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Gene ERBB2
Variant positive
Impact List unknown
Protein Effect unknown
Gene Variant Descriptions ERBB2 (HER2) positive indicates the presence of the ERBB2 (HER2) gene, mRNA, and/or protein. ERBB2 (HER2) positive has been used alternatively to refer to overexpression and/or amplification of ERBB2 (HER2). For related data, refer to ERBB2 amp or ERBB2 over exp in CKB.
Associated Drug Resistance

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No Variant Reference Transcript is Available.
No transcript is Available.

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Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References
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 gastroesophageal junction adenocarcinoma predicted - sensitive 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 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 sensitive 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 breast adenocarcinoma sensitive Trastuzumab deruxtecan Preclinical - Cell culture Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) inhibited growth of an ERBB2 (HER2)-positive breast adenocarcinoma cell line in culture (PMID: 27026201). 27026201
ERBB2 positive esophageal cancer predicted - sensitive 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 predicted - sensitive Ado-trastuzumab emtansine + Tucatinib Phase Ib/II Actionable In a Phase Ib clinical trial, treatment with the combination of Tukysa (tucatinib) 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 Ado-trastuzumab emtansine + Tucatinib Phase Ib/II Actionable In a Phase Ib trial, the combination of Tukysa (tucatinib) 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 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 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 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 Her2-receptor positive breast cancer predicted - sensitive Capecitabine + Pyrotinib Phase I Actionable In a Phase I trial, Pyrotinib and Xeloda (capecitabine) combination treatment was well-tolerated, and resulted in an overall response rate of 78.6% (22/28) in patients with Erbb2 (Her2)-positive metastatic breast cancer, with a median progression-free survival of 22.1 months (PMID: 31138588; NCT02361112). 31138588
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive Trastuzumab + Tucatinib Phase Ib/II Actionable In a Phase Ib clinical trial, the combination of Tukysa (tucatinib) 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 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 uterine corpus serous adenocarcinoma sensitive Carboplatin + Paclitaxel + Trastuzumab Guideline Actionable Combination Paraplatin (carboplatin), Taxol (paclitaxel), and Herceptin (trastuzumab) is in guidelines for ERBB2 (HER2)-positive patients with advanced and recurrent uterine serous carcinoma (NCCN.org). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive 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 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 stomach cancer sensitive Trastuzumab deruxtecan Phase II Actionable In a Phase II trial (DESTINY-Gastric01), Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51.3%, 61/119 vs 14.3%, 8/56, p<0.0001), median progression-free survival (5.6 vs 3.5 mo, HR=0.47, p=0.0003), and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.0097) compared to chemotherapy in patients with advanced ERBB2 (HER2)-positive gastric cancer or gastroesophageal junction adenocarcinoma (J Clin Oncol 38: 2020 (suppl; abstr 4513); NCT03329690). detail...
