PRIMADOS Study:A Study of Avastin (Bevacizumab) Plus Docetaxel for First Line Treatment of Patients With Metastatic Breast Cancer
- Registration Number
- NCT00774241
- Lead Sponsor
- Hoffmann-La Roche
- Brief Summary
This single arm study will assess the efficacy and safety of first line combination treatment with Avastin + docetaxel in patients with HER2 negative metastatic breast cancer.Patients will receive Avastin (15mg/kg iv every 3 weeks) plus docetaxel (75mg/m2 every 3 weeks for 6 cycles). The anticipated time on study treatment is until disease progression, and the target sample size is 100 individuals.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
Inclusion Criteria
- male and female patients, >=18 years of age;
- stage IV, HER2 negative metastatic breast cancer;
- candidate for taxane-based therapy;
- ECOG performance status 0-2.
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Exclusion Criteria
- prior chemotherapy for metastatic breast cancer;
- concomitant primary malignant disease, except for adequately treated cervical cancer in situ, or basal or squamous cell skin cancer within last 5 years;
- suspicion of CNS metastasis;
- clinically significant cardiovascular disease.
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Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description 1 bevacizumab [Avastin] - 1 docetaxel -
- Primary Outcome Measures
Name Time Method Response rate, median progression free survival, overall survival Event driven
- Secondary Outcome Measures
Name Time Method Adverse events Throughout study