Exemestane Compared With Tamoxifen in Treating Postmenopausal Women With Breast Cancer

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically or cytologically confirmed early adenocarcinoma of the breast
• * Completely excised by surgery with curative intent (R0)
• * Any N OR
• * Any primary tumor greater than 3 cm OR
• * Any primary tumor grade III and greater than 1 cm
• * M0
• No positive supraclavicular nodes
• Hormone receptor status:
• * Estrogen and/or progesterone receptor positive
• PATIENT CHARACTERISTICS:
• Age:
• Any age
• See Menopausal status
• Sex:
• Female
• Menopausal status:
• Postmenopausal
• * Any age with bilateral oophorectomy or amenorrhea for at least 5 years OR
• * Age 50 or over:
• * Natural amenorrhea for at least 1 year OR
• * Chemotherapy-induced amenorrhea for at least 2 years OR
• * Radiation-induced amenorrhea (at least 3 months since prior radiotherapy) OR
• * Under age 50:
• * If amenorrheic for less than 5 years (any cause) or prior hysterectomy without bilateral surgical oophorectomy, follicle-stimulating hormone must be assayed to confirm postmenopausal status
• Performance status:
• ECOG 0-2
• Life expectancy:
• Not specified
• Hematopoietic:
• Platelet count greater than 100,000/mm3
• WBC greater than 3,000/mm3
• Hepatic:
• SGOT or SGPT less than 2.5 times upper limit of normal (ULN)
• Renal:
• Creatinine less than 1.5 times ULN
• Cardiovascular:
• No uncontrolled cardiac disease
• No unstable angina
• No congestive heart failure or arrhythmia requiring medical therapy
• No myocardial infarction within the past 3 months
• Other:
• No severe osteoporosis
• No other malignancies within the past 5 years except adequately treated carcinoma in situ of the cervix or basal cell skin cancer
• No other serious concurrent disease that would preclude study
• No psychiatric disorders that would preclude study
• PRIOR CONCURRENT THERAPY:
• Biologic therapy:
• Not specified
• Chemotherapy:
• No prior neoadjuvant chemotherapy
• No more than 10 weeks since completion of prior adjuvant chemotherapy
• Endocrine therapy:
• No prior adjuvant hormonal therapy for breast cancer
• No prior neoadjuvant hormonal therapy (prior to surgery) for duration of more than 4 weeks
• At least 4 weeks since prior hormone replacement therapy
• Radiotherapy:
• Not specified
• Surgery:
• See Disease Characteristics
• No more than 10 weeks since completion of curative surgery
• Other:
• No other concurrent investigational agents or participation in another clinical study (except adjuvant cytotoxic chemotherapy studies)
• Concurrent bisphosphonates allowed