Efficacy of BSI-201, a poly (ADP-ribose) polymerase-1 (PARP1) inhibitor, in combination with gemcitabine/carboplatin (G/C) in patients with metastatic triple-negative breast cancer (TNBC): Results of a randomized phase II trial

摘要: 3 Background: TNBC is an aggressive breast cancer subtype that shares molecular and pathologic features with BRCA1-related cancers. BRCA-deficient cells are sensitive to inhibition of PARP1, a critical enzyme cell proliferation DNA repair, thus represent rational target PARP inhibitor-based therapy. The objectives this study were evaluate BSI-201, potent PARP1 inhibitor, in combination gemcitabine/carboplatin (G/C) subjects metastatic TNBC. Methods: Eligible had measurable disease ≤2 prior cytotoxic regimens for ER-, PR-, HER2-negative cancer. Patients randomized (1:1) G/C alone or + BSI-201. Gemcitabine (1000 mg/m2) carboplatin (AUC=2) given on days 1 8, BSI-201 (5.6 mg/kg; iv; biweekly) 1, 4, 11 every 21 days. Endpoints clinical benefit rate (CBR = CR PR SD ≥6 months), progression-free survival (PFS) overall (OS). Results: Analyses the first 86 of...