high-dose esterified estrogens in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy

Conditions: Breast Cancer

Summary: rationale: high doses of esterified estrogens may stop the growth of breast cancer cells that no longer respond to hormone therapy. purpose: this phase ii trial is studying how well high-dose esterified estrogens work in treating postmenopausal women with metastatic breast cancer that has failed previous hormone therapy.

objectives: primary * determine the clinical response rate in postmenopausal women with estrogen and/or progesterone receptor-positive metastatic breast cancer that has failed prior sequential endocrine therapy treated with high-dose esterified estrogens (menest\^®). secondary * determine time to disease progression in patients treated with this drug. * determine the toxic effects of this drug in these patients. outline: patients receive oral high-dose esterified estrogens (menest\^®) 3 times daily. treatment continues in the absence of disease progression or unacceptable toxicity. after completion of study treatment, patients are followed for 2 months. projected accrual: a total of 18-35 patients will be accrued for this study within 2 years.

Eligibility criteria:
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

Keywords: recurrent breast cancer stage iv breast cancer