High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy

You may be eligible if

• DISEASE CHARACTERISTICS:
• Histologically confirmed breast cancer
• * Metastatic disease
• Documented disease progression
• * Must have received and subsequently failed (due to disease progression) ≥ 2 prior sequential endocrine therapies for treatment of metastatic breast cancer
• * Disease progression during adjuvant tamoxifen is considered 1 prior therapy
• * The 2 most recent treatments must have been endocrine agents
• At least 1 objective measurable disease parameter
• Brain metastases allowed provided both of the following criteria are met:
• * Brain metastases were previously treated AND are currently stable
• * Brain metastases are not the only site of metastatic disease
• Hormone receptor status
• * Estrogen and/or progesterone receptor-positive tumor
• PATIENT CHARACTERISTICS:
• Age
• 18 and over
• Sex
• Female
• Menopausal status
• Postmenopausal, as defined by any of the following:
• * At least 50 years of age with an intact uterus AND amenorrheic for the past 12 months
• * At least 50 years of age without a uterus AND follicle-stimulating hormone (FSH) level within postmenopausal range
• * Under 50 years of age and FSH level within postmenopausal range
• * Prior bilateral oophorectomy
• Performance status
• ECOG 0-2
• Life expectancy
• At least 6 months
• Hematopoietic
• Adequate hematologic function
• Hepatic
• Adequate hepatic function
• Bilirubin ≤ 1.5 times upper limit of normal
• No history of hepatic adenoma
• Renal
• Adequate renal function
• No history of hypercalcemia or severe hypocalcemia
• Cardiovascular
• No history of thrombophlebitis or thromboembolic disorders associated with prior estrogen use
• No active thrombophlebitis or thromboembolic disorders
• No history of uncontrolled hypertension
• Other
• Not pregnant
• No undiagnosed abnormal vaginal bleeding
• No other serious medical illness
• No psychiatric illness that would preclude giving informed consent
• No other invasive malignancy within the past 5 years except curatively treated basal cell or squamous cell skin cancer or carcinoma in situ of the cervix
• PRIOR CONCURRENT THERAPY:
• Biologic therapy
• Not specified
• Chemotherapy
• Prior chemotherapy for metastatic disease allowed
• Prior adjuvant chemotherapy allowed
• Endocrine therapy
• See Disease Characteristics
• Radiotherapy
• Prior radiotherapy allowed provided the only site of measurable disease was not irradiated
• Surgery
• Not specified