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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 Inhibitor Neratinib FDA approved Actionable In a Phase III trial that supported FDA approval, ERBB2 (HER2)-positive (overexpressing and/or amplification) breast cancer patients previously treated with Herceptin (trastuzumab) demonstrated a significantly greater two year invasive disease-free survival rate (93.9%) when treated with Nerlynx (neratinib) compared to the rate (91.6%) in those patients treated with placebo (PMID: 26874901; NCT00878709). 26874901 detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 Inhibitor Neratinib Guideline Actionable Nerlynx (neratinib) is included in guidelines for patients with high-risk ERBB2 (HER2)-positive early breast cancer (PMID: 31236598; ESMO.org). 31236598 detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 Inhibitor 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 stomach cancer sensitive HER2 (ERBB2) Antibody MM-302 + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, combination of MM-302 and Herceptin (trastuzumab) resulted in improved tumor growth inhibition in cell line xenograft models of Erbb2 (Her2)-over expressing gastric cancer (PMID: 26759238). 26759238
ERBB2 over exp colorectal cancer resistant Cetuximab Preclinical - Cell line xenograft Actionable In a preclinical study, ERBB2 (HER2) over expression was associated with resistance to Erbitux (cetuximab) treatment in a human cell line xenograft model of colorectal cancer (PMID: 26296355). 26296355
ERBB2 over exp colorectal cancer resistant Cetuximab Clinical Study - Cohort Actionable In a retrospective analysis, patients with metastatic KRAS exon 2 wild-type colorectal cancer harboring ERBB2 (HER2) amplification or overexpression (n=79) demonstrated poorer objective response rate (31.2 vs 46.9, p=0.031) and progression-free survival (5.7 vs 7 months, p=0.087) to anti-EGFR treatment (Vectibix (panitumumab) or Erbitux (cetuximab), as monotherapy or combined with chemotherapy) when compared to ERBB2 (HER2)-negative patients (n=113) (PMID: 30952821). 30952821
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib Preclinical - Cell culture Actionable In a preclinical study, Tykerb (lapatinib) inhibited growth of HER2-over expressing breast carcinoma cell lines in culture (PMID: 27450453). 27450453
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody HER2 Inhibitor Capecitabine + Trastuzumab + Tucatinib FDA approved Actionable In a Phase II trial (HER2CLIMB) that supported FDA approval, addition of Tukysa (tucatinib) to Herceptin (trastuzumab) and Xeloda (capecitabine) significantly improved progression-free survival at 1 year (PFS1) compared to placebo (33.1% vs 12.3%, HR=0.54, p<0.001) in patients with metastatic ERBB2 (HER2)-positive breast cancer who received prior HER2-targeted therapy, PFS1 was significantly improved (24.9% vs 0%, HR=0.48, p<0.001) in patients with brain metastasis (PMID: 31825569; NCT02614794). detail... 31825569
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody HER2 Inhibitor Capecitabine + Trastuzumab + Tucatinib Guideline Actionable Tukysa (tucatinib), Herceptin (trastuzumab), and Xeloda (capecitabine) combination therapy is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Immune Cell Therapy HER2 CAR-T cells Preclinical - Cell line xenograft Actionable In a preclinical study, ERBB2 (HER2)-specific CAR-T cells induced cell death in ERBB2 (HER2)-over expressing gastric cancer cell lines in culture, and inhibited tumor growth and improved survival in a ERBB2 (HER2)-over expressing gastric cancer cell line xenograft model (PMID: 28284008). 28284008
ERBB2 over exp colorectal cancer decreased response Panitumumab Clinical Study - Cohort Actionable In a retrospective analysis, patients with metastatic KRAS exon 2 wild-type colorectal cancer harboring ERBB2 (HER2) amplification or overexpression (n=79) demonstrated poorer objective response rate (31.2 vs 46.9, p=0.031) and progression-free survival (5.7 vs 7 months, p=0.087) to anti-EGFR treatment (Vectibix (panitumumab) or Erbitux (cetuximab), as monotherapy or combined with chemotherapy) when compared to ERBB2 (HER2)-negative patients (n=113) (PMID: 30952821). 30952821
ERBB2 over exp 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 stomach cancer predicted - sensitive HER2 (ERBB2) Antibody MM-302 Preclinical Actionable In a preclinical study, ERBB2 (HER2) over expressing gastric cancer xenograft models demonstrated anti-tumor activity when treated with MM-302 (Cancer Res December 15, 2010 70; P3-14-09). detail...
