Table 3.

Ongoing clinical trials in BRCA-mutant or BRCAness-associated TNBC

Clinicaltrials.gov identifierTitleBRCA status eligibility criteriaPhase
Neoadjuvant
NCT03109080A Phase I of Olaparib with Radiation Therapy in Patients with Inflammatory, Locoregionally Advanced or Metastatic TNBC or Patient with Operated TNBC with Residual DiseaseBRCA mutation not required.I
NCT03329937An Open-Label, Single-Arm Pilot Study Evaluating the Antitumor Activity and Safety of Niraparib as Neoadjuvant Treatment in Localized, HER2-Negative, BRCA-Mutant Breast Cancer PatientsDeleterious or suspected deleterious BRCA1 or BRCA2 mutation (germline or somatic).I
NCT02978495Neoadjuvant Carboplatin in Triple-Negative Breast Cancer—A Prospective Phase II Study (NACATRINE Trial)BRCA mutation not required. Includes BRCA-mutant–specific cohorts.II
NCT02789332A Randomized Phase II Trial to Assess the Efficacy of Paclitaxel and Olaparib in Comparison with Paclitaxel/Carboplatin Followed by Epirubicin/Cyclophosphamide as Neoadjuvant Chemotherapy in Patients with HER2-Negative Early Breast Cancer and Homologous Recombination DeficiencyBRCA deleterious tumor or germline mutation and/or high HRD score.II
NCT03150576Randomized, Phase II/III, 3 Stage Trial to Evaluate the Safety and Efficacy of the Addition of Olaparib to Platinum-Based Neoadjuvant Chemotherapy in Breast Cancer Patients with TNBC and/or gBRCATNBC or germline BRCA mutation HER2-negative breast cancer.II/III
Adjuvant
NCT02032823A Randomized, Double-Blind, Parallel Group, Placebo-Controlled Multicenter Phase III Study to Assess the Efficacy and Safety of Olaparib versus Placebo as Adjuvant Treatment in Patients with gBRCA1/2 Mutations and High-Risk HER2-Negative Primary Breast Cancer Who Have Completed Definitive Local Treatment and Neoadjuvant or Adjuvant ChemotherapySuspected deleterious or deleterious BRCA1 and/or BRCA2 germline mutation.III
Locally advanced, recurrent, or metastatic
NCT02950064Escalation Study of BTP-114 in Patients with Advanced Solid Tumors and BRCA or DNA-Repair MutationDeleterious germline or somatic BRCA mutation or DNA-repair mutation. Abnormal HRD tests are also allowed.I
NCT00576654A Phase I Dose-Escalation Study of Oral ABT-888 (NSC #737664) plus Intravenous Irinotecan (CPT-11, NSC#616348) Administered in Patients with Advanced Solid TumorsBRCA mutation not required. Includes BRCA-mutant–specific cohort.I
NCT02227082Olaparib Dose Escalation in Combination with High Dose Radiotherapy to the Breast and Regional Lymph NodesBRCA mutation not required.I
NCT02898207A Phase 1 Study of PARP Inhibitor Olaparib and HSP90 Inhibitor AT13387 for Treatment of Advanced Solid Tumors with Expansion in Patients with Recurrent Epithelial Ovarian, Fallopian Tube, Peritoneal Cancer or Recurrent TNBCBRCA mutation not required. Dose expansion excludes germline BRCA1 or BRCA2 mutations.I
NCT03075462An Open, Nonrandomized, Multicenter Phase I Study to Assess the Safety and Efficacy of Fluzoparib Given in Combination with Apatinib in Patients with Recurrent Ovarian Cancer or TNBCBRCA mutation not required.I
NCT03109080A Phase I of Olaparib with Radiation Therapy in Patients with Inflammatory, Locoregionally Advanced or Metastatic TNBC or Patients with Operated TNBC with Residual DiseaseBRCA mutation not required.I
NCT03101280A Phase IB Combination Study of Rucaparib (CO-338) and Atezolizumab (MPDL3280A) in Participants with Advanced Gynecologic Cancers and TNBCPart 1: All comers; part 2: deleterious germline or somatic BRCA mutation, or wild-type tumor BRCA but high levels of LOH.I
