A Randomized Phase III Trial Comparing FEC-Chemotherapy vs. EC-Doc-Chemotherapy in Patients With Primary Breast Cancer
- Compare the time to progression of women with primary breast cancer treated with
fluorouracil, epirubicin, and cyclophosphamide vs docetaxel, epirubicin, and
- Compare the overall survival of patients treated with these regimens.
- Compare the toxicity of these regimens in these patients.
- Compare quality of life of patients treated with these regimens.
OUTLINE: This is a randomized, open-label, multicenter study. Patients are stratified
according to metastatic axillary lymph node involvement (4-9 vs 10 or more), hormone
receptor status (estrogen and/or progesterone) of the primary tumor (negative vs positive),
and timing of adjuvant radiotherapy (intermittently after completion of 50% of chemotherapy
vs after completion of all chemotherapy). Patients are randomized to 1 of 2 treatment arms.
- Arm I: Patients receive fluorouracil IV over 10-15 minutes and epirubicin IV over 15
minutes on days 1 and 8 and oral cyclophosphamide on days 1-14. Treatment repeats every
4 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.
- Arm II: Patients receive epirubicin IV over 15 minutes and cyclophosphamide IV over 1
hour on days 1, 21, 42, and 63 and docetaxel IV over 1 hour on days 84, 105, 126, and
147 in the absence of disease progression or unacceptable toxicity.
Within 21 days after the completion of chemotherapy, patients undergo adjuvant radiotherapy
5 days a week for 5.5 weeks. Alternatively, patients may undergo radiotherapy intermittently
after completion of 50% of chemotherapy.
Upon completion of chemotherapy, patients with positive hormone receptor status (estrogen
and/or progesterone) receive oral tamoxifen daily for 5 years. Additionally, patients with
positive hormone receptor status who are under age 40 receive goserelin subcutaneously every
4 weeks for 2 years.
Quality of life is assessed at baseline, prior to each course of chemotherapy, 4 weeks after
completion of chemotherapy, 6 weeks after completion of radiotherapy, and then at 6 months
after completion of chemotherapy.
Patients are followed every 3 months for 3 years, every 6 months for 3 years, and then
PROJECTED ACCRUAL: A total of 446 patients (223 per treatment arm) will be accrued for this
study within 3 years.
Allocation: Randomized, Masking: Open Label, Primary Purpose: Treatment
Comparison of time to progression
Harald Sommer, MD
Ludwig-Maximilians - University of Munich
United States: Federal Government