A Phase 3, Multi-Center, Open-Label, Randomized Study of Gemcitabine/Carboplatin, With or Without BSI-201, in Patients With ER-, PR-, and Her2-Negative Metastatic Breast Cancer
Participants were treated for 21-day cycles until disease progression, unacceptable
toxicity, or consent withdrawal. After treatment discontinuation, participants were followed
until end of study or death or receipt of new anticancer therapy, whichever was first.
Interventional
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
progression free survival
Progression free survival was defined as the time interval from the date of randomization to the date of first disease progression (as assessed by Independent Radiologic Review (IRR) based on Response Evaluation Criteria in Solid Tumor (RECIST) criteria), or the date of death due to any cause, whichever occurred first. In the absence disease progression or death, the participant was censored at the date of the last valid tumor assessment performed before the cut-off date.
until cut-off date established from deaths rate
No
Clinical Sciences & Operations
Study Director
Sanofi
United States: Food and Drug Administration
EFC11486
NCT00938652
July 2009
February 2012
Name | Location |
---|---|
Research Site | Alabaster, Alabama |
Research Site | Mesa, Arizona |
Research Site | Bentonville, Arkansas |
Research Site | Anaheim, California |
Research Site | Boulder, Colorado |
Research Site | Washington, District of Columbia |
Research Site | Boca Raton, Florida |
Research Site | Albany, Georgia |
Research Site | Boise, Idaho |
Research Site | Arlington Heights, Illinois |
Research Site | Bloomington, Indiana |
Research Site | Hays, Kansas |
Research Site | Baltimore, Maryland |
Research Site | Beverly, Massachusetts |
Research Site | Battle Kreek, Michigan |
Research Site | Alexandria, Minnesota |
Research Site | Hattiesburg, Mississippi |
Research Site | Branson, Missouri |
Research Site | Grand Island, Nebraska |
Research Site | Las Vegas, Nevada |
Research Site | Hooksett, New Hampshire |
Research Site | Belleville, New Jersey |
Research Site | Albuquerque, New Mexico |
Research Site | Albany, New York |
Research Site | Asheville, North Carolina |
Research Site | Akron, Ohio |
Research Site | Bend, Oregon |
Research Site | Allentown, Pennsylvania |
Research Site | Chattanooga, Tennessee |
Research Site | Abilene, Texas |
Research Site | Ivins, Utah |
Research Site | Abington, Virginia |
Research Site | Auburn, Washington |
Reserach Site | Billings, Montana |
Reserach Site | Durham, North Carolina |
Reserach Site | Columbia, South Carolina |
Research Sites | Seattle, Washington |