ERBB2 positive stomach cancer sensitive Trastuzumab deruxtecan Preclinical - Pdx & cell culture Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) 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 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 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 colorectal cancer predicted - sensitive Trastuzumab deruxtecan Phase I Actionable In a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) 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 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 pancreatic cancer sensitive Trastuzumab deruxtecan Preclinical - Cell line xenograft Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) inhibited tumor growth in a pancreatic cancer cell line xenograft model with low ERBB2 (HER2) expression (PMID: 27026201). 27026201
ERBB2 positive Her2-receptor positive breast cancer sensitive Disitamab vedotin 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 Oxaliplatin + Tegafur-gimeracil-oteracil Potassium + Trastuzumab 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 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 breast carcinoma sensitive Trastuzumab Duocarmazine Preclinical - Pdx & cell culture Actionable In a preclinical study, Trastuzumab Duocarmazine (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 Her2-receptor positive breast cancer sensitive Trastuzumab deruxtecan FDA approved Actionable In a Phase II trial (DESTINY-Breast01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment resulted in an objective response rate of 60.9% (112/184) in patients with unresectable or metastatic ERBB2 (HER2)-positive breast cancer who have received two or more prior anti-HER2 therapies, with a median response duration of 14.8 months and a median progression-free survival of 16.4 months (PMID: 31825192; NCT03248492). 31825192
ERBB2 positive Her2-receptor positive breast cancer sensitive Trastuzumab deruxtecan Preclinical - Pdx & cell culture Actionable In a preclinical study, Enhertu (fam-trastuzumab deruxtecan-nxki) inhibited growth of ERBB2 (HER2)-positive breast cancer cell lines in culture and xenograft models, and demonstrated antitumor activity in patient-derived xenograft (PDX) models of ERBB2 (HER2)-positive breast cancer, including models with low ERBB2 (HER2) expression (PMID: 27026201). 27026201
ERBB2 positive Advanced Solid Tumor predicted - sensitive Epertinib 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 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 sensitive XMT-1522 Preclinical - Cell line xenograft Actionable In a preclinical study, XMT-1522 demonstrated improved efficacy compared to Kadcyla (ado-trastuzumab emtansine), inhibited growth of Erbb2 (Her2)-positive gastric cancer cell lines in culture, resulted in tumor regression and prolonged survival in cell line xenograft models (PMID: 31292166). 31292166
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive 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 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 stomach cancer predicted - sensitive Margetuximab Phase I Actionable In a Phase I trial, Margetuximab (MGAH22) treatment resulted in partial responses in 12% (7/60) and stable disease in 50% (30/60) of patients with ERBB2 (HER2)-positive breast or gastric cancer, or other carcinomas that overexpress Erbb2 (Her2) (PMID: 28119295). 28119295
ERBB2 positive Advanced Solid Tumor predicted - sensitive MT-5111 Preclinical - Cell culture Actionable In a preclinical study, MT-5111 demonstrated toxicity against Erbb2 (Her2) positive tumor cell lines in culture regardless of their sensitivity to Kadcyla (ado-trastuzumab emtansine) (Cancer Res 2018;78(13 Suppl):Abstract nr 5769). detail...
ERBB2 positive Advanced Solid Tumor predicted - sensitive 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 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 Her2-receptor positive breast cancer sensitive 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 Her2-receptor positive breast cancer no benefit Trastuzumab + Vinorelbine Phase Ib/II Actionable In a Phase Ib/II trial, the combination of Herceptin (trastuzumab) and Navelbine (vinorelbine) resulted in a 0% objective response rate in pretreated ERBB2 (HER2)-receptor positive breast cancer patients (N=5) (PMID: 31892325). 31892325
ERBB2 positive breast cancer predicted - sensitive Trastuzumab Duocarmazine Phase I Actionable In a Phase I trial, Trastuzumab Duocarmazine (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 predicted - sensitive Margetuximab + MGD013 Case Reports/Case Series Actionable In a Phase I trial, MGD013 and Margetuximab (MGAH22) combination treatment resulted in a partial response in 2 patients with ERBB2 (HER2)-positive breast cancer (J Clin Oncol 38: 2020 (suppl; abstr 3004); NCT03219268). 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 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 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 esophageal cancer predicted - sensitive 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 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 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 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 Her2-receptor positive breast cancer sensitive 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... detail...
ERBB2 positive gastroesophageal junction adenocarcinoma predicted - sensitive Trastuzumab deruxtecan Phase II Actionable In a Phase II trial (DESTINY-Gastric01), Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51.3%, 61/119 vs 14.3%, 8/56, p<0.0001), median progression-free survival (5.6 vs 3.5 mo, HR=0.47, p=0.0003), and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.0097) compared to chemotherapy in patients with advanced ERBB2 (HER2)-positive gastric or gastroesophageal junction adenocarcinoma (J Clin Oncol 38: 2020 (suppl; abstr 4513); NCT03329690). detail...
