Advanced Breast Cancer Clinical Trial
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.
Status | Completed |
Enrollment | 588 |
Est. completion date | September 2004 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
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 . |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | time to tumor progression | Every 3 months | ||
Secondary | objective tumor response | Every 3 months | ||
Secondary | time to treatment failure | Every 3 months | ||
Secondary | time to death | Every 3 months |
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