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STMP V Chemotherapy with or without Trastuzumab for High-Risk Breast Cancer
NCT00182793Phase 2
Key facts
- Status
- Completed
- Start
- Jul 2005
- Primary completion
- Oct 2014
- Countries
- 1
- Sponsor
- City of Hope
- Modality
- Antibody Conjugates, Monoclonal Antibodies, DNA Intercalators/Alkylators
- Conditions
- breast cancer
01
Overview
Phase 2, open-label, single-arm trial of melphalan, carboplatin, thiotepa, cyclophosphamide and trastuzumab in breast cancer, sponsored by City of Hope. Primary endpoints: Relapse-free Survival Rate at 5 years and Overall Survival Rate at 5 years. Started Jul 2005; status: completed.
02
Design
1 arm- Study design
- Non-randomizedOpen-label
STMP V +/- Trastuzumab
Tandem high-dose chemotherapy with stem cell support and radiation
03
Who it enrols
Patients with Stage IIIB, IIIC, or IV breast cancer who have completed prior chemotherapy, surgery, or radiotherapy. Must have adequate organ function and no other malignancies within 5 years.
04
Endpoints
Primary
Relapse-free Survival Rate
Overall Survival Rate
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