ERBB2 positive breast cancer sensitive XMT-1522 Preclinical - Cell line xenograft Actionable In a preclinical study, XMT-1522 demonstrated improved efficacy compared to Kadcyla (ado-trastuzumab emtansine), inhibited growth of Erbb2 (Her2)-positive breast cancer cells in culture, resulted in tumor regression and prolonged survival in cell line xenograft models (PMID: 31292166). 31292166
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 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 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 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 uterine corpus serous adenocarcinoma sensitive Trastuzumab Duocarmazine Preclinical - Cell line xenograft Actionable In a preclinical study, Trastuzumab Duocarmazine (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 salivary gland cancer sensitive Trastuzumab Guideline Actionable ERBB2 (HER2)-targeted therapy, including Herceptin (trastuzumab) is included in guidelines for patients with ERBB2 (HER2)-positive salivary gland tumors with distant metastases (NCCN.org). detail...
ERBB2 positive 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 Advanced Solid Tumor predicted - sensitive Margetuximab + MGD013 Phase I Actionable In a Phase I trial, MGD013 and Margetuximab (MGAH22) combination treatment resulted in a partial response in 50% (3/6) and stable disease in 33.3% (2/6) of patients with ERBB2 (HER2)-positive advanced solid tumors (J Clin Oncol 38: 2020 (suppl; abstr 3004); NCT03219268). detail...
ERBB2 positive Her2-receptor positive breast cancer sensitive 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 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 MBS301 Preclinical - Cell line xenograft Actionable In a preclinical study, MBS301 inhibited proliferation of ERBB2 (HER2)-positive breast cancer cell lines expressing high or low levels of ERBB2 (HER2) in culture, and inhibited tumor growth in xenograft models (PMID: 30081724). 30081724
ERBB2 positive Her2-receptor positive breast cancer sensitive 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 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 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 ovarian carcinoma sensitive Trastuzumab Duocarmazine Preclinical - Cell culture Actionable In a preclinical study, Trastuzumab Duocarmazine (SYD985) decreased survival of a ERBB2 (HER2)-positive ovarian carcinoma cell line in culture (PMID: 25589493). 25589493
ERBB2 positive salivary gland cancer predicted - sensitive Trastuzumab deruxtecan Phase I Actionable In a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) 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 gastroesophageal cancer predicted - sensitive Margetuximab + Pembrolizumab Phase Ib/II Actionable In a Phase Ib/II study, the combination of Margetuximab (MGAH22) and Keytruda (pembrolizumab) demonstrated safety and tolerability with an overall response rate of 18.5% (17/92), median progression-free survival of 2.7 months, and median overall survival of 12.5 months in patients with ERBB2 (HER2)-positive gastroesophogeal adenocarcinoma (PMID: 32653053; NCT02689284). 32653053
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 gastric adenocarcinoma no benefit Ado-trastuzumab emtansine Phase III Actionable In a Phase III trial (GATSBY), Kadcyla (trastuzumab emtansine) did not demonstrate efficacy benefit over Taxol (paclitaxel) in 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 (PMID: 28343975; NCT01641939). detail... 28343975
ERBB2 positive breast cancer sensitive 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 Tukysa (tucatinib) and Kadcyla (trastuzumab emtansine) compared to 6.5 months with Herceptin (trastuzumab) and Perjeta (pertuzumab) treatment (PMID: 29955792; NCT01983501). 29955792
ERBB2 positive gastric adenocarcinoma predicted - sensitive 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 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 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 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 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 colorectal cancer predicted - sensitive Margetuximab + MGD013 Case Reports/Case Series Actionable In a Phase I trial, MGD013 and Margetuximab (MGAH22) combination treatment resulted in a partial response in a patient with ERBB2 (HER2)-positive colorectal cancer (J Clin Oncol 38: 2020 (suppl; abstr 3004); NCT03219268). detail...
