Bicalutamide in Treating Patients With Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: bicalutamide; diagnostic laboratory biomarker analysis; immunohistochemistry staining method
Intervention MeSH terms: Bicalutamide
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 28.0
Sex: All
Minimum age: 18 Years
Maximum age: 120 Years
Healthy volunteers: No
Keywords: stage IV breast cancer; recurrent breast cancer; male breast cancer

Summary:

      RATIONALE: Androgens can cause the growth of breast cancer cells. Antihormone therapy, such
      as bicalutamide, may stop the adrenal glands from making androgens.

      PURPOSE: This phase II trial is studying how well bicalutamide works in treating patients
      with metastatic breast cancer.
    

Eligibility 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