ERBB2 over exp biliary tract cancer predicted - sensitive HER2 (ERBB2) Immune Cell Therapy HER2 CAR-T cells Phase I Actionable In a Phase I trial, treatment with ERBB2 (HER2)-specific CAR-T cells demonstrated safety and preliminary activity in patients with biliary tract or pancreatic carcinoma with ERBB2 (HER2) over expression, resulting in partial response in one of 11 patients and stable disease in 5, and a median progression free survival of 4.8 months (PMID: 28710747; NCT01935843). 28710747
ERBB2 over exp 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 carcinoma predicted - sensitive HER2 (ERBB2) Antibody Margetuximab Phase I Actionable In a Phase I trial, Margetuximab (MGAH22) treatment resulted in partial responses in 12% (7/60) and stable disease in 50% (30/60) of patients with ERBB2 (HER2)-positive breast or gastric cancer, or other carcinomas that overexpress Erbb2 (Her2) (PMID: 28119295). 28119295
ERBB2 over exp 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 Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Paclitaxel + Pertuzumab + Trastuzumab Guideline Actionable Perjeta (pertuzumab), Herceptin (trastuzumab), and Taxol (paclitaxel) therapy is included in the guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2) receptor-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Docetaxel + Pertuzumab + Trastuzumab Guideline Actionable Perjeta (pertuzumab), Herceptin (trastuzumab), and Taxotere (docetaxel) therapy is included in the guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Docetaxel + Pertuzumab + Trastuzumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (CLEOPATRA) that supported FDA approval, treatment with Perjeta (pertuzumab), combined with Herceptin (trastuzumab) and Taxotere (docetaxel), improved median progression free survival to 18.5 months compared to 12.4 months with placebo plus Herceptin (trastuzumab) and Taxotere (docetaxel) in patients with ERBB2 (HER2)-positive (overexpression and amplification) metastatic breast cancer (PMID: 23801166). detail... 23801166 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 stomach cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Preclinical - Cell line xenograft Actionable In a preclinical study, Kadcyla (trastuzumab emtansine) inhibited tumor growth in human cell line xenograft models of gastric cancer with ERBB2 (HER2) amplification and over expression (PMID: 21458915). 21458915
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody 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 urinary bladder cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 33% (3/9, 1 complete response, 1 partial response) and stable disease lasting over 120 days in 22% (2/9) of patients with bladder cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp colorectal cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 38% (14/37, all partial response) and stable disease lasting over 120 days in 11% (4/37) of patients with colorectal cancer harboring ERBB2 (HER2) amplification or overexpression, with a median duration of response of 11 months (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Capecitabine + Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with Xeloda (capecitabine) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp gastric adenocarcinoma predicted - sensitive HER2 (ERBB2) Antibody Capecitabine + Lapatinib + Oxaliplatin Phase II Actionable In a Phase II trial, Tykerb (lapatinib), Xeloda (capecitabine), and Eloxatin (oxaliplatin) combination treatment resulted in a disease control rate of 81.3% (26/32, 7 complete response, 15 partial response, 4 stable disease) in patients with Erbb2 (Her2)-positive (defined as IHC3+ or IHC 2+ with ERBB2 amplification) gastric adenocarcinoma (PMID: 29409051; NCT02015169). 29409051
ERBB2 over exp breast cancer sensitive HER2 (ERBB2) Antibody MM-302 + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, combination of MM-302 and Herceptin (trastuzumab) synergistically inhibited tumor growth in cell line xenograft models of Erbb2 (Her2)-over expressing breast cancer (PMID: 26759238). 26759238
ERBB2 over exp 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 cholangiocarcinoma predicted - sensitive HER2 (ERBB2) Immune Cell Therapy HER2 CAR-T cells Phase I Actionable In a Phase I trial, a patient with perihilar cholangiocarcinoma over expressing ERBB2 achieved a partial response and progression-free survival for 4.5 months following treatment with ERBB2 (HER2)-specific CAR-T cells (PMID: 28710747, NCT01935843). 28710747
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody 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 gastroesophageal junction adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable Herceptin (trastuzumab), in combination with fluoropyrimidine and cisplatin, or other chemotherapy agents, but not anthracyclines, is included in guidelines for Erbb2 (Her2)-overexpressing metastatic esophagogastric junction adenocarcinoma patients (NCCN.org) detail...
ERBB2 over exp gastroesophageal junction adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ToGA) that supported FDA approval, patients with either gastric cancer or gastroesophageal junction adenocarcinoma with ERBB2 (HER2) overexpression or ERBB2 (HER2) amplification had increased overall survival (13.8 mo vs 11.1 mo) when treated with Herceptin (trastuzumab) in combination with chemotherapy compared to chemotherapy alone (PMID: 20728210; NCT01041404). 20728210 detail... detail...
