A Phase II Study of Goserelin Plus Anastrozole for the Treatment of Male Patients With Hormone-Receptor Positive Metastatic or Recurrent 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