drugset / Trial / NCT00256360
Trial Exploring Feasibility of Densification and Optimal Sequencing of Postoperative Adjuvant Fluorouracil, Epirubicin Plus Cyclophosphamide (FEC) and Docetaxel Chemotherapy in Patients With High Risk Primary Operable Breast Cancer
RandomizedParallel-groupOpen-labelTreatment
Summary
The rationale of this randomized phase II study is to investigate the feasibility of sequenced densified FEC and docetaxel based regimens in patients with primary operable high-risk breast cancer. Several phase III and phase II clinical trials showed the benefits of dose-dense therapy (Q2W) over conventional treatment in breast cancer, lymphoma and SCLC. The aim of the study is also to demonstrate that further shortening of treatment interval from 14 days to 10-11 days in FEC regimen is feasible and will not compromise patient's safety. The results of this randomized phase II study should serve as a basis for follow-up randomized phase III trial comparing conventional versus densified sequential FEC and docetaxel based regimens.
Timeline
- Start
- 2005-09
- Primary completion
- —
- Completion
- 2006-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 375 mg/m2 | Intravenous |
| Subject | Cyclophosphamide | Other / unclassified | 500 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Docetaxel | Small molecule | 100 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 75 mg/m2 | Intravenous |
| Subject | Epirubicin | Small molecule | 100 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 375 mg/m2 | Intravenous |
| Subject | fluorouracil | Small molecule | 500 mg/m2 | Intravenous |
| Background | Pegfilgrastim | Protein / enzyme biologic | 6 mg | Subcutaneous |
| Background | filgrastim | Protein / enzyme biologic | — | — |