Epirubicin Plus Paclitaxel Versus Cyclophosphamide, Epirubicin and 5-Fluorouracil as Adjuvant Treatment of Node Positive Breast Cancer Patients: A Controlled Randomized Phase III Study
OBJECTIVES: I. Compare overall survival and disease free survival after adjuvant
chemotherapy with epirubicin plus paclitaxel versus cyclophosphamide, epirubicin, and
fluorouracil in women with stage IIA, IIB, or III breast cancer. II. Compare quality of life
in these women with these treatment regimens.
OUTLINE: This is a randomized, multicenter study. Patients are randomized to one of two
treatment arms within 35 days of surgery. Arm I: Patients receive epirubicin IV followed by
paclitaxel IV over 3 hours on day 1. Treatment repeats every 21 days for 4 courses. Arm II:
Patients receive cyclophosphamide IV, epirubicin IV, and fluorouracil IV on day 1. Treatment
repeats every 21 days for 6 courses. Treatment continues in the absence of disease
progression or unacceptable toxicity. Patients who are postmenopausal, or premenopausal and
hormone receptor positive, receive tamoxifen orally once a day for 5 years starting on day
1. Patients receive radiotherapy to residual breast after 4 courses of chemotherapy. Quality
of life is assessed. Patients are followed every 3 months for 3 years, every 6 months for 2
years, and then annually thereafter.
PROJECTED ACCRUAL: Approximately 1,000 patients will be accrued for this study over 5 years.
Allocation: Randomized, Primary Purpose: Treatment
Riccardo Rosso, MD
National Institute for Cancer Research, Italy
United States: Federal Government