A clinical trial to study the effects of bevacizumab plus capecitabine vs. bevacizumab alone as maintenance therapy in patients with HER2-negative metastatic breast cancer that has not progressed during initial docetaxel plus bevacizumab therapy
Phase 3
Completed
- Conditions
- Health Condition 1: null- Metastatic breast cancer
- Registration Number
- CTRI/2009/091/000423
- Lead Sponsor
- F HoffmannLa Roche
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 360
Inclusion Criteria
adult patients, greater or equal to18 years of age;
-HER2-negative metastatic breast cancer
-candidates for taxane-based chemotherapy;
-ECOG performance status of 0 or 1.
Exclusion Criteria
-previous chemotherapy for metastatic breast cancer;
-prior adjuvant/neo-adjuvant chemotherapy within 6 months prior to study;
-prior radiotherapy for treatment of metastatic disease;
chronic daily treatment with aspirin (325 mg/day) or clopidogrel(>75mg/day).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method