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.
Phase 3
18 Years
N/A
18 Years
N/A
Not Enrolling
Female
Advanced Breast Cancer
Female
Advanced Breast Cancer
Trial Information
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.
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 .
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment
Outcome Measure:
time to tumor progression
Outcome Time Frame:
Every 3 months
Principal Investigator
Guido Hoctin-Boes
Investigator Role:
Study Director
Investigator Affiliation:
AstraZeneca
Authority:
United States: Food and Drug Administration
Study ID:
9238IL/0021
NCT ID:
NCT00635713
Start Date:
May 1997
Completion Date:
September 2004
Related Keywords:
- Advanced Breast Cancer
- Advanced breast cancer, FASLODEX, ARIMIDEX, Fulvestrant, Anastrozole, postmenopausal
- Breast Neoplasms
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