Letrozole and Goserelin or Leuprolide in Treating Premenopausal Estrogen Receptor-Positive Patients With Stage IV Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed carcinoma of the breast
• * Metastatic disease
• Measurable disease (i.e., unidimensional by RECIST)
• No rapidly progressing visceral involvement (e.g., liver or lymphangitic lung disease)
• No known marrow involvement as evidenced by diffuse uptake by imaging studies or bone marrow biopsy or aspirate
• No evidence of CNS metastases
• Estrogen- and/or progesterone-receptor positive status confirmed in primary breast tumor or in recent biopsy of metastatic site
• PATIENT CHARACTERISTICS:
• Female
• Premenopausal\*, as defined by the following criteria:
• * Less than 12 months from last menstrual period or premenopausal estradiol within the past 12 months
• * No prior bilateral oophorectomy
• * 45 years old or younger with intact ovaries and not a candidate for aromatase inhibitor therapy alone due to the potential for recurrent ovarian function NOTE: \*Women are considered premenopausal after prior hysterectomy if they have intact ovaries and follicular hormone levels consistent with the institutional normal values for the premenopausal state
• Women meeting premenopausal criteria prior to receiving ovarian suppression are eligible
• ECOG performance status 0-2
• Life expectancy ≥ 3 months
• Not pregnant or nursing
• Negative pregnancy test
• Fertile patients must use effective nonhormonal contraception during and for 12 weeks after discontinuation of study therapy
• ANC ≥ 500 cells/mm³
• Platelet count ≥ 50,000 cells/mm³
• Hematocrit ≥ 28%
• In the absence of liver metastases:
• * AST and ALT ≤ 2.5 times upper limit of normal (ULN)
• * Alkaline phosphatase ≤ 2.5 times ULN
• In the presence of liver metastases:
• * AST and ALT ≤ 5 times ULN
• * Alkaline phosphatase ≤ 5 times ULN
• In the presence of bone metastases:
• * AST and ALT ≤ 10 times ULN
• * Alkaline phosphatase ≤ 10 times ULN
• Total bilirubin ≤ 2 times ULN
• No significant comorbid conditions, including any of the following:
• * Clinically significant cardiac disease not well controlled with medication (e.g., congestive heart failure, symptomatic coronary artery disease, or cardiac arrhythmias)
• * Myocardial infarction within the past 12 months
• * Serious concurrent infection
• No lack of physical integrity of the upper gastrointestinal tract
• No inability to swallow or malabsorption syndrome
• No other carcinoma within the past 5 years except nonmelanoma skin cancer and treated in situ cervical cancer
• No mental illness
• No known hypersensitivity to luteinizing hormone-releasing hormone (LHRH), LHRH-agonist analogues, or any of the components in goserelin
• PRIOR CONCURRENT THERAPY:
• No concurrent chemotherapy and/or additional hormonal therapy
• Concurrent trastuzumab (Herceptin®) for patients with HER2 overexpression allowed