drugset / Trial / NCT00429871
Randomized Phase III Trial With Docetaxel Plus Epirubicine Versus Docetaxel Plus Capecitabine for Metastatic Breast Cancer
Phase 3
Completed
272 enrolled
Hellenic Oncology Research Group
University Hospital of Crete · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
The combination of docetaxel+epirubicin is highly effective and well tolerated as first line treatment in patients with metastatic breast cancer (MBC). Capecitabine is an active drug in women with MBC pretreated with taxane and anthracycline. Docetaxel increases the intracellular levels of thymidilate phosphorylase and thus is synergistic with capecitabine. The combination of docetaxel plus capecitabine is highly active and superior to docetaxel monotherapy in women with MBC pretreated with an anthracycline
Timeline
- Start
- 2002-05
- Primary completion
- 2007-11
- Completion
- 2007-11
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Capecitabine | Small molecule | 950 mg/m2 | Oral |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 75 mg/m2 | Intravenous |