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
18 Years
N/A
Female
Advanced Breast Cancer
Trial Information
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
Inclusion Criteria:
- Written informed consent
- Females with histological/cytological confirmation of hormone sensitive breast cancer
with evidence of metastatic disease
- One or more evaluable lesions
Exclusion Criteria:
- Prior hormonal therapy with fulvestrant
- More than one course of prior systemic cytotoxic chemotherapy for metastatic breast
cancer
- Prior biologic therapy for ABC including Anti-VEGF agents
- Radiation therapy within 4 weeks prior to provision of consent
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
Name | Location |
|---|---|
| Research Site | Anaheim, California |
| Research Site | Boca Raton, Florida |
| Research Site | Honolulu, Hawaii |
| Research Site | Albany, New York |