ERBB2 positive gastroesophageal junction adenocarcinoma no benefit Ado-trastuzumab emtansine Phase III Actionable In a Phase III trial (GATSBY), Kadcyla (trastuzumab emtansine) did not demonstrate efficacy benefit over Taxol (paclitaxel) in 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 (PMID: 28343975; NCT01641939). detail... 28343975
ERBB2 positive Her2-receptor positive breast cancer no benefit Ado-trastuzumab emtansine + Capecitabine Phase II Actionable In a Phase II trial, the combination therapy of Xeloda (capecitabine) and Kadcyla (ado-trastuzumab emanstine) resulted in increased toxicity and did not lead to improved clinical benefit compared to Kadcyla (ado-trastuzumab emanstine)as a single agent in ERBB2 (HER2)-positive breast cancer patients, with an overall response rate of 44% (36/81) versus 36% (29/80; P=0.34), respectively (PMID: 32584367; NCT01702558). 32584367
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive Abemaciclib + Fulvestrant + Trastuzumab Phase II Actionable In a Phase II trial, the combination therapy of Verzenio (abemaciclib), Herceptin (trastuzumab), and Faslodex (fulvestrant) in patients with ERBB2 (HER2)-receptor positive breast cancer (n=79) resulted in safety and a greater progression-free survival (PFS) compared to patients treated with standard of care chemotherapy plus Herceptin (trastuzumab) (n=79), demonstrating a PFS of 8.3 months versus 5.7 months (p=0.051), respectively (PMID: 32353342; NCT02675231). 32353342
ERBB2 positive gastric adenocarcinoma predicted - sensitive 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 stomach carcinoma sensitive Trastuzumab Duocarmazine Preclinical - Cell culture Actionable In a preclinical study, Trastuzumab Duocarmazine (SYD985) decreased survival of a ERBB2 (HER2)-positive gastric carcinoma cell line in culture (PMID: 25589493). 25589493
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive 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 Her2-receptor positive breast cancer predicted - sensitive Capecitabine + Tucatinib Phase Ib/II Actionable In a Phase Ib trial, the combination of Tukysa (tucatinib) 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 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 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 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 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 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 Advanced Solid Tumor predicted - sensitive Trastuzumab deruxtecan Phase I Actionable In a Phase I trial, treatment with Enhertu (fam-trastuzumab deruxtecan-nxki) 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 breast cancer sensitive ZW49 Preclinical - Pdx Actionable In a preclinical study, ZW49 treatment induced tumor regression in patient-derived xenograft (PDX) models of breast cancer expressing low and high levels of ERBB2 (HER2) (Cancer Res 2019;79(4 Suppl):Abstract nr P6-17-13). detail...
ERBB2 positive stomach carcinoma sensitive Tucatinib Preclinical - Cell culture Actionable In a preclinical study, Tukysa (tucatinib) inhibited tumor growth in a ERBB2 (HER2)-positive gastric carcinoma cell line xenograft model (Cancer Res April 15, 2012 72:852). detail...
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 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 breast cancer predicted - sensitive MP0274 Preclinical - Cell line xenograft Actionable In a preclinical study, MP0274 inhibited proliferation of Erbb2 (Her2)-positive breast cancer cells in culture and induced tumor regression in cell line xenograft models (Cancer Res 2013;73(24 Suppl): Abstract nr P4-12-30). 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 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 Capecitabine + Trastuzumab + Tucatinib Phase Ib/II Actionable In a Phase Ib trial, the combination of Tukysa (tucatinib), Herceptin (trastuzumab), and Capecitabine demonstrated clinical activity in CNS metastases in patients with ERBB2 (HER2)-positive metastatic breast cancer, with 50% (1/2) of evaluable patients achieving CNS partial response and 50% (1/2) achieving CNS stable disease (San Antonio Breast Cancer Symposium 2015, Abstract P4-14-19). detail...
