Ignite Creation Date:
2024-05-06 @ 6:44 PM
Last Modification Date:
2024-10-26 @ 2:53 PM
Study NCT ID:
NCT05766410
Status:
RECRUITING
Last Update Posted:
2023-03-16
First Post:
2023-02-03
Brief Title:
A Randomized Study Comparing the Immune Modulation Effect of Ribociclib Palbociclib and Abemaciclib in ERHER2- EBC
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
A Randomized Open-label Parallel-group Study Comparing the Immune Modulation Effect of Ribociclib Palbociclib and Abemaciclib in Early ERHER2- Breast Cancer
Status:
RECRUITING
Status Verified Date:
2022-09
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:
ORACLE-RIPA
Brief Summary:
The 3 FDA-approved CDK4 6 inhibitors palbociclib ribociclib and abemciclib all provided progression-free survival benefits when combined with endocrine therapy in advanced ERHER2- breast cancer But not all of them provided overall survival benefit in the same setting One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4 6 inhibitors on tumor microenvironment and or immune system However there was no head-to-head comparison of the 3 CDK4 6 inhibitors in the same study Neoadjuvant therapy provides a window to obtain tissue samples before treatment during treatment and after treatment We aim to compare the immune modulation effects of palbociclib ribociclib and abemaciclib with letrozole in neoadjuvant treatment for ERHER2- early breast cancer
Detailed Description:
The 3 FDA-approved CDK4 6 inhibitors palbociclib ribociclib and abemciclib all provided progression-free survival benefits when combined with endocrine therapy in advanced ERHER2- breast cancer But not all of them provided overall survival benefit in the same setting One of the proposed mechanisms that influence the overall survival difference is from the different influence of the 3 CDK4 6 inhibitors on tumor microenvironment and or immune system However there was no head-to-head comparison of the 3 CDK4 6 inhibitors in the same study Neoadjuvant therapy provides a window to obtain tissue samples before treatment during treatment and after treatment We aim to compare the immune modulation effects of palbociclib ribociclib and abemaciclib with letrozole in neoadjuvant treatment for ERHER2- early breast cancer We will collect tumor tissue blood and stool samples prospectively before treatment at 2 weeks after treatment and after 12 weeks of treatment at the time of surgery Immune modulation effects will be compared between 3 treatment groups from breast tumor RNAseq analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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