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About
RATIONALE: Drugs used in chemotherapy, such as cyclophosphamide, methotrexate, fluorouracil, and epirubicin hydrochloride, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. It is not yet known whether giving cyclophosphamide together with methotrexate and fluorouracil before, after, or without epirubicin hydrochloride is more effective in treating patients with breast cancer that can be removed by surgery.
PURPOSE: This randomized phase III trial is comparing three regimens of cyclophosphamide given together with methotrexate and fluorouracil, with or without epirubicin hydrochloride, to see how well it works in treating women who have undergone surgery for breast cancer. (Group III was closed to new patients as of 12/7/2009.)
Full description
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multicenter study. Patients are stratified according to center, lymph node status (N0 vs N1-3), and estrogen receptor status (negative vs positive). Patients are randomized to 1 of 3 treatment arms.
Patients with estrogen receptor-positive disease receive tamoxifen daily for 5 years after completing chemotherapy.
After completion of study therapy, patients are followed every 3 months for 1 year, every 6 months for 4 years, and then annually for 5 years.
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Inclusion and exclusion criteria
DISEASE CHARACTERISTICS:
Histologically confirmed breast cancer
Underwent radical mastectomy, guadrantectomy, or tumorectomy with axillary node dissection within the past 4-6 weeks
Biologically aggressive disease
At least 10 lymph nodes removed
Node-negative (> 1 cm, or > 2 cm if histology is favorable, esp. tubular carcinoma and/or prevalent intraductal component > 50%) tumors OR node-positive (1-3) tumors, meeting the following criteria:
No bilateral breast cancer
No T4a, inoperable T4b, T4c, or T4d disease
Any estrogen receptor status (positive, negative, unknown)
No distant metastases
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
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Data sourced from clinicaltrials.gov
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