Combination Chemotherapy Plus Biological Therapy in Treating Patients With Stage II or Stage III Breast Cancer

DISEASE CHARACTERISTICS:

• Histologically confirmed stage II or III adenocarcinoma of the breast

• High-risk disease

  • At least 4 positive lymph nodes

  • Fewer than 4 positive lymph nodes considered high-risk if one of the following is present:

    • HER2/neu-positive disease
    • Enlarged axillary nodes
    • Extra capsular extension of tumor from lymph node
    • Dermal lymphatic invasion
    • Vascular invasion
    • Bilateral disease
    • Familial breast cancer
    • T4 locally advanced disease

• Clinically chemosensitive to prior paclitaxel (or other taxane), doxorubicin, and cyclophosphamide

  • No relapse after chemotherapy
• No clinical evidence of brain metastases

• Hormone receptor status:

  • Estrogen and progesterone receptor status known

PATIENT CHARACTERISTICS:

Age:

• 18 and over

Sex:

• Female

Menopausal status:

• Not specified

Performance status:

• Karnofsky 70-100% OR
• ECOG 0-2

Life expectancy:

• At least 3 months

Hematopoietic:

• Granulocyte count at least 1,500/mm^3
• Platelet count at least 50,000/mm^3
• Hemoglobin greater than 8 g/dL

Hepatic:

• Bilirubin less than 1.5 times normal
• SGOT less than 1.5 times normal

Renal

• Creatinine less than 1.8 mg/dL
• Creatinine clearance at least 60 mL/min
• BUN less than 1.5 times normal

Cardiovascular:

• Ejection fraction at least 45% by MUGA
• No uncontrolled or significant cardiovascular disease
• No myocardial infarction within the past year
• No significant congestive heart failure

Pulmonary:

• FEV_1 at least 60% predicted
• DLCO at least 60% predicted
• FVC at least 60% predicted

Other:

• No other malignancy except curatively treated squamous cell carcinoma in situ of the cervix or basal cell skin cancer
• No other serious medical or psychiatric illness that would preclude study participation
• HIV negative
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception

PRIOR CONCURRENT THERAPY:

Biologic therapy:

• Not specified

Chemotherapy:

• See Disease Characteristics
• Prior standard chemotherapy with anthracyclines or combination chemotherapy involving a combination of taxanes, doxorubicin, and/or cyclophosphamide allowed

Endocrine therapy:

• No concurrent hormonal therapy for breast cancer
• Concurrent hormonal therapy for nondisease-related conditions (e.g., insulin for diabetes) allowed
• Concurrent steroids for adrenal failure, septic shock, or pulmonary toxicity allowed

Radiotherapy:

• Not specified

Surgery:

• Prior complete resection of tumor allowed

Other:

• Prior successful neoadjuvant therapy allowed