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Bevacizumab in Inflammatory or Locally Advanced Breast Cancer
NCT00559845Phase 2
Key facts
- Status
- Completed
- Start
- Feb 2008
- Primary completion
- Jul 2015
- Countries
- 1
- Sponsor
- Roche
- Modality
- Monoclonal Antibodies
- Drugs
- bevacizumab
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of bevacizumab in breast cancer, sponsored by Roche. Primary endpoint: Pathological Complete Response up to 7.5 years. Started Feb 2008; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-labelSingle group
Bevacizumab Arm
Participants receive FEC followed by Paclitaxel + Bevacizumab
03
Who it enrols
Female patients >=18 years with Stage III or inflammatory breast cancer, HER2 negative, normal LVEF. Excludes prior chemotherapy/endocrine therapy, distant metastases, and chronic high-dose aspirin/clopidogrel.
04
Endpoints
Primary
Pathological Complete Response
Secondary
Objective Response Rate
Breast-Conserving Surgery Rate
Disease-Free Interval
Overall Survival
Adverse Events
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