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| Profile Name | ERBB2 mutant |
| Gene Variant Detail | |
| Relevant Treatment Approaches |
| Molecular Profile | Indication/Tumor Type | Response Type | Relevant Treatment Approaches | Therapy Name | Approval Status | Evidence Type | Efficacy Evidence | References |
|---|---|---|---|---|---|---|---|---|
| ERBB2 mutant | endometrial cancer | no benefit | Neratinib | Phase II | Actionable | In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 28.6% (2/7), and a median progression-free survival of 2.6 months in patients with endometrial cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). | 29420467 | |
| ERBB2 mutant | colorectal cancer | no benefit | Neratinib | Phase II | Actionable | In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 8.3% (1/12), and a median progression-free survival of 1.8 months in patients with colorectal cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). | 29420467 | |
| ERBB2 mutant | ovarian cancer | no benefit | Neratinib | Phase II | Actionable | In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, no clinical benefit, and a median progression-free survival of 2.1 months in patients with ovarian cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). | 29420467 | |
| ERBB2 mutant | cervical cancer | predicted - sensitive | Neratinib | Phase II | Actionable | In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate of 20% (1/5), a clinical benefit rate of 60% (3/5), and a median progression-free survival of 20.1 months in patients with cervical cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). | 29420467 | |
| ERBB2 mutant | Her2-receptor negative breast cancer | sensitive | Neratinib | Phase II | Actionable | In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an object response rate of 24% (6/25), a clinical benefit rate of 40% (10/25), and a median progression-free survival of 3.5 months in patients with Erbb2 (Her2) receptor negative (non-amplified) breast cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). | 29420467 | |
| ERBB2 mutant | lung cancer | sensitive | Neratinib | Phase I | Actionable | In a Phase I clinical trial, Nerlynx (neratinib) administered with Torisel (temsirolimus) was tolerable and demonstrated antitumor activity in ERBB2 (HER2)-mutant non-small-cell lung cancer (PMID: 24323026). | 24323026 | |
| ERBB2 mutant | lung non-small cell carcinoma | predicted - sensitive | Trastuzumab + Vinorelbine | Case Reports/Case Series | Actionable | In a clinical study, treatment with Herceptin (trastuzumab) in combination with chemotherapy resulted in an objective response rate of 67% (4/6) in non-small cell lung carcinoma patients harboring ERBB2 (HER2) mutations that progressed during previous therapies (PMID: 28167203). | 28167203 | |
| ERBB2 mutant | lung non-small cell carcinoma | sensitive | Neratinib | Phase II | Actionable | In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate of 3.8% (1/26), a clinical benefit rate of 42.3% (11/26), and a median progression-free survival of 5.5 months in patients with non-small cell lung cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). | 29420467 | |
| ERBB2 mutant | lung non-small cell carcinoma | sensitive | Neratinib | Phase I | Actionable | In a Phase I study, Nerlynx (neratinib) administered with temsirolimus was tolerable and demonstrated antitumor activity in ERBB2-mutant non-small-cell lung cancer (PMID: 24323026). | 24323026 | |
| ERBB2 mutant | biliary tract cancer | predicted - sensitive | Neratinib | Phase II | Actionable | In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in an objective response rate at 8 weeks of 22.2% (2/9), a clinical benefit rate of 33.3% (3/9), and a median progression-free survival of 2.8 months in patients with biliary tract cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). | 29420467 | |
| ERBB2 mutant | invasive bladder transitional cell carcinoma | predicted - sensitive | Cisplatin + Gemcitabine + Sorafenib | Phase II | Actionable | In a Phase II trial, ERBB2 (HER2) mutations were only detected in patients with muscle-invasive urothelial bladder cancer that responded to Nexavar (sorafenib), Platinol (cisplatin) and Gemzar (gemcitabine) combination therapy (J Clin Oncol 35, 2017 (suppl 6S; abstract 345)). | detail... | |
| ERBB2 mutant | gastroesophageal junction adenocarcinoma | no benefit | Neratinib | Phase II | Actionable | In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 20% (1/5), and a median progression-free survival of 1.7 months in patients with gastroesophageal cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). | 29420467 | |
| ERBB2 mutant | Her2-receptor positive breast cancer | sensitive | Neratinib | Phase II | Actionable | In a Phase II trial, Nerlynx (neratinib) treatment resulted in complete response in 12.5% (3/24) and partial response in 20.8% (5/24) of ERBB2 (HER2) mutant but not amplified breast cancer patients (Cancer Res 2017;77(4 Suppl):Abstract nr PD2-08). | detail... | |
| ERBB2 mutant | urinary bladder cancer | no benefit | Neratinib | Phase II | Actionable | In a Phase II trial (SUMMIT), Nerlynx (neratinib) treatment resulted in no objective response, a clinical benefit rate of 18.8% (3/16), and a median progression-free survival of 1.8 months in patients with bladder cancer harboring ERBB2 (HER2) mutations (PMID: 29420467; NCT01953926). | 29420467 | |
