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Preoperative Herceptin and Navelbine in HER-2 Positive Breast Cancer
NCT00148681Phase 2
Key facts
- Status
- Completed
- Start
- May 2001
- Primary completion
- May 2003
- Countries
- 1
- Sponsor
- Dana-Farber Cancer Institute
- Modality
- Antibody Conjugates, Monoclonal Antibodies, Engineered Antibody Formats
- Conditions
- breast cancer
01
Overview
Phase 2, open-label trial of trastuzumab and vinorelbine in breast cancer (2 arms), sponsored by Dana-Farber Cancer Institute. Primary endpoint: Complete Response Rate at 2 years. Started May 2001; status: completed.
02
Design
2 arms- Study design
- Non-randomizedOpen-label
Lower Risk Regimen
Neoadjuvant Herceptin+Navelbine -> Surgery -> AC -> Optional Herceptin
Higher Risk Regimen
Neoadjuvant Herceptin+Navelbine -> Surgery -> AC -> Paclitaxel+Herceptin -> Herceptin
03
Who it enrols
Patients with HER2-overexpressing (IHC 3+ or FISH+) Stage II or III breast cancer, including inflammatory (T4) and limited metastatic (supraclavicular/infraclavicular node positive) disease. Must have adequate cardiac function (LVEF >= 50%).
04
Endpoints
Primary
Complete Response Rate
Secondary
Safety of Herceptin and Navelbine
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