Ignite Creation Date:
2024-05-06 @ 10:35 AM
Last Modification Date:
2024-10-26 @ 12:32 PM
Study NCT ID:
NCT03304080
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-09-06
First Post:
2017-10-03
Brief Title:
Anastrozole Palbociclib Trastuzumab and Pertuzumab in HR-positive HER2-positive Metastatic Breast
Sponsor:
Icahn School of Medicine at Mount Sinai
Organization:
Icahn School of Medicine at Mount Sinai
Study Overview
Official Title:
A Multicenter Phase III Trial of Anastrozole Palbociclib Trastuzumab and Pertuzumab in HR-positive HER2-positive Metastatic Breast Cancer
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2024-07
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:
This is a multicenter phase III trial of anastrozole palbociclib trastuzumab and pertuzumab is proposed as first-line therapy in metastatic hormone receptor-positive HER2-positive breast cancer patients In this phase III clinical trial the researchers aim to establish the safety and efficacy of dual HER2 therapy in combination with palbociclib and anastrozole which represents a novel and all biologic approach to the treatment of HR HER2 metastatic breast cancer Additionally the researchers aim to examine potential biomarkers of response to palbociclib including cyclin D1 cyclin E1 and cyclin E2 expression levels CDK 2 4 and 6 levels phosphorylated retinoblastoma expression and p16 levels The researchers intend to use RNA sequencing to assess for other predictors of response in an unbiased manner to see if this correlates with inhibition of Ki-67 and phosphorylated retinoblastoma expression as well as evaluate for potential mechanisms of resistance
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