Ignite Creation Date:
2024-05-06 @ 1:18 PM
Last Modification Date:
2024-10-26 @ 1:12 PM
Study NCT ID:
NCT03988114
Status:
WITHDRAWN
Last Update Posted:
2019-09-06
First Post:
2019-06-12
Brief Title:
A Study of Abemaciclib LY2835219 in Participants With HR HER2- Advanced Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Single-Arm Global Phase 4 Study of Abemaciclib a CDK 4 6 Inhibitor in Combination With Nonsteroidal Aromatase Inhibitors Anastrozole or Letrozole in Participants With Hormone Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Advanced Breast Cancer With Poor Prognostic Factors
Status:
WITHDRAWN
Status Verified Date:
2019-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Strategic decision due to emerging new data for patients with HR HER2- metastatic breast cancer
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03763604
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
proMONARCH
Brief Summary:
The reason for this study is to see if the drug abemaciclib in combination with nonsteroidal aromatase inhibitors anastrozole or letrozole is effective in participants with Hormone Receptor Positive HR Human Epidermal Growth Factor Receptor 2 Negative HER2- advanced breast cancer that have certain disease characteristics
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 |
|---|---|---|---|
| 2019-001781-16 | EUDRACT_NUMBER | Eli Lilly and Company | None |
| I3Y-MC-JPCX | OTHER | None | None |