ERBB2 positive gastroesophageal junction adenocarcinoma predicted - sensitive 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 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 inflammatory breast carcinoma predicted - sensitive 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 Tucatinib Phase I Actionable In a Phase I trial, treatment with Tukysa (tucatinib) resulted in a response rate of 14% (3/22; all partial responses (PR)) and a clinical benefit rate (PR plus stable disease for greater than or equal to 24 weeks) of 27% (6/22) in Erbb2 (Her2)-positive breast cancer patients (PMID: 28053022). 28053022
ERBB2 positive 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 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 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 ovarian carcinoma sensitive ADC ST8176AA1 Preclinical - Cell line xenograft Actionable In a preclinical study, ADC ST8176AA1 treatment induced apoptosis and inhibited proliferation of ERBB2 (HER2) expressing ovary carcinoma cells in culture, and inhibited tumor growth, and increased median survival in cell line xenograft models (PMID: 32039017). 32039017
ERBB2 positive Her2-receptor positive breast cancer predicted - sensitive Epertinib + Trastuzumab Phase Ib/II Actionable In a Phase Ib/II trial, the combination therapy of Epertinib (S-222611) and Herceptin (trastuzumab) resulted in an objective response rate of 67% (6/9) in pretreated ERBB2 (HER2)-receptor positive breast cancer patients, including 6 patients with a partial response (PMID: 31892325). 31892325
ERBB2 positive Her2-receptor positive breast cancer sensitive Capecitabine + Trastuzumab Phase Ib/II Actionable In a Phase Ib/II trial, the combination therapy of Herceptin (trastuzumab) and Xeloda (capecitabine) resulted in an objective response rate of 56% (5/9) in pretreated ERBB2 (HER2)-receptor positive breast cancer patients, including 5 patients with a partial response (PMID: 31892325). 31892325
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 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 Her2-receptor positive breast cancer predicted - sensitive Margetuximab 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 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 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 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 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 ovarian cancer sensitive Disitamab vedotin Preclinical - Cell line xenograft Actionable In a preclinical study, treatment with Hertuzumab-vc-MMAE decreased viability of ERBB2 (HER2)-positive ovarian cancer cell lines in culture and inhibited tumor growth in ERBB2 (HER2)-positive ovarian cancer cell line xenograft models (PMID: 27509865). 27509865
ERBB2 positive colon carcinoma sensitive ADC ST8176AA1 Preclinical - Cell line xenograft Actionable In a preclinical study, ADC ST8176AA1 treatment reversed epithelial to mesenchymal (EMT) transition, induced DNA damage, increased apoptosis, and inhibited Erbb2 (Her2) signaling and proliferation of ERBB2 (HER2) expressing colon carcinoma cells in culture, and increased median survival in a cell line xenograft model (PMID: 32039017). 32039017
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 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 pos PIK3CA act mut Her2-receptor positive breast cancer decreased response Trastuzumab Clinical Study - Cohort Actionable In a retrospective analysis, ERBB2 (HER2)-positive breast cancer patients with PI3K pathway activation due to PTEN loss and/or PIK3CA activating mutation demonstrated a decreased median progression-free survival of 4.5 months, compared to 9.0 months for patients without PI3K pathway activation following treatment with a Herceptin (trastuzumab) containing regimen (PMID: 21676217). 21676217
ERBB2 pos PIK3CA act mut 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 pos PIK3CA act mut Her2-receptor positive breast cancer predicted - sensitive Buparlisib + Trastuzumab Phase I Actionable In a Phase I 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 trastuzumab-based therapy (PMID: 24470511). 24470511
