Ignite Creation Date:
2024-07-17 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06492616
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-10
First Post:
2024-07-01
Brief Title:
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ERHER2- Early Breast Cancer With High Risk of Recurrence
Sponsor:
Stemline Therapeutics Inc
Organization:
Stemline Therapeutics Inc
Study Overview
Official Title:
Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive Estrogen Receptor-positive HER2-negative Early Breast Cancer With High Risk of Recurrence-A Global Multicenter Randomized Open-label Phase 3 Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
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:
ELEGANT
Brief Summary:
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive Estrogen Receptor-positive ER Human Epidermal Growth Factor-2 negative HER2- early breast cancer with high risk of recurrence
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None