Trial Information

MULTIMODALITY TREATMENT STRATEGY FOR STAGE III BREAST CANCER

OBJECTIVES:

- Compare the response in women with stage III breast cancer treated with neoadjuvant
fluorouracil, doxorubicin, and cyclophosphamide (FAC) vs cyclophosphamide,
methotrexate, and fluorouracil (CMF).

- Compare the rates of conservative surgical resectability and locoregional control in
patients treated with these neoadjuvant therapy regimens.

- Compare the disease-free and overall survival of patients treated with these regimens.

- Compare the toxic effects of these regimens in these patients.

- Compare the compliance of patients treated with these regimens.

- Assess the cosmetic results in patients treated with conservative surgery.

- Compare the quality of life of patients treated with these regimens.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to
participating center.

- Arm I: Patients receive fluorouracil (5-FU) IV on days 1 and 8 and doxorubicin IV and
cyclophosphamide (CTX) IV on day 1 (FAC). Treatment continues every 3 weeks for 3
courses in the absence of disease progression.

- Arm II: Patients receive CTX IV, methotrexate IV, and 5-FU IV on days 1 and 8 (CMF).
Treatment continues every 4 weeks for 3 courses in the absence of disease progression.

Patients on both arms with resectable disease after the third course of chemotherapy undergo
quadrantectomy with axillary node dissection (preferred) or modified radical mastectomy,
followed by 6 additional courses of chemotherapy on the arm to which they were randomized
initially. Those patients without distant metastasis undergo locoregional radiotherapy
beginning concurrently with the initiation of postoperative chemotherapy. Patients on both
arms with unresectable disease after the initial 3 courses of chemotherapy undergo
locoregional radiotherapy and then surgical resection (if feasible).

Quality of life is assessed at baseline and then monthly thereafter.

Patients are followed every 3-4 months for 2 years, every 4-6 months for 3 years, and then
annually thereafter.

PROJECTED ACCRUAL: Not specified