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Profile Name | ERBB2 over exp |
Gene Variant Detail | |
Relevant Treatment Approaches | HER inhibitor (Pan) HER2 (ERBB2) Antibody HER2 (ERBB2) Immune Cell Therapy HER2 (ERBB2) Vaccine HER2 Inhibitor |
Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
---|---|---|---|---|---|---|---|---|
ERBB2 over exp | salivary gland cancer | sensitive | HER2 (ERBB2) Antibody | Pertuzumab + Trastuzumab | Phase II | Actionable | In a Phase II trial (MyPathway), Herceptin (trastuzumab) and Perjeta (pertuzumab) combination treatment resulted in objective response in 80% (4/5, all partial response) of patients with salivary gland cancer harboring ERBB2 (HER2) amplification or overexpression (PMID: 29320312; NCT02091141). | 29320312 |
ERBB2 over exp | salivary gland cancer | sensitive | HER2 (ERBB2) Antibody | Pertuzumab + Trastuzumab | Guideline | Actionable | Herceptin (trastuzumab) and Perjeta (pertuzumab) combination therapy is included in guidelines for patients with recurrent, unresectable, or metastatic salivary gland tumors that are ERBB2 (HER2)-positive (overexpression or amplification), as defined by the ASCO/CAP guidelines for ERBB2 (HER2) testing (NCCN.org). | detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Trastuzumab deruxtecan | Guideline | Actionable | Enhertu (fam-trastuzumab deruxtecan-nxki) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). | detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Trastuzumab deruxtecan | FDA approved | Actionable | In a Phase II trial (DESTINY-Breast01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment resulted in an objective response rate of 60.9% (112/184) in patients with unresectable or metastatic ERBB2 (HER2)-positive (IHC 3+ or FISH +) 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). | detail... 31825192 |
ERBB2 over exp | Her2-receptor positive breast cancer | predicted - sensitive | HER2 (ERBB2) Antibody HER2 Inhibitor | Entinostat + Lapatinib + Trastuzumab | Phase I | Actionable | In a Phase Ib trial, combination treatment consisted of Entinostat, Tykerb (lapatinib) and Herceptin (trastuzumab) resulted in complete response in 9.5% (2/21), partial response in 14.3% (3/21), and stable disease in 38.1% (8/21) of patients with ERBB2 (HER2)-positive breast cancer that progressed through Herceptin (trastuzumab) treatment (PMID: 31097774; NCT01434303). | 31097774 |
ERBB2 over exp | 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 | stomach cancer | sensitive | HER2 Inhibitor | Varlitinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Varlitinib (ARRY-334543) resulted in a 74% tumor growth inhibition and tumor regression in 88% (7/8) of human cell line xenograft models of gastric cancer overexpressing ERBB2 (HER2) (Cancer Res January 15, 2009 69; 2150). | detail... |
ERBB2 over exp | stomach cancer | 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 | Her2-receptor positive breast cancer | sensitive | HER2 Inhibitor | 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 | 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 | 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 | HER2 Inhibitor | 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 | 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 | estrogen-receptor positive breast cancer | predicted - sensitive | HER2 Inhibitor | Pyrotinib | Case Reports/Case Series | Actionable | In a clinical case study, Pyrotinib treatment resulted in stable disease for 4 months in a patient with advanced metastatic ER-positive, ERBB2 (HER2)-overexpressing breast cancer (PMID: 32547945). | 32547945 |
ERBB2 over exp | 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 | gastric adenocarcinoma | sensitive | HER2 (ERBB2) Antibody | Trastuzumab | Guideline | Actionable | Herceptin (trastuzumab) in combination with fluoropyrimidine and cisplatin (category 1) or other chemotherapy agents, but not anthracyclines, is included in guidelines as first-line therapy for Erbb2 (Her2)-overexpressing gastric adenocarcinoma patients (NCCN.org) | detail... |
ERBB2 over exp | gastric adenocarcinoma | sensitive | HER2 (ERBB2) Antibody | Trastuzumab | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial (ToGA) that supported FDA approval, patients with either gastric or gastroesophageal junction adenocarcinoma with ERBB2 (HER2) overexpression or ERBB2 (HER2) amplification had increased overall survival (13.8 mo vs 11.1 mo) when treated with Herceptin (trastuzumab) in combination with chemotherapy compared to chemotherapy alone (PMID: 20728210; NCT01041404). | 20728210 detail... detail... |
ERBB2 over exp | lung non-small cell carcinoma | predicted - sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Case Reports/Case Series | Actionable | In a Phase II trial, Kadcyla (ado-trastuzumab emtansine) treatment demonstrated limited efficacy in patients with relapsed non-small cell lung cancer harboring ERBB2 (Her2) overexpression (n=5) or amplification (n=3), resulting in stable disease as best response in 37.5% (3/8) of the patients (PMID: 29313813). | 29313813 |
ERBB2 over exp | lung non-small cell carcinoma | predicted - sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Phase II | Actionable | In a Phase II trial, Kadcyla (ado-trastuzumab emtansine) treatment in non-small cell lung cancer patients who were ERBB2 positive (defined as IHC 2+ or IHC 3+) resulted in an objective response rate of 20% (4/20), with 4 partial responses, a median progression-free survival (PFS) of 2.7 mo, and a median overall survival (OS) of 15.3 mo in patients who were IHC 3+ (n=20) while patients who were IHC 2+ (n=29) had a median PFS of 2.6 mo, a median OS of 12.2 mo, and no responses (PMID: 30206164; NCT02289833). | 30206164 |
