Bicalutamide in Treating Patients With Metastatic Breast Cancer

Inclusion Criteria

• •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