ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
- Conditions
- Breast Cancer
- Registration Number
- NCT00006369
- Brief Summary
RATIONALE: Estrogen can stimulate the growth of breast cancer cells. Hormone therapy using ERA-923 may fight breast cancer by blocking the uptake of estrogen by the tumor cells.
PURPOSE: Randomized phase II trial to study the effectiveness of ERA-923 in treating postmenopausal women who have metastatic breast cancer that no longer responds to tamoxifen.
- Detailed Description
OBJECTIVES: I. Compare the efficacy of 2 dose levels of ERA-923 in postmenopausal patients with metastatic breast cancer refractory to tamoxifen. II. Determine the safety and plasma levels of this drug in these patients. III. Determine the impact on quality of life of these patients by this drug.
OUTLINE: This is a randomized, double blind, multicenter study. Patients are randomized to one of two treatment arms receiving different doses of ERA-923. Patients receive oral ERA-923 daily for 48 weeks in the absence of disease progression or unacceptable toxicity. Quality of life is assessed at baseline; at weeks 4, 8, 16, 24, 32, 40, and 48; and then at 4 weeks after last dose. Patients are followed at 4 weeks and then every 3 months thereafter.
PROJECTED ACCRUAL: At total of 36-100 patients (18-50 per arm) will be accrued for this study within 1 year.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- Female
- Target Recruitment
- Not specified
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
H. Lee Moffitt Cancer Center and Research Institute
🇺🇸Tampa, Florida, United States