Ignite Creation Date:
2024-05-06 @ 2:41 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02107703
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-05-31
First Post:
2014-04-04
Brief Title:
A Study of Abemaciclib LY2835219 Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
MONARCH 2 A Randomized Double-Blind Placebo-Controlled Phase 3 Study of Fulvestrant With or Without Abemaciclib a CDK46 Inhibitor for Women With Hormone Receptor Positive HER2 Negative Locally Advanced or Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
MONARCH 2
Brief Summary:
The main purpose of this study is to compare progression-free survival for women with hormone receptor positive HR human epidermal growth factor receptor HER2 negative advanced breast cancer receiving either abemaciclib fulvestrant or fulvestrant alone Participants will be randomized to abemaciclib or placebo in a 21 ratio The study will last about 9 months for each participant
For the endocrine naïve cohort all participants will received abemaciclib fulvestrant
For the endocrine naïve cohort all participants will received abemaciclib fulvestrant
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 |
|---|---|---|---|
| 2013-004728-13 | EUDRACT_NUMBER | Eli Lilly and Company | None |
| I3Y-MC-JPBL | OTHER | None | None |