Ignite Creation Date:
2024-05-06 @ 1:13 PM
Last Modification Date:
2024-10-26 @ 1:11 PM
Study NCT ID:
NCT03969121
Status:
COMPLETED
Last Update Posted:
2023-03-10
First Post:
2019-05-13
Brief Title:
Neoadjuvant Hormonal Therapy Plus Palbociclib in Operable Hormone Sensitive and HER2-Negative Primary Breast Cancer
Sponsor:
Kyoto Breast Cancer Research Network
Organization:
Kyoto Breast Cancer Research Network
Study Overview
Official Title:
A Phase III Randomized Double-Blind Neoadjuvant Study of Hormonal Therapy Plus Palbociclib Versus Hormonal Therapy Plus Placebo in Women With Operable Hormone Sensitive and HER2-Negative Primary Breast Cancer
Status:
COMPLETED
Status Verified Date:
2021-06
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 study is a randomized double blind placebo controlled Phase 3 clinical trial with the primary objective of demonstrating the efficacy of palbociclib in combination with Endocrine therapy over Endocrine therapy alone measured by PEPI and EndoPredict EPclin Score in women with operable HR HER2 negative breast cancer The Clinical Response Rate drop in Ki67 index 27 and Breast conserving rate will be compared between two arms
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