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 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 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 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 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 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 ovarian cancer no benefit PARP Inhibitor (Pan) Cyclophosphamide + Veliparib 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
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) 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
Clinical Trial Phase Therapies Title Recruitment Status
NCT03845296 Phase II Rucaparib Rucaparib in Treating Patients With Genomic LOH High and/or Deleterious BRCA1/2 Mutation Stage IV or Recurrent Non-small Cell Lung Cancer (A Lung-MAP Treatment Trial) Recruiting
NCT03570476 Phase II Olaparib Olaparib Before Surgery in Treating Participants With Localized Prostate Cancer Recruiting
NCT03140670 Phase II Rucaparib Rucaparib in BRCA1/2 or PALB2 Mutated Pancreatic Cancer Recruiting
NCT01945775 Phase III Gemcitabine Capecitabine Vinorelbine Talazoparib Eribulin A Study Evaluating Talazoparib (BMN 673), a PARP Inhibitor, in Advanced and/or Metastatic Breast Cancer Patients With BRCA Mutation (EMBRACA Study) (EMBRACA) Active, not recruiting
NCT02401347 Phase II Talazoparib Phase II Talazoparib in BRCA1 +BRCA2 Wild-Type &Triple-Neg /HER2-Negative Breast Cancer /SolidTumors Recruiting
NCT03740165 Phase III Bevacizumab + Carboplatin + Paclitaxel Carboplatin + Paclitaxel Carboplatin + Paclitaxel + Pembrolizumab Bevacizumab + Carboplatin + Olaparib + Paclitaxel + Pembrolizumab Carboplatin + Olaparib + Paclitaxel + Pembrolizumab 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
NCT02163694 Phase III Carboplatin + Paclitaxel + Veliparib Carboplatin + Paclitaxel A Phase 3 Randomized, Placebo-controlled Trial of Carboplatin and Paclitaxel With or Without Veliparib (ABT-888) in HER2-negative Metastatic or Locally Advanced Unresectable BRCA-associated Breast Cancer Active, not 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
NCT02184195 Phase III Olaparib Olaparib in gBRCA Mutated Pancreatic Cancer Whose Disease Has Not Progressed on First Line Platinum-Based Chemotherapy (POLO) Active, not recruiting
NCT02317874 Phase I Carboplatin + Paclitaxel + Talazoparib Talazoparib, Carboplatin, and Paclitaxel in Treating Patients With Solid Tumors That Are Metastatic or Cannot Be Removed by Surgery Recruiting
NCT03718091 Phase II VX-970 M6620 (VX-970) in Selected Solid Tumors Recruiting
NCT03329937 Phase I Niraparib Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment Recruiting
NCT03712930 Phase II Pamiparib Treatment of Patients With Metastatic Castration-Resistant Prostate Cancer With Homologous Recombination Deficiency 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
NCT01853306 Phase I Veliparib A Study to Evaluate the Safety, Pharmacokinetics and Oral Bio Availability of Veliparib in Subjects With Solid Tumors Completed
NCT01844986 Phase III Olaparib Olaparib Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy (SOLO-1) Active, not recruiting
NCT03402841 Phase III Olaparib Multicentre Study of Olaparib Maintenance Monotherapy in Platinum Sensitive Relapsed Non gBRCAm Ovarian Cancer Patients (OPINION) Active, not recruiting
NCT02208375 Phase Ib/II Capivasertib + Olaparib Olaparib + Vistusertib A Phase Ib Study of the Oral PARP Inhibitor Olaparib With the Oral mTORC1/2 Inhibitor AZD2014 or the Oral AKT Inhibitor AZD5363 for Recurrent Endometrial, Triple Negative Breast, and Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Active, not recruiting
NCT02345265 Phase II Cediranib + Olaparib Olaparib and Cediranib Maleate in Treating Patients With Recurrent Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Active, not recruiting
NCT03565991 Phase II Avelumab + Talazoparib Javelin BRCA/ATM: Avelumab Plus Talazoparib in Patients With BRCA or ATM Mutant Solid Tumors Recruiting
NCT03047135 Phase II Olaparib Olaparib in Men With High-Risk Biochemically-Recurrent Prostate Cancer Following Radical Prostatectomy, With Integrated Biomarker Analysis Recruiting
NCT03375307 Phase II Olaparib Olaparib in Treating Patients With Metastatic or Advanced Urothelial Cancer With DNA-Repair Defects Recruiting
NCT03586661 Phase I Copanlisib + Niraparib Niraparib and Copanlisib in Treating Participants With Recurrent Endometrial, Ovarian, Primary Peritoneal, or Fallopian Tube Cancer Not yet 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
NCT02000622 Phase III Olaparib Vinorelbine Eribulin Capecitabine Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations. (OlympiAD) Active, not recruiting
NCT03601923 Phase II Niraparib Niraparib in Patients With Pancreatic Cancer Recruiting
NCT02476968 FDA approved Olaparib To Assess the Efficacy and Safety of Olaparib Maintenance Monotherapy in the Treatment of Ovarian Cancer (ORZORA) Active, not recruiting
NCT02693535 Phase II Cobimetinib + Vemurafenib Regorafenib Pembrolizumab Temsirolimus Dasatinib Pertuzumab + Trastuzumab Ipilimumab + Nivolumab Crizotinib Palbociclib Sunitinib Olaparib Cetuximab 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
NCT03810105 Phase II Durvalumab + Olaparib A Study of Olaparib and Durvalumab in Prostate Cancer Recruiting
NCT02446600 Phase III Cediranib + Olaparib Olaparib Carboplatin + Gemcitabine + Paclitaxel + Pegylated liposomal-doxorubicin Olaparib or Cediranib Maleate and Olaparib Compared With Standard Platinum-Based Chemotherapy in Treating Patients With Recurrent Platinum-Sensitive Ovarian, Fallopian Tube, or Primary Peritoneal Cancer Active, not recruiting
NCT01874353 Phase III Olaparib Olaparib Treatment in BRCA Mutated Ovarian Cancer Patients After Complete or Partial Response to Platinum Chemotherapy Active, not 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
NCT03233204 Phase II Olaparib Olaparib in Treating Patients With Relapsed or Refractory Advanced Solid Tumors, Non-Hodgkin Lymphoma, or Histiocytic Disorders With Defects in DNA Damage Repair Genes (A Pediatric MATCH Treatment Trial) Recruiting
NCT03209401 Phase I Carboplatin + Niraparib Niraparib Plus Carboplatin in Patients With Homologous Recombination Deficient Advanced Solid Tumor Malignancies 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
NCT03786796 Phase II Olaparib Study of Olaparib in Metastatic Renal Cell Carcinoma Patients With DNA Repair Gene Mutations (ORCHID) Not yet recruiting
NCT03286842 Phase III Olaparib To Study Clinical Effectiveness and Safety of Olaparib Monotherapy in Metastatic Breast Cancer Patients. Active, not recruiting
NCT02975934 Phase III Rucaparib Docetaxel Enzalutamide Abiraterone A Study of Rucaparib Versus Physician's Choice of Therapy in Patients With Metastatic Castration-resistant Prostate Cancer and Homologous Recombination Gene Deficiency (TRITON3) Recruiting
NCT02282345 Phase II Talazoparib Neoadjuvant Talazoparib for Patients With a BRCA Deleterious Mutation Active, not recruiting