ERBB2 over exp breast cancer sensitive HER2 (ERBB2) Antibody M802 Preclinical - Cell culture Actionable In a preclinical study, treatment with M802 increased apoptosis and inhibited growth of breast cancer cell lines expressing high levels of ERBB2 (HER2) in culture (PMID: 31412896). 31412896
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody 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 biliary tract cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 29% (2/7, all partial response) and stable disease lasting over 120 days in 38% (3/7) of patients with biliary cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib + Trastuzumab Guideline Actionable The combination of Herceptin (trastuzumab) and Tykerb (lapatinib) is included in guidelines for patients with ERBB2 (HER2)-positive advanced breast cancer who progressed on Herceptin (trastuzumab)-based therapy, however, the combination therapy is not recommended as neoadjuvant therapy for ERBB2 (HER2)-positive patients with early breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). detail... 30032243 31236598
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Lapatinib + Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with Tykerb (lapatinib) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab + Vinorelbine Guideline Actionable The combination of Herceptin (trastuzumab) and Navelbine (vinorelbine) is included in guidelines as first-line therapy for patients with ERBB2 (HER2)-positive advanced breast cancer (PMID: 30032243; ESMO.org). 30032243 detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab + Vinorelbine Guideline Actionable Herceptin (trastuzumab) combined with Navelbine (vinorelbine) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab FDA approved - On Companion Diagnostic Actionable Herceptin (trastuzumab) is FDA approved as an adjuvant treatment for ERBB2 (HER2)-overexpressing (or amplification) breast cancer patients and for metastatic ERBB2 (HER2)-overexpressing (or amplification) breast cancer patients as indicated by an FDA approved companion diagnostic (FDA.gov). detail... detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with a taxane, such as Taxotere (docetaxel) or Taxol (paclitaxel), is included in guidelines as neoadjuvant therapy for patients with ERBB2 (HER2)-positive early breast cancer or as first-line therapy for patients with ERBB2 (HER2)-positive advanced breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). detail... 31236598 30032243
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody M802 Preclinical - Cell culture Actionable In a preclinical study, M802 inhibited growth of a gastric cancer cell line expressing high levels of ERBB2 (HER2) in culture, and inhibited tumor growth in xenograft models (PMID: 31412896). 31412896
ERBB2 over exp lung non-small cell carcinoma predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 13% (2/16, all partial response) and stable disease lasting over 120 days in 13% (2/16) of patients with non-small cell lung cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp gastroesophageal adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab-anns FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, the Herceptin (trastuzumab) biosimilar Kanjinti (Trastuzumab-anns) demonstrated structure, function, and pharmacokinetic profile comparable to Herceptin (trastuzumab) (PMID: 28341959), thus supporting the extrapolation of data from the Phase III trial that supported the approval of Herceptin (trastuzumab) in Erbb2 (Her2) overexpressing gastrioesophageal adenocarcinoma (PMID: 20728210; NCT01041404) for approval of Kanjinti (Trastuzumab-anns) (FDA.gov). 20728210 detail... 28341959 detail... detail...
ERBB2 over exp uterine cancer no benefit HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in no objective response (0/7) in patients with uterine cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Carboplatin + Paclitaxel + Trastuzumab Guideline Actionable Herceptin combined with Paraplatin (carboplatin) and Taxol (paclitaxel) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp stomach cancer sensitive HER2 (ERBB2) Antibody MM-111 + Paclitaxel + Trastuzumab Preclinical - Cell line xenograft Actionable In a preclinical study, MM-111, in combination with Herceptin (trastuzumab) and Taxol (paclitaxel), resulted in a synergistic effect thereby inhibiting ErbB2 in ERBB2 (HER2) over expressing gastric cancer cell line xenograft models (J Clin Oncol 31, 2013 (suppl 4; abstr 48)). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Guideline Actionable The combination of Herceptin (trastuzumab) and Perjeta (pertuzumab) with a taxane, such as Taxotere (docetaxel) or Taxol (palictaxel), is included in guidelines for patients with ERBB2 (HER2)-positive early breast cancer patients or advanced breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). 31236598 detail... 30032243
ERBB2 over exp breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab-anns FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, the Herceptin (trastuzumab) biosimilar Kanjinti (Trastuzumab-anns) demonstrated structure, function, and pharmacokinetic profile comparable to Herceptin (trastuzumab) (PMID: 28341959), thus supporting the extrapolation of data from the Phase III trial that supported the approval of Herceptin (trastuzumab) in Erbb2 (Her2) overexpressing breast cancer (PMID: 23801166) for approval of Kanjinti (Trastuzumab-anns) (FDA.gov). detail... 23801166 28341959 detail... detail...
ERBB2 over exp pancreatic carcinoma predicted - sensitive HER2 (ERBB2) Immune Cell Therapy HER2 CAR-T cells Phase I Actionable In a Phase I trial, treatment with ERBB2 (HER2)-specific CAR-T cells demonstrated safety and preliminary activity in patients with biliary tract or pancreatic carcinoma with ERBB2 (HER2) over expression, resulting in partial response in one of 11 patients and stable disease in 5, and a median progression free survival of 4.8 months (PMID: 28710747; NCT01935843). 28710747
ERBB2 over exp 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 Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Docetaxel + Trastuzumab Guideline Actionable Herceptin (trastuzumab) combined with Taxotere (docetaxel) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp 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 Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Fam-trastuzumab deruxtecan-nxki Guideline Actionable Enhertu (fam-trastuzumab deruxtecan-nxki) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Advanced Solid Tumor predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 26% (30/114, 2 complete response, 28 partial response) and stable disease lasting over 120 days in 14% (16/114) of patients with advanced solid tumors harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp stomach cancer sensitive HER inhibitor (Pan) Dacomitinib Preclinical Actionable In a preclinical study, ERBB2 (HER2) over expressing gastric cancer cells were sensitive to Vizimpro (dacomitinib), resulting in inhibition of ERBB2 (HER2)/ERBB3 (HER3) heterodimers (PMID: 22135232). 22135232
ERBB2 over exp stomach cancer sensitive 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 Her2-receptor positive breast cancer sensitive HER2 Inhibitor Capecitabine + Neratinib FDA approved Actionable In a Phase III (NALA) trial that supported FDA approval, combination of Nerlynx (neratinib) and Xeloda (capecitabine) reduced risk of disease progression or death (HR=0.76, p=0.006), improved 12-month PFS (28.8%, 88/307 vs 14.8%, 46/314) compared to lapatinib and capecitabine combination in patients with metastatic ERBB2 (HER2)-positive (amp/over exp) breast cancer who had 2 or more prior ERBB2 (HER2)-targeted therapies (J Clin Oncol 37, no. 15_suppl (May 20, 2019) 1002-1002; NCT01808573). detail...
