Trial Information

A Randomised Trial Of Standard Anthracycline-Based Chemotherapy With Fluorouracil, Epirubicin And Cyclophosphamide (FEC) Or Epirubicin And CMF (Epi-CMF) Versus FEC Followed By Sequential Docetaxel As Adjuvant Treatment For Women With Early Breast Cancer

OBJECTIVES:

- Compare the disease-free and overall survival of women with completely resected stage I
or II breast cancer adjuvantly treated with fluorouracil, epirubicin, and
cyclophosphamide (FEC) or epirubicin followed by cyclophosphamide, methotrexate, and
fluorouracil (EPI-CMF) versus FEC followed by sequential docetaxel.

- Compare the acute toxicity of these regimens in these patients.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center, estrogen receptor status (positive vs negative), and nodal status.
Within 8 weeks after definitive surgery, patients are randomized to 1 of 2 treatment arms.

- Arm I: Patients are assigned to 1 of 2 standard adjuvant chemotherapy regimens.

- Regimen A: Patients receive fluorouracil, epirubicin, and cyclophosphamide (FEC)
IV on day 1. Treatment repeats every 3 weeks for 8 courses.

- Regimen B: Patients receive epirubicin IV on day 1. Treatment repeats every 3
weeks for 4 courses. Patients then receive cyclophosphamide orally on days 1-14 or
IV on days 1 and 8 and methotrexate IV and fluorouracil IV on days 1 and 8 (CMF).
Treatment with CMF repeats every 4 weeks for 4 courses.

- Arm II: Patients receive 4 courses of adjuvant chemotherapy with FEC as in arm I,
regimen A. Patients then receive sequential docetaxel IV over 1 hour once every 3 weeks
for 4 courses.

Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are not
concurrently enrolled in the Standardization of Breast Radiotherapy (START) trial receive
localized radiotherapy once daily, 5 days a week, for 3-5 weeks, according to local
practice.

Beginning within 4 weeks after completion of adjuvant chemotherapy, patients who are
estrogen receptor and/or progesterone receptor positive receive oral tamoxifen once daily
for at least 5 years.

Quality of life is assessed at baseline, before course 5, at 3-4 weeks after course 8, and
then at 9, 12, 18, and 24 months after initiation of adjuvant chemotherapy.

Patients are followed every 3 months for 2 years and then every 6 months thereafter.

Peer Reviewed and Funded or Endorsed by Cancer Research UK

PROJECTED ACCRUAL: A total of 3,340 patients (1,670 per treatment arm) will be accrued for
this study within 2 years.