Ignite Creation Date:
2025-12-24 @ 11:03 PM
Ignite Modification Date:
2025-12-28 @ 3:17 PM
Study NCT ID:
NCT00006369
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-10-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Organization:
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2001-10
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: