Missing content? – Request curation!
Request curation for specific Genes, variants, or PubMed publications.
Have questions, comments or suggestions? - Let us know!
Email us at : ckbsupport@jax.org
Profile Name | ERBB2 amp |
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 amp | 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... 23602601 detail... detail... |
ERBB2 amp | Her2-receptor positive breast cancer | predicted - sensitive | BGB-283 | Preclinical - Cell culture | Actionable | In a preclinical study, BGB-283 inhibited proliferation of ERBB2 (HER2) amplified breast cancer cells in culture (PMID: 26208524). | 26208524 | |
ERBB2 amp | endometrial serous adenocarcinoma | sensitive | HER2 Inhibitor | Neratinib | Preclinical - Cell culture | Actionable | In a preclinical study, a uterine serous carcinoma cell line harboring ERBB2 (HER2) amplification demonstrated sensitivity to treatment with Nerlynx (neratinib) in culture, resulting in inhibition of cell growth (PMID: 26333383). | 26333383 |
ERBB2 amp | 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 amp | urinary bladder cancer | sensitive | HER inhibitor (Pan) | Afatinib | Phase II | Actionable | In a Phase II clinical trial, patients with ERBB2 (HER2) amplified urothelial carcinoma had improved progression free survival when treated with Gilotrif (afatinib), and median PFS was 6.6 months for patients with ERBB2 or ERBB3 alterations relative to 1.4 months for patients lacking alterations (PMID: 27044931). | 27044931 |
ERBB2 amp | 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 amp | 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 ERBB2 (HER2)-positive patients with early breast cancer or as first-line therapy for ERBB2 (HER2)-positive patients with advanced breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). | 31236598 detail... 30032243 |
ERBB2 amp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Trastuzumab | Clinical Study - Meta-analysis | Actionable | In a meta-analysis, breast cancer patients with >12 copies of ERBB2 (HER2) had a better response to Herceptin (trastuzumab) than patients with 6-12 copies of ERBB2 (HER2) (PMID: 24691421). | 24691421 |
ERBB2 amp | 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 amp | breast cancer | sensitive | Buparlisib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, a breast cancer cell line xenograft model harboring ERBB2 (HER2) amplification demonstrated tumor regression within the mammary fat pad when treated with Buparlisib (BKM120) (PMID: 28539475). | 28539475 | |
ERBB2 amp | lung squamous cell carcinoma | resistant | Gefitinib | Preclinical | Actionable | In a preclinical study, a lung squamous cell carcinoma cell line with ERBB2 (HER2) amplification demonstrated resistance to treatment with Iressa (gefitinib) in culture (PMID: 26545934). | 26545934 | |
ERBB2 amp | vulva squamous cell carcinoma | sensitive | Depatuxizumab mafodotin | Preclinical - Cell line xenograft | Actionable | In a preclinical study, ABT-414 demonstrated cytoxicity against a EGFR-amplified vulvar epidermoid carcinoma cell line in culture and induced tumor regression in EGFR-amplified vulvar epidermoid carcinoma cell line xenograft models (PMID: 26846818). | 26846818 | |
ERBB2 amp | 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 amp | stomach carcinoma | no benefit | Debio 1347 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Debio 1347 did not inhibit tumor growth in cell line xenograft models of ERBB2 (HER2) amplified gastric carcinoma (PMID: 26438159). | 26438159 | |
ERBB2 amp | esophagus adenocarcinoma | no benefit | HER2 Inhibitor | Lapatinib | Phase III | Actionable | In a Phase III clinical trial, the addition of Tykerb (lapatinib) to Xeloda (capecitabine) and Eloxatin (oxaliplatin) combination treatment did not significantly prolong overall survival compared to placebo, but did improve progression-free survival and response rate in esophagus adenocarcinoma patients harboring ERBB2 amplification (PMID: 26628478). | 26628478 |
ERBB2 amp | 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 amp | breast cancer | sensitive | Torkinib | Preclinical - Cell culture | Actionable | In a preclinical study, ERBB2 (HER2) amplified breast cancer cells treated with Torkinib (PP242) demonstrated some efficacy in culture including reduced phosphorylation of S6 and Akt, apoptosis, and decreased cell growth (PMID: 27197158). | 27197158 | |
ERBB2 amp | colorectal cancer | decreased response | HER2 Inhibitor | Lapatinib | Preclinical - Pdx | Actionable | In a preclinical study, treatment with Tykerb (lapatinib) resulted in initial disease stabilization with subsequent progression, in patient-derived colorectal cancer tumorgraft models with ERBB2 (HER2) amplification (PMID: 26296355). | 26296355 |
ERBB2 amp | Her2-receptor positive breast cancer | sensitive | HER2 Inhibitor | Lapatinib + S63845 | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Tykerb (lapatinib) and S63845 demonstrated synergy in an ERBB2 (HER2)-amplified breast cancer cell line in culture, resulting in decreased cell viability (PMID: 28768804). | 28768804 |
ERBB2 amp | 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 amp | lung non-small cell carcinoma | sensitive | HER inhibitor (Pan) | Afatinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited proliferation and induced cell-cycle arrest and apoptosis of non-small cell lung cancer (NSCLC) cell lines with ERBB2 (HER2) amplification in culture, and inhibited tumor growth in ERBB2 (HER2)-amplified NSCLC cell line xenograft models (PMID: 26545934). | 26545934 |
ERBB2 amp | endometrial serous adenocarcinoma | sensitive | HER2 Inhibitor | Neratinib + Taselisib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of Taselisib (GDC-0032) and Nerlynx (neratinib) resulted in a synergistic effect, demonstrating greater cell growth inhibitory activity in uterine serous carcinoma cells harboring ERBB2 (HER2) amplification compared to either agent alone (PMID: 26333383). | 26333383 |
