Exemestane Compared With Tamoxifen in Treating Women With Locally Recurrent or Metastatic Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically proven adenocarcinoma of the breast that is metastatic and progressive or locally recurrent and inoperable
• At least one bidimensionally measurable or evaluable lesion
• * Lytic bone lesions on x-ray/CT scan, surrounded by calcified bone, and at least 1 cm
• * Bidimensionally measurable extraosseous disease required for patients on bisphosphonates
• * The following are not considered evaluable:
• * Previously irradiated lesions
• * Lymphangitic spread
• * Ascites
• * Blastic bone lesions
• * Pleural effusions
• No rapidly progressive disease for which hormonal therapy is not indicated
• No massive visceral disease (i.e., more than one third of any organ)
• No brain metastases
• Hormone receptor status:
• * Estrogen receptor positive or progesterone receptor positive, defined by 1 of the following:
• * At least 10 femtomoles H3-estrogen or at least 20 femtomoles
• * H3 progesterone binding per mg of cytosol protein by DCC or sucrose density method
• * At least 0.10 femtomoles H3-estrogen or at least 0.20 femtomoles
• * H3-progesterone binding per mg of DNA by IF/EIA technique
• * Positive immunohistochemistry noted on pathology report
• * Unknown receptor status eligible provided:
• * Disease-free interval of at least 2 years since adjuvant therapy or initial surgery (if no adjuvant therapy), including most recently treated tumor in bilateral breast cancer if status unknown in one primary tumor
• PATIENT CHARACTERISTICS:
• Age:
• 18 and over
• Sex:
• Female
• Menopausal status:
• Postmenopausal by 1 of the following:
• * Natural menopause and more than 1 year since last menstrual period (LMP)
• * Radiation-induced oophorectomy and more than 1 year since LMP
• * Chemotherapy induced menopause if:
• * At least 1 year since LMP (+ 1 year post-tamoxifen)
• * Serum FSH and LH and plasma estradiol levels in postmenopausal range
• * LHRH-induced amenorrhea
• * Surgical castration
• * Patients under age 56 with prior hysterectomy and 1 or both ovaries intact or tamoxifen-induced amenorrhea with at least 12 months since prior tamoxifen must have postmenopausal serum FSH and LH and plasma estradiol concentrations
• Performance status:
• ECOG (WHO) 0-2
• Hematopoietic:
• Absolute neutrophil count at least 1,500/mm\^3
• Platelet count at least 100,000/mm\^3
• Hepatic:
• Bilirubin less than 1.5 times upper limit of normal (ULN)
• SGOT/SGPT less than 2.5 times ULN (less than 5 times ULN with liver metastases)
• Renal:
• Creatinine less than 1.5 times ULN
• Cardiovascular:
• No deep venous thrombosis
• Other:
• No mental incapacitation
• No severe concurrent disease
• No prior or concurrent malignancy except curatively treated carcinoma in situ of the cervix or basal cell or squamous cell skin cancer
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• No concurrent immunotherapy
• Chemotherapy:
• See Disease Characteristics
• At least 3 weeks since chemotherapy for metastatic disease and recovered
• No more than 1 prior chemotherapy regimen for metastatic disease
• Prior adjuvant chemotherapy allowed if disease free for at least 6 months
• No concurrent chemotherapy
• Endocrine therapy:
• No prior hormonal therapy for advanced disease (e.g., tamoxifen or LHRH agonists)
• Prior adjuvant tamoxifen allowed if disease free for at least 6 months
• No other concurrent hormonal therapy, including steroids
• Radiotherapy:
• Recovered from toxic effects of prior radiotherapy
• Concurrent palliative radiotherapy, including whole brain irradiation, allowed
• Surgery:
• See Disease Characteristics
• No prior ovariectomy for advanced disease
• Other:
• No other concurrent investigational drugs
• Concurrent bisphosphonates allowed if short term (7 days) for hypercalcemia due to suspect tumor flare or if on prior bisphosphonates with bidimensionally measurable extraosseous lesion