drugset / Trial / NCT00286819

Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer

NCT00286819 ↗

Phase 2 Completed 50 enrolled Central European Cooperative Oncology Group
RandomizedParallel-groupOpen-labelTreatment

Summary

This is an open -label randomized phase II study of dose-dense Fluorouracil/Epirubicin/Cyclophosphamide (FEC) administered with Epirubicin of 75mg/m2 (FEC75) and Epirubicin 90mg/m2 (FEC90) in untreated patients with early breast cancer.

Timeline

Start
2005-04
Primary completion
—
Completion
2006-09

Drugs

EvaluationDrugModalityDoseRoute
Subject Epirubicin Small molecule 75 mg/m2 Intravenous
Subject Epirubicin Small molecule 90 mg/m2 Intravenous
Background Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Background Pegfilgrastim Protein / enzyme biologic 6 mg Subcutaneous
Background fluorouracil Small molecule 500 mg/m2 Intravenous

Indications