ERBB2 amp | Advanced Solid Tumor | sensitive | HER inhibitor (Pan) | Afatinib | Phase II | Actionable | In a Phase II trial, Gilotrif (afatinib), demonstrated safety and efficacy in various advanced solid tumor patients with ERBB2 (HER2) amplification (PMID: 23775486). | 23775486 |
ERBB2 amp | Her2-receptor positive breast cancer | sensitive | HER2 Inhibitor | TAS0728 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, TAS0728 inhibited Erbb2 downstream signaling and proliferation of ERBB2 (HER2) amplified breast cancer cell lines in culture, and induced tumor regression in cell line xenograft models (PMID: 30787176). | 30787176 |
ERBB2 amp | 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 amp | 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 amp | breast cancer | sensitive | HER2 (ERBB2) Antibody | Pertuzumab + Trastuzumab | Preclinical - Cell line xenograft | Actionable | In a preclinical study, breast cancer cell line xenograft models harboring ERBB2 (HER2) amplification were sensitive to the combination of Herceptin (trastuzumab) and Perjeta (pertuzumab), resulting in a delay of brain lesion growth and improved survival (PMID: 28539475). | 28539475 |
ERBB2 amp | Her2-receptor positive breast cancer | predicted - sensitive | HER inhibitor (Pan) | Poziotinib | Phase II | Actionable | In a Phase II trial, increased copy number (CN) of ERBB2 (HER2) was associated with improved response to Poziotinib (HM781-36B) treatment in patients with Erbb2 (Her2)-positive breast cancer, with a median progression-free survival of 4.86 months in patients with CN over 8 and 2.99 months in patients with CN equal to or less than 8 (HR=0.61, p=0.037) (PMID: 30720867, NCT02418689). | 30720867 |
ERBB2 amp | 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 amp | stomach cancer | sensitive | HER2 Inhibitor | Lapatinib | Preclinical | Actionable | In preclinical studies, Tykerb (lapatinib) demonstrated antiproliferative activity in HER2-amplified gastric cancer in cell assays and in xenograft models (PMID: 20179222). | 20179222 |
ERBB2 amp | 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... detail... |
ERBB2 amp | Her2-receptor positive breast cancer | sensitive | HER2 Inhibitor | Capecitabine + Neratinib | Guideline | Actionable | Nerlynx (neratinib) 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 amp | endometrial serous adenocarcinoma | sensitive | HER2 (ERBB2) Antibody | Trastuzumab Duocarmazine | Preclinical | Actionable | In a preclinical study, Trastuzumab Duocarmazine (SYD895) induced cell death in ERBB2 (HER2)-amplified primary uterine serous carcinoma (USC) cell lines in culture and inhibited tumor growth and improved survival in ERBB2 (HER2)-amplified USC primary cell line xenografts (PMID: 27256376). | 27256376 |
ERBB2 amp | lung cancer | sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Phase II | Actionable | In a Phase II trial, Kadcyla (ado-trastuzumab emtansine) treatment in lung cancer patients harboring ERBB2 (HER2) activating mutations and/or ERBB2 (HER2) amplification resulted in a RECIST overall response rate of 51% (25/49) and a median progression-free survival of 5 months, with a RECIST response rate of 55% (6/11) for patients with ERBB2 (HER2) amplification (PMID: 32213539; NCT02675829). | 32213539 |
ERBB2 amp | endometrial serous adenocarcinoma | sensitive | Taselisib | Preclinical - Cell culture | Actionable | In a preclinical study, a uterine serous carcinoma cell line harboring ERBB2 (HER2) amplification demonstrated sensitivity to treatment with Taselisib (GDC-0032) in culture, resulting in inhibition of cell growth (PMID: 26333383). | 26333383 | |
ERBB2 amp | breast cancer | sensitive | HER2 (ERBB2) Antibody HER2 Inhibitor | Neratinib + Pertuzumab | Preclinical - Cell line xenograft | Actionable | In a preclinical study, breast cancer cell line xenograft models harboring ERBB2 (HER2) amplification were sensitive to the combination of Perjeta (pertuzumab) and Nerlynx (neratinib), resulting in a delay of brain lesion growth and improved survival (PMID: 28539475). | 28539475 |
ERBB2 amp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | S63845 + Trastuzumab | Preclinical - Pdx & cell culture | Actionable | In a preclinical study, S63845 and Herceptin (trastuzumab) demonstrated synergy in ERBB2 (HER2)-amplified breast cancer cells in culture and in ERBB2 (HER2)-amplified breast cancer patient-derived xenograft (PDX) models, resulting in enhanced tumor growth inhibition and overall survival compared to either agent alone (PMID: 28768804). | 28768804 |
ERBB2 amp | esophageal cancer | sensitive | HER2 Inhibitor | Ibrutinib | Preclinical - Cell culture | Actionable | In a preclinical study, esophageal cancer cells with ERBB2 (HER2) amplification demonstrated sensitivity to Imbruvica (ibrutinib), resulting in decreased survival in culture (PMID: 28830912). | 28830912 |
ERBB2 amp | scrotum Paget's disease | predicted - sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Case Reports/Case Series | Actionable | In a Phase II (MATCH) trial, Kadcyla (trastuzumab emtansine) treatment resulted in partial response in a patient with ERBB2 (HER2) amplified Paget’s disease of the scrotum (J Clin Oncol 36, 2018 (suppl; abstr 100); NCT02465060). | detail... |
ERBB2 amp | 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 ERBB2 (HER2)-positive patients with advanced breast cancer (PMID: 30032243; ESMO.org). | 30032243 detail... |
ERBB2 amp | 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 amp | breast cancer | sensitive | HER2 Inhibitor | Lapatinib + S63845 | Preclinical - Cell culture | Actionable | In a preclinical study, the combination of S63845 and Tykerb (lapatinib) resulted in potent cytotoxic effects in ERBB2 (HER2)-amplified breast cancer cells in culture compared to the cytostatic effect of Tykerb (lapatinib) alone (PMID: 27760111). | 27760111 |