ERBB2 over exp | 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 | 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 | 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 | Her2-receptor positive breast cancer | sensitive | HER2 Inhibitor | 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 | 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 | 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 | 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 | 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 | Trazimera | Preclinical | Actionable | In a preclinical study, PF-05280014 inhibited growth of ERBB2 (HER2)-over expressing breast cancer cells with activity comparable to Herceptin (trastuzumab) in culture (PMID: 25001079). | 25001079 |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Margetuximab-cmkb | FDA approved | Actionable | In a Phase III trial (SOPHIA) that supported FDA approval, Margenza (margetuximab-cmkb) in combination with chemotherapy resulted in improved progression-free survival (5.8 vs 4.9 mo, HR=0.76, p=0.033) compared to Herceptin (trastuzumab) plus chemotherapy in patients with ERBB2 (HER2)-positive (IHC 3+ or FISH amplified) metastatic breast cancer whose disease progressed after two or more lines of anti-ERBB2 (HER2) therapies (Cancer Res 2020;80(4 Suppl):Abstract nr GS1-02; NCT02492711). | detail... detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Margetuximab-cmkb | Phase Ib/II | Actionable | In Phase I clinical trial, Margenza (margetuximab-cmkb) 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 | 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 | 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 | 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 | gastric adenocarcinoma | predicted - sensitive | HER2 Inhibitor | 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 | 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 | breast cancer | sensitive | HER2 Inhibitor | AV-412 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, AV-412 inhibited growth of ERBB2 (HER2)-over expressing breast cancer cell lines in culture, and inhibited tumor growth in a ERBB2 (HER2)-over expressing breast cancer cell line xenograft model (PMID: 17888033). | 17888033 |
ERBB2 over exp | stomach cancer | sensitive | HER2 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 | 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 | 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 | gastroesophageal junction adenocarcinoma | sensitive | HER2 (ERBB2) Antibody | Trastuzumab | Guideline | Actionable | Herceptin (trastuzumab), in combination with first-line chemotherapy including fluoropyrimidine, cisplatin, or other chemotherapy agents, but not anthracyclines, is included in guidelines as preferred first-line therapy for patients with Erbb2 (Her2)-overexpressing esophagogastric junction adenocarcinoma (NCCN.org). | detail... |
ERBB2 over exp | gastric adenocarcinoma | sensitive | HER2 (ERBB2) Antibody | Trastuzumab deruxtecan | FDA approved | Actionable | In a Phase II trial (DESTINY-Gastric01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51%, 61/119 vs 14%, 8/56, p<0.0001) and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.01) compared to chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma with Erbb2 (Her2)-positive (IHC 3+ or IHC 2+ plus ISH +), whose have received a prior trastuzumab-based therapy (PMID: 32469182; NCT03329690). | detail... 32469182 |
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 | 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 | 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 | stomach cancer | sensitive | HER2 Inhibitor | Epertinib | Phase I | Actionable | In a Phase I trial, S-222611 resulted in a complete response in a gastric-esophageal junction cancer patient overexpressing ERBB2 (HER2) and a partial response in a gastric cancer patient also overexpressing ERBB2 (HER2) (J Clin Oncol 33, 2015 (suppl; abstr 2511)). | detail... |
ERBB2 over exp | 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 | Pertuzumab/trastuzumab/hyaluronidase-zzxf | FDA approved | Actionable | In a Phase III trial (FeDeriCa) that supported FDA approval, Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) treatment in combination with chemotherapy in the neoadjuvant-adjuvant setting demonstrated safety and total pathological complete response rate (59.7% vs 59.5%) comparable to intravenous Perjeta (pertuzumab) and Herceptin (trastuzumab) plus chemotherapy in patients with ERBB2 (HER2)-positive early breast cancer (Cancer Res 2020;80(4 Suppl):Abstract nr PD4-07; NCT03493854). | detail... detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | 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 | 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 | gastroesophageal junction adenocarcinoma | sensitive | HER2 (ERBB2) Antibody | Trastuzumab deruxtecan | FDA approved | Actionable | In a Phase II trial (DESTINY-Gastric01) that supported FDA approval, Enhertu (fam-trastuzumab deruxtecan-nxki) treatment improved objective response rate (51%, 61/119 vs 14%, 8/56, p<0.0001) and overall survival (12.5 vs 8.4 mo, HR=0.59, p=0.01) compared to chemotherapy in patients with advanced gastric or gastroesophageal junction adenocarcinoma with Erbb2 (Her2)-positive (IHC 3+ or IHC 2+ plus ISH +), whose have received a prior trastuzumab-based therapy (PMID: 32469182; NCT03329690). | 32469182 detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody HER2 Inhibitor | 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 HER2 Inhibitor | 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 | ARX-788 | Preclinical - Pdx | Actionable | In a preclinical study, treatment with ARX-788 led to greater activity compared to Kadcyla (ado-trastuzumab emtansine) in ERBB2 (HER2)-overexpressing breast cancer cell line xenograft models and patient-derived xenograft (PDX) models, including induced tumor regression for both (PMID: 32669315). | 32669315 |
