Phase III Study of Adriamycin/Taxotere Versus Adriamycin/Cytoxan for the Adjuvant Treatment of Node Positive or High Risk Node Negative Breast Cancer

Inclusion Criteria

DISEASE CHARACTERISTICS: Histologically confirmed resectable adenocarcinoma of the breast
Histologically positive lymph nodes (1 to 3) OR Lymph node negative and high risk disease
Tumor greater than 1.0 cm diameter May have undergone an axillary dissection with at least
6 nodes removed and examined or a sentinel node biopsy Patients who are positive by
sentinel node biopsy will receive an axillary dissection No locally advanced or
inflammatory or metastatic breast cancer Hormone receptor status: Not specified

PATIENT CHARACTERISTICS: Age: 18 and over Sex: Female Menopausal status: Not specified
Performance status: Not specified Life expectancy: Not specified Hematopoietic: Neutrophil
count at least 1,500/mm3 Platelet count at least 100,000/mm3 Hepatic: Adequate hepatic
function Bilirubin no greater than upper limit of normal Renal: Adequate renal function
Cardiovascular: Adequate cardiac function Normal MUGA or echocardiogram Other: Not
pregnant or nursing Fertile patients must use effective barrier method contraception At
least 5 years since prior invasive malignancies, except basal cell or squamous cell
carcinoma of the skin or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior
chemotherapy for this malignancy Endocrine therapy: No concurrent tamoxifen Up to 4 weeks
of tamoxifen treatment for this malignancy allowed Radiotherapy: No prior radiotherapy for
this malignancy Prior radiotherapy to the breast for ductal carcinoma in situ allowed
Surgery: Tumor should be removed by either a modified radical mastectomy and/or a
segmental mastectomy plus axillary lymph node dissection or sentinel node biopsy before
beginning treatment on protocol No greater than 84 days since last surgical procedure that
constitutes or completes definitive surgical therapy (mastectomy; axillary
dissection/sentinel node biopsy; or resection of primary site to obtain a negative margin