ERBB2 amp | 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 amp | breast cancer | sensitive | HER inhibitor (Pan) | Dacomitinib | Preclinical | Actionable | In a preclinical study, Vizimpro (dacomitinib) was more effective in preventing proliferation in ERBB2 (HER2) amplified breast cancer cells than in wild-type ERBB2 (HER2) breast cancer cells (PMID: 22761403). | 22761403 |
ERBB2 amp | 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 amp | colorectal cancer | resistant | HER2 (ERBB2) Antibody | Trastuzumab | Preclinical | Actionable | In a preclinical study, colorectal cancer tumorgrafts with ERBB2 (HER2) amplification demonstrated resistance to Herceptin (trastuzumab) treatment in animal models (PMID: 26296355). | 26296355 |
ERBB2 amp | 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 amp | parotid gland cancer | predicted - sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Case Reports/Case Series | Actionable | In a Phase II (MATCH) trial, Kadcyla (trastuzumab emtansine) treatment resulted in partial response in a patient with ERBB2 (HER2) amplified salivary duct carcinoma of the parotid gland and a patient with ERBB2 (HER2) amplified squamous cell carcinoma of the parotid gland (J Clin Oncol 36, 2018 (suppl; abstr 100); NCT02465060). | detail... |
ERBB2 amp | Her2-receptor positive breast cancer | sensitive | 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 amp | lung adenocarcinoma | no benefit | HER inhibitor (Pan) | Dacomitinib | Case Reports/Case Series | Actionable | In a Phase II trial, Vizimpro (dacomitinib) treatment resulted in an overall response rate of 0% (0/4) in patients with lung adenocarcinoma harboring ERBB2 (HER2) amplification (PMID: 25899785; NCT00818441). | 25899785 |
ERBB2 amp | 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 amp | 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 amp | 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 amp | 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 amp | 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 amp | breast cancer | sensitive | eFT226 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, eFT226 inhibited cell growth and induced apoptosis in a ERBB2 (HER2)-amplified breast cancer cell line in culture, and induced tumor regression in a cell line xenograft model (Mol Cancer Ther 2019;18(12 Suppl):Abstract nr B133). | detail... | |
ERBB2 amp | gastroesophageal junction adenocarcinoma | no benefit | HER2 Inhibitor | Lapatinib | Phase III | Actionable | In a Phase III clinical trial, the addition of Tykerb (lapatinib) to Xeloda (capecitabine) and Eloxatin (oxaliplatin) combination treatment did not significantly prolong overall survival compared to placebo, but did improve progression-free survival and response rate in gastroesophageal junction adenocarcinoma patients harboring ERBB2 amplification (PMID: 26628478). | 26628478 |
ERBB2 amp | Her2-receptor positive breast cancer | sensitive | HER2 Inhibitor | Neratinib | Guideline | Actionable | Nerlynx (neratinib) is included in guidelines for ERBB2 (HER2)-positive patients with high-risk early breast cancer (PMID: 31236598; ESMO.org). | detail... 31236598 |
ERBB2 amp | 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 amp | Advanced Solid Tumor | predicted - sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Phase II | Actionable | In a Phase II (MATCH) trial, Kadcyla (trastuzumab emtansine) treatment resulted in partial response in 8.1% (3/37) and stable disease in 43% (16/37) of patients with ERBB2 (HER2) amplified non-breast, non-gastric advanced solid tumors, with a 6-month progression-free survival rate of 24.8% (J Clin Oncol 36, 2018 (suppl; abstr 100); NCT02465060). | detail... |
ERBB2 amp | 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 amp | breast cancer | decreased response | HER2 Inhibitor | Lapatinib | Preclinical - Cell culture | Actionable | In a preclinical study, ERBB2 (HER2) amplified breast cancer cells treated with Tykerb (lapatinib) demonstrated decreased phosphorylation of Erbb2 (her2) and Akt, however, after 4-8 hours, Akt-driven Rictor showed upregulation, thereby resulting in a decreased treatment response (PMID: 27197158). | 27197158 |
ERBB2 amp | stomach cancer | sensitive | HER inhibitor (Pan) | Poziotinib | Preclinical | Actionable | In a preclinical study, Poziotinib suppressed cell growth, decreased phosphorylation of downstream signaling molecules, and induced apoptosis of human gastric cancer cells harboring ERBB2 (HER2) amplification (PMID: 21306821). | 21306821 |
ERBB2 amp | 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 amp | 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 amp | breast cancer | predicted - sensitive | HER2 Inhibitor | Neratinib + Temsirolimus | Phase I | Actionable | In a Phase I clinical trial, Nerlynx (neratinib) administered with Torisel (temsirolimus) was tolerable and demonstrated antitumor activity in ERBB2 (HER2)-amplified breast cancer resistant to (Herceptin) trastuzumab (PMID: 24323026). | 24323026 |
ERBB2 amp | colorectal cancer | sensitive | HER2 Inhibitor | Cetuximab + Lapatinib | Preclinical - Pdx | Actionable | In a preclinical study, the combination of Erbitux (cetuximab) and Tykerb (lapatinib) induced tumor regression in patient-derived xenograft (PDX) models of colorectal cancer with ERBB2 (HER2) amplification (PMID: 22586653). | 22586653 |
