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Docetaxel, Capecitabine, and Bevacizumab in Metastatic Breast Cancer
NCT00088998Phase 2
Key facts
- Status
- Completed
- Start
- Dec 2004
- Primary completion
- Aug 2006
- Sponsor
- Cancer and Leukemia Group B
- Modality
- Monoclonal Antibodies
- Drugs
- bevacizumab
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of bevacizumab in breast cancer, sponsored by Cancer and Leukemia Group B. Primary endpoint: Confirmed tumor response rate up to 5 years. Started Dec 2004; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
docetaxel + bevacizumab + capecitabine
Docetaxel, Bevacizumab, and Capecitabine combination therapy
03
Who it enrols
Patients with histologically confirmed invasive metastatic breast cancer, measurable disease, no prior chemotherapy for metastatic disease, and adequate organ function. HER2-positive patients are excluded unless they have progressed on trastuzumab.
04
Endpoints
Primary
Confirmed tumor response rate
Secondary
Progression-free survival
Overall survival
Toxicity profile
Duration of response
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