drugset / Trial / NCT02450058
Adjuvant FEC Versus EP in Breast Cancer (MIG5)
Phase 3
Completed
1055 enrolled
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
RandomizedParallel-groupOpen-labelTreatment
Summary
In this multicenter, randomized phase III trial, node positive early breast cancer patients are randomly assigned to receive either 6 cycles of FEC (5-fluorouracil 600 mg/m2, epirubicin 60 mg/m2 and cyclophosphamide 600 mg/m2, on day 1, every three weeks) or 4 cycles of EP (epirubicin 90 mg/m2 and paclitaxel 175 mg/m2, on day 1, every three weeks). The primary study endpoint is overall survival (OS). Secondary endpoints include toxicity and event free survival (EFS).
Timeline
- Start
- 1996-11
- Primary completion
- 2012-05
- Completion
- 2012-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Cyclophosphamide | Other / unclassified | 600 mg/m2 | Intravenous |
| Comparator | Epirubicin | Small molecule | 60 mg/m2 | Intravenous |
| Comparator | Epirubicin | Small molecule | 90 mg/m2 | Intravenous |
| Comparator | Paclitaxel | Small molecule | 175 mg/m2 | — |
| Comparator | fluorouracil | Small molecule | 600 mg/m2 | Intravenous |