TRAFIC

Disease site: Breast Cancer

Treatment Modality: Chemotherapy

Status: In active follow-up

Randomised trial comparing the efficacy and toxicity of adjuvant chemotherapy (infusional 5FU, epirubicin and cisplatin) with conventional FEC (5FU, epirubicin and cyclophosphamide) in women requiring chemotherapy for poor prognosis breast cancer, irrespective of age and nodal status. 348 patients were randomised from 11 centres between May 1995 and January 2002 to receive either infusional 5-fluorouracil (5-FU) by daily 24 hour continuous infusion via a Hickman line for 18 weeks with epirubicin and cisplatin given as intravenous bolus injections, or 5FU, epirubicin and cyclophosphamide given as intravenous bolus injection. Both regimens were repeated 3 weekly for 6 courses. All patients were offered tamoxifen 20mg orally daily in addition to chemotherapy.

Chief Investigator: Professor I. Smith, Royal Marsden Hospital, Sutton.

ISRCTN: 83324925.