Randomized And Multicentric Phase III Study Evaluating The Benefit By Using A Chemotherapy With FEC 100 And Docetaxel In Non Metastatic Breast Cancer Which Has Relapsed After A Conservative Surgery
- Compare the efficacy of adjuvant cyclophosphamide, epirubicin, and fluorouracil vs
observation, in terms of disease-free 5-year survival, in women who have undergone
resection for relapsed nonmetastatic breast cancer after initial conservative surgery.
- Compare the overall survival of women treated with these regimens.
- Determine the tolerance of these women to the chemotherapy regimen.
- Correlate prognostic factors of survival with efficacy of the chemotherapy regimen in
OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
menopausal status and participating center. Patients are randomized to 1 of 2 treatment
arms. Study begins within 42 days after resection of recurrent disease.
- Arm I: Patients receive fluorouracil IV over 1 hour, epirubicin IV over 1 hour, and
cyclophosphamide IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses
in the absence of disease progression or unacceptable toxicity. Patients then receive
docetaxel IV over 1 hour on day 1. Treatment repeats every 3 weeks for 3 courses in the
absence of disease progression or unacceptable toxicity.
- Arm II: Patients are examined on days 1 and 63.
Patients who are hormone receptor positive also receive one of the following hormonal
therapy regimens, depending on menopausal status:
- Oral tamoxifen daily for 5 years
- Oral tamoxifen daily for 5 years and oral luteinizing hormone-releasing hormone (LHRH)
agonist therapy (e.g., goserelin) for 3 years
- Oral LHRH agonist therapy (e.g., goserelin) for 3 years
- Oral antiaromatase therapy (e.g., anastrozole) for 5 years Patients also undergo
radiotherapy and may also undergo second complete resection.
Patients are followed every 6 months for 5 years and then annually thereafter.
PROJECTED ACCRUAL: A total of 370 patients (185 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Primary Purpose: Treatment
Gilles Romieu, MD
Centre Val d'Aurelle - Paul Lamarque
United States: Federal Government