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

Inclusion Criteria

• •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