A Double-Blind, Randomized, Multicentre Trial Comparing the Efficacy and Tolerability of 250mg of Faslodex (Long Acting ICI 182,780) With 20mg of Nolvadex (Tamoxifen) in Postmenopausal Women With Advanced Breast Cancer
Phase 3
- Conditions
- Breast Cancer Metastasis
- Registration Number
- JPRN-jRCT2080220407
- Lead Sponsor
- AstraZeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- Female
- Target Recruitment
- Not specified
Inclusion Criteria
Genders Eligible for Study: Female
Inclusion Criteria:
Biopsy confirmation of breast cancer. Evidence of breast cancer that is not considered amenable to curative treatment.
Postmenopausal women. Written informed consent to participate in the study.
Exclusion Criteria
Previous treatment with hormonal therapy unless that therapy was tamoxifen for adjuvant breast cancer. The use of tamoxifen must have ceased at least one year before this study.
Previous treatment with Faslodex. Any existing serious disease, illness, or condition that will prevent participation or compliance with the study procedures.
Treatment with an investigational or non-approved drug within one month of then start of the study.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Efficacy Primary Outcome Measures: Time to disease progression (TTP) Secondary Outcome Measures: Objective response rate (ORR), Duration of response (DoR), Time to treatment failure (TTF), Overall survival (OS), Quality of Life (QOL) and Tolerability.
- Secondary Outcome Measures
Name Time Method