ERBB2 over exp | salivary gland cancer | sensitive | HER2 (ERBB2) Antibody | Trastuzumab deruxtecan | Guideline | Actionable | Enhertu (trastuzumab deruxtecan) is included in guidelines for patients with recurrent, unresectable, or metastatic salivary gland tumors that are ERBB2 (HER2)-positive (overexpression or amplification), as defined by the ASCO/CAP guidelines for ERBB2 (HER2) testing (NCCN.org). | detail... |
ERBB2 over exp | gastric adenocarcinoma | sensitive | VS-5584 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, VS-5584 inhibited tumor growth in human gastric cancer cell line xenograft models overexpressing ERBB2 (HER2) (PMID: 23270925). | 23270925 | |
ERBB2 over exp | 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 | stomach cancer | sensitive | HER2 Inhibitor | KU004 | Preclinical | Actionable | In a preclinical study, KU004 inhibited growth and induced apoptosis in gastric cancer cell lines over expressing ERBB2 in culture and suppressed growth in a dose dependent manner in xenograft models (PMID: 26437915). | 26437915 |
ERBB2 over exp | breast cancer | sensitive | HER2 (ERBB2) Antibody | Trastuzumab-anns | FDA approved - On Companion Diagnostic | Actionable | In a Phase I trial that supported FDA approval, the Herceptin (trastuzumab) biosimilar Kanjinti (Trastuzumab-anns) demonstrated structure, function, and pharmacokinetic profile comparable to Herceptin (trastuzumab) (PMID: 28341959), thus supporting the extrapolation of data from the Phase III trial that supported the approval of Herceptin (trastuzumab) in Erbb2 (Her2) overexpressing breast cancer (PMID: 23602601; NCT00567190) for approval of Kanjinti (Trastuzumab-anns) (FDA.gov). | 23602601 detail... 28341959 detail... detail... |
ERBB2 over exp | 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 | 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 | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | CT-P6 | Phase III | Actionable | In a Phase III trial, adjuvant CT-6 treatment demonstrated safety profile and efficacy comparable to Herceptin (trastuzumab) in patients with ERBB2 (HER2)-positive early breast cancer, resulting in a pathological complete response (pCR) in 45.2% (14/31) and 43.3% (104/240) of patients over or under 65 years of age, respectively, compared to 50.0% (20/40) and 46.6% (111/238) in patients treated with Herceptin (trastuzumab) (PMID: 31428820; NCT02162667). | 31428820 |
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 | Trastuzumab + Vinorelbine | Guideline | Actionable | Herceptin (trastuzumab) combined with Navelbine (vinorelbine) is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). | detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Trastuzumab + Vinorelbine | Guideline | Actionable | The combination of Herceptin (trastuzumab) and Navelbine (vinorelbine) is included in guidelines as first-line therapy for patients with ERBB2 (HER2)-positive advanced breast cancer (PMID: 30032243; ESMO.org). | 30032243 detail... |
ERBB2 over exp | salivary gland cancer | sensitive | HER2 (ERBB2) Antibody | Trastuzumab | Guideline | Actionable | Herceptin (trastuzumab) is included in guidelines for patients with recurrent, unresectable, or metastatic salivary gland tumors that are ERBB2 (HER2)-positive (overexpression or amplification), as defined by the ASCO/CAP guidelines for ERBB2 (HER2) testing (NCCN.org). | detail... |
ERBB2 over exp | breast cancer | sensitive | HER2 Inhibitor | KU004 | Preclinical | Actionable | In a preclinical study, KU004 inhibited growth and induced apoptosis in breast cancer cell lines over expressing ERBB2 in culture (PMID: 26437915). | 26437915 |
ERBB2 over exp | 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 | 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 | esophagus adenocarcinoma | sensitive | HER2 (ERBB2) Antibody | Trastuzumab | Guideline | Actionable | Herceptin (trastuzumab), in combination with first-line chemotherapy including fluoropyrimidine, cisplatin, or other chemotherapy agents, but not anthracyclines, is included in guidelines as preferred first-line therapy for patients with Erbb2 (Her2)-overexpressing esophageal adenocarcinoma (NCCN.org). | detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Guideline | Actionable | Kadcyla (ado-trastuzumab emtansine) is included in the guidelines for patients with ERBB2 (HER2)-positive advanced breast cancer who progressed through one line of Herceptin (trastuzumab)-based therapy or ERBB2 (HER2)-positive patients with early breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). | 31236598 detail... 30032243 |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | 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 (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 | 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 | 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 | 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 | 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 (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 | salivary gland cancer | sensitive | HER2 (ERBB2) Antibody | Docetaxel + Trastuzumab | Guideline | Actionable | Herceptin (trastuzumab) and Taxotere (docetaxel) combination therapy is included in guidelines for patients with recurrent, unresectable, or metastatic salivary gland tumors that are ERBB2 (HER2)-positive (overexpression or amplification), as defined by the ASCO/CAP guidelines for ERBB2 (HER2) testing (NCCN.org). | detail... |