ERBB2 over exp 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 (ERBB2) Antibody MBS301 Preclinical - Cell line xenograft Actionable In a preclinical study, MBS301 inhibited proliferation of a gastric cancer cell line expressing high levels of ERBB2 (HER2) in culture, and inhibited tumor growth in xenograft models (PMID: 30081724). 30081724
ERBB2 over exp 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 Her2-receptor positive breast cancer predicted - sensitive HER2 (ERBB2) Antibody Margetuximab Phase Ib/II Actionable In Phase I clinical trial, Margetuximab (MGAH22) displayed safety and had initial efficacy in patients with ERBB2 (HER2) positive breast cancer (J Clin Oncol 31, 2013 (suppl; abstr 3004)). detail...
ERBB2 over exp gastric adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab-anns FDA approved - On Companion Diagnostic Actionable In a Phase I trial that supported FDA approval, the Herceptin (trastuzumab) biosimilar Kanjinti (Trastuzumab-anns) demonstrated structure, function, and pharmacokinetic profile comparable to Herceptin (trastuzumab) (PMID: 28341959), thus supporting the extrapolation of data from the Phase III trial that supported the approval of Herceptin (trastuzumab) in Erbb2 (Her2) overexpressing gastric adenocarcinoma (PMID: 20728210; NCT01041404) for approval of Kanjinti (Trastuzumab-anns) (FDA.gov). 20728210 28341959 detail... detail... detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Capecitabine + Lapatinib Guideline Actionable Tykerb (lapatinib) combined with Xeloda (capecitabine) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp esophagus adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable Herceptin (trastuzumab), in combination with first-line chemotherapy with fluoropyrimidine and cisplatin or other chemotherapy agents, but not anthracyclines, is included in guidelines for Erbb2 (Her2)-overexpressing metastatic esophageal adenocarcinoma patients (NCCN.org) detail...
ERBB2 over exp ovarian cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 13% (1/8, all partial response) of patients with ovarian cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp 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 HER2 (ERBB2) Antibody trastuzumab and hyaluronidase-oysk injection FDA approved - On Companion Diagnostic Actionable In a Phase III trial (HannaH) that supported FDA approval, Herceptin Hylecta (trastuzumab and hyaluronidase-oysk injection) treatment demonstrated safety and efficacy profile comparable to intravenous trastuzumab treatment, resulted in pathologic complete response in 45.4% (118/260) of patients with ERBB2 (HER2)-positive (IHC 3+ or ISH positive) breast cancer (PMID: 22884505; NCT00950300). detail... detail... 22884505
ERBB2 over exp pancreatic carcinoma sensitive HER2 (ERBB2) Antibody ADC ST8176AA1 Preclinical - Pdx Actionable In a preclinical study, ADC ST8176AA1 treatment inhibited tumor growth in patient-derived xenograft (PDX) models of pancreatic carcinoma overexpressing ERBB2 (HER2) (PMID: 32039017). 32039017
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Trastuzumab-anns Phase III Actionable In a Phase III (LILAC) trial, Kanjinti (Trastuzumab-anns) treatment demonstrated safety and efficacy similar to Herceptin (trastuzumab) in neoadjuvant and adjuvant settings, resulted in a complete response in 48% (172/358) of patients with Erbb2 (Her2)-positive breast cancer, compared to 41% (137/338) in Herceptin (trastuzumab)-treated patients (PMID: 29880292; NCT01901146). 29880292
ERBB2 over exp 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 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 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 Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine FDA approved - On Companion Diagnostic Actionable In a Phase III trial (KATHERINE) that supported FDA approval, treatment with Kadclya (trastuzumab emtansine) resulted in improved invasive disease-free survival (HR=0.50, p<0.001) compared to Herceptin (trastuzumab) in patients with ERBB2 (HER2)-positive early breast cancer who had residual invasive disease after taxane and trastuzumab-based neoadjuvant therapy (PMID: 30516102; NCT01772472). detail... detail... 30516102
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Guideline Actionable Kadcyla (ado-trastuzumab emtansine) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). detail...
