Molecular Profile Detail

Profile Name BRCA2 inact mut
Gene Variant Detail

BRCA2 inact mut (loss of function)

Relevant Treatment Approaches PARP Inhibitor (Pan) PARP-1 Inhibitor

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Molecular Profile Indication/Tumor Type Response Type Relevant Treatment Approaches Therapy Name Approval Status Evidence Type Efficacy Evidence References
BRCA2 inact mut breast cancer sensitive PARP Inhibitor (Pan) Olaparib Phase II Actionable In a Phase II clinical trial, Lynparza (olaparib) demonstrated safety and efficacy in breast cancer patients with BRCA2 inactivating mutations (PMID: 20609467). 20609467
BRCA2 inact mut Her2-receptor negative breast cancer sensitive PARP Inhibitor (Pan) Talazoparib FDA approved Actionable In a Phase III trial (EMBRACA) that supported FDA approval, Talzenna (talazoparib) treatment resulted in significantly longer median progression-free survival (8.6 vs 5.6 months, HR=0.54, p<0.001), and higher objective response rate (62.6% vs 27.2%, OR=5.0, p<0.001) compared to standard chemotherapy in patients with advanced ERBB2 (HER2)-negative breast cancer harboring known deleterious or suspected deleterious germline mutations in BRCA1 or BRCA2 (PMID: 30110579; NCT01945775). 30110579
BRCA2 inact mut breast cancer sensitive PARP Inhibitor (Pan) AZD2461 Preclinical - Cell culture Actionable In a preclinical study, a BRCA2-deficient breast cancer cell line resistant to Lynparza (olaparib) demonstrated sensitivity to treatment with AZD2461 in culture, resulting in reduced cell viability (PMID: 27550455). 27550455
BRCA2 inact mut Advanced Solid Tumor predicted - sensitive PARP Inhibitor (Pan) Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment demonstrated safety and preliminary efficacy in patients with advanced solid tumors harboring deleterious BRCA1/2 mutations (J Clin Oncol 31, 2013 (suppl; abstr 2580)). detail...
BRCA2 inact mut breast cancer predicted - sensitive PARP Inhibitor (Pan) Carboplatin + Paclitaxel + Veliparib Phase II Actionable In a Phase II trial, the combination of Veliparib (ABT-888), Paraplatin (carboplatin), and Taxol (paclitaxel) resulted in a higher objective response rate (77.8% vs 61.3%) compared to placebo plus Paraplatin (carboplatin) and Taxol (paclitaxel) in breast cancer patients harboring either BRCA1 or BRCA2 deleterious mutations (SABCS, 2016, Abstract # S2-05). detail...
BRCA2 inact mut prostate cancer predicted - sensitive PARP Inhibitor (Pan) Talazoparib Phase I Actionable In a Phase I trial, Talazoparib (BMN-673) treatment demonstrated safety and preliminary efficacy in patients with advanced solid tumors harboring deleterious BRCA1/2 mutations, including one patient with prostate cancer (J Clin Oncol 31, 2013 (suppl; abstr 2580)). detail...
BRCA2 inact mut Advanced Solid Tumor sensitive PARP Inhibitor (Pan) E7449 Preclinical Actionable In a preclinical study, E7449 inhibited proliferation of a BRCA2-deficient cell line in culture, which demonstrated increased sensitivity compared to cells without DNA repair mutations (PMID: 26513298). 26513298
BRCA2 inact mut ovarian cancer no benefit PARP Inhibitor (Pan) Veliparib + Cyclophosphamide Phase II Actionable In a Phase II clinical trial, the combination of Veliparib (ABT-888) and Cytoxan (cyclophosphamide) did not demonstrate improved response rate or progression-free survival over Cytoxan (cyclophosphamide) alone in ovarian cancer patients harboring deleterious mutations in BRCA1 or BRCA2 (PMID: 25589624). 25589624
Clinical Trial Phase Therapies Title Recruitment Status
NCT03586661 Phase I Copanlisib + Niraparib Niraparib and Copanlisib in Treating Participants With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Not yet recruiting
NCT03601923 Phase II Niraparib Niraparib in Patients With Pancreatic Cancer Recruiting
NCT03570476 Phase II Olaparib Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer Recruiting
NCT03740165 Phase III Bevacizumab + Carboplatin + Paclitaxel Paclitaxel + Carboplatin Carboplatin + Paclitaxel + Pembrolizumab Bevacizumab + Carboplatin + Paclitaxel + Pembrolizumab + Olaparib Carboplatin + Paclitaxel + Pembrolizumab + Olaparib Bevacizumab + Carboplatin + Paclitaxel + Pembrolizumab Study of Chemotherapy With Pembrolizumab (MK-3475) Followed by Maintenance With Olaparib (MK-7339) for the First-Line Treatment of Women With BRCA Non-mutated Advanced Epithelial Ovarian Cancer (EOC) (MK-7339-001/ENGOT-ov43/KEYLYNK-001) Recruiting
NCT03442556 Phase II Carboplatin + Docetaxel + Rucaparib Docetaxel, Carboplatin, and Rucaparib Camsylate in Treating Patients With Metastatic Castration Resistant Prostate Cancer With Homologous Recombination DNA Repair Deficiency Recruiting
NCT03329937 Phase I Niraparib Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment Recruiting
NCT03233204 Phase II Olaparib Pediatric MATCH: Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes Recruiting
NCT03810105 Phase II Durvalumab + Olaparib A Study of Olaparib and Durvalumab in Prostate Cancer Not yet recruiting
NCT03140670 Phase II Rucaparib Rucaparib in BRCA1/2 or PALB2 Mutated Pancreatic Cancer Recruiting
NCT03047135 Phase II Olaparib Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis Recruiting
NCT02855944 Phase III Cisplatin Rucaparib Carboplatin Gemcitabine Paclitaxel ARIEL4: A Study of Rucaparib Versus Chemotherapy BRCA Mutant Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Patients Recruiting
NCT02975934 Phase III Rucaparib A Study of Rucaparib Verses Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency Recruiting
NCT01853306 Phase I Veliparib A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors Completed
NCT03533946 Phase II Rucaparib Rucaparib in Nonmetastatic prOstAte With BRCAness (ROAR) Recruiting
NCT02693535 Phase II Vemurafenib + Cobimetinib Regorafenib Vismodegib Bosutinib Palbociclib Cetuximab Axitinib Pembrolizumab Temsirolimus Dasatinib Pertuzumab + Trastuzumab Crizotinib Sunitinib Olaparib Erlotinib 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
NCT02952534 Phase II Rucaparib A Study of Rucaparib in Patients With MetA Study of Rucaparib in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON2) Recruiting
NCT03718091 Phase II VX-970 M6620 (VX-970) in Selected Solid Tumors Recruiting
NCT02282020 Phase III Olaparib Olaparib Treatment in Relapsed Breast Cancer Susceptibility Gene (BRCA) Mutated Ovarian Cancer Patients Who Have Progressed at Least 6 Months After Last Platinum Treatment and Have Received at Least 2 Prior Platinum Treatments. Active, not recruiting
NCT02660034 Phase I BGB-A317 + Pamiparib The Safety, Pharmacokinetics and Antitumor Activity of BGB-A317 in Combination With BGB-290 in Subjects With Advanced Solid Tumors Recruiting
NCT03209401 Phase I Carboplatin + Niraparib Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies Recruiting
NCT02345265 Phase II Cediranib + Olaparib Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Peritoneal, or Fallopian Tube Cancer Active, not recruiting