High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy
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.
|Study Design:||Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies|
- Clinical response rate [ Designated as safety issue: No ]
- Time to disease progression [ Designated as safety issue: No ]
- Toxicity [ Designated as safety issue: Yes ]
|Study Start Date:||March 2004|
|Study Completion Date:||January 2006|
|Primary Completion Date:||January 2006 (Final data collection date for primary outcome measure)|
- 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^®).
- 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.
|United States, Illinois|
|Robert H. Lurie Comprehensive Cancer Center at Northwestern University|
|Chicago, Illinois, United States, 60611-3013|
|Principal Investigator:||William J. Gradishar, MD||Robert H. Lurie Cancer Center|