Combination Chemotherapy in Treating Women With Breast Cancer
Combination Chemotherapy in Treating Women With Breast Cancer
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so
 they stop growing or die. Combining more than one drug may kill more tumor cells. It is not
 yet known which combination chemotherapy regimen is more effective for breast cancer.

 PURPOSE: Randomized phase III trial to compare the effectiveness of two combination
 chemotherapy regimens in treating women with breast cancer who have undergone surgery to
 remove the tumor.
OBJECTIVES: I. Determine whether doxorubicin/docetaxel (DD) will improve disease-free
 survival and overall survival when compared to doxorubicin/cyclophosphamide (DC) in women
 with lymph node positive (1-3 positive nodes) or high risk lymph node negative breast cancer.
 II. Compare the toxicity of DD to DC in this patient population.

 OUTLINE: This is a randomized study. Patients are stratified by node status (positive vs
 negative), menopause status (pre- vs post), estrogen receptor (ER) status/progesterone
 receptor (PR) status (ER/PR unknown vs ER+/PR+ vs ER+/PR- vs ER-/PR+ vs ER-/PR-). Patients in
 arm I receive doxorubicin IV plus docetaxel IV over 1 hour every 3 weeks for 4 treatment
 courses. Patients in arm II receive doxorubicin IV plus cyclophosphamide IV every 3 weeks for
 4 treatment courses. All patients who are estrogen receptor or progesterone receptor positive
 receive oral tamoxifen daily for 5 years following chemotherapy. Some patients may also
 receive radiotherapy following chemotherapy. Patients are followed every 3 months if patient
 is less than 2 years from study entry; every 6 months if patient is 2-5 years from study
 entry; and every 12 months if patient is greater than 5 years from study entry.

 PROJECTED ACCRUAL: Approximately 2778 patients will be accrued for this study within 2.5
 years.
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