Official Title: “A Double-Blind, Randomized, Multi-Center Trial Comparing the Efficacy and Tolerability of 125 and 250mg of Faslodex (Long Acting ICI 182,780) With 1mg Arimidex (Anastrazole) in Postmenopausal Women With Advanced Breast Cancer.”

The main purpose of this study is to compare the effect of 2 doses of FASLODEX with 1 dose of ARIMIDEX in terms of time to tumor progression in postmenopausal women with advanced breast cancer.

Study Type: Interventional

Study Design: Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2004

Intervention(s) in this Clinical Trial

• Drug: Fulvestrant
  • 125mg
• Drug: Anastrozole
  • ARIMIDEX
• Drug: Fulvestrant
  • 250mg

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
  • Faslodex 125mg and Arimidex 1 mg
• Experimental: 2
  • Faslodex 250mg and Arimidex 1mg

Primary Measures

• time to tumor progression
  • Time Frame: Every 3 months
    

Secondary Measures

• objective tumor response
  • Time Frame: Every 3 months
    
• time to treatment failure
  • Time Frame: Every 3 months
    
• time to death
  • Time Frame: Every 3 months
    

Inclusion Criteria:

• postmenopausal women with confirmation of breast cancer
• objective evidence of recurrence or progression of breast cancer no more than 1 prior hormonal therapy for breast cancer

Exclusion Criteria:

• presence of life-threatening metastatic visceral disease
• previous treatment with FASLODEX, ARIMIDEX or any aromatase inhibitor for breast cancer
• more than 1 prior endocrine medical treatment for advanced breast cancer .

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Guido Hoctin-Boes Study Director AstraZeneca  

Information obtained from ClinicalTrials.gov on November 20, 2008

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00635713

Study ID Number: 9238IL/0021

ClinicalTrials.gov Identifier: NCT00635713

Health Authority: United States: Food and Drug Administration