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

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