Spots Global Cancer Trial Database for Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer

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Trial Identification

Brief Title: Combination Chemotherapy Following Surgery in Treating Women With Early Stage Breast Cancer

Official Title: A Prospective Randomized Comparison of CMF Versus Sequential Epirubicin Followed by SMF as Adjuvant Chemotherapy for Women With Early Breast Cancer

Study ID: NCT00003012

Conditions

Breast Cancer

Interventions

CMF regimen

cyclophosphamide

epirubicin hydrochloride

fluorouracil

methotrexate

Study Description

Brief Summary: 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.

Detailed Description: 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.