A Phase II, Double-Blind, Placebo Controlled, Randomized Study to Assess the Efficacy and Safety of AZD2171 in Combination With Fulvestrant vs Fulvestrant Alone in Hormone Sensitive (ER+ve or PgR+ve) Post Menopausal Metastatic Breast Cancer Patients
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Progression Free Survival
Number of months from randomisation until progressive disease based on RECIST (progression of target lesions, clear progression of existing non-target lesions or the appearance of one or more new lesions) or death in the absence of progression.
RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.
Bijoyesh Mookerjee, MD
United States: Food and Drug Administration
|Research Site||Anaheim, California|
|Research Site||Boca Raton, Florida|
|Research Site||Honolulu, Hawaii|
|Research Site||Albany, New York|