Ignite Creation Date:
2024-05-06 @ 10:05 AM
Last Modification Date:
2024-10-26 @ 12:24 PM
Study NCT ID:
NCT03155997
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2017-05-15
Brief Title:
Endocrine Therapy With or Without Abemaciclib LY2835219 Following Surgery in Participants With Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Randomized Open-Label Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk Node Positive Early Stage Hormone Receptor Positive Human Epidermal Receptor 2 Negative Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03763604
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
monarchE
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk node positive early stage hormone receptor positive HR human epidermal receptor 2 negative HER2- breast cancer
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I3Y-MC-JPCF | OTHER | None | None |
| 2016-004362-26 | EUDRACT_NUMBER | None | None |
| NSABP B-58 | OTHER | NSABP | None |