ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00006369|
Recruitment Status : Unknown
Verified October 2001 by National Cancer Institute (NCI).
Recruitment status was: Active, not recruiting
First Posted : April 2, 2004
Last Update Posted : November 6, 2013
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.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: ERA-923||Phase 2|
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.
|Study Type :||Interventional (Clinical Trial)|
|Official Title:||A Phase II, Randomized, Double-Masked, Multicenter Study of Two Dose Levels of ERA-923 for the Treatment of Metastatic Breast Cancer in Postmenopausal Women Who Have Failed Tamoxifen Therapy|
|Study Start Date :||June 2000|
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): NCT00006369
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612-9497|
|Study Chair:||Susan Minton, DO||H. Lee Moffitt Cancer Center and Research Institute|