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

PHASE2CompletedINTERVENTIONAL
Enrollment

50

Participants

Timeline

Start Date

April 30, 2005

Study Completion Date

September 30, 2006

Conditions
Breast Cancer
Interventions
DRUG

the FEC75 and 95 regimen

"Fluorouracil 500mg/m2 by i.v. bolus or infusion. Epirubicin 75mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion. All three drugs will be administered intravenously on Day 1 of each 14-day cycles.~Arm B: the FEC90 regimen will be given at the following doses:~Fluorouracil 500mg/m2 by i.v. bolus or infusion.Epirubicin 90mg/m2 by 30 minutes i.v infusion and Cyclophosphamide 500mg/m2 by i.v bolus or infusion.~All three drugs will be administered intravenously on Day 1 of each 14-day cycles.~Pegfilgrastim fixed dose of 6mg as a single subcutaneous injection will be given in both arms on Day 2 of each cycle.~Six cycles of adjuvant chemotherapy will be administered in both arms (A + B"

Trial Locations (5)

1090

AKH, Universitätsklinik für Innere Medizin 1, Vienna

81250

Nomocnica Sv. Alzbety, Narodny Onkologicky Ustav, Bratislava

Unknown

Onkotherápiás Klinika,, Szeged

80-211

Medical University of Gdansk, Dept. of Oncology and Radiotherapy, Gdansk

04191

Oncology Institute, Department of Radiotherapy and Onclogy, Košice

All Listed Sponsors
lead

Central European Cooperative Oncology Group

OTHER

NCT00286819 - Dose Density FU 75 and FU 90 as Adjuvant Therapy for Early Breast Cancer | Biotech Hunter | Biotech Hunter