Study of Docetaxel in Breast Cancer Patients
Summary
Primary objectives: * To compare the disease free survival (DFS) in patients treated with the sequential epidoxorubicin, cyclophosphamide, methotrexate, and fluorouracil (CMF) regimen to that in patients treated with the same treatment plus docetaxel given sequentially after epidoxorubicin Secondary objectives: * To compare the DFS in patients treated with the sequential epidoxorubicin, docetaxel and CMF (only patients with \> or = 4 lymph nodes) regimen to that in patients treated with sequential intensified epidoxorubicin/docetaxel/high dose (HD) cyclophosphamide regimen * To evaluate the overall survival in each arm * To evaluate the tolerability of a sequential intensified epidoxorubicin/docetaxel/HD-cyclophosphamide (arm C) * To compare the safety of a sequential epidoxorubicin/docetaxel/CMF (arm B) regimen versus a standard sequential epidoxorubicin/CMF regimen (arm A)
Timeline
- Start
- 1997-12
- Primary completion
- 2007-12
- Completion
- 2007-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | CYCLOPHOSPHAMIDE ANHYDROUS | Small molecule | — | — |
| Subject | Cyclophosphamide | Other / unclassified | — | — |
| Subject | Docetaxel | Small molecule | — | — |
| Comparator | Fluorouracile | Unknown | — | — |
| Comparator | Methotrexate | Small molecule | — | — |
| Comparator | epidoxorubicine | Unknown | — | — |