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