Molecular Profile Detail

Profile Name ERBB2 act mut
Gene Variant Detail

ERBB2 act mut (gain of function)

Relevant Treatment Approaches HER inhibitor (Pan) HER2 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
ERBB2 act mut breast cancer sensitive HER2 Inhibitor Neratinib Phase II Actionable In a Phase II clinical trial, Nerlynx (neratinib) treatment resulted in clinical benefit in 36% (5/14) of metastatic breast cancer patients harboring ERBB2 (HER2) activating mutations, with 1 complete response, 1 partial response, and 2 patients achieving stable disease for greater than 6 months, and a median progression-free survival of 5 months (J Clin Oncol 34, 2016 (suppl; abstr 516)). detail...
ERBB2 act mut lung adenocarcinoma predicted - sensitive trastuzumab emtansine Phase II Actionable In a Phase II trial, treatment with Kadcyla (trastuzumab emtansine) resulted in best overall response rates of 44% (8/18) and 39% (7/18) partial response and stable disease, respectively, and median progression-free survival of 5 months in patients with lung adenocarcinoma harboring ERBB2 (HER2) activating mutations (PMID: 29989854; NCT02675829). 29989854
ERBB2 act mut Advanced Solid Tumor sensitive HER2 Inhibitor AEE788 Preclinical Actionable In a preclinical study, transformed cells expressing ERBB2 (HER2) activation loop mutations demonstrated sensitivity to AEE788 in culture (PMID: 22046346). 22046346
ERBB2 act mut estrogen-receptor positive breast cancer predicted - sensitive Vistusertib Phase I Actionable In a Phase I trial, Vistusertib (AZD2014) demonstrated safety and preliminary efficacy in patients with advanced solid tumors, including a patient with ER-positive breast cancer harboring an ERBB2 activating mutation (PMID: 25805799). 25805799
Clinical Trial Phase Therapies Title Recruitment Status
NCT02465060 Phase II Dabrafenib Trametinib Crizotinib Sunitinib Sapanisertib Nivolumab AZD4547 Dasatinib Binimetinib Adavosertib Osimertinib Trastuzumab Palbociclib Afatinib Capivasertib Defactinib GSK2636771 Vismodegib trastuzumab emtansine Larotrectinib Pertuzumab Taselisib Targeted Therapy Directed by Genetic Testing in Treating Patients With Advanced Refractory Solid Tumors, Lymphomas, or Multiple Myeloma (The MATCH Screening Trial) Recruiting
NCT01953926 Phase II Neratinib An Open-label, Phase 2 Study of Neratinib in Patients With Solid Tumors With Somatic Human Epidermal Growth Factor Receptor (EGFR, HER2, HER3) Mutations or EGFR Gene Amplification Recruiting
NCT03805841 Phase II Tarloxotinib Phase 2 Study of Tarloxotinib in Patients With NSCLC Harboring EGFR Exon 20 Insertion or HER2-activating Mutations (RAIN) Not yet recruiting
NCT02675829 Phase II trastuzumab emtansine Trial of Ado-Trastuzumab Emtansine for Patients With HER2 Amplified or Mutant Cancers Active, not recruiting
NCT02673398 Phase II Neratinib Neratinib in Treating Older Patients With Locally Advanced or Metastatic HER2-Positive Breast Cancer Recruiting
NCT02949843 Phase II Nivolumab + Pembrolizumab Targeted Therapy in Treating Patients With Incurable Non-Small Cell Lung Cancer With Genetic Mutations Recruiting
NCT02716116 Phase Ib/II AP32788 A Trial of AP32788 in Non-Small Cell Lung Cancer Recruiting
NCT02091141 Phase II Erlotinib Alectinib Vemurafenib + Cobimetinib Pertuzumab + Trastuzumab Vismodegib Atezolizumab My Pathway: A Study Evaluating Herceptin/Perjeta, Tarceva, Zelboraf/Cotellic, Erivedge, Alecensa, and Tecentriq Treatment Targeted Against Certain Molecular Alterations in Participants With Advanced Solid Tumors Recruiting