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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


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Advanced Breast Cancer

Thank you

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 SiteAnaheim, California  
Research SiteBoca Raton, Florida  
Research SiteHonolulu, Hawaii  
Research SiteAlbany, New York