ERBB2 amp | Her2-receptor positive breast cancer | predicted - sensitive | HER2 (ERBB2) Antibody HER2 Inhibitor | Ado-trastuzumab emtansine + Neratinib | Case Reports/Case Series | Actionable | In a Phase II trial, a patient with ERBB2 (HER2) amplified breast cancer who had progressed on Kadcyla (ado-trastuzumab emtansine) was switched to combination therapy with Kadcyla (ado-trastuzumab emtansine) and Nerlynx (neratinib), which led to a partial response (38%) after 6 weeks, and remained on combination treatment for an additional 12 weeks at which intracranial progression was observed (PMID: 32213539; NCT01494662). | 32213539 |
ERBB2 amp | 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 amp | Her2-receptor positive breast cancer | predicted - sensitive | KRIBB11 + MK2206 | Preclinical - Cell culture | Actionable | In a preclinical study, MK-2206 and KRIBB11 synergistically inhibited growth of ERBB2 (HER2)-amplified breast cancer cell lines in culture (PMID: 28598816). | 28598816 | |
ERBB2 amp | 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 amp | stomach cancer | predicted - sensitive | HER inhibitor (Pan) HER2 (ERBB2) Antibody | Afatinib + Trastuzumab | Case Reports/Case Series | Actionable | In a Phase II clinical trial, a gastric cancer patient with ERBB2 (HER2) amplification who progressed on previous therapy demonstrated a 22% regression in a metastatic site when treated with a combination of Gilotrif (afatinib) and Herceptin (trastuzumab) (PMID: 30463996; NCT01522768). | 30463996 |
ERBB2 amp | breast cancer | sensitive | HER2 (ERBB2) Antibody | Elgemtumab + Trastuzumab | Preclinical - Cell line xenograft | Actionable | In a preclinical study, breast cancer cell line xenograft models harboring ERBB2 (HER2) amplification were sensitive to the combination of Herceptin (trastuzumab) and LJM716, resulting in a delay of brain lesion growth and improved survival (PMID: 28539475). | 28539475 |
ERBB2 amp | 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 amp | 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 amp | 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 amp | 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)-positive breast cancer (NCCN.org). | detail... |
ERBB2 amp | gastrointestinal system cancer | sensitive | HER inhibitor (Pan) | Dacomitinib | Preclinical | Actionable | In a preclinical study, Vizimpro (dacomitinib) demonstrated significant growth-inhibitory effects in HER2- amplified gastric cancer cells (PMID: 18606718). | 18606718 |
ERBB2 amp | 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 amp | stomach cancer | predicted - sensitive | HER2 (ERBB2) Antibody | Fluorouracil + Oxaliplatin + Trastuzumab | Case Reports/Case Series | Actionable | In a Phase II clinical trial, a gastric cancer patient with ERBB2 (HER2) amplification demonstrated a response for 24 months when treated with the combination of Adrucil (fluorouracil), Eloxatin (oxaliplatin), and Herceptin (trastuzumab) (PMID: 30463996; NCT01522768). | 30463996 |
ERBB2 amp | 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). | detail... 20728210 detail... |
ERBB2 amp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Palbociclib + Trastuzumab | Preclinical | Actionable | In a preclinical study, the combination of Ibrance (palbociclib) and Herceptin (trastuzumab) worked synergistically to inhibit growth of ERBB2 (HER2)-amplified breast cancer cells in culture (PMID: 19874578). | 19874578 |
ERBB2 amp | stomach cancer | sensitive | HER2 (ERBB2) Antibody HER2 Inhibitor | Lapatinib + Trastuzumab | Preclinical - Cell line xenograft | Actionable | In a preclinical study, the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) treatment induced tumor regression in ERBB2 (HER2)-amplified cell line xenograft models of gastric cancer (PMID: 26296355). | 26296355 |
ERBB2 amp | colorectal cancer | sensitive | HER2 (ERBB2) Antibody HER2 Inhibitor | Lapatinib + Pertuzumab | Preclinical - Pdx | Actionable | In a preclinical study, the combination of Perjeta (pertuzumab) and Tykerb (lapatinib) induced tumor regression in patient-derived xenograft (PDX) models of colorectal cancer with ERBB2 (HER2) amplification (PMID: 22586653). | 22586653 |
ERBB2 amp | colorectal cancer | 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 amp | 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 amp | 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 23020162 detail... detail... |
ERBB2 amp | 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 amp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Guideline | Actionable | Kadcyla (ado-trastuzumab emtansine) is included in the guidelines for ERBB2 (HER2)-positive patients with 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). | detail... 31236598 30032243 |
ERBB2 amp | stomach cancer | sensitive | HER2 Inhibitor | BMS-690514 | Preclinical | Actionable | In a preclinical study, BMS-690514 inhibited tumor growth in a gastric cancer xenograft model with ERBB2 (HER2) amplification and overexpression (PMID: 21531814). | 21531814 |
ERBB2 amp | lung cancer | sensitive | HER2 Inhibitor | Lapatinib | Preclinical - Cell culture | Actionable | In a preclinical study, Tykerb (lapatinib) treatment reduced viability of a lung cancer cell line harboring an ERBB2 (HER2) amplification in culture (PMID: 30674502). | 30674502 |
ERBB2 amp | lung cancer | predicted - sensitive | HER2 Inhibitor | TAS0728 | Preclinical - Cell culture | Actionable | In a preclinical study, TAS0728 inhibited Erbb2 downstream signaling and proliferation of ERBB2 (HER2) amplified lung cancer cells in culture (PMID: 30787176). | 30787176 |
ERBB2 amp | Her2-receptor positive breast cancer | sensitive | HER2 (ERBB2) Antibody | CDX-3379 + Trastuzumab | Preclinical | Actionable | In a preclinical study, the combination of Herceptin (trastuzumab) and CDX-3379 (KTN3379) inhibited tumor growth in xenograft models of ERBB2 (HER2)-amplified breast cancer, with increased efficacy compared to KTN3379 alone (PMID: 26880266). | 26880266 |
