S0511, Goserelin and Anastrozole in Treating Men With Recurrent or Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed breast cancer
• * Recurrent or metastatic (stage IV) disease
• * Patients with a local regional recurrence, including axillary and/or chest wall involvement, are eligible
• Measurable or non-measurable disease
• Brain metastases allowed provided they have been treated with surgery or radiotherapy AND have remained stable for ≥ 3 months
• Hormone receptor status:
• * Estrogen receptor- OR progesterone receptor- positive disease by standard immunohistochemical techniques
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Male
• Performance status
• Zubrod 0-2
• Life expectancy
• Not specified
• Hematopoietic
• Not specified
• Hepatic
• No evidence of severe or uncontrolled hepatic disease
• Renal
• No evidence of severe or uncontrolled renal disease
• Cardiovascular
• No evidence of severe or uncontrolled cardiac disease
• Pulmonary
• No evidence of severe or uncontrolled respiratory disease
• Other
• Fertile patients must use effective barrier-method contraception during and for 12 weeks after the completion of study treatment
• No known HIV positivity
• Able to receive oral medication
• * Patients with a gastrointestinal tube are eligible
• No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH agonist analogues, or any components of the study drugs
• No active infection requiring systemic therapy
• No other malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer
• No evidence of other severe or uncontrolled systemic disease
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• No concurrent prophylactic filgrastim (G-CSF) or other hematopoietic growth factors
• Chemotherapy
• At least 14 days since prior chemotherapy for this cancer and recovered
• No more than 1 prior chemotherapy regimen for metastatic disease
• No concurrent chemotherapy
• Endocrine therapy
• At least 14 days since prior hormonal therapy for this cancer and recovered
• Prior tamoxifen allowed
• No prior gonadotropin-releasing hormone antagonist, aromatase inhibitors, or fulvestrant
• No other concurrent hormonal therapy (e.g., estrogen-based therapies)
• Radiotherapy
• See Disease Characteristics
• At least 14 days since prior radiotherapy for this cancer and recovered
• No concurrent radiotherapy
• Surgery
• See Disease Characteristics