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 HER2 Inhibitor | Capecitabine + Trastuzumab + Tucatinib | Guideline | Actionable | Tukysa (tucatinib), Herceptin (trastuzumab), and Xeloda (capecitabine) combination therapy is included in guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). | detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody HER2 Inhibitor | Capecitabine + Trastuzumab + Tucatinib | FDA approved | Actionable | In a Phase II trial (HER2CLIMB) that supported FDA approval, addition of Tukysa (tucatinib) to Herceptin (trastuzumab) and Xeloda (capecitabine) significantly improved progression-free survival at 1 year (PFS1) compared to placebo (33.1% vs 12.3%, HR=0.54, p<0.001) in patients with metastatic ERBB2 (HER2)-positive breast cancer who received prior HER2-targeted therapy, PFS1 was significantly improved (24.9% vs 0%, HR=0.48, p<0.001) in patients with brain metastasis (PMID: 31825569; NCT02614794). | detail... 31825569 |
ERBB2 over exp | stomach cancer | sensitive | HER2 (ERBB2) Immune Cell Therapy | HER2 CAR-T cells | Preclinical - Cell line xenograft | Actionable | In a preclinical study, ERBB2 (HER2)-specific CAR-T cells induced cell death in ERBB2 (HER2)-over expressing gastric cancer cell lines in culture, and inhibited tumor growth and improved survival in a ERBB2 (HER2)-over expressing gastric cancer cell line xenograft model (PMID: 28284008). | 28284008 |
ERBB2 over exp | stomach cancer | sensitive | HER2 Inhibitor | TAK-285 | Preclinical | Actionable | In a preclinical study, the N87 gastric cancer cell line, which has been demonstrated to have ERBB2 (HER2) amplification and over expression, was sensitive to TAK-285, inhibiting phosphorylation of ERBB2 (HER2) and ERBB3 (HER3) (PMID: 25594012, PMID: 18441328). | 18441328 25594012 |
ERBB2 over exp | stomach cancer | sensitive | HER2 Inhibitor | TAK-285 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, TAK-285 inhibited tumor growth in gastric cancer cell line xenograft models over expressing ERBB2 (HER2) (PMID: 23983820). | 23983820 |
ERBB2 over exp | gastroesophageal junction adenocarcinoma | sensitive | HER2 Inhibitor | Epertinib | Phase I | Actionable | In a Phase I trial, S-222611 resulted in a complete response in a gastric-esophageal junction cancer patient over expressing ERBB2 (HER2) and a partial response in a gastric cancer patient also over expressing ERBB2 (HER2) (J Clin Oncol 33, 2015 (suppl; abstr 2511)). | detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | 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 | 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 | stomach cancer | sensitive | HER inhibitor (Pan) | Dacomitinib | Phase II | Actionable | In a Phase II trial, Vizimpro (dacomitinib) resulted in a 7.4% (2/27) response rate and 40.7% (11/27) disease control rate when treating advanced gastric cancer patients with ERBB2 (HER2) over expression (J Clin Oncol 30, 2012 (suppl 4; abstr 54)). | detail... |
ERBB2 over exp | stomach cancer | sensitive | HER inhibitor (Pan) | Dacomitinib | Preclinical | Actionable | In a preclinical study, ERBB2 (HER2) over expressing gastric cancer cells were sensitive to Vizimpro (dacomitinib), resulting in inhibition of ERBB2 (HER2)/ERBB3 (HER3) heterodimers (PMID: 22135232). | 22135232 |
ERBB2 over exp | Her2-receptor positive breast cancer | predicted - sensitive | HER2 Inhibitor | Entinostat + Lapatinib | Phase I | Actionable | In a Phase Ib trial, Entinostat and Tykerb (lapatinib) combination therapy resulted in complete response in 7.1% (1/14) and stable disease in 28.6% (4/14) of patients with ERBB2 (HER2)-positive breast cancer that progressed through Herceptin (trastuzumab) treatment (PMID: 31097774; NCT01434303). | 31097774 |
ERBB2 over exp | 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 | Tucatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Tukysa (tucatinib) inhibited proliferation of an ERBB2 (HER2) over expressing gastric cancer cell line in culture (Cancer Res April 15, 2010 70:3610). | detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 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 | Advanced Solid Tumor | predicted - sensitive | HER2 (ERBB2) Antibody | Margetuximab-cmkb | Phase I | Actionable | In a Phase I trial, Margenza (margetuximab-cmkb) 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; NCT01148849). | 28119295 |
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 | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Docetaxel + Pertuzumab + Trastuzumab | FDA approved - On Companion Diagnostic | Actionable | In a Phase III trial (CLEOPATRA) that supported FDA approval, treatment with Perjeta (pertuzumab), combined with Herceptin (trastuzumab) and Taxotere (docetaxel), improved median progression free survival to 18.5 months compared to 12.4 months with placebo plus Herceptin (trastuzumab) and Taxotere (docetaxel) in patients with ERBB2 (HER2)-positive (overexpression and amplification) metastatic breast cancer (PMID: 23602601; NCT00567190). | detail... 23602601 detail... |
