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.
Study Type
INTERVENTIONAL
Purpose
TREATMENT
Masking
NONE
Enrollment
1
Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Chicago, Illinois, United States
Clinical response rate
Time to disease progression
Toxicity
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