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine FDA approved - On Companion Diagnostic Actionable In a Phase III trial (EMILIA) that supported FDA approval, treatment with Kadclya (trastuzumab emtansine) improved median progression free survival (9.6 mo vs 6.4 mo) and overall survival (30.9 mo vs 25.1 mo) compared to Tykerb (lapatinib) combined with Xeloda (capecitabine) in patients with metastatic ERBB2 (HER2)-positive breast cancer (PMID: 24879797, PMID: 23020162; NCT00829166). 24879797 detail... detail... 23020162
ERBB2 over exp Her2-receptor positive breast cancer sensitive HER2 (ERBB2) Antibody Ado-trastuzumab emtansine Guideline Actionable Kadcyla (ado-trastuzumab emtansine) is included in the guidelines for patients with ERBB2 (HER2)-positive advanced breast cancer who progressed through one line of Herceptin (trastuzumab)-based therapy or ERBB2 (HER2)-positive patients with early breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). 31236598 detail... 30032243
ERBB2 over exp salivary gland carcinoma predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II (MyPathway) trial, Perjeta (pertuzumab) and Herceptin (trastuzumab) combination therapy resulted in an objective response rate of 60% (9/15, 1 complete response, 8 partial responses) and a clinical benefit rate of 67% (10/15) in patients with advanced salivary gland carcinoma harboring ERBB2 (HER2) amplification or overexpression, with a median progression- free survival of 8.6 months, and a median overall survival of 20.4 months (PMID: 32067683; NCT02091141). 32067683
ERBB2 over exp pancreatic cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 22% (2/9, all partial response) and stable disease lasting over 120 days in 11% (1/9) of patients with pancreatic cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
ERBB2 over exp stomach cancer sensitive HER2 Inhibitor Tucatinib Preclinical - Cell culture Actionable In a preclinical study, Tukysa (tucatinib) inhibited proliferation of an ERBB2 (HER2) over expressing gastric cancer cell line in culture (Cancer Res April 15, 2010 70:3610). detail...
ERBB2 over exp gastric adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab FDA approved - On Companion Diagnostic Actionable In a Phase III trial (ToGA) that supported FDA approval, patients with either gastric or gastroesophageal junction adenocarcinoma with ERBB2 (HER2) overexpression or ERBB2 (HER2) amplification had increased overall survival (13.8 mo vs 11.1 mo) when treated with Herceptin (trastuzumab) in combination with chemotherapy compared to chemotherapy alone (PMID: 20728210; NCT01041404). 20728210 detail... detail...
ERBB2 over exp gastric adenocarcinoma sensitive HER2 (ERBB2) Antibody Trastuzumab Guideline Actionable Herceptin (trastuzumab) in combination with fluoropyrimidine and cisplatin (category 1) or other platinum agents (category 2A), but not anthracyclines, is included in guidelines as first-line therapy for Erbb2 (Her2)-overexpressing metastatic gastric adenocarcinoma patients (NCCN.org) detail...
ERBB2 over exp breast cancer sensitive HER2 (ERBB2) Antibody ZW49 Preclinical - Pdx Actionable In a preclinical study, ZW49 treatment induced tumor regression in a patient-derived xenograft (PDX) model of breast cancer overexpressing ERBB2 (HER2) (Cancer Res 2019;79(4 Suppl):Abstract nr P6-17-13). detail...
ERBB2 over exp salivary gland cancer predicted - sensitive HER2 (ERBB2) Antibody Pertuzumab + Trastuzumab Phase II Actionable In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 80% (4/5, all partial response) of patients with salivary gland cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). 29320312
Clinical Trial Phase Therapies Title Recruitment Status
NCT04298918 Phase Ib/II Ado-trastuzumab emtansine + Venetoclax Ado-trastuzumab emtansine A Study Evaluating the Safety and Efficacy of Venetoclax in Combination With Trastuzumab Emtansine in Patients With Previously Treated HER2-Positive Locally Advanced or Metastatic Breast Cancer Not yet recruiting
NCT03716180 Phase I Paclitaxel + Pertuzumab + Trastuzumab DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC Active, not recruiting
NCT03289039 Neratinib Fulvestrant + Neratinib A Phase 2 Study of Neratinib With or Without Fulvestrant in HER2-Positive, ER-Positive Metastatic Breast Cancer Recruiting
NCT03929666 Phase II Fluorouracil + Leucovorin + Oxaliplatin + ZW25 Cisplatin + Fluorouracil + Leucovorin + ZW25 Capecitabine + Cisplatin + ZW25 A Safety and Efficacy Study of ZW25 Plus Combination Chemotherapy in HER2-expressing Gastroesophageal Adenocarcinoma Recruiting
NCT01808573 Phase III Capecitabine + Lapatinib Capecitabine + Neratinib A Study of Neratinib Plus Capecitabine Versus Lapatinib Plus Capecitabine in Patients With HER2+ Metastatic Breast Cancer Who Have Received Two or More Prior HER2 Directed Regimens in the Metastatic Setting (NALA) Completed
NCT03505710 Phase II Fam-trastuzumab deruxtecan-nxki DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer Recruiting
NCT04042701 Phase I Fam-trastuzumab deruxtecan-nxki + Pembrolizumab DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer Recruiting
