget’s disease of the scrotum (J Clin Oncol 36, 2018 (suppl; abstr 100); NCT02465060). detail...
ERBB2 amp gastric adenocarcinoma sensitive Trastuzumab FDA approved 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
ERBB2 amp Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine FDA approved 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 23020162
ERBB2 amp uterine corpus serous adenocarcinoma sensitive HER2 Inhibitor Neratinib Preclinical - Cell culture Actionable In a preclinical study, a uterine serous carcinoma cell line harboring ERBB2 (HER2) amplification demonstrated sensitivity to treatment with Nerlynx (neratinib) in culture, resulting in inhibition of cell growth (PMID: 26333383). 26333383
ERBB2 amp salivary gland cancer predicted - sensitive 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 amp stomach cancer sensitive Lapatinib Preclinical Actionable In preclinical studies, Tykerb (lapatinib) demonstrated antiproliferative activity in HER2-amplified gastric cancer in cell assays and in xenograft models (PMID: 20179222). 20179222
ERBB2 amp breast cancer sensitive Lapatinib + Torkinib Preclinical - Cell culture Actionable In a preclinical study, the combination therapy of Tykerb (lapatinib) and Torkinib (PP242) in ERBB2 (HER2) amplified breast cancer cells in culture blocked cell growth, inhibited phosphorylation of Akt and S6, and led to greater caspase activity when compared to each agent alone (PMID: 27197158). 27197158
ERBB2 amp breast cancer sensitive Lapatinib + S63845 Preclinical - Cell culture Actionable In a preclinical study, the combination of S63845 and Tykerb (lapatinib) resulted in potent cytotoxic effects in ERBB2 (HER2)-amplified breast cancer cells in culture compared to the cytostatic effect of Tykerb (lapatinib) alone (PMID: 27760111). 27760111
ERBB2 amp esophageal cancer sensitive HER2 Inhibitor Ibrutinib Preclinical - Cell culture Actionable In a preclinical study, esophageal cancer cells with ERBB2 (HER2) amplification demonstrated sensitivity to Imbruvica (ibrutinib), resulting in decreased survival in culture (PMID: 28830912). 28830912
ARID1A loss ERBB2 amp breast cancer sensitive MK2206 + Trastuzumab Preclinical - Cell culture Actionable In a preclinical study, a breast cancer cell line with ARID1A loss and harboring ERBB2 (HER2) amplification demonstrated restored sensitivity to Herceptin (trastuzumab) when additionally treated with MK2206 in culture (PMID: 27172896). 27172896
ERBB2 amp SRC E527K gastroesophageal junction adenocarcinoma sensitive Lapatinib + Saracatinib Preclinical - Cell culture Actionable In a preclinical study, the combination of Tykerb (lapatinib) and Saracatinib (AZD0530) inhibited growth of ERBB2 (HER2)-amplified gastroesophageal adenocarcinoma cells harboring SRC E527K in culture (PMID: 25350844). 25350844
ERBB2 amp SRC E527K gastroesophageal junction adenocarcinoma resistant Lapatinib Preclinical - Cell culture Actionable In a preclinical study, an ERBB2 (HER2)-amplified gastroesophageal cancer cell line initially sensitive to treatment with Tykerb (lapatinib) in culture developed resistance and was subsequently found to have acquired a secondary drug resistant mutation, SRC E527K (PMID: 25350844). 25350844
FGFR2 wild-type ERBB2 amp stomach cancer resistant AZD4547 Preclinical Actionable In a preclinical study, gastric cancer cells with wild-type FGFR2 and ERBB2 (HER2) amplification were resistant to treatment with AZD4547 in culture (PMID: 22869148). 22869148
ERBB2 amp PTEN dec exp Her2-receptor positive breast cancer decreased response CDX-3379 Preclinical Actionable In a preclinical study, knockdown of PTEN expression resulted in a decreased response to treatment with CDX-3379 (KTN3379) in ERBB2 (HER2)-amplified breast cancer cells in culture (PMID: 26880266). 26880266
ERBB2 amp TP53 R158H gastric adenocarcinoma predicted - resistant AMG 337 Clinical Study Actionable In a clinical case study, a patient with gastric adenocarcinoma containing amplification of ERBB2 (HER2) and a TP53 R158H mutation progressed and developed metastases while being treated with AMG 337 (PMID: 26432108). 26432108
ERBB2 exon 20 ins non-small cell lung 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 non-small cell lung 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 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 Her2-receptor negative breast cancer predicted - sensitive HER2 Inhibitor Neratinib Phase II 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 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 non-small cell lung carcinoma predicted - sensitive 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) 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 D821N Advanced Solid Tumor sensitive HER2 Inhibitor XL647 Preclinical Actionable In a preclinical study, XL647 inhibited survival of transformed cells over expressing ERBB2 (HER2) D821N in culture (PMID: 18413839). 18413839
Clinical Trial Phase Therapies Title Recruitment Status