Trastuzumab and Interleukin-2 in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria

• •Histologically or cytologically confirmed breast cancer
• •* Primary and/or metastatic disease
• •HER2 overexpression 3+ by immunohistochemistry (IHC) or fluorescence in situ hybridization (FISH)
• •* Tumors with HER2 2+ overexpression by IHC allowed if confirmed by FISH
• •Progressive disease during or within 12 months of receiving prior regimen containing trastuzumab (Herceptin)
• •Unidimensionally measurable disease
• •* At least 20 mm by conventional techniques OR at least 10 mm by spiral CT scan
• •* The following are not considered measurable:
• •* Bone metastases
• •* Pleural or peritoneal effusion
• •* Ascites
• •* Leptomeningeal disease
• •* Lymphangitic disease
• •* Inflammatory breast cancer
• •* Cystic lesions
• •* CNS lesions
• •CNS metastases allowed if all of the following conditions are met:
• •* Asymptomatic
• •* At least 3 months since prior surgery and/or cranial irradiation
• •* At least 3 weeks since prior steroids
• •Hormone receptor status:
• •* Not specified
• •Male or female
• •Performance status - ECOG 0-2
• •Granulocyte count at least 1,000/mm\^3
• •Platelet count at least 100,000/mm\^3
• •Bilirubin no greater than 1.5 times upper limit of normal (ULN)
• •SGOT and SGPT no greater than 2 times ULN (5 times ULN for liver metastases)
• •Alkaline phosphatase no greater than 2 times ULN (5 times ULN for liver metastases)
• •Creatinine no greater than 1.5 times ULN
• •LVEF at least lower limit of normal by MUGA or echocardiogram
• •No congestive heart failure or active ischemic heart disease
• •Not pregnant or nursing
• •Negative pregnancy test
• •Fertile patients must use effective contraception
• •No psychiatric illness, medical condition, or uncontrolled infection that would preclude study
• •No underlying immunodeficiency (e.g., HIV or autoimmune disease)
• •No other prior malignancy within the past 5 years except nonmelanoma skin cancer or carcinoma in situ of the cervix
• •See Disease Characteristics
• •Prior cumulative doxorubicin dose no greater than 360 mg/m\^2
• •At least 3 weeks since prior chemotherapy
• •No more than 2 prior chemotherapy regimens for metastatic disease
• •No concurrent chemotherapy
• •See Disease Characteristics
• •At least 3 weeks since prior endocrine therapy
• •No concurrent corticosteroids or dexamethasone
• •Concurrent hormones allowed for conditions unrelated to disease (e.g., insulin for diabetes)
• •See Disease Characteristics
• •At least 3 weeks since prior radiotherapy
• •No prior radiotherapy to study lesion, unless evidence of disease progression
• •No concurrent palliative radiotherapy
• •See Disease Characteristics
• •At least 4 weeks since prior major surgery
• •No concurrent immunosuppressive drugs