Monoclonal Antibody HuHMFG1 in Treating Women With Locally Advanced or Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed breast cancer
• * Locally advanced or metastatic disease
• * No inflammatory breast cancer
• Measurable (RECIST) or evaluable disease (e.g., cytologically or radiologically detectable disease that does not fulfill RECIST criteria)
• Failed prior OR not a candidate for OR refused anthracycline- and taxane-containing chemotherapy
• Patients whose tumor overexpresses HER-2 must have failed prior trastuzumab (Herceptin®)
• No known CNS metastases
• No metastases accessible to complete surgical resection
• Unstained slides cut from formalin-fixed and paraffin-embedded tumor blocks available
• * Appropriate tumor block also acceptable
• Hormone receptor status:
• * Not specified
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female
• Menopausal status
• Not specified
• Performance status
• WHO 0-1
• Life expectancy
• At least 4 months
• Hematopoietic
• Hemoglobin ≥ 10 g/dL
• Absolute neutrophil count ≥ 1,500/mm\^3
• WBC ≥ 1,000/mm\^3
• Platelet count ≥ 100,000/mm\^3
• Hepatic
• Bilirubin ≤ 1.5 mg/dL
• ALT or AST ≤ 2.5 times upper limit of normal (ULN) (\< 5 times ULN in patients with liver metastases) OR
• Alkaline phosphatase ≤ 2.5 times ULN (\< 5 times ULN in patients with liver metastases)
• * Any degree of elevated alkaline phosphatase allowed provided it is due to bone metastases
• Renal
• Creatinine ≤ 1.5 times ULN OR
• Creatinine clearance \> 60 mL/min
• Uric acid \< 1.25 times ULN (for patients with hyperuricemia only)
• Calcium (corrected for serum albumin) \< 11.5 mg/dL (for patients with hypercalcemia only)
• Cardiovascular
• LVEF ≥ 45% by MUGA or echocardiogram within the past 4 weeks
• Other
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective barrier contraception
• No other malignancy within the past 5 years except adequately treated nonmelanoma skin cancer or cervical intra-epithelial neoplasia
• No other uncontrolled illness that would preclude study participation
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• See Disease Characteristics
• Prior biological therapy allowed
• More than 2 weeks since prior blood transfusions or growth factors to aid hematological recovery
• No other concurrent antitumor immunotherapy
• Chemotherapy
• See Disease Characteristics
• More than 4 weeks since prior cytotoxic chemotherapy
• No more than 3 prior chemotherapy regimens, including adjuvant/neoadjuvant therapy
• No concurrent antitumor chemotherapy
• Endocrine therapy
• Prior hormonal therapy allowed
• No concurrent corticosteroids except as physiologic replacement and/or for acute short-term treatment of, or prophylaxis against, infusion reactions
• No concurrent antitumor hormonal therapy
• Radiotherapy
• See Disease Characteristics
• More than 4 weeks since prior radiotherapy (except for palliative radiotherapy)
• No concurrent antitumor radiotherapy, except for palliation to non-study lesions
• * Irradiated area should be as small as possible and involve ≤ 10% of the bone marrow in any given 4-week period
• Surgery
• More than 4 weeks since prior major surgery
• Other
• More than 30 days since prior investigational agents
• No other concurrent investigational agents