ERBB2 amp | 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 amp | lung non-small cell carcinoma | unknown | unspecified immune checkpoint inhibitor | Clinical Study - Cohort | Actionable | In a retrospective clinical study, patients with non-small cell lung cancer harboring rare targetable drivers (RTD) (BRAF, ERBB2/3, RET, MET, ROS1, NTRK) who received immune checkpoint inhibitors (ICI) achieved longer median overall survival (mOS) (32 vs 13 mo, p=0.01) compared to those who did not receive ICI, mOS was 15.7 mo in patients harboring ERBB2 (HER2) amplifications (n=5), although RTD type was not associated with OS in a univariate analysis (PMID: 30268448). | 30268448 | |
ERBB2 amp | 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 amp | 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). | 23602601 detail... detail... |
ERBB2 amp | gastric adenocarcinoma | no benefit | HER2 Inhibitor | Lapatinib | Phase III | Actionable | In a Phase III clinical trial, the addition of Tykerb (lapatinib) to Xeloda (capecitabine) and Eloxatin (oxaliplatin) combination treatment did not significantly prolong overall survival compared to placebo, but did improve progression-free survival and response rate in gastric adenocarcinoma patients harboring ERBB2 amplification (PMID: 26628478). | 26628478 |
ERBB2 amp | 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 amp | 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 amp | 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 amp | colorectal cancer | no benefit | HER2 (ERBB2) Antibody | Pertuzumab | Preclinical - Pdx | Actionable | In a preclinical study, Perjeta (pertuzumab) did not inhibit tumor growth in patient-derived xenograft (PDX) models of ERBB2 (HER2)-amplified colorectal cancer (PMID: 22586653). | 22586653 |
ERBB2 amp | 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 ERBB2 (HER2)-positive patients with early breast cancer patients or advanced breast cancer (PMID: 31236598, PMID: 30032243; ESMO.org). | detail... 31236598 30032243 |
ERBB2 amp | breast cancer | sensitive | CH5132799 | Preclinical | Actionable | In a preclinical study, CH5132799 inhibited proliferation of breast cancer cells with ERBB2 (HER2) amplification in culture (PMID: 21558396). | 21558396 | |
ERBB2 amp | breast cancer | sensitive | HER inhibitor (Pan) | Afatinib | Preclinical | Actionable | In a preclinical study, Gilotrif (afatinib) inhibited proliferation of breast cancer cell lines with ERBB2 (HER2) amplification in culture (PMID: 26545934). | 26545934 |
ERBB2 amp | colorectal adenocarcinoma | predicted - sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Case Reports/Case Series | Actionable | In a clinical case study, a patient with metastatic colorectal adenocarcinoma harboring ERBB2 (HER2) amplification demonstrated clinical benefit with stable disease in the primary tumor for 7 months following treatment with Kadcyla (trastuzumab emtansine) (PMID: 28040715). | 28040715 |
ERBB2 amp | breast cancer | sensitive | HER2 Inhibitor | Elgemtumab + Neratinib | Preclinical - Cell line xenograft | Actionable | In a preclinical study, breast cancer cell line xenograft models harboring ERBB2 (HER2) amplification were sensitive to the combination of LJM716 and Nerlynx (neratinib), resulting in a delay of brain lesion growth and improved survival (PMID: 28539475). | 28539475 |
ERBB2 amp | 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 amp | breast cancer | sensitive | HER2 Inhibitor | Lapatinib + Torkinib | Preclinical - Cell culture | Actionable | In a preclinical study, the combination therapy of Tykerb (lapatinib) and Torkinib (PP242) in ERBB2 (HER2) amplified breast cancer cells in culture blocked cell growth, inhibited phosphorylation of Akt and S6, and led to greater caspase activity when compared to each agent alone (PMID: 27197158). | 27197158 |
ERBB2 amp | 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 amp | colorectal cancer | resistant | Cetuximab | Clinical Study - Cohort | Actionable | In a clinical study, ERBB2 (HER2) amplification was associated with resistance to Erbitux (cetuximab) in colorectal cancer patients (PMID: 21900593). | 21900593 | |
ERBB2 amp | colorectal cancer | 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 amp | colorectal cancer | sensitive | HER2 (ERBB2) Antibody HER2 Inhibitor | Lapatinib + Trastuzumab | Preclinical - Pdx | Actionable | In a preclinical study, the combination of Herceptin (trastuzumab) and Tykerb (lapatinib) treatment induced tumor regression in patient-derived colorectal cancer tumorgraft models harboring ERBB2 (HER2) amplification (PMID: 26296355). | 26296355 |
ERBB2 amp | stomach cancer | sensitive | HER2 Inhibitor | TAS0728 | Preclinical - Cell line xenograft | Actionable | In a preclinical study, TAS0728 inhibited Erbb2 downstream signaling and proliferation of ERBB2 (HER2) amplified gastric cancer cells in culture, and induced tumor regression in cell line xenograft models (PMID: 30787176). | 30787176 |
ERBB2 amp | acral lentiginous melanoma | sensitive | HER2 (ERBB2) Antibody | Ado-trastuzumab emtansine | Case Reports/Case Series | Actionable | In a clinical case study, Kadcyla (trastuzumab emtansine) treatment resulted in complete radiographic response that lasted over 28 months in a patient with acral melanoma harboring ERBB2 (HER2) amplification (26-fold) that was resistant to check-point inhibition (PMID: 30093446). | 30093446 |
ERBB2 amp | duodenum adenocarcinoma | predicted - sensitive | HER2 (ERBB2) Antibody | Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab | Case Reports/Case Series | Actionable | In a clinical case study, a patient with duodenal adenocarcinoma harboring ERBB2 (HER2) amplification demonstrated a complete pathologic response after treatment with a combination of Herceptin (trastuzumab), Adrucil (fluorouracil), Wellcovorin (leucovorin), and Eloxatin (oxaliplatin) (PMID: 28784859). | 28784859 |
