drugset / Trial / NCT03888677
Dose-adjusted Adjuvant FEC Compared to Standard FEC for Breast Cancer
Phase 3
Completed
1535 enrolled
Henrik Lindman
Danish Breast Cancer Cooperative Group · collabPharmacia Pharmaceutical Company · collabScandinavian Breast Group · collabSwedish Breast Cancer Group · collabSwedish Cancer Foundation · collabSwedish Cancer Society · collab
RandomizedParallel-groupOpen-labelTreatment
Summary
This is an open randomized phase III study. The primary objective of this study is to compare FEC adjuvant chemotherapy in operable breast cancer given either as fixed doses calculated according to the patients surface area or with doses adjusted according to leukopenia after course one in order to achieve hematological equitoxicity. The main aim of the study is to test whether chemotherapy dosage aimed at hematological equitoxicity will improve the effect of adjuvant chemotherapy.
Timeline
- Start
- 2001-02
- Primary completion
- 2003-08
- Completion
- 2014-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Cyclophosphamide | Other / unclassified | 600 unknown | — |
| Subject | Cyclophosphamide | Other / unclassified | 900 unknown | — |
| Subject | Cyclophosphamide | Other / unclassified | 1200 unknown | — |
| Subject | Epirubicin | Small molecule | 60 unknown | — |
| Subject | Epirubicin | Small molecule | 75 unknown | — |
| Subject | Epirubicin | Small molecule | 90 unknown | — |
| Subject | fluorouracil | Small molecule | 600 unknown | — |