ERBB2 pos PIK3CA act mut Her2-receptor positive breast cancer sensitive Palbociclib + Pictilisib Preclinical Actionable In a preclinical study, Ibrance (palbociclib) and Pictilisib (GDC-0941) worked synergistically to inhibit survival of ERBB2 (HER2)-positive breast cancer cell lines harboring PIK3CA mutations in culture (PMID: 27020857). 27020857
ERBB2 pos PIK3CA act mut uterine cancer sensitive Taselisib Preclinical Actionable In a preclinical study, Taselisib (GDC-0032) inhibited growth of HER2 positive uterine cancer cell lines with PIK3CA mutations (PMID: 25172762). 25172762
ERBB2 pos PIK3CA E545K Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine Preclinical - Cell line xenograft Actionable In a preclinical study, Kadcyla (trastuzumab emtansine) inhibited survival of Herceptin (trastuzumab)-resistant ERBB2 (HER2) positive breast cancer cells harboring PIK3CA E545K in culture, and induced tumor regression in cell line xenograft models (PMID: 26920887). 26920887
ERBB2 pos PIK3CA E545K Her2-receptor positive breast cancer predicted - sensitive Neratinib Phase III Actionable In a Phase III trial (ExteNET), Nerlynx (neratinib) treatment resulted in improved 5-year invasive disease-free survival (92.4% vs 84.5%, HR=0.41, p=0.028) and clinical benefit (HR=0.40, p=0.041) compared to placebo in patients with ERBB2 (HER2)-positive early breast cancer who completed trastuzumab-based adjuvant therapy, and harbored PIK3CA amplification (n=61) or mutations (n=210), including H1047R (n=110), E542K (n=18), and E545K/D (n=82) (PMID: 30867034; NCT00878709). 30867034
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer decreased response Lapatinib + Trastuzumab Clinical Study - Cohort Actionable In a clinical study, a retrospective analysis of the combined treatment, Herceptin (trastuzumab) and Tykerb (lapatinib), in ERBB2 (HER2) positive breast cancer patients demonstrated patients harboring a PIK3CA mutation trended towards a decreased response when compared to patients with wild-type PIK3CA (PMID: 28177460). 28177460
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer decreased response Lapatinib + Trastuzumab Phase II Actionable In a Phase II trial, ERBB2-positive breast cancer patients harboring PIK3CA mutations demonstrated lower pathologic complete remission rate (12.5%) compared to those with wild-type PIK3CA (48.4%) after Herceptin (trastuzumab) and Tykerb (lapatinib) combination therapy (PMID: 26245675). 26245675
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer decreased response Trastuzumab Clinical Study - Cohort Actionable In a clinical study, a retrospective analysis of Herceptin (trastuzumab) treatment in ERBB2 (HER2) positive breast cancer patients demonstrated patients harboring a PIK3CA mutation trended towards a decreased response when compared to patients with wild-type PIK3CA (PMID: 28177460). 28177460
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer decreased response Lapatinib Clinical Study - Cohort Actionable In a clinical study, a retrospective analysis of Tykerb (lapatinib) treatment in ERBB2 (HER2) positive breast cancer patients demonstrated patients harboring a PIK3CA mutation trended towards a decreased response when compared to patients with wild-type PIK3CA (PMID: 28177460). 28177460
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer sensitive AT13148 Preclinical - Cell line xenograft Actionable In a preclinical study, AT13148 inhibited tumor growth in a ERBB2 (HER2)-positive human breast cancer cell line xenograft model harboring mutant PIK3CA (PMID: 22781553). 22781553
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer decreased response Capecitabine + Lapatinib Phase III Actionable In a Phase III trial, Tykerb (lapatinib) and Xeloda (capecitabine) combination treatment resulted in decreased median progression free survival (4.3 vs. 6.4 months), median overall survival (17.3 vs. 27.8 months), and overall response rate(17.1% vs. 39.7%) in ERBB2 (HER2) positive breast cancer patients harboring PIK3CA mutations compared to PIK3CA wild type patients (PMID: 26920887). 26920887