ERBB2 over exp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Docetaxel + Pertuzumab + Trastuzumab | Guideline | Actionable | Perjeta (pertuzumab), Herceptin (trastuzumab), and Taxotere (docetaxel) therapy is included in the guidelines as systemic therapy for patients with recurrent or metastatic hormone receptor-positive (ER and/or PR) or negative, ERBB2 (HER2)-positive breast cancer (NCCN.org). | detail... |
ERBB2 over exp | 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 | HER2 (ERBB2) Antibody | Docetaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf | FDA approved | Actionable | In a Phase III trial (FeDeriCa) that supported FDA approval, Phesgo (pertuzumab/trastuzumab/hyaluronidase-zzxf) demonstrated pharmacokinetics, safety, and efficacy comparable to i.v. pertuzumab and trastuzumab (H+P) (Cancer Res 2020;80(4 Suppl):Abstract nr PD4-07; NCT03493854), warranted the extrapolation of data from a Phase III trial supporting the approval of H+P plus docetaxel in Erbb2 (Her2)-positive metastatic breast cancer (PMID: 23602601; NCT00567190) for approval of Phesgo (FDA.gov). | detail... detail... 23602601 detail... |
ERBB2 over exp | 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 |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT01526473 | Phase I | AVX901 | A Phase I Study To Evaluate The Antitumor Activity And Safety Of AVX901 | Completed | USA | 0 |
NCT01872260 | Phase I | Alpelisib + Letrozole Alpelisib + Letrozole + Ribociclib Letrozole + Ribociclib | Study of LEE011, BYL719 and Letrozole in Advanced ER+ Breast Cancer | Active, not recruiting | USA | 7 |
NCT03043313 | Phase II | Trastuzumab + Tucatinib Tucatinib | Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer | Recruiting | USA | 4 |
NCT02892123 | Phase I | Capecitabine + ZW25 ZW25 Paclitaxel + ZW25 Vinorelbine + ZW25 | Trial of ZW25 (Zanidatamab) in Patients With Advanced HER2-expressing Cancers | Recruiting | USA | CAN | 1 |
NCT02066532 | Phase Ib/II | Ruxolitinib + Trastuzumab | Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer | Active, not recruiting | USA | 0 |
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 | USA | CAN | 0 |
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 | USA | 1 |
NCT01622868 | Phase II | Lapatinib | Whole-Brain Radiation Therapy or Stereotactic Radiosurgery With or Without Lapatinib Ditosylate in Treating Patients With Brain Metastasis From HER2-Positive Breast Cancer | Active, not recruiting | USA | CAN | 1 |
NCT04172597 | Phase II | Poziotinib | A Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies | Recruiting | USA | 0 |
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 | USA | 0 |
NCT03529110 | Phase III | Trastuzumab deruxtecan Ado-trastuzumab emtansine | DS-8201a Versus T-DM1 for Human Epidermal Growth Factor Receptor 2 (HER2)-Positive, Unresectable and/or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane [DESTINY-Breast03] | Active, not recruiting | USA | CAN | 13 |
NCT04243616 | Phase II | Carboplatin + Cemiplimab + Cyclophosphamide + Doxorubicin + Paclitaxel Cemiplimab + Cyclophosphamide + Doxorubicin + Paclitaxel | Cemiplimab in High Risk or Locally Advanced Hormone Receptor Positive HER2 Negative or Triple-Negative Breast Cancer | Recruiting | USA | 0 |
NCT04686305 | Phase I | Durvalumab + Pemetrexed Disodium + Trastuzumab deruxtecan Carboplatin + Durvalumab + Trastuzumab deruxtecan Durvalumab + Trastuzumab deruxtecan Cisplatin + Durvalumab + Trastuzumab deruxtecan | Phase Ib Study of the Safety of T-DXd and Durvalumab With Chemotherapy in Advanced or Metastatic HER2+ Non-squamous NSCLC (DL03) | Recruiting | USA | CAN | 6 |
NCT01466972 | Phase II | Pazopanib | Reversing Hormone Resistance in Advanced Breast Cancer With Pazopanib | Completed | USA | 0 |
NCT03505710 | Phase II | Trastuzumab deruxtecan | DS-8201a in Human Epidermal Growth Factor Receptor 2 (HER2)-Expressing or -Mutated Non-Small Cell Lung Cancer | Active, not recruiting | USA | 4 |
NCT00796978 | Phase II | Trastuzumab | Trastuzumab in Treating Older Women With Early-Stage Breast Cancer | Completed | USA | 0 |
NCT04460456 | Phase I | SBT6050 Pembrolizumab + SBT6050 | A Study of SBT6050 Alone and in Combination With Pembrolizumab in Patients With Advanced HER2 Expressing Solid Tumors | Recruiting | USA | 1 |
NCT02063724 | Phase I | HER2-pulsed DC1 vaccine | HER-2 Pulsed DC Vaccine to Prevent Recurrence of Invasive Breast Cancer (Adjuvant) | Active, not recruiting | USA | 0 |
NCT02564900 | Phase I | Trastuzumab deruxtecan | Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors | Active, not recruiting | USA | 1 |
NCT01148849 | Phase I | Margetuximab-cmkb | Safety Study of MGAH22 in HER2-positive Carcinomas | Active, not recruiting | USA | 1 |
NCT03523585 | Phase III | Trastuzumab deruxtecan Capecitabine + Lapatinib Capecitabine + Trastuzumab | DS-8201a in Pre-treated HER2 Breast Cancer That Cannot be Surgically Removed or Has Spread [DESTINY-Breast02] | Active, not recruiting | USA | 14 |
NCT04639219 | Phase II | Trastuzumab deruxtecan | A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (DPT01) | Recruiting | USA | 2 |
