Combination Chemotherapy in Treating Women With Stage I, Stage II, or Stage IIIA (cT1-3, N0-1, M0) Breast Cancer and Positive Axillary Lymph Nodes

Inclusion Criteria

• •DISEASE CHARACTERISTICS:
• •Histologically confirmed invasive adenocarcinoma of the breast
• •* Confined to the breast and ipsilateral axilla on clinical exam
• •* Stage I, II, or IIIA (cT1-3, N0-1, M0)
• •At least one axillary lymph node with evidence of tumor on histologic exam
• •* Sentinel node biopsy allowed if followed by axillary dissection
• •* No suspicious palpable nodes in the contralateral axilla or palpable supraclavicular or infraclavicular nodes, unless proven on biopsy to not be involved with tumor
• •No bilateral malignancy or mass in the opposite breast, unless mass is histologically proven to be benign
• •Must have undergone either a prior total mastectomy and axillary dissection (modified radical mastectomy) OR
• •Prior lumpectomy and axillary dissection
• •* Patients must receive radiotherapy after randomization (not before) AND after chemotherapy
• •* Margins must be clear
• •* No ipsilateral lymph nodes that are fixed to one another or to other structures (N2 disease) and/or any positive nonaxillary lymph nodes (intramammary nodes are considered axillary nodes)
• •* No histologically evident invasive tumor or ductal carcinoma in situ
• •* No diffuse tumors by mammography that would not be surgically amenable to lumpectomy
• •* No other dominant mass in the ipsilateral breast remnant unless one of the following is true:
• •* Histologically benign
• •* Surgically removed with clear margins if malignant
• •No ulceration, erythema, infiltration of the skin or underlying chest wall (complete fixation), peau d'orange, or skin edema of any magnitude
• •* Tethering or dimpling of the skin or nipple inversion allowed
• •No metastatic disease
• •* Skeletal pain allowed if bone scan negative for metastases
• •Hormone receptor status:
• •* Estrogen and progesterone status determined
• •PATIENT CHARACTERISTICS:
• •Age:
• •greater than or equal to 18 years
• •Sex:
• •Female
• •Menopausal status:
• •Not specified
• •Performance status:
• •Not specified
• •Life expectancy:
• •At least 10 years, excluding diagnosis of cancer
• •Hematopoietic:
• •Absolute neutrophil count at least 1,500/mm\^3 (may be less, if in the opinion of the investigator, this represents an ethnic or racial variation)
• •Platelet count at least 100,000/mm\^3\* NOTE: \*If platelet count is above the upper limit of normal (ULN), significant underlying hematologic disorders must be excluded
• •Hepatic:
• •Bilirubin no greater than ULN
• •Alkaline phosphatase less than 2.5 times ULN\*
• •SGOT less than 1.5 times ULN\*
• •No nonmalignant systemic hepatic disease that would preclude study participation NOTE: \*Alkaline phosphatase and SGOT cannot both be greater than ULN
• •Renal:
• •Creatinine no greater than normal
• •No nonmalignant systemic renal disease that would preclude study participation
• •Cardiovascular:
• •No nonmalignant systemic cardiovascular disease that would preclude study participation
• •LVEF at least lower limit of normal (LLN) by MUGA or echocardiogram
• •No active cardiac disease that would preclude use of doxorubicin or docetaxel, including the following:
• •* Any prior myocardial infarction
• •* Angina pectoris requiring anti-anginal medication
• •* History of congestive heart failure
• •* Cardiac arrhythmia requiring medication
• •* Severe conduction abnormality
• •* Valvular disease with documented cardiac function compromise
• •* Cardiomegaly on chest x-ray or ventricular hypertrophy on EKG, unless LVEF at least LLN
• •* Poorly controlled hypertension (diastolic greater than 100 mm/Hg)
• •* Hypertension well controlled by medication allowed
• •Other:
• •No grade 2 or greater peripheral neuropathy
• •No other prior malignancy within the past 5 years except:
• •* Effectively treated squamous cell or basal cell skin cancer
• •* Surgically treated carcinoma in situ of the cervix
• •* Segmentally resected lobular carcinoma in situ of the ipsilateral or contralateral breast
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective barrier contraception
• •No nonmalignant systemic disease that would preclude study participation
• •No diabetes with morning fasting blood glucose of 200 mg/dL or greater
• •No psychiatric or addictive disorders that would preclude informed consent
• •No contraindication to corticosteroids that would preclude study participation
• •PRIOR CONCURRENT THERAPY:
• •Biologic therapy:
• •No prior immunotherapy for breast cancer
• •Chemotherapy:
• •No prior chemotherapy for breast cancer
• •No prior anthracyclines or taxanes
• •No other concurrent investigational chemotherapy
• •Endocrine therapy:
• •No prior hormonal therapy for breast cancer
• •No concurrent hormonal birth control methods or other hormonal therapy
• •No concurrent raloxifene, including for osteoporosis
• •Concurrent low-dose topical estrogen in the form of conjugated estrogen ring or conjugated estrogen vaginal cream (dose no more than 0.3 mg or 1/8 of an applicator applied vaginally 3 times a week) allowed
• •Radiotherapy:
• •See Disease Characteristics
• •No prior radiotherapy for this malignancy
• •Surgery:
• •See Disease Characteristics
• •No more than 84 days since prior surgery for breast cancer (e.g., lumpectomy, mastectomy, sentinel node biopsy, axillary dissection, or re-excision of lumpectomy margins)
• •Other:
• •No prior systemic therapy for this malignancy
• •No concurrent medications that alter cardiac conduction (e.g., digitalis, beta blockers, or calcium-channel blockers) for cardiac arrhythmia, angina, or congestive heart failure (allowed if administered for other reasons \[e.g., hypertension\])
• •Concurrent bisphosphonates allowed