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Randomized Comparison of a Preoperative, Dose-Intensified, Interval-Shortened, Sequential Chemotherapy With Epirubicin, Paclitaxel and CMF ± Darbepoetin Alfa Versus a Preoperative, Sequential Chemotherapy With Epirubicin and Cyclophosphamide Followed by Paclitaxel in Standard Dosage ± Darbepoetin Alfa in Patients With Primary Breast Cancer
The present clinical trial will investigate the efficacy of a sequential interval-shortened and dose-intensified preoperative use of epirubicin, paclitaxel and CMF with preoperative sequential administration of epirubicin and cyclophosphamide followed by paclitaxel in breast cancer. In addition, the influence of darbepoetin alfa on the response rate and quality of life is to be investigated in both treatment arms.
Details
| Lead sponsor | GBG Forschungs GmbH |
|---|---|
| Phase | Phase 3 |
| Status | COMPLETED |
| Enrolment | 720 |
| Start date | 2002-08 |
| Completion | 2006-09 |
Conditions
- Breast Cancer
Interventions
- Epirubicin, paclitaxel, cyclophosphamide, Methotrexate, 5 FU, darbepoetin alfa
- Epirubicin, Cyclophosphamide, Paclitaxel, dabepoetin alfa
Primary outcomes
- Relapse-free survival time and overall survival — 2007