Biological Therapy in Treating Women With Stage IV Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Phase I:
• Histologically confirmed infiltrating ductal carcinoma of the breast
• Metastatic disease
• * Clinically asymptomatic with non-life-threatening metastases allowed
• Measurable or evaluable disease by radiograph, CT scan, MRI, nuclear medicine bone scan, or physical examination
• * No measurable disease allowed if tumor or metastasis has been removed or successfully treated prior to study
• No rapidly progressive symptomatic disease affecting major organ systems (e.g., lungs and liver)
• Stable or unstable disease for 3 months on hormonal therapy
• Stable or unstable disease for at least 1 month after chemotherapy
• No active brain metastases
• * Brain metastases previously treated with definitive radiotherapy and/or surgical resection allowed
• Hormone receptor status:
• * Estrogen and progesterone receptor status known
• Phase II:
• All Phase I criteria
• HER2/neu overexpression (2+ or 3+) by immunohistochemistry
• * Prior trastuzumab (Herceptin) allowed if disease still overexpresses HER2/neu
• 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 at least 8 g/dL
• Hepatic:
• Bilirubin less than 1.5 times normal
• SGOT less than 1.5 times normal
• Renal:
• Creatinine no greater than 1.8 mg/dL
• Creatinine clearance at least 60 mL/min
• BUN no greater than 1.5 times normal
• Cardiovascular:
• No myocardial infarction within the past year
• No prior myocardial infarction with coronary symptoms requiring medication and/or depressed left ventricular function (LVEF less than 50% by MUGA)
• No angina or coronary symptoms requiring medication and/or with depressed left ventricular function (LVEF less than 50% by MUGA)
• No congestive heart failure requiring medical management
• LVEF at least 50% at rest by MUGA
• No uncontrolled hypertension (i.e., systolic blood pressure \[BP\] ≥ 130 mm Hg or diastolic BP ≥ 80 mm Hg)
• Pulmonary:
• FEV1, DLCO, and FVC at least 50% predicted
• Other:
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective contraception
• HIV negative
• No other serious medical or psychiatric illness that would preclude study participation
• No other prior or concurrent malignancy within the past 5 years except curatively treated squamous cell carcinoma in situ of the cervix, basal cell skin cancer, or any other curatively treated disease in complete remission
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• See Disease Characteristics
• Prior trastuzumab allowed for phase I
• Chemotherapy:
• See Disease Characteristics
• At least 4 weeks since prior chemotherapy
• Endocrine therapy:
• See Disease Characteristics
• Concurrent hormonal therapy for breast cancer must continue during study
• No other concurrent hormonal therapy except steroids for adrenal failure, septic shock, or pulmonary toxicity or hormonal therapy for non-disease-related conditions (e.g., insulin for diabetes)
• Radiotherapy:
• See Disease Characteristics
• Surgery:
• See Disease Characteristics