ERBB2 amp | stomach cancer | sensitive | HER2 (ERBB2) Antibody | Trastuzumab | Preclinical - Cell line xenograft | Actionable | In a preclinical study, Herceptin (trastuzumab) inhibited tumor growth in human cell line xenograft models of gastric cancer with ERBB2 (HER2) amplification (PMID: 26296355). | 26296355 |
ERBB2 amp | breast cancer | sensitive | CYH33 | Preclinical - Cell culture | Actionable | In a preclinical study, breast cancer cell lines harboring ERBB2 (HER2) amplification demonstrated increased sensitivity to CYH33 compared to cells with normal ERBB2 (HER2) expression in culture (p<0.05) (PMID: 30003928). | 30003928 | |
ERBB2 amp | 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 amp | Her2-receptor positive breast cancer | sensitive | CDX-3379 | Preclinical | Actionable | In a preclinical study, CDX-3379 (KTN3379) inhibited tumor growth in xenograft models of ERBB2 (HER2)-amplified breast cancer (PMID: 26880266). | 26880266 | |
ERBB2 amp | 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 amp | 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... |
Clinical Trial | Phase | Therapies | Title | Recruitment Status | Covered Countries | Other Countries |
---|---|---|---|---|---|---|
NCT03783936 | Phase II | Avelumab + Trastuzumab Avelumab + Fluorouracil + Leucovorin + Oxaliplatin + Trastuzumab | Trial of mFOLFOX6 + Trastuzumab + Avelumab in Gastric and Esophageal Adenocarcinomas | Active, not recruiting | USA | 0 |
NCT03820141 | Phase II | Durvalumab + Pertuzumab + Trastuzumab | Durvalumab With Trastuzumab and Pertuzumab in HER2-Enriched Breast Cancer (DTP) | Recruiting | USA | 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 |
NCT03344536 | Phase Ib/II | Debio 1347 + Fulvestrant | A Study of Debio 1347 Plus Fulvestrant in Patients With Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
NCT03387553 | Phase I | HER2-pulsed DC1 vaccine | HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer | 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 |
NCT03696030 | Phase I | HER2 CAR-T cells | HER2-CAR T Cells in Treating Patients With Recurrent Brain or Leptomeningeal Metastases | Recruiting | USA | 0 |
NCT03289039 | Phase II | Neratinib Fulvestrant + Neratinib | Neratinib +/- Fulvestrant in HER2+, ER+ Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
NCT02536794 | Phase II | Durvalumab + Tremelimumab | MEDI4736 and Tremelimumab in Treating Patients With Metastatic HER2 Negative Breast Cancer | Recruiting | 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 |
NCT04579380 | Phase II | Trastuzumab + Tucatinib Fulvestrant + Trastuzumab + Tucatinib | Basket Study of Tucatinib and Trastuzumab in Solid Tumors With HER2 Alterations | 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 |
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 |
NCT03394027 | Phase II | ONC201 | ONC201 in Recurrent/Refractory Metastatic Breast Cancer and Advanced Endometrial Carcinoma | Active, not 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 |
NCT03523572 | Phase I | Nivolumab + Trastuzumab deruxtecan | Trastuzumab Deruxtecan With Nivolumab in Advanced Breast and Urothelial Cancer | Active, not recruiting | USA | 6 |
NCT03366844 | Phase Ib/II | Pembrolizumab | Breast Cancer Study of Preoperative Pembrolizumab + Radiation | 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 |
NCT01522768 | Phase II | Afatinib + Paclitaxel | Afatinib and Paclitaxel in Patients With Advanced HER2-Positive Trastuzumab-Refractory Advanced Esophagogastric Cancer | Active, not 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 |
NCT04294628 | Phase I | Trastuzumab deruxtecan | Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer | Recruiting | USA | 0 |
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 |
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 |
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 |
NCT03501979 | Phase II | Capecitabine + Trastuzumab + Tucatinib | Tucatinib, Trastuzumab, and Capecitabine for the Treatment of HER2+ LMD | Recruiting | 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 |
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 |
NCT04632992 | Phase II | Ipatasertib Atezolizumab + Capecitabine Entrectinib Atezolizumab + Docetaxel Ado-trastuzumab emtansine + Atezolizumab Capecitabine + Pertuzumab/trastuzumab/hyaluronidase-zzxf Paclitaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Alectinib GDC-0077 Pertuzumab/trastuzumab/hyaluronidase-zzxf Docetaxel + Pertuzumab/trastuzumab/hyaluronidase-zzxf Atezolizumab + Paclitaxel Ado-trastuzumab emtansine + Tucatinib | A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response (MyTACTIC) | Recruiting | USA | 0 |
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 |
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 |
NCT02675829 | Phase II | Ado-trastuzumab emtansine | Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers | Recruiting | USA | 0 |
NCT03846583 | Phase I | Abemaciclib + Trastuzumab + Tucatinib | Tucatinib + Abemaciclib + Herceptin for HER2+ MBC | Withdrawn | 0 | |
NCT04315233 | Phase I | Belinostat + Ribociclib | Ribociclib&Belinostat In Patients w Metastatic Triple Neg Breast Cancer & Recurrent Ovarian Cancer w Response Prediction By Genomics (CHARGE) | 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 |
NCT04294225 | Phase II | Anastrozole + Letrozole | Anastrozole and Letrozole After Surgery for the Treatment of Stage I-III 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 |
NCT02659514 | Phase II | Poziotinib | Study of Poziotinib in Patients With HER2-Positive Metastatic Breast Cancer | Active, not 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 |
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 |
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 |
