A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
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.
|Triple Negative Breast Cancer||Drug: gemcitabine plus carboplatin plus BSI-201||Phase 2|
Access to an investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Design:||Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
- pathologic complete response [ Time Frame: 4 months ]
|Study Start Date:||December 2008|
|Study Completion Date:||October 2012|
|Primary Completion Date:||October 2012 (Final data collection date for primary outcome measure)|
standard chemotherapy plus BSI-201
Drug: gemcitabine plus carboplatin plus BSI-201
iv, 3 week cycles
Please refer to this study by its ClinicalTrials.gov identifier: NCT00813956
|United States, California|
|Stanford Comprehensive Cancer Center|
|Stanford, California, United States, 94305|
|United States, Pennsylvania|
|Philadelphia, Pennsylvania, United States, 19103|
|Study Director:||Clinical Sciences & Operations||Sanofi|