Ignite Creation Date:
2024-05-06 @ 8:29 AM
Last Modification Date:
2024-10-26 @ 12:00 PM
Study NCT ID:
NCT02747004
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-21
First Post:
2016-04-19
Brief Title:
A Study of Abemaciclib LY2835219 Plus Tamoxifen or Abemaciclib Alone in Women With Metastatic Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Randomized Open-Label Phase 2 Study of Abemaciclib Plus Tamoxifen or Abemaciclib Alone in Women With Previously Treated Hormone Receptor-Positive HER2-Negative Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-06
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:
Next MONARCH 1
Brief Summary:
The main purpose of this study is to evaluate the safety and efficacy of abemaciclib plus tamoxifen or abemaciclib alone in women with previously treated hormone receptor-positive HR human epidermal growth factor receptor 2 negative HER2- 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 |
|---|---|---|---|
| 2016-000288-18 | EUDRACT_NUMBER | Eli Lilly and Company | None |
| I3Y-MC-JPCG | OTHER | None | None |