NCT03364348 Phase I Trastuzumab + Utomilumab Ado-trastuzumab emtansine + Utomilumab 4-1BB Agonist Monoclonal Antibody PF-05082566 With Trastuzumab Emtansine or Trastuzumab in Treating Patients With Advanced HER2-Positive Breast Cancer Recruiting
NCT03414658 Phase II Avelumab + Trastuzumab + Utomilumab + Vinorelbine Avelumab + Trastuzumab + Vinorelbine Avelumab + Trastuzumab + Utomilumab Trastuzumab + Vinorelbine The AVIATOR Study: Trastuzumab and Vinorelbine With Avelumab OR Avelumab & Utomilumab in Advanced HER2+ Breast Cancer Recruiting
NCT01160211 Phase III Lapatinib + Trastuzumab Letrozole Anastrozole Lapatinib Trastuzumab Exemestane A Study to Compare the Safety and Efficacy of an Aromatase Inhibitor in Combination With Lapatinib, Trastuzumab or Both for the Treatment of Hormone Receptor Positive, HER2+ Metastatic Breast Cancer Active, not recruiting
NCT02063724 Phase I HER2-pulsed DC1 vaccine HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer (Adjuvant) Active, not recruiting
NCT01730833 Phase II Paclitaxel + Pertuzumab + Trastuzumab Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer Active, not recruiting
NCT00651976 Phase I Letrozole Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery Terminated
NCT02073487 Phase II Paclitaxel Ado-trastuzumab emtansine + Lapatinib Lapatinib + Trastuzumab Nab-paclitaxel Neoadjuvant TDM1 With Lapatinib and Abraxane Compared With Trastuzumab With Lapatinib and Paclitaxel Completed
NCT03043313 Phase II Trastuzumab + Tucatinib Tucatinib (ONT-380) and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer (MOUNTAINEER)Tucatinib (ONT-380) and Trastuzumab for Patients With HER2-positive Metastatic Colorectal Cancer (MOUNTAINEER) (MOUNTAINEER) Recruiting
NCT02091141 Phase II Erlotinib Alectinib Cobimetinib + Vemurafenib Pertuzumab + Trastuzumab Vismodegib Atezolizumab My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Recruiting
NCT02124148 Phase I Cisplatin + Prexasertib Cetuximab + Prexasertib Pemetrexed + Prexasertib LY3023414 + Prexasertib Fluorouracil + Leucovorin + Prexasertib A Study of Prexasertib (LY2606368) With Chemotherapy or Targeted Agents in Participants With Advanced Cancer Completed
NCT00796978 Phase II Trastuzumab Trastuzumab in Treating Older Women With Early-Stage Breast Cancer Active, not recruiting
NCT01148849 Phase I Margetuximab Safety Study of MGAH22 in HER2-positive Carcinomas Active, not recruiting
NCT04379596 Phase Ib/II Cisplatin + Fluorouracil + Trastuzumab Capecitabine + Oxaliplatin + Trastuzumab Capecitabine + Cisplatin + Trastuzumab Fam-trastuzumab deruxtecan-nxki Fluorouracil + Oxaliplatin + Trastuzumab Fam-trastuzumab deruxtecan-nxki + Fluorouracil Capecitabine + Fam-trastuzumab deruxtecan-nxki Durvalumab + Fam-trastuzumab deruxtecan-nxki Fam-trastuzumab deruxtecan-nxki + Fluorouracil + Oxaliplatin Capecitabine + Fam-trastuzumab deruxtecan-nxki + Oxaliplatin Durvalumab + Fam-trastuzumab deruxtecan-nxki + Fluorouracil Capecitabine + Durvalumab + Fam-trastuzumab deruxtecan-nxki Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03) (DG-03) Not yet recruiting
NCT04209465 Phase I BDTX-189 A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. Recruiting
NCT02605486 Phase Ib/II Bicalutamide + Palbociclib Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) Recruiting
NCT00968968 Phase III Trastuzumab Lapatinib + Trastuzumab Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone Terminated
NCT03674112 Phase II Pertuzumab + Trastuzumab A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer Active, not recruiting
NCT04296942 Phase I FPV-Brachyury + M7824 + MVA-BN-Brachyury Ado-trastuzumab emtansine + Entinostat + FPV-Brachyury + M7824 + MVA-BN-Brachyury Ado-trastuzumab emtansine + FPV-Brachyury + M7824 + MVA-BN-Brachyury BN-Brachyury, Entinostat, Adotrastuzumab Emtansine and M7824 in Advanced Stage Breast Cancer (BrEAsT) Not yet recruiting
NCT03387553 Phase I HER2-pulsed DC1 vaccine HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer Recruiting
NCT00411788 Phase II Sirolimus + Trastuzumab A Phase II Study of Rapamycin and Trastuzumab for Patients With HER-2 Receptor Positive Metastatic Breast Cancer Completed
NCT01922921 Phase Ib/II HER-2/neu intracellular domain protein + Pertuzumab + Polysaccharide-K + Trastuzumab HER-2/neu intracellular domain protein + Pertuzumab + Trastuzumab Vaccine Therapy With or Without Polysaccharide-K in Treating Patients With Stage IV HER2 Positive Breast Cancer Receiving HER2-Targeted Monoclonal Antibody Therapy Unknown status
NCT03429101 Phase I Ado-trastuzumab emtansine + Poziotinib A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer Terminated
NCT02152943 Phase I Everolimus + Letrozole + Trastuzumab Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients Active, not recruiting
NCT03125928 Phase II Atezolizumab + Paclitaxel + Pertuzumab + Trastuzumab Clinical Trial of Atezolizumab With Paclitaxel, Trastuzumab, and Pertuzumab in Patients With Metastatic HER-2 Positive Breast Cancer Recruiting
NCT02139358 Phase Ib/II Gemcitabine + Pertuzumab + Trastuzumab Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer Active, not recruiting