NCT04538742 | Phase Ib/II | Durvalumab + Trastuzumab deruxtecan Pertuzumab + Trastuzumab deruxtecan Durvalumab + Paclitaxel + Trastuzumab deruxtecan Paclitaxel + Trastuzumab deruxtecan Trastuzumab deruxtecan | A Phase 1b/2 Study of T-DXd Combinations in HER2-positive Metastatic Breast Cancer (DB-07) | Recruiting | USA | 9 |
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 | Completed | USA | 0 |
NCT03587740 | Phase II | Ado-trastuzumab emtansine | ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer | Active, not recruiting | USA | 0 |
NCT03501979 | Phase II | Capecitabine + Trastuzumab + Tucatinib | Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD | Recruiting | USA | 0 |
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 | USA | 0 |
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 | Recruiting | USA | 0 |
NCT02152943 | Phase I | Everolimus + Letrozole + Trastuzumab | Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients | Completed | USA | 0 |
NCT03377387 | Phase Ib/II | Capecitabine + Neratinib | Capecitabine 7/7 Schedule With Neratinib in Patients With Metastatic HER2-Positive Breast Cancer | Recruiting | USA | 0 |
NCT02073916 | Phase I | Ado-trastuzumab emtansine + Lapatinib + Nab-paclitaxel | TDM1 With Abraxane and Lapatinib for Metastatic HER2 Positive Breast Cancer | Completed | USA | 0 |
NCT04108858 | Phase Ib/II | Copanlisib + Pertuzumab + Trastuzumab Pertuzumab + Trastuzumab | Testing the Addition of an Anti-cancer Drug, Copanlisib, to the Usual Maintenance Treatment (Trastuzumab and Pertuzumab) After Initial Chemotherapy in a Phase Ib/II Trial for Advanced HER2 Positive Breast Cancer | Recruiting | USA | 0 |
NCT02139358 | Phase Ib/II | Gemcitabine + Pertuzumab + Trastuzumab | Phase I/IIa Trial of Gemcitabine Plus Trastuzumab and Pertuzumab in Previously Treated Metastatic HER2+ Breast Cancer | Completed | USA | 0 |
NCT04209465 | Phase I | BDTX-189 | A Study of BDTX-189, an Orally Available Allosteric ErbB Inhibitor, in Patients With Advanced Solid Tumors. | Recruiting | USA | 0 |
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 | USA | 0 |
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 | USA | CAN | 26 |
NCT04512261 | Phase Ib/II | Pembrolizumab + Trastuzumab + Tucatinib | TOPAZ: Tucatinib in COmbination With Pembrolizumab And TrastuZumab in Women With HER2-Positive Breast Cancer Brain Metastases (TOPAZ) | Not yet recruiting | USA | 0 |
NCT02673398 | Phase II | Neratinib | Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer | Active, not recruiting | USA | 0 |
NCT04510285 | Phase II | Pembrolizumab + Trastuzumab Trastuzumab | Study of Pembrolizumab Plus Trastuzumab or Trastuzumab Alone After Surgery in Patients With Esophagogastric Tumors | Recruiting | USA | 0 |
NCT04294225 | Phase II | Anastrozole + Letrozole | Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III Breast Cancer | Recruiting | USA | 0 |
NCT03289039 | Phase II | Neratinib Fulvestrant + Neratinib | Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
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 | USA | 0 |
NCT02954536 | Phase II | Capecitabine + Cisplatin + Pembrolizumab + Trastuzumab | Phase II Trial of Pembrolizumab With Trastuzumab and Chemotherapy in Advanced HER2 Positive Esophagogastric (EG) Cancer | Active, not recruiting | USA | 0 |
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 | USA | 0 |
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 | USA | 0 |
NCT04215146 | Phase II | Paclitaxel Avelumab + Paclitaxel + Pelareorep Paclitaxel + Pelareorep | A Study to Assess Overall Response Rate by Inducing an Inflammatory Phenotype in Metastatic BReast cAnCEr With the Oncolytic Reovirus PeLareorEp in CombinaTion With Anti-PD-L1 Avelumab and Paclitaxel - BRACELET-1 Study | Recruiting | USA | 0 |
NCT03696030 | Phase I | HER2 CAR-T cells | HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases | Recruiting | USA | 0 |
NCT03417544 | Phase II | Atezolizumab + Pertuzumab + Trastuzumab | Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC | Active, not recruiting | USA | 0 |
NCT04539938 | Phase II | Trastuzumab deruxtecan + Tucatinib | A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer (HER2CLIMB-04) | Recruiting | USA | 0 |
NCT04744831 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02) | Not yet recruiting | USA | 9 |
NCT02605486 | Phase Ib/II | Bicalutamide + Palbociclib | Palbociclib in Combination With Bicalutamide for the Treatment of AR(+) Metastatic Breast Cancer (MBC) | Active, not recruiting | USA | 0 |
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 | Recruiting | USA | 1 |
NCT03846583 | Phase I | Abemaciclib + Trastuzumab + Tucatinib | Tucatinib + Abemaciclib + Herceptin for HER2+ MBC | Withdrawn | 0 | |
NCT04457596 | Phase III | Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Tucatinib | T-DM1 and Tucatinib Compared With T-DM1 Alone in Preventing Relapses in People With High Risk HER2-Positive Breast Cancer, the CompassHER2 RD Trial | Recruiting | USA | 0 |
NCT01934894 | Phase II | Cabazitaxel + Lapatinib | Cabazitaxel Plus Lapatinib as Therapy for HER2-Positive Metastatic Breast Cancer Patients With Intracranial Metastases | Terminated | USA | 0 |
NCT02789657 | Phase II | Carboplatin + Paclitaxel + Pertuzumab + Trastuzumab Cyclophosphamide + Doxorubicin | Neoadjuvant Therapy in Clinical Stage I-III HER2-positive Breast Cancer. | Active, not recruiting | USA | 0 |
NCT03523572 | Phase I | Nivolumab + Trastuzumab deruxtecan | Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer | Active, not recruiting | USA | 6 |