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 |
NCT04639219 | Phase II | Trastuzumab deruxtecan | A Study of T-DXd for the Treatment of Solid Tumors Harboring HER2 Activating Mutations (DPT01) | Recruiting | USA | 2 |
NCT03587740 | Phase II | Ado-trastuzumab emtansine | ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer | Active, not recruiting | USA | 0 |
NCT04425018 | Phase II | Paclitaxel + Pertuzumab + Trastuzumab Margetuximab-cmkb + Paclitaxel + Pertuzumab | MARGetuximab Or Trastuzumab (MARGOT) (MARGOT) | Recruiting | USA | 0 |
NCT01465802 | Phase II | Dacomitinib Alclometasone Doxycycline | Study Of Dacomitinib (PF-00299804) In Advanced NSCLC Patients (Post Chemo Or Select First Line) To Evaluate Prophylactic Intervention On Derm And GI AEs And PRO | Completed | USA | 1 |
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 |
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 |
NCT03457896 | Phase II | Cetuximab + Neratinib Neratinib + Trastuzumab | Study of Neratinib +Trastuzumab or Neratinib + Cetuximab in Patients With KRAS/NRAS/BRAF/PIK3CA Wild-Type Metastatic Colorectal Cancer by HER2 Status | 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 |
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 |
NCT02137837 | Phase III | Everolimus + Fulvestrant Anastrozole + Everolimus + Fulvestrant Fulvestrant | S1222 Trial (Everolimus, Anastrozole and Fulvestrant) in Post-Menopausal Stage IV Breast Cancer | Terminated | USA | 0 |
NCT04278144 | Phase I | BDC-1001 + Pembrolizumab BDC-1001 | A First-in-human Study Using BDC-1001 in Advanced HER2-Expressing Solid Tumors | Recruiting | 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 |
NCT04614194 | Phase II | Letrozole Abemaciclib + Letrozole | Single Cell Immune and Non-immune Correlates of Response to Neoadjuvant Abemaciclib | Not yet 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 |
NCT02924883 | Phase II | Trastuzumab Atezolizumab + Trastuzumab | A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy (KATE2) | Completed | USA | CAN | 7 |
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 |
NCT03524170 | Phase I | M7824 + Radiotherapy | Radiation Therapy and M7824 in Treating Patients With Metastatic Hormone Receptor Positive, HER2 Negative Breast Cancer | Recruiting | USA | 0 |
NCT04197687 | Phase II | Ado-trastuzumab emtansine + Sargramostim + TPIV100 Ado-trastuzumab emtansine + Sargramostim Pertuzumab + Trastuzumab Ado-trastuzumab emtansine | TPIV100 and Sargramostim for the Treatment of HER2 Positive, Stage II-III Breast Cancer in Patients With Residual Disease After Chemotherapy and Surgery | Recruiting | USA | 0 |
NCT03379428 | Phase Ib/II | Trastuzumab Ibrutinib + Trastuzumab | Trial of Ibrutinib Plus Trastuzumab in HER2-amplified Metastatic Breast Cancer | Recruiting | USA | 0 |
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 |
NCT02774681 | Phase II | Trastuzumab Palbociclib | Palbociclib in Treating Patients With Metastatic HER-2 Positive Breast Cancer With Brain Metastasis | 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 |
NCT01873833 | Phase II | Capecitabine + Cyclophosphamide + Lapatinib + Trastuzumab | Capecitabine, Cyclophosphamide, Lapatinib Ditosylate, and Trastuzumab in Treating Patients With HER2-Positive Metastatic Breast Cancer | Active, not recruiting | USA | 0 |
NCT04172597 | Phase II | Poziotinib | A Study of Poziotinib in Patients With EGFR or HER2 Activating Mutations in Advanced Malignancies | Recruiting | 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 |
NCT02066532 | Phase Ib/II | Ruxolitinib + Trastuzumab | Ruxolitinib in Combination With Trastuzumab in Metastatic HER2 Positive Breast Cancer | Active, not recruiting | USA | 0 |
NCT01111825 | Phase Ib/II | Neratinib + Temsirolimus | Temsirolimus Plus Neratinib for Patients With Metastatic HER2-Amplified or Triple Negative Breast Cancer | Completed | USA | 5 |
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 |
NCT04744831 | Phase II | Trastuzumab deruxtecan | Trastuzumab Deruxtecan in Participants With HER2-overexpressing Advanced or Metastatic Colorectal Cancer (DESTINY-CRC02) | Not yet recruiting | USA | 9 |
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 |
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 |
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 |
NCT03992456 | Phase II | Panitumumab Regorafenib Trifluridine-tipiracil hydrochloride | Panitumumab, Regorafenib, or TAS-102, in Treating Patients With Metastatic and/or Unresectable RAS Wild-Type Colorectal Cancer | Recruiting | USA | 0 |
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 |
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 |
NCT02152943 | Phase I | Everolimus + Letrozole + Trastuzumab | Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients | Completed | USA | 0 |
NCT00968968 | Phase III | Trastuzumab Lapatinib + Trastuzumab | Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone | Terminated | USA | CAN | 0 |
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 |
NCT03304080 | Phase Ib/II | Anastrozole + Palbociclib + Pertuzumab + Trastuzumab | Anastrozole, Palbociclib, Trastuzumab and Pertuzumab in Her-positive, Her2-positive Metastatic Breast | Recruiting | USA | 0 |
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 |
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 |
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 |
NCT02047747 | Phase II | Dacomitinib | A Phase II Study of Dacomitinib in Progressive Brain Metastases | Terminated | USA | 0 |
NCT02500199 | Phase I | Pyrotinib | Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors | Active, not recruiting | USA | 0 |
NCT03765983 | Phase II | GDC-0084 + Trastuzumab | GDC-0084 in Combination With Trastuzumab for Patients With HER2-Positive Breast Cancer Brain Metastases | 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 |