NCT01466972 Phase II Pazopanib Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib Unknown status
NCT02952729 Phase I XMT-1522 Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2 Active, not recruiting
NCT04134884 Phase I ASTX727 + Talazoparib Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer Recruiting
NCT02066532 Phase Ib/II Ruxolitinib + Trastuzumab Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer Active, not recruiting
NCT02187744 Phase III Carboplatin + Docetaxel + Trastuzumab A Study Of PF-05280014 Or Trastuzumab Plus Taxotere&#174; And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04) Completed
NCT03501979 Phase II Capecitabine + Trastuzumab + Tucatinib Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD Recruiting
NCT01596751 Phase Ib/II Eribulin Pexidartinib Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer Completed
NCT04351230 Phase II Abemaciclib + Ado-trastuzumab emtansine Ado-trastuzumab emtansine Abemaciclib With or Without T-DM1 for the Treatment of HER2-Positive Metastatic Breast Cancer Not yet recruiting
NCT01989676 Phase III Paclitaxel + Trastuzumab Paclitaxel + PF-05280014 A Study Of PF-05280014 [Trastuzumab-Pfizer] Or Herceptin® [Trastuzumab-EU] Plus Paclitaxel In HER2 Positive First Line Metastatic Breast Cancer Treatment (REFLECTIONS B327-02) Active, not recruiting
NCT01526473 Phase I AVX901 A Phase I Study To Evaluate The Antitumor Activity And Safety Of AVX901 Completed
NCT03630809 Phase II HER2-pulsed DC1 vaccine Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1 Recruiting
NCT03094052 Phase II Neratinib Loperamide Crofelemer Neratinib + Trastuzumab Diarrhea Prophylaxis in Patients With HER2+ Breast Cancer Treated With Trastuzumab and Neratinib, Followed by Neratinib Monotherapy Recruiting
NCT01934894 Phase II Cabazitaxel + Lapatinib Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases Terminated
NCT02400476 Phase II Neratinib A Study Looking the Incidence and Severity of Diarrhea in Patients With Early-Stage HER2+ Breast Cancer Treated With Neratinib and Loperamide Recruiting
NCT01924351 Phase II HER2-positive Breast Cancer With Brain Metastasis (GCC 1345) Withdrawn
NCT02073916 Phase I Ado-trastuzumab emtansine + Lapatinib + Nab-paclitaxel TDM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer Completed
NCT02892123 Phase I Capecitabine + ZW25 ZW25 Paclitaxel + ZW25 Vinorelbine + ZW25 Trial of ZW25 in Patients With Advanced HER2-expressing Cancers Recruiting
NCT04172597 Phase II Poziotinib A Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies Recruiting
NCT02659514 Phase II Poziotinib Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer Active, not recruiting
NCT04294225 Phase II Anastrozole + Letrozole Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer Recruiting
NCT02189174 Phase Ib/II CLR457 Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies Terminated
NCT03620201 Phase I M7824 M7824 (Anti-PD-L1/TGF-Beta TRAP) in a Window Setting in Patients With Stage II-III HER2/Neu Positive (HER2+) Breast Cancer (BC) Recruiting
NCT02954536 Phase II Capecitabine + Cisplatin + Pembrolizumab + Trastuzumab Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2 Positive Esophagogastric (EG) Cancer Recruiting
NCT03696030 Phase I HER2 CAR-T cells HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases Recruiting
NCT02213042 Phase II Lapatinib + Trastuzumab Trastuzumab Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer Active, not recruiting
NCT01275677 Phase III Cyclophosphamide + Doxorubicin + Paclitaxel + Trastuzumab Cyclophosphamide + Docetaxel Cyclophosphamide + Docetaxel + Trastuzumab Cyclophosphamide + Doxorubicin + Paclitaxel Chemotherapy With or Without Trastuzumab After Surgery in Treating Women With Invasive Breast Cancer Active, not recruiting
NCT03821233 Phase I ZW49 A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers Recruiting
NCT02650752 Phase I Capecitabine + Lapatinib Intermittent High-Dose Lapatinib in Tandem With Capecitabine for HER2 Overexpressed/Amplified Metastatic Breast Cancer With Central Nervous System (CNS) Metastases Active, not recruiting
NCT03804515 Phase I Poziotinib A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib Recruiting
NCT03602079 Phase Ib/II A166 Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene Recruiting
NCT04224272 Phase II Fulvestrant + Palbociclib + ZW25 A Study of ZW25 With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer Recruiting
NCT02564900 Phase I Fam-trastuzumab deruxtecan-nxki Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors Active, not recruiting
NCT03765983 Phase II GDC-0084 + Trastuzumab GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases Recruiting
NCT02726399 Phase II Capecitabine + Cisplatin Ramucirumab + Trastuzumab Ramucirumab With Trastuzumab and Capecitabine/Cisplatin in Patients With Metastatic HER2-Positive Gastroesophageal Junction and Gastric Cancer Terminated
NCT03410927 Phase Ib/II TAS0728 A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities Active, not recruiting
