Cyclophosphamide, Methotrexate, and Fluorouracil, With or Without Epirubicin Hydrochloride, in Treating Women Who Have Undergone Surgery for Breast Cancer (Group III Closed to New Patients as of 12/7/2009)

• Status: Unknown status
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: Female

Summary

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.)

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Istituto Scientifico Romagnolo per lo Studio e la cura dei Tumori
• Treatments: Cyclophosphamide; Epirubicin; Fluorouracil; Methotrexate

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:

• High thymidine-labeling index (> 3%)

• Poorly differentiated tumor (grade III)

• High S-phase fraction (> 10% by flow cytometry)

• High Ki67/MIB1 expression (< 20%)

• No bilateral breast cancer

• No T4a, inoperable T4b, T4c, or T4d disease

• Any estrogen receptor status (positive, negative, unknown)

• No distant metastases

PATIENT CHARACTERISTICS:

• Any menopause status

• WBC ≥ 3,500/mL

• ANC ≥ 1,500/mL

• Platelet count ≥ 120,000/mL

• AST and ALT ≤ 1.5 times upper limit of normal (ULN)

• Creatinine ≤ 1.5 mg/mL

• Bilirubin ≤ 1.5 times ULN

• Not pregnant

• Geographically accessible for follow-up

• No prior breast cancer and/or other cancer except for carcinoma in situ of the cervix or basal cell skin cancer treated with radical intent

• No significant alterations in cardiovascular function

• No serious psychiatric disorders

• No impaired renal or liver function

PRIOR CONCURRENT THERAPY:

• See Disease Characteristics