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

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