Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
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.
Interventional
Masking: Open Label, Primary Purpose: Treatment
Clinical response rate
No
William J. Gradishar, MD
Principal Investigator
Robert H. Lurie Cancer Center
United States: Federal Government
NCI 03B5
NCT00131924
March 2004
January 2006
Name | Location |
---|---|
Robert H. Lurie Comprehensive Cancer Center at Northwestern University | Chicago, Illinois 60611 |