Phase II Study of High-Dose Estrogen in Postmenopausal Women With Hormone Receptor-Positive Metastatic Breast Cancer After Failure of Sequential Endocrine Therapies
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Breast Cancer
- Sponsor
- Northwestern University
- Enrollment
- 1
- Locations
- 1
- Primary Endpoint
- Clinical response rate
- Status
- Terminated
- Last Updated
- 13 years ago
Overview
Brief 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.
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- Not provided
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Clinical response rate
Secondary Outcomes
- Time to disease progression
- Toxicity