Phase III Randomized Study Of Adjuvant Fluourouracil, Epirubicin And Cyclophosphamide, In Women With Stage I Breast Cancer
- Compare the efficacy of 4 vs 6 courses of adjuvant fluorouracil, epirubicin, and
cyclophosphamide, in terms of 5-year survival, in women with stage I breast cancer.
- Compare the toxicity of these regimens in these patients.
- Determine the correlation of length of survival with biological factors in patients
treated with these regimens.
- Determine biological factors significant for prognosis and prediction of survival of
patients treated with these regimens.
- Determine the overall survival of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are randomized to 1
of 2 treatment arms.
- Arm I: Patients receive fluorouracil IV, epirubicin IV, and cyclophosphamide IV on day
1. Treatment repeats every 3 weeks for up to 6 courses in the absence of disease
progression or unacceptable toxicity.
- Arm II: Patients receive the same regimen as in arm I for up to 4 courses. After
completion of chemotherapy, patients undergo radiotherapy 5 days a week for 6 weeks.
Patients who are estrogen or progesterone receptor positive also receive oral tamoxifen
daily for 5 years, beginning after completion of chemotherapy.
Patients are followed every 6 months for 5 years.
PROJECTED ACCRUAL: A total of 1,512 patients (756 per treatment arm) will be accrued for
this study within 3 years.
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Efficacy, in terms of 5-year survival
5 years from randomization
Pierre Kerbrat, MD, PhD
Centre Eugene Marquis
France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)