A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer
OBJECTIVES: I. Compare the effects of 4 courses of epirubicin followed by 4 courses of
cyclophosphamide/methotrexate/fluorouracil (CMF) versus 8 courses of CMF as adjuvant
chemotherapy in women with node positive early breast cancer, as measured by overall and
event free survival from the date or randomization. II. Compare the effects of 4 courses of
epirubicin followed by 4 courses of CMF with 8 courses of CMF as adjuvant chemotherapy in
these patients, as measured by acute and chronic toxicities. III. Compare the effects of 4
courses of epirubicin followed by 4 courses of CMF versus 8 courses of CMF as adjuvant
chemotherapy in these patients, as measured by quality of life.
OUTLINE: This is a randomized, multicenter study. Patients are randomized into 2 treatment
arms within 4 weeks of surgery. Treatment begins within 6 weeks of surgery. One treatment
arm receives 8 courses of cyclophosphamide/methotrexate/fluorouracil (CMF) given
intravenously (IV) every 3 weeks. The other arm receives 4 courses of epirubicin followed by
4 courses of CMF given IV every 3 weeks. Patients are followed annually for 10 years.
PROJECTED ACCRUAL: A total of 1,000 patients will be accrued over 3 years.
Interventional
Allocation: Randomized, Primary Purpose: Treatment
Chris Twelves, MD, BMedSci, FRCP
Study Chair
University of Glasgow
United States: Federal Government
CDR0000065590
NCT00003012
October 1996
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