A Randomized, Double-Blind, Multi-Center Phase II Trial of Exemestane (Aromasin®) Plus Dasatinib Versus Exemestane Plus Placebo in Advanced Estrogen Receptor-Positive Breast Cancer After Disease Progression on a Non-Steroidal Aromatase Inhibitor (NSAI)
Interventional
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Progression Free Survival (PFS) Distribution for Exemestane Plus Dasatinib vs Exemestane Plus Placebo
PFS= The time (weeks) from date of randomization to date of progressive disease(PD). PFS for each randomization arm was estimated using the Kaplan-Meier product-limit method. A point estimate and a 95% confidence interval (CI) for the median PFS was computed for each randomization arm using the Brookmeyer & Crowley method. PD=Increase (≥ 20%) in sum of longest diameters from smallest value during study (including baseline).
Prior to study therapy, at 8 week intervals until progression occurs (maximum participant PFS of 71 weeks)
No
Bristol-Myers Squibb
Study Director
Bristol-Myers Squibb
United States: Food and Drug Administration
CA180-261
NCT00767520
February 2009
December 2012
Name | Location |
---|---|
The West Clinic | Memphis, Tennessee 38120 |
Compassionate Cancer Care Medical Group, Inc | Fountain Valley, California 92708 |
Compassionate Cancer Care Medical Group Inc | Fountain Valley, California 92708 |
Pennsylvania Oncology/Hematology Associates | Philadelphia, Pennsylvania 19106 |