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High-Dose vs Standard CMF Chemotherapy in High-Risk Breast Cancer
NCT00003680Phase 3
Key facts
- Status
- Unknown
- Start
- Nov 1998
- Countries
- 1
- Sponsor
- Scottish Cancer Therapy Network
- Modality
- Small Molecules
- Drugs
- thiotepa
- Conditions
- breast cancer
01
Overview
Phase 3, randomised, open-label trial of thiotepa in breast cancer (2 arms), sponsored by Scottish Cancer Therapy Network. Primary endpoint: Overall Survival at 5 years. Status: unknown.
02
Design
2 arms- Study design
- RandomizedOpen-label
Standard CMF
Cyclophosphamide, Methotrexate, Fluorouracil x 8 cycles
High Dose Chemo + PBPC
High dose Cyclophosphamide + Thiotepa with Stem Cell Support
03
Who it enrols
Women aged 18-60 with histologically proven locally advanced, inflammatory, or operable large primary breast cancer (>3 cm) and at least 1 positive axillary lymph node. Patients must have completed 2-6 courses of primary anthracycline-containing chemotherapy and potentially curative surgery.
04
Endpoints
Primary
Overall Survival
Secondary
Relapse-Free Survival
Quality of Life
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