Ignite Creation Date:
2024-05-06 @ 5:01 PM
Last Modification Date:
2024-10-26 @ 2:20 PM
Study NCT ID:
NCT05169567
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-06-26
First Post:
2021-12-22
Brief Title:
Abemaciclib LY2835219 Plus Fulvestrant Compared to Placebo Plus Fulvestrant in Previously Treated Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
postMONARCH A Randomized Double Blind Placebo-Controlled Phase 3 Study to Compare the Efficacy of Abemaciclib Plus Fulvestrant to Placebo Plus Fulvestrant in Participants With HR HER2- Advanced or Metastatic Breast Cancer Following Progression on a CDK4 6 Inhibitor and Endocrine Therapy
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-09
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:
postMONARCH
Brief Summary:
This study will evaluate the effect of adding abemaciclib to fulvestrant for the treatment of hormone receptor-positive HR human epidermal growth factor receptor 2-negative HER2- breast cancer that progressed or recurred after previous treatment with a type of drug known as a CDK46 inhibitor and endocrine therapy Participation could last up to 5 years depending on how you and your tumor respond
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
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 |
|---|---|---|---|
| 2023-506771-10-00 | OTHER | EU Trial Number | None |
| I3Y-MC-JPEF | OTHER | None | None |
| 2021-002301-10 | EUDRACT_NUMBER | None | None |