Ignite Creation Date:
2024-05-06 @ 8:08 AM
Last Modification Date:
2024-10-26 @ 11:56 AM
Study NCT ID:
NCT02675231
Status:
COMPLETED
Last Update Posted:
2024-03-19
First Post:
2016-02-03
Brief Title:
A Study of Abemaciclib LY2835219 in Women With HR HER2 Locally Advanced or Metastatic Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
monarcHER A Phase 2 Randomized Multicenter 3-Arm Open-Label Study to Compare the Efficacy of Abemaciclib Plus Trastuzumab With or Without Fulvestrant to Standard-of-Care Chemotherapy of Physicians Choice Plus Trastuzumab in Women With HR HER2 Locally Advanced or Metastatic Breast Cancer
Status:
COMPLETED
Status Verified Date:
2024-03
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:
monarcHER
Brief Summary:
The purpose of this study is to evaluate the effectiveness of abemaciclib plus trastuzumab with or without fulvestrant versus trastuzumab plus physicians choice standard of care chemotherapy in women with hormone receptor positive HR human epidermal growth factor receptor 2 positive HER2 locally advanced or metastatic breast cancer after prior exposure to at least two HER2-directed therapies for advanced disease
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 |
|---|---|---|---|
| 2015-003400-24 | EUDRACT_NUMBER | Eli Lilly and Company | None |
| I3Y-MC-JPBZ | OTHER | None | None |