Ignite Creation Date:
2024-05-06 @ 3:46 PM
Last Modification Date:
2024-10-26 @ 1:56 PM
Study NCT ID:
NCT04752332
Status:
TERMINATED
Last Update Posted:
2024-05-29
First Post:
2021-02-11
Brief Title:
A Study of Abemaciclib LY2835219 Plus Hormone Therapy in Participants With Early Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
eMonarcHER A Randomized Double Blind Placebo-Controlled Phase 3 Study of Abemaciclib Plus Standard Adjuvant Endocrine Therapy in Participants With High-Risk Node-Positive HR HER2 Early Breast Cancer Who Have Completed Adjuvant HER2-Targeted Therapy
Status:
TERMINATED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study is terminated due to inability to enroll study participants
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03763604
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
eMonarcHER
Brief Summary:
The main purpose of this study is to measure how well abemaciclib works in participants with early breast cancer who are taking hormone therapy after surgery Participants must have breast cancer that is hormone receptor positive HR and human epidermal receptor 2 positive HER2 Your participation could last up to 10 years depending on how you and your tumor respond
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 |
|---|---|---|---|
| 2020-004035-24 | EUDRACT_NUMBER | Eli Lilly and Company | None |
| I3Y-MC-JPCW | OTHER | None | None |