NCT04042701 | Phase I | Pembrolizumab + Trastuzumab deruxtecan | DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer | Recruiting | USA | 1 |
NCT04757363 | Phase II | Fluorouracil + Leucovorin + Nivolumab + Oxaliplatin + Regorafenib | A Study of Nivolumab Combined With FOLFOX and Regorafenib in People Who Have HER2-Negative Esophagogastric Cancer | Recruiting | USA | 0 |
NCT03135171 | Phase I | Pertuzumab + Tocilizumab + Trastuzumab | Trastuzumab and Pertuzumab in Combination With Tocilizumab in Subjects With Metastatic HER2 Positive Breast Cancer Resistant to Trastuzumab | Recruiting | USA | 0 |
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 | USA | 0 |
NCT01989676 | Phase III | Paclitaxel + Trastuzumab Paclitaxel + Trazimera | 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) | Completed | USA | 23 |
NCT03602079 | Phase Ib/II | A166 | Study of A166 in Patients With Relapsed/Refractory Cancers Expressing HER2 Antigen or Having Amplified HER2 Gene | Recruiting | USA | 0 |
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) | Recruiting | USA | 0 |
NCT04430738 | Phase I | Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab + Tucatinib | Tucatinib Plus Trastuzumab and Oxaliplatin-based Chemotherapy for HER2+ Gastrointestinal Cancers | Recruiting | USA | 0 |
NCT03094052 | Phase II | Neratinib Loperamide Crofelemer Neratinib + Trastuzumab | Diarrhea Prophylaxis in Patients With HER2+ Breast Cancer Treated With Neratinib, With or Without Trastuzumab | Recruiting | USA | 0 |
NCT04499924 | Phase II | Paclitaxel + Ramucirumab + Trastuzumab + Tucatinib Paclitaxel + Ramucirumab + Tucatinib Paclitaxel + Ramucirumab | Tucatinib, Trastuzumab, Ramucirumab, and Paclitaxel Versus Paclitaxel and Ramucirumab in Previously Treated HER2+ Gastroesophageal Cancer (MOUNTAINEER-02) | Recruiting | USA | 0 |
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 | Active, not recruiting | USA | 0 |
NCT04481113 | Phase I | Abemaciclib + Niraparib | Abemaciclib and Niraparib Before Surgery for the Treatment of Hormone Receptor Positive HER2 Negative Breast Cancer | Not yet recruiting | USA | 0 |
NCT02038010 | Phase I | Ado-trastuzumab emtansine + Alpelisib | BYL719 + T-DM1 in HER2(+) Metastatic Breast Cancer Pts Who Progress on Prior Trastuzumab & Taxane Tx | Completed | USA | 0 |
NCT01924351 | Phase II | HER2-positive Breast Cancer With Brain Metastasis (GCC 1345) | Withdrawn | USA | 0 | |
NCT04762901 | Phase I | Cyclophosphamide + Doxorubicin + Niraparib + Pegfilgrastim Cyclophosphamide + Doxorubicin + Niraparib Niraparib + Paclitaxel Carboplatin + Niraparib + Paclitaxel | LCI-BRE-MTN-NIR-001:Ph I Study of Niraparib in Combo With Standard Chemo in Metastatic Trip Neg Breast Cancer | Not yet recruiting | USA | 0 |
NCT03366844 | Phase Ib/II | Pembrolizumab | Breast Cancer Study of Preoperative Pembrolizumab + Radiation | Active, not recruiting | USA | 0 |
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 | Recruiting | USA | 0 |
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 | USA | 16 |
NCT04469127 | Phase Ib/II | AIP-303 | A Study of AIP-303 in HER2 Positive Breast Cancer and/or Metastatic Breast Cancer Patients (Heroine01) | Not yet recruiting | USA | 5 |
NCT01596751 | Phase Ib/II | Eribulin Pexidartinib | Phase Ib/II Study of PLX 3397 and Eribulin in Patients With Metastatic Breast Cancer | Completed | USA | 0 |
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 | USA | 0 |
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 | USA | 0 |
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 | USA | 0 |
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 | Active, not recruiting | USA | 8 |
NCT04450732 | Phase I | GQ1001 | Safety of GQ1001 in Adult Patients With HER2-Positive Advanced Solid Tumors | Recruiting | USA | 1 |
NCT03804515 | Phase I | Poziotinib | A Mass Balance and Pharmacokinetics Study of 14C-Labeled Poziotinib in Cancer Patients Suitable for Treatment With Poziotinib | Active, not recruiting | USA | 0 |
NCT02213042 | Phase II | Lapatinib + Trastuzumab Trastuzumab | Evaluation of Biomarkers Associated With Response to Subsequent Therapies in Subjects With HER2-Positive Metastatic Breast Cancer | Completed | USA | 11 |
NCT03716180 | Phase I | Paclitaxel + Pertuzumab + Trastuzumab | DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC | Active, not recruiting | USA | 0 |
NCT03821233 | Phase I | ZW49 | A Dose Finding Study of ZW49 in Patients With HER2-Positive Cancers | Recruiting | USA | CAN | 0 |
NCT02187744 | Phase III | Carboplatin + Docetaxel + Trastuzumab | A Study Of PF-05280014 Or Trastuzumab Plus Taxotere® And Carboplatin In HER2 Positive Breast Cancer In The Neoadjuvant Setting (REFLECTIONS B327-04) | Completed | USA | 9 |
NCT04588545 | Phase Ib/II | Pertuzumab + Trastuzumab | Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease | Recruiting | USA | 0 |
NCT03630809 | Phase II | HER2-pulsed DC1 vaccine | Immune Response and Potential Booster for Patients Who Have Received HER2-pulsed DC1 | Suspended | USA | 0 |
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 | USA | 0 |
NCT02659514 | Phase II | Poziotinib | Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
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 | USA | CAN | 36 |
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 | Suspended | USA | 0 |
NCT02952729 | Phase I | XMT-1522 | Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2 | Completed | USA | 0 |
NCT03530696 | Phase II | Ado-trastuzumab emtansine Ado-trastuzumab emtansine + Palbociclib | T-DM1 and Palbociclib for Metastatic HER2 Breast Cancer (T-DM1) | Recruiting | USA | 0 |
