Breast Cancer Clinical Trial
Official title:
A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing
so they stop growing or die. It is not yet known which combination chemotherapy regimen is
more effective following surgery for breast cancer.
PURPOSE: Randomized phase III trial to study the effectiveness of combination chemotherapy
consisting of cyclophosphamide, methotrexate, and fluorouracil with or without epirubicin in
treating women who have early stage 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.
;
Allocation: Randomized, Primary Purpose: Treatment
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