Ignite Creation Date:
2024-05-06 @ 1:28 PM
Last Modification Date:
2024-10-26 @ 1:14 PM
Study NCT ID:
NCT04031885
Status:
TERMINATED
Last Update Posted:
2021-08-24
First Post:
2019-07-23
Brief Title:
A Study of Abemaciclib LY2835219 in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive HER2 Negative Metastatic Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Multicenter Open-Label Randomized-Controlled Study of Abemaciclib a CDK4 and 6 Inhibitor in Combination With Fulvestrant Compared to Chemotherapy in Women With HR Positive HER2 Negative Metastatic Breast Cancer With Visceral Metastases
Status:
TERMINATED
Status Verified Date:
2021-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Business decision based on the inability to enroll subjects into the trial
Has Expanded Access:
True
If Expanded Access, NCT#:
NCT03763604
Has Expanded Access, NCT# Status:
AVAILABLE
Acronym:
None
Brief Summary:
The reason for this study is to compare the efficacy of abemaciclib in combination with fulvestrant to that of physicians choice of chemotherapy in women with hormone receptor-positive HR human epidermal growth factor receptor 2-negative HER2- metastatic breast cancer that has spread to internal organs Your participation in this trial could last up to 31 months depending on your cancer type and 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 |
|---|---|---|---|
| I3Y-MC-JPCU | OTHER | Eli Lilly and Company | None |