High-Dose Esterified Estrogens in Treating Postmenopausal Women With Metastatic Breast Cancer That Has Failed Previous Hormone Therapy
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|ClinicalTrials.gov Identifier: NCT00131924|
Recruitment Status : Terminated (Data Monitoring Committee recommended closure due to poor accrual.)
First Posted : August 19, 2005
Last Update Posted : June 11, 2012
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Biological: esterified estrogens||Phase 2|
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||1 participants|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||March 2004|
|Actual Primary Completion Date :||January 2006|
|Actual Study Completion Date :||January 2006|
- Clinical response rate
- Time to disease progression
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00131924
|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|