| ERBB2 mutant | lung squamous cell carcinoma | predicted - sensitive | Afatinib | Phase III | Actionable | In a Phase III trial (LUX-Lung 8), secondary analysis demonstrated favorable outcomes with Gilotrif (afatinib) treatment compared to Tarceva (erlotinib) in lung squamous cell carcinoma patients with ERBB (HER) family mutations, and ERBB2 (HER2) mutations predicted an OS (HR=0.06, p=0.02) and PFS (HR=0.06, p=0.02) benefit for Gilotrif (afatinib) over Tarceva (erlotinib) treatment (PMID: 29902295; NCT01523587). | 29902295 | |
| ERBB2 mutant | lung non-small cell carcinoma | no benefit | Trastuzumab | Guideline | Actionable | Herceptin (trastuzumab) is not recommended as a monotherapy in guidelines for non-small cell lung cancer patients with ERBB2 mutations (NCCN.org). | detail... | |
| ERBB2 mutant | lung non-small cell carcinoma | sensitive | Pyrotinib | Phase II | Actionable | In a Phase II trial, Pyrotinib treatment in non-small cell lung cancer patients harboring an ERBB2 (HER2) mutation resulted in a partial response in 54.5% (6/11) of patients and stable disease in 27.3% (3/11) of patients, and a PFS of 6.2 months (Journal of Thoracic Oncology, Vol. 12, Issue 1, S359). | detail... | |
| ERBB2 mutant | lung non-small cell carcinoma | no benefit | Afatinib | Guideline | Actionable | Gilotrif (afatinib) is not recommended as a monotherapy in guidelines for non-small cell lung cancer patients with ERBB2 mutations (NCCN.org). | detail... | |
| ERBB2 mutant | breast cancer | predicted - sensitive | Neratinib | Phase II | Actionable | In a Phase II trial, Nerlynx (neratinib) demonstrated activity in metastatic breast cancer patients harboring ERBB2 (HER2) mutations, with treatment resulting in a clinical benefit rate of 31% (5/16; 1 complete response, 1 partial response, and 3 patients achieving stable disease for 24 weeks or more) and a median progression-free survival of 16 weeks (PMID: 28679771). | 28679771 | |
| ERBB2 mutant | lung adenocarcinoma | sensitive | Afatinib | Phase II | Actionable | In a Phase II trial, treatment with Gilotrif (afatinib) resulted in objective response in 3 lung adenocarcinoma patients harboring ERBB2 (HER2) mutations (PMID: 22325357). | 22325357 | |
| ERBB2 mutant | lung non-small cell carcinoma | sensitive | Ado-trastuzumab emtansine | Guideline | Actionable | Kadcyla (trastuzumab emtansine) is included in guidelines for non-small cell lung cancer patients with ERBB2 (HER2) mutations (NCCN.org). | detail... | |
| ERBB2 mutant | lung non-small cell carcinoma | sensitive | AV-412 | Preclinical | Actionable | In a preclinical study, non-small cell lung cancer cells harboring an ERBB2 (HER2) mutation demonstrated sensitivity to AV-412, resulting in decreased phosphorylation of Erbb2, Akt, and Erk (PMID: 19459856). | 19459856 |
| Clinical Trial | Phase | Therapies | Title | Recruitment Status |
|---|---|---|---|---|
| NCT02689336 | Phase II | Erlotinib + Temozolomide | Erlotinib in Combination With Temozolomide in Treating Relapsed/Recurrent/Refractory Pediatric Solid Tumors | Withdrawn |
| 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 |
| NCT03255083 | Phase I | DS-1205c + Osimertinib | DS-1205c With Osimertinib for Metastatic or Unresectable Epidermal Growth Factor Receptor (EGFR)-Mutant Non-Small Cell Lung Cancer | Active, not recruiting |
| NCT02564900 | Phase I | Trastuzumab deruxtecan | Study of DS-8201a in Subjects With Advanced Solid Malignant Tumors | Active, not recruiting |
| NCT03410927 | Phase Ib/II | TAS0728 | A Study of TAS0728 in Patients With Solid Tumors With HER2 or HER3 Abnormalities | Active, not recruiting |
| 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 |
| 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 |
| 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 |
| 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 |
| NCT02500199 | Phase I | Pyrotinib | Phase I Study of Pyrotinib in Patients With HER2-positive Solid Tumors | Active, not recruiting |
| NCT04294628 | Phase I | Trastuzumab deruxtecan | Testing the Biological Effects of DS-8201a on Patients With Advanced Cancer | Recruiting |
| NCT02372006 | Phase Ib/II | Afatinib | Trial of Afatinib in Pediatric Tumours | Active, not recruiting |
| NCT04482309 | Phase II | Trastuzumab deruxtecan | A Phase 2 Study of T-DXd in Patients With Selected HER2 Expressing Tumors (DPT02) | Not yet recruiting |
| NCT02152943 | Phase I | Everolimus + Letrozole + Trastuzumab | Everolimus, Letrozole and Trastuzumab in HR- and HER2/Neu-positive Patients | Active, not recruiting |
| NCT03297606 | Phase II | Bosutinib Palbociclib Vismodegib Ipilimumab + Nivolumab Cobimetinib + Vemurafenib Temsirolimus Olaparib Erlotinib Crizotinib Sunitinib Afatinib Dasatinib Pertuzumab + Trastuzumab Axitinib | Canadian Profiling and Targeted Agent Utilization Trial (CAPTUR) (CAPTUR) | Recruiting |
| 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 |
| NCT04129502 | Phase III | AP32788 Cisplatin + Pemetrexed Disodium Carboplatin + Pemetrexed Disodium | TAK-788 as First-line Treatment Versus Platinum-Based Chemotherapy for Non-Small Cell Lung Cancer (NSCLC) With EGFR Exon 20 Insertion Mutations | Recruiting |
| NCT04042701 | Phase I | Pembrolizumab + Trastuzumab deruxtecan | DS8201a and Pembrolizumab in Participants With Locally Advanced/Metastatic Breast or Non-Small Cell Lung Cancer | Recruiting |
| 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 |