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

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer
Eligibility Criteria
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
Sites / Locations
- Roger Williams Medical Center