A Phase 2, Multi-center, Open-Label, Randomized Trial of Gemcitabine/ Carboplatin, With or Without BSI-201, in Patients With ER, PR and HER2-negative Metastatic Breast Cancer
Patients were treated until disease progression, unacceptable toxicity, Investigator's
decision to discontinue, or withdrawal of consent. After treatment discontinuation, all
patients were evaluated every 90 days after last dose of gemcitabine/carboplatin with or
without iniparib, for up to 3 years or death or end of study, which ever occurred first.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Clinical benefit rate
Clinical benefit rate was defined as the percentage of patients with complete response, partial response or stable disease ≥6 months.
until cut-off date established so that all patients were evaluable for primary outcome measure
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
TCD11485
NCT00540358
October 2007
June 2010
Name | Location |
---|---|
Research Site | Alabaster, Alabama |
Research Site | Boulder, Colorado |
Research Site | Danbury, Connecticut |
Research Site | Boca Raton, Florida |
Research Site | Bloomington, Indiana |
Research Site | Hays, Kansas |
Research Site | Las Vegas, Nevada |
Research Site | Hooksett, New Hampshire |
Research Site | Asheville, North Carolina |
Research Site | Abilene, Texas |
Research Site | Abington, Virginia |
Research Site | Auburn, Washington |