Ignite Creation Date:
2024-05-06 @ 9:25 AM
Last Modification Date:
2024-10-26 @ 12:14 PM
Study NCT ID:
NCT02977468
Status:
RECRUITING
Last Update Posted:
2024-06-20
First Post:
2016-11-28
Brief Title:
Effects of MK-3475 Pembrolizumab on the Breast Tumor Microenvironment in Triple Negative Breast Cancer
Sponsor:
Eileen Connolly
Organization:
Columbia University
Study Overview
Official Title:
Effects of MK-3475 Pembrolizumab on the Breast Tumor Microenvironment in Triple Negative Breast Cancer With and Without Intra-operative RT a Window of Opportunity Study
Status:
