A randomised phase III trial of standard anthracycline-based chemotherapy with fluorouracil, epirubicin and cyclophosphamide (FEC) or epirubicin and CMF (E-CMF) versus FEC followed by sequential docetaxel as adjuvant treatment for women with early breast cancer.

Objectives

Primary:

• To assess the effects on disease-free survival of the addition of sequential docetaxel to 4 cycles of standard FEC chemotherapy compared with 8 cycles of FEC (control A) or E-CMF (control B) in patients with operable early breast cancer.

Secondary:

• To assess the effects on overall survival of the addition of sequential docetaxel to 4 cycles of standard FEC chemotherapy compared with the control arms.
• To compare acute toxicity and quality of life in patients allocated to the study and control arms.
• To compare the costs incurred by FEC followed by docetaxel compared to standard anthracyline-based chemotherapy from a health service perspective.

Target accrual: 3340

Trial closing date: Closed for recruitment on 16th June 2003

For further information regarding the trial contact Julian Lipscombe
For information on the Quality of Life study contact Susan Russell