Bicalutamide in Treating Patients With Metastatic Breast Cancer

DISEASE CHARACTERISTICS:

Histologically confirmed adenocarcinoma of the breast

Stage IV disease
Measurable or non-measurable disease
Patients with HER2/neu-positive disease must have received prior trastuzumab (Herceptin®)

No active brain metastases or leptomeningeal disease

History of brain metastases allowed provided lesions are stable for at least 3 months as documented by head CT scan or MRI of the brain

Hormone receptor status:

Estrogen receptor- and progesterone receptor-negative*
Androgen receptor-positive* NOTE: *Samples are considered positive if greater than 10% of cell nuclei are immunoreactive

PATIENT CHARACTERISTICS:

Male or female
Menopausal status not specified
ECOG performance status 0-1
Absolute neutrophil count ≥ 1,500/mm³
Platelet count ≥ 100,000/mm³
Hemoglobin ≥ 9 g/dL
AST and ALT ≤ 2.5 times upper limit of normal (ULN)
Bilirubin ≤ 1.5 times ULN
Alkaline phosphatase ≤ 2.5 times ULN (unless bone metastases are present in the absence of liver metastases)
Creatinine ≤ 1.5 mg/dL
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No serious medical or psychiatric illness
No serious active infection
No other malignancy within the past 5 years except nonmelanoma skin cancer
No hypersensitivity reaction to bicalutamide or any of the tablet's components

PRIOR CONCURRENT THERAPY:

At least 2 weeks since prior cytotoxic chemotherapy and recovered
At least 3 weeks since prior investigational drugs
At least 4 weeks since prior major surgery and recovered

Prior neoadjuvant or adjuvant chemotherapy allowed

Any number of chemotherapy regimens are allowed for metastatic disease
Prior hormonal therapy allowed
No concurrent chemotherapy, other hormonal therapy, immunotherapy, or biological therapy
No concurrent trastuzumab (Herceptin®)
No concurrent enrollment in another clinical trial in which investigational procedures are performed or investigational therapies are administered