Ignite Creation Date:
2024-05-05 @ 11:20 AM
Last Modification Date:
2024-10-26 @ 9:05 AM
Study NCT ID:
NCT00006369
Status:
UNKNOWN
Last Update Posted:
2013-11-06
First Post:
2000-10-04
Brief Title:
ERA-923 in Treating Postmenopausal Women With Metastatic Breast Cancer
Sponsor:
H Lee Moffitt Cancer Center and Research Institute
Organization:
National Cancer Institute NCI
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| NCI-G00-1871 | None | None | None |
| MCC-12235 | None | None | None |
| GENE-C9944-33 | None | None | None |
| MCC-IRB-5757 | None | None | None |
| W-AR-3077A1-200-US | None | None | None |