NCT00635713
Completed
Phase 3
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.
Overview
- Phase
- Phase 3
- Intervention
- Fulvestrant
- Conditions
- Advanced Breast Cancer
- Sponsor
- AstraZeneca
- Enrollment
- 588
- Primary Endpoint
- time to tumor progression
- Status
- Completed
- Last Updated
- 17 years ago
Overview
Brief Summary
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.
Investigators
Eligibility Criteria
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 .
Arms & Interventions
1
Faslodex 125mg and Arimidex 1 mg
Intervention: Fulvestrant
1
Faslodex 125mg and Arimidex 1 mg
Intervention: Anastrozole
2
Faslodex 250mg and Arimidex 1mg
Intervention: Anastrozole
2
Faslodex 250mg and Arimidex 1mg
Intervention: Fulvestrant
Outcomes
Primary Outcomes
time to tumor progression
Time Frame: Every 3 months
Secondary Outcomes
- time to treatment failure(Every 3 months)
- time to death(Every 3 months)
- objective tumor response(Every 3 months)
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