NCT02393794Phase I/II Study of Cisplatin plus Romidepsin and Nivolumab in Metastatic Triple-Negative Breast Cancer or BRCA Mutation-Associated Locally Recurrent or Metastatic Breast CancerTNBC or germline BRCA mutation breast cancer.I/II
NCT02264678A Modular Phase I, Open-Label, Multicenter Study to Assess the Safety, Tolerability, Pharmacokinetics and Preliminary Anti-tumor Activity of AZD6738 in Combination with Cytotoxic Chemotherapy and/or DNA Damage Repair/Novel Anticancer Agents in Patients with Advanced Solid MalignanciesCohort HER2-negative breast cancer: with BRCA mutation (germline or somatic); cohort TNBC: without known BRCA mutation.I/II
NCT02484404Phase I/II Study of the Anti-Programmed Death Ligand-1 Antibody MEDI4736 in Combination with Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple-Negative Breast, Lung, Prostate and Colorectal CancersTNBC cohort requires germline BRCA1 or BRCA2 mutation.I/II
NCT02401347A Phase II Clinical Trial of the PARP Inhibitor Talazoparib in BRCA1 and BRCA2 Wild-Type Patients with (i) Advanced Triple-Negative Breast Cancer and Homologous Recombination Deficiency (HRD), and (ii) Advanced HER2-Negative Breast Cancer or Other Solid Tumors with Either a Mutation in Homologous Recombination (HR) Pathway GenesNo deleterious BRCA mutation. TNBC with high HRD score or HER2-negative breast cancer with germline or somatic mutation in the HR pathway.II
NCT02203513A Phase II Single-Arm Pilot Study of the Chk1/2 Inhibitor (LY2606368) in BRCA1/2 Mutation-Associated Breast or Ovarian Cancer, TNBC, and High-Grade Serous Ovarian CancerTNBC or germline BRCA mutation breast cancer.II
NCT03205761A Phase II Clinical Trial to Analyze Olaparib Response in Patients with BRCA1 and/or 2 Promoter Methylation Diagnosed of Advanced Breast CancerAbsence of deleterious or suspected deleterious germline BRCA mutations. Documented BRCA1 and/or BRCA2 promoter methylation.II
NCT03330847A Phase II, Open-Label, Randomized, Multicenter Study to Assess the Safety and Efficacy of Agents Targeting DNA Damage Repair in Combination with Olaparib Versus Olaparib Monotherapy in the Treatment of Metastatic TNBC Patients Stratified by Alterations in Homologous Recombinant Repair (HRR)-Related Genes (including BRCA1/2)BRCA mutation not required. Stratification by mutation in BRCA and HRR genes.II
NCT02595905Phase II Randomized Placebo-Controlled Trial of Cisplatin with or without ABT-888 (Veliparib) in Metastatic TNBC and/or BRCA Mutation-Associated Breast Cancer, with or without Brain MetastasesTNBC or germline BRCA mutation breast cancer.II
NCT01898117Biomarker Discovery Randomized Phase IIb Trial with Carboplatin–Cyclophosphamide versus Paclitaxel with or without Atezolizumab as First-line Treatment in Advanced TNBCBRCA mutation not required.II
NCT03414684A Randomized Phase II Trial of Carboplatin with or without Nivolumab in First- or Second-Line Metastatic TNBCBRCA mutation not required. Stratification by germline BRCA mutation.II
NCT02498613A Phase 2 Study of Cediranib in Combination with Olaparib in Advanced Solid TumorsBRCA mutation not required.II
  • NOTE: The Clinicaltrials.gov database was searched for interventional-only clinical trials that are recruiting as of April 14, 2018. Only drug-based interventions were considered. Search terms included “triple-negative breast cancer,” “HER2-negative breast cancer,” “BRCA,” and “PARP.”