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

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Progression Free Survival

Outcome Description:

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.

Outcome Time Frame:

RECIST performed at screening and every 8 weeks through to progression or discontinuation whichever is earliest.

Safety Issue:

No

Principal Investigator

Bijoyesh Mookerjee, MD

Investigator Role:

Study Director

Investigator Affiliation:

AstraZeneca

Authority:

United States: Food and Drug Administration

Study ID:

D8480C00007

NCT ID:

NCT00454805

Start Date:

March 2007

Completion Date:

June 2013

Related Keywords:

• Advanced Breast Cancer
• Advanced Breast Cancer
• Breast Neoplasms