NCT00651976 | Phase I | Letrozole | Letrozole in Treating Postmenopausal Women With Stage I, II or III Breast Cancer That Can Be Removed by Surgery | Terminated | USA | 0 |
NCT03429101 | Phase I | Ado-trastuzumab emtansine + Poziotinib | A Study of Poziotinib in Combination With T-DM1 in HER2-Positive Breast Cancer | Terminated | USA | 0 |
NCT00411788 | Phase II | Sirolimus + Trastuzumab | A Phase II Study of Rapamycin and Trastuzumab for Patients With HER-2 Receptor Positive Metastatic Breast Cancer | Completed | USA | 0 |
NCT04120246 | Phase I | alpha-TEA + Trastuzumab | Alpha-TEA and Trastuzumab for the Treatment of Refractory HER2+ Metastatic Breast Cancer | Recruiting | USA | 0 |
NCT04224272 | Phase II | Fulvestrant + Palbociclib + ZW25 | A Study of ZW25 (Zanidatamab) With Palbociclib Plus Fulvestrant in Patients With HER2+/HR+ Advanced Breast Cancer | Recruiting | USA | CAN | 1 |
NCT04513665 | Phase II | ZW25 | ZW25 in Women With Endometrial Cancers | Recruiting | USA | 0 |
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 | Completed | USA | 0 |
NCT04134884 | Phase I | Decitabine and Cedazuridine + Talazoparib | Study of ASTX727 Plus Talazoparib in Patients With Triple Negative or Hormone Resistant/HER2-negative Metastatic Breast Cancer | Recruiting | USA | 0 |
NCT04579380 | Phase II | Trastuzumab + Tucatinib Fulvestrant + Trastuzumab + Tucatinib | Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations | Recruiting | USA | 0 |
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 | Active, not recruiting | USA | 0 |
NCT04379596 | Phase II | Cisplatin + Fluorouracil + Trastuzumab Capecitabine + Oxaliplatin + Trastuzumab Capecitabine + Cisplatin + Trastuzumab Trastuzumab deruxtecan Fluorouracil + Oxaliplatin + Trastuzumab Fluorouracil + Trastuzumab deruxtecan Capecitabine + Trastuzumab deruxtecan Durvalumab + Trastuzumab deruxtecan Fluorouracil + Oxaliplatin + Trastuzumab deruxtecan Capecitabine + Oxaliplatin + Trastuzumab deruxtecan Durvalumab + Fluorouracil + Trastuzumab deruxtecan Capecitabine + Durvalumab + Trastuzumab deruxtecan | Ph1b/2 Study of the Safety and Efficacy of T-DXd Combinations in Advanced HER2+ Gastric Cancer (DESTINY-Gastric03) (DG-03) | Recruiting | USA | CAN | 9 |
NCT03929666 | Phase II | Cisplatin + Fluorouracil + ZW25 Capecitabine + Oxaliplatin + ZW25 Fluorouracil + Leucovorin + Oxaliplatin + ZW25 | A Safety and Efficacy Study of ZW25 (Zanidatamab) Plus Combination Chemotherapy in HER2-expressing Gastroesophageal Adenocarcinoma | Recruiting | USA | CAN | 1 |
NCT01118975 | Phase Ib/II | Lapatinib + Vorinostat | GCC 0845:Vorinostat and Lapatinib in Advanced Solid Tumors and Advanced Breast Cancer to Evaluate Response and Biomarkers | Terminated | USA | 0 |
NCT02500199 | Phase I | Pyrotinib | Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors | Active, not recruiting | USA | 0 |
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 | USA | CAN | 2 |
NCT04143711 | Phase Ib/II | DF1001 DF1001 + Pembrolizumab | Study of DF1001 in Patients With Advanced Solid Tumors | Recruiting | USA | 0 |
NCT02751528 | Phase I | ETBX-021 | QUILT-3.013: Study of Ad5 [E1-, E2b-]-HER2/Neu Vaccine (ETBX-021) in Subjects With Unresectable Locally Advanced or Metastatic HER2-Expressing Breast Cancer | Unknown status | USA | 0 |
NCT02124148 | Phase I | Cisplatin + Prexasertib Cetuximab + Prexasertib Pemetrexed Disodium + Prexasertib LY3023414 + Prexasertib Fluorouracil + Leucovorin + Prexasertib | A Study of Prexasertib (LY2606368) With Chemotherapy or Targeted Agents in Participants With Advanced Cancer | Completed | USA | 0 |
NCT01973309 | Phase I | Paclitaxel + Vantictumab | A Study of Vantictumab (OMP-18R5) in Combination With Paclitaxel in Locally Recurrent or Metastatic Breast Cancer | Completed | USA | 0 |
NCT00968968 | Phase III | Trastuzumab Lapatinib + Trastuzumab | Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone | Terminated | USA | CAN | 0 |
NCT04509596 | Phase I | DZD1516 + Trastuzumab Capecitabine + DZD1516 Ado-trastuzumab emtansine + DZD1516 Capecitabine + DZD1516 + Trastuzumab DZD1516 | DZD1516 in Combination With Trastuzumab and Capecitabine, or in Combination With T-DM1, in Patients With Metastatic HER2 Positive Breast Cancer | Recruiting | USA | 0 |
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 | USA | 0 |
NCT01522768 | Phase II | Afatinib + Paclitaxel | Afatinib and Paclitaxel in Patients With Advanced HER2-Positive Trastuzumab-Refractory Advanced Esophagogastric Cancer | Active, not recruiting | USA | 0 |
NCT03734029 | Phase III | Trastuzumab deruxtecan Nab-paclitaxel Capecitabine Paclitaxel Gemcitabine Eribulin | Trastuzumab Deruxtecan (DS-8201a) Versus Investigator's Choice for HER2-low Breast Cancer That Has Spread or Cannot be Surgically Removed [DESTINY-Breast04] | Active, not recruiting | USA | CAN | 18 |
NCT03765983 | Phase II | GDC-0084 + Trastuzumab | GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases | Recruiting | USA | 0 |
NCT02189174 | Phase Ib/II | CLR457 | Study of CLR457 Administered Orally in Adult Patients With Advanced Solid Malignancies | Terminated | USA | CAN | 3 |
NCT03387553 | Phase I | HER2-pulsed DC1 vaccine | HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer | Recruiting | USA | 0 |
NCT03410927 | Phase Ib/II | TAS0728 | A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities | Active, not recruiting | USA | 3 |
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 | USA | 4 |