This study will investigate whether the neoadjuvant combination of gemcitabine, carboplatin, and BSI-201 will cause a high percentage of triple negative breast cancer patients to achieve a pathologic complete response prior to surgery. Based on data generated by BiPar/Sanofi, it is concluded that iniparib does not possess characteristics typical of the PARP inhibitor class. The exact mechanism has not yet been fully elucidated, however based on experiments on tumor cells performed in the laboratory, iniparib is a novel investigational anti-cancer agent that induces gamma-H2AX (a marker of DNA damage) in tumor cell lines, induces cell cycle arrest in the G2/M phase in tumor cell lines, and potentiates the cell cycle effects of DNA damaging modalities in tumor cell lines. Investigations into potential targets of iniparib and its metabolites are ongoing.
Stanford is not currently accepting new patients for this trial. You may want to check clinicaltrials.gov to see if other locations are recruiting.
- drug : gemcitabine plus carboplatin plus BSI-201
Phase: Phase 2
Ages Eligible For Study:
- invasive breast cancer - stage I-IIIA disease - ER, PR, Her2/neu-negative status - no prior treatment for breast cancer - age 18 years of greater - normal renal, liver function - normal hematologic status - ECOG Performance status 0, 1 - Evaluation by a surgeon to determine breast conservation eligibility - Women of childbearing potential must have a documented negative pregnancy test within 2 months of study trial entry and agree to birth control during the duration of the trial therapy - Ability to understand and the willingness to sign a written informed consent document