ERBB2 pos PIK3CA mut Her2-receptor positive breast cancer predicted - sensitive Neratinib Phase III Actionable In a Phase III trial (ExteNET), Nerlynx (neratinib) treatment resulted in improved 5-year invasive disease-free survival (92.4% vs 84.5%, HR=0.41, p=0.028) and clinical benefit (HR=0.40, p=0.041) compared to placebo in patients with ERBB2 (HER2)-positive early breast cancer who completed trastuzumab-based adjuvant therapy, and harbored PIK3CA amplification (n=61) or mutations (n=210), including H1047R (n=110), E542K (n=18), and E545K/D (n=82) (PMID: 30867034; NCT00878709). 30867034
ERBB2 pos PIK3CA K111N Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine Preclinical - Cell line xenograft Actionable In a preclinical study, Kadcyla (trastuzumab emtansine) inhibited survival of ERBB2 (HER2) positive breast cancer cells harboring PIK3CA K111N in culture, and induced tumor regression in cell line xenograft models (PMID: 26920887). 26920887
ERBB2 pos PIK3CA I391M Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine Preclinical - Cell culture Actionable In a preclinical study, Kadcyla (trastuzumab emtansine) inhibited survival of ERBB2 (HER2) positive breast cancer cells harboring PIK3CA K111N in culture (PMID: 26920887). 26920887
ERBB2 pos PIK3CA C420R Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine Preclinical - Cell culture Actionable In a preclinical study, Kadcyla (trastuzumab emtansine) inhibited survival of ERBB2 (HER2) positive breast cancer cells harboring PIK3CA C420R in culture (PMID: 26920887). 26920887
ERBB2 pos PIK3CA H1047R Her2-receptor positive breast cancer sensitive Ado-trastuzumab emtansine Preclinical - Cell line xenograft Actionable In a preclinical study, Kadcyla (trastuzumab emtansine) inhibited survival of Herceptin (trastuzumab)-resistant ERBB2 (HER2) positive breast cancer cells harboring PIK3CA H1047R in culture, and induced tumor regression in cell line xenograft models (PMID: 26920887). 26920887
ERBB2 pos PIK3CA H1047R Her2-receptor positive breast cancer predicted - sensitive Neratinib Phase III Actionable In a Phase III trial (ExteNET), Nerlynx (neratinib) treatment resulted in improved 5-year invasive disease-free survival (92.4% vs 84.5%, HR=0.41, p=0.028) and clinical benefit (HR=0.40, p=0.041) compared to placebo in patients with ERBB2 (HER2)-positive early breast cancer who completed trastuzumab-based adjuvant therapy, and harbored PIK3CA amplification (n=61) or mutations (n=210), including H1047R (n=110), E542K (n=18), and E545K/D (n=82) (PMID: 30867034; NCT00878709). 30867034
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 PIK3CA amp Her2-receptor positive breast cancer predicted - sensitive Neratinib Phase III Actionable In a Phase III trial (ExteNET), Nerlynx (neratinib) treatment resulted in improved 5-year invasive disease-free survival (92.4% vs 84.5%, HR=0.41, p=0.028) and clinical benefit (HR=0.40, p=0.041) compared to placebo in patients with ERBB2 (HER2)-positive early breast cancer who completed trastuzumab-based adjuvant therapy, and harbored PIK3CA amplification (n=61) or mutations (n=210), including H1047R (n=110), E542K (n=18), and E545K/D (n=82) (PMID: 30867034; NCT00878709). 30867034
ERBB2 pos PIK3CA E542K Her2-receptor positive breast cancer predicted - sensitive Neratinib Phase III Actionable In a Phase III trial (ExteNET), Nerlynx (neratinib) treatment resulted in improved 5-year invasive disease-free survival (92.4% vs 84.5%, HR=0.41, p=0.028) and clinical benefit (HR=0.40, p=0.041) compared to placebo in patients with ERBB2 (HER2)-positive early breast cancer who completed trastuzumab-based adjuvant therapy, and harbored PIK3CA amplification (n=61) or mutations (n=210), including H1047R (n=110), E542K (n=18), and E545K/D (n=82) (PMID: 30867034; NCT00878709). 30867034
ERBB2 pos PIK3CA E545D Her2-receptor positive breast cancer predicted - sensitive Neratinib Phase III Actionable In a Phase III trial (ExteNET), Nerlynx (neratinib) treatment resulted in improved 5-year invasive disease-free survival (92.4% vs 84.5%, HR=0.41, p=0.028) and clinical benefit (HR=0.40, p=0.041) compared to placebo in patients with ERBB2 (HER2)-positive early breast cancer who completed trastuzumab-based adjuvant therapy, and harbored PIK3CA amplification (n=61) or mutations (n=210), including H1047R (n=110), E542K (n=18), and E545K/D (n=82) (PMID: 30867034; NCT00878709). 30867034
Molecular Profile Indication/Tumor Type Response Type Therapy Name Approval Status Evidence Type Efficacy Evidence References