Ignite Creation Date:
2024-05-06 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 1:54 PM
Study NCT ID:
NCT04707196
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2021-01-12
Brief Title:
A Study of Abemaciclib in Indian Women With Advanced Breast Cancer
Sponsor:
Eli Lilly and Company
Organization:
Eli Lilly and Company
Study Overview
Official Title:
A Single-Arm Phase 4 Study of Abemaciclib a CDK4 and CDK6 Inhibitor in Combination With Endocrine Therapy AnastrozoleLetrozole or Fulvestrant in Participants With Hormone Receptor Positive Human Epidermal Growth Factor Receptor 2 Negative Locally Advanced andor Metastatic Breast Cancer in India
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The main purpose of this study is to learn more about the safety and tolerability of abemaciclib when given in combination with hormone therapy in Indian women with advanced breast cancer Participants must have hormone receptor positive HR human epidermal growth factor receptor 2 negative HER2- breast cancer and must live in India For each participant the study could last up to eight months and may include up to eight visits to the study center
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?:
True
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| I3Y-IN-JPEC | OTHER | Eli Lilly and Company | None |