A Phase 2 Study of Standard Chemotherapy Plus BSI-201 (a PARP Inhibitor) in the Neoadjuvant Treatment of Triple Negative Breast Cancer
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00813956|
Recruitment Status : Completed
First Posted : December 23, 2008
Last Update Posted : March 17, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: gemcitabine plus carboplatin plus BSI-201||Phase 2|
Expanded Access : An investigational treatment associated with this study is no longer available outside the clinical trial. More info ...
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Study Start Date :||December 2008|
|Actual Primary Completion Date :||October 2012|
|Actual Study Completion Date :||October 2012|
standard chemotherapy plus BSI-201
Drug: gemcitabine plus carboplatin plus BSI-201
iv, 3 week cycles
- pathologic complete response [ Time Frame: 4 months ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|