Bicalutamide in Treating Patients With Metastatic Breast Cancer

For people ages 18–120

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