Ignite Creation Date:
2024-05-06 @ 8:34 AM
Last Modification Date:
2024-10-26 @ 12:01 PM
Study NCT ID:
NCT02763566
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-16
First Post:
2016-05-04
Brief Title:
A Study of Abemaciclib LY2835219 in Participants With Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Randomized Double-Blind Placebo-Controlled Phase 3 Study to Compare NSAI Anastrozole or Letrozole Plus Abemaciclib a CDK4 and CDK6 Inhibitor or Plus Placebo and to Compare Fulvestrant Plus Abemaciclib or Plus Placebo in Postmenopausal Women With Hormone Receptor-Positive HER2-Negative Locoregionally Recurrent or Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-10
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:
MONARCH plus
Brief Summary:
The main purpose of this study is to evaluate the efficacy of the study drug abemaciclib in postmenopausal women with hormone receptor-positive HR human epidermal growth factor receptor 2-negative HER2- locoregionally recurrent or metastatic breast cancer
Detailed Description:
None
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 |
|---|---|---|---|
| I3Y-CR-JPBQ | OTHER | Eli Lilly and Company | None |