Ignite Creation Date:
2024-05-06 @ 4:04 AM
Last Modification Date:
2024-10-26 @ 11:43 AM
Study NCT ID:
NCT02441946
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2015-05-08
Brief Title:
A Neoadjuvant Study of Abemaciclib LY2835219 in Postmenopausal Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
neoMONARCH A Phase 2 Neoadjuvant Trial Comparing the Biological Effects of 2 Weeks of Abemaciclib LY2835219 in Combination With Anastrozole to Those of Abemaciclib Monotherapy and Anastrozole Monotherapy and Evaluating the Clinical Activity and Safety of a Subsequent 14 Weeks of Therapy With Abemaciclib in Combination With Anastrozole in Postmenopausal Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Status:
COMPLETED
Status Verified Date:
2020-06
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:
neoMONARCH
Brief Summary:
The purpose of this study is to evaluate the biological effects of abemaciclib in combination with anastrozole and compare those to the effects of abemaciclib alone and anastrozole alone in the tumors of postmenopausal women with hormone receptor positive HR human epidermal growth factor receptor 2 HER2 negative 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-MC-JPBY | OTHER | None | None |
| 2014-005486-75 | EUDRACT_NUMBER | Eli Lilly and Company | None |