Phase III study of iniparib plus gemcitabine and carboplatin versus gemcitabine and carboplatin in patients with metastatic triple-negative breast cancer.

Publication Type:

Journal Article


Journal of clinical oncology : official journal of the American Society of Clinical Oncology, Volume 32, Issue 34, p.3840-7 (2014)


2014, Antineoplastic Combined Chemotherapy Protocols, Benzamides, Carboplatin, Deoxycytidine, DISEASE PROGRESSION, Disease-Free Survival, Female, Humans, Kaplan-Meier Estimate, Middle Aged, Neoplasm Recurrence, Local, Neoplasm Staging, Proportional Hazards Models, Risk Factors, Time Factors, Treatment Outcome, Triple Negative Breast Neoplasms, United States


There is a lack of treatments providing survival benefit for patients with metastatic triple-negative breast cancer (mTNBC), with no standard of care. A randomized phase II trial showed significant benefit for gemcitabine, carboplatin, and iniparib (GCI) over gemcitabine and carboplatin (GC) in clinical benefit rate, response rate, progression-free survival (PFS), and overall survival (OS). Here, we formally compare the efficacy of these regimens in a phase III trial.