NCT02060253 Phase I Ganetespib + Paclitaxel + Trastuzumab Ganetespib, Paclitaxel and Trastuzumab for Advanced or Metastatic Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Breast Cancer Completed
NCT01983501 Phase I Ado-trastuzumab emtansine + Tucatinib A Phase 1b Study of ONT-380 Combined With Ado-trastuzumab Emtansine (T-DM1) in Patients With HER2+ Breast Cancer Completed
NCT02673398 Phase II Neratinib Neratinib in Treating Older Patients With Locally Advanced or Metastatic HER2-Positive Breast Cancer Active, not recruiting
NCT03417544 Phase II Atezolizumab + Pertuzumab + Trastuzumab Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC Recruiting
NCT01622868 Phase II Lapatinib Whole-Brain Radiation Therapy With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer Active, not recruiting
NCT04143711 Phase Ib/II DF1001 DF1001 + Pembrolizumab Study of DF1001 in Patients With Advanced Solid Tumors Recruiting
NCT00194714 Phase Ib/II HER2 Vaccine Vaccine Therapy in Treating Patients With Stage IV HLA-A2 and HER2 Positive Breast or Ovarian Cancer Receiving Trastuzumab Active, not recruiting
NCT01973309 Phase I Paclitaxel + Vantictumab A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer Completed
NCT03587740 Phase II Ado-trastuzumab emtansine ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer Recruiting
NCT02623972 Phase II Cyclophosphamide + Doxorubicin + Eribulin A Phase 2 Study of Eribulin Followed by AC as Preoperative Therapy for HER2-negative Inflammatory Breast Cancer Recruiting
NCT04120246 Phase I alpha-TEA + Trastuzumab Alpha-TEA and Trastuzumab for the Treatment of Refractory HER2+ Metastatic Breast Cancer Recruiting
NCT03135171 Phase I Pertuzumab + Tocilizumab + Trastuzumab Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab Suspended
NCT02025192 Phase I Capecitabine + Trastuzumab + Tucatinib Trastuzumab + Tucatinib Capecitabine + Tucatinib A Study of Tucatinib (ONT-380) Combined With Capecitabine and/or Trastuzumab in Patients With HER2+ Metastatic Breast Cancer Active, not recruiting
NCT04147819 Phase I BAY2701439 A First in Human Study of BAY2701439 to Look at Safety, How the Body Absorbs, Distributes and Excretes the Drug, and How Well the Drug Works in Participants With Advanced Cancer Expressing the HER2 Protein Not yet recruiting
NCT03846583 Phase I Abemaciclib + Trastuzumab + Tucatinib Tucatinib + Abemaciclib + Herceptin for HER2+ MBC Not yet recruiting
NCT01864746 Phase III Palbociclib A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery (PENELOPE-B) Active, not recruiting
NCT04395508 Expanded access Pertuzumab + Trastuzumab An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic Available
NCT02038010 Phase I Ado-trastuzumab emtansine + Alpelisib BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx Completed
NCT01857193 Phase Ib/II Everolimus + Exemestane + Ribociclib Exemestane + Ribociclib Phase Ib Trial of LEE011 With Everolimus (RAD001) and Exemestane in the Treatment of Hormone Receptor Positive HER2 Negative Advanced Breast Cancer Completed
NCT01872260 Phase I Alpelisib + Letrozole Alpelisib + Letrozole + Ribociclib Letrozole + Ribociclib Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer Active, not recruiting
NCT01912963 Phase II Eribulin Pertuzumab Trastuzumab Phase II Study of Eribulin Mesylate, Trastuzumab, and Pertuzumab in Women With Metastatic, Unresectable Locally Advanced, or Locally Recurrent HER2-Positive Breast Cancer Terminated
NCT01676753 Phase I Dinaciclib + Pembrolizumab Phase 1b Dose De-escalation Trial of Dinaciclib With Pembrolizumab for Advanced Breast Cancer Active, not recruiting
NCT02595905 Phase II Cisplatin Cisplatin + Veliparib Cisplatin With or Without Veliparib in Treating Patients With Recurrent or Metastatic Triple-Negative and/or BRCA Mutation-Associated Breast Cancer With or Without Brain Metastases Active, not recruiting
NCT03377387 Phase Ib/II Capecitabine + Neratinib Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer Recruiting
NCT01875666 Phase I Lapatinib + Trastuzumab Trastuzumab Pertuzumab Pertuzumab + Trastuzumab Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuzumab, or Combination Trastuzumab + Lapatinib Completed
NCT04329065 Phase II Paclitaxel + Pertuzumab + pUMVC3-IGFBP2-HER2-IGF1R vaccine + Trastuzumab Concurrent WOKVAC Vaccination, Chemotherapy, and HER2-Targeted Monoclonal Antibody Therapy Before Surgery for the Treatment of Patients With Breast Cancer Not yet recruiting
NCT02693535 Phase II Cobimetinib + Vemurafenib Regorafenib Ipilimumab + Nivolumab Palbociclib Afatinib Talazoparib Pembrolizumab Temsirolimus Pertuzumab + Trastuzumab Crizotinib Abemaciclib Sunitinib Olaparib TAPUR: Testing the Use of Food and Drug Administration (FDA) Approved Drugs That Target a Specific Abnormality in a Tumor Gene in People With Advanced Stage Cancer Recruiting
NCT02500199 Phase I Pyrotinib Open Label Oral Use of Pyrotinib in Patients With HER2 Positive Solid Tumors Who Failed Prior HER2 Targeted Therapy Active, not recruiting
NCT03734029 Phase III Fam-trastuzumab deruxtecan-nxki Nab-paclitaxel Capecitabine Paclitaxel Gemcitabine Eribulin DS-8201a Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] Recruiting