NCT04466891 | Phase II | ZW25 | A Study of ZW25 (Zanidatamab) in Subjects With Advanced or Metastatic HER2-Amplified Biliary Tract Cancers | Recruiting | USA | 4 |
NCT03321981 | Phase II | Letrozole + Zenocutuzumab Anastrozole + Zenocutuzumab Fulvestrant + Zenocutuzumab Exemestane + Zenocutuzumab Trastuzumab + Zenocutuzumab Trastuzumab + Vinorelbine + Zenocutuzumab | MCLA-128 With Trastuzumab/Chemotherapy in HER2+ and With Endocrine Therapy in ER+ and Low HER2 Breast Cancer | Active, not recruiting | USA | 6 |
NCT02673398 | Phase II | Neratinib | Neratinib in Treating Older Patients With Stage IV HER2-Positive Breast Cancer | 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 |
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 |
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 |
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 |
NCT03939897 | Phase Ib/II | Abemaciclib + Fulvestrant Abemaciclib + Copanlisib + Fulvestrant | Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer | 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 |
NCT01828021 | Phase II | Margetuximab-cmkb | Phase 2 Study of the Monoclonal Antibody MGAH22(Margetuximab)in Patients With Relapsed or Refractory Advanced Breast Cancer | 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 |
NCT04539938 | Phase II | Trastuzumab deruxtecan + Tucatinib | A Study of Tucatinib Plus Trastuzumab Deruxtecan in HER2+ Breast Cancer (HER2CLIMB-04) | Recruiting | USA | 0 |
NCT02465060 | Phase II | Erdafitinib Copanlisib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Pertuzumab + Trastuzumab Dabrafenib + Trametinib Binimetinib Adavosertib Osimertinib Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib Ado-trastuzumab emtansine Larotrectinib Taselisib | Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) | 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 |
NCT04553770 | Phase II | Trastuzumab deruxtecan Anastrozole + Trastuzumab deruxtecan | Trastuzumab Deruxtecan Alone or in Combination With Anastrozole for the Treatment of Early Stage HER2 Low, Hormone Receptor Positive Breast Cancer | Recruiting | USA | 0 |
NCT03065387 | Phase I | Everolimus + Neratinib Neratinib + Palbociclib Neratinib + Trametinib | Neratinib and Everolimus, Palbociclib, or Trametinib in Treating Participants With Refractory and Advanced or Metastatic Solid Tumors With EGFR Mutation/Amplification, HER2 Mutation/Amplification, or HER3/4 Mutation or KRAS Mutation | 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 |
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 |
NCT04092673 | Phase Ib/II | eFT226 | Study of eFT226 in Subjects With Selected Advanced Solid Tumor Malignancies | Recruiting | USA | 0 |
NCT03564782 | Phase I | PVSRIPO | Examining Bioactivity of PVSRIPO in Invasive Breast Cancer | Recruiting | USA | 0 |
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 |
NCT04510285 | Phase II | Pembrolizumab + Trastuzumab Trastuzumab | Study of Pembrolizumab Plus Trastuzumab or Trastuzumab Alone After Surgery in Patients With Esophagogastric Tumors | 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 |
NCT01384253 | Phase I | 212Pb-TCMC-Trastuzumab + Trastuzumab | Safety Study of ²¹²Pb-TCMC-Trastuzumab Radio Immunotherapy | Completed | USA | 0 |
NCT03685331 | Phase I | Fulvestrant + Olaparib + Palbociclib | Olaparib, Palbociclib and Fulvestrant in Patients With BRCA Mutation-associated, HR+, HER2-metastatic Breast Cancer | Recruiting | 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 |
NCT00796978 | Phase II | Trastuzumab | Trastuzumab in Treating Older Women With Early-Stage Breast Cancer | Completed | 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 |
NCT03043313 | Phase II | Trastuzumab + Tucatinib Tucatinib | Tucatinib Plus Trastuzumab in Patients With HER2+ Colorectal Cancer | Recruiting | USA | 4 |
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 |
NCT01306045 | Phase II | Erlotinib Lapatinib MK2206 Sunitinib Selumetinib | Molecular Profiling and Targeted Therapy for Advanced Non-Small Cell Lung Cancer, Small Cell Lung Cancer, and Thymic Malignancies | Active, not recruiting | USA | 0 |
NCT03716180 | Phase I | Paclitaxel + Pertuzumab + Trastuzumab | DAPHNe: Paclitaxel/Trastuzumab/Pertuzumab in HER2-Positive BC | Active, not recruiting | USA | 0 |
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 |
NCT04513665 | Phase II | ZW25 | ZW25 in Women With Endometrial Cancers | Recruiting | USA | 0 |
NCT01924351 | Phase II | HER2-positive Breast Cancer With Brain Metastasis (GCC 1345) | Withdrawn | USA | 0 | |
NCT02952729 | Phase I | XMT-1522 | Study of Antibody Drug Conjugate in Patients With Advanced Breast Cancer Expressing HER2 | Completed | USA | 0 |
NCT04345913 | Phase Ib/II | Eribulin Copanlisib + Eribulin | Testing the Addition of Copanlisib to Eribulin for the Treatment of Advanced-Stage Triple Negative 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 |
NCT04588545 | Phase Ib/II | Pertuzumab + Trastuzumab | Radiation Therapy Followed by Intrathecal Trastuzumab/Pertuzumab in HER2+ Breast Leptomeningeal Disease | Recruiting | 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 |
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 |
NCT04272801 | Phase I | Anastrozole Letrozole Tamoxifen Exemestane | Neoadjuvant Endocrine Therapy Tolerance in Geriatric Early Stage ER+ Breast Cancer (Breast52) | Recruiting | USA | 0 |
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 |
NCT01570036 | Phase II | E75 Sargramostim Trastuzumab | Combination Immunotherapy With Herceptin and the HER2 Vaccine NeuVax | Completed | 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 |
NCT03417544 | Phase II | Atezolizumab + Pertuzumab + Trastuzumab | Atezolizumab + Pertuzumab + Trastuzumab In CNS Mets In BC | Active, not recruiting | USA | 0 |