Biological Therapy in Treating Women With Stage IV Breast Cancer

Inclusion Criteria

• •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