SAKK - a Trial to Evaluate Antitumor Efficacy of Faslodex® After Aromatase Inhibitor Failure in Advanced Breast Cancer
Phase 2
Completed
- Conditions
- Breast Neoplasms
- Registration Number
- NCT00272740
- Lead Sponsor
- AstraZeneca
- Brief Summary
The primary objective of the study is to assess the activity of fulvestrant in postmenopausal women with advanced breast cancer failing treatment with non-steroidal or steroidal aromatase inhibitors by estimating the Clinical Benefit Rate
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 93
Inclusion Criteria
- Histological/cytological confirmation of breast cancer
- progression under treatment with an aromatase inhibitor
- At least one measurable or non-measurable lesion
Exclusion Criteria
- Prior treatment for breast cancer with more than 2 different hormonal agents
- More than 1 chemotherapy for advanced disease
- Presence of life-threatening metastatic visceral disease
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Clinical Benefit Rate
- Secondary Outcome Measures
Name Time Method Duration of clinical benefit Time to progression Duration of response Time to treatment failure Safety and tolerability 6. clinical benefit rate according to HER2/neu status
Trial Locations
- Locations (1)
Research Site
🇨🇭St.Gallen, Switzerland
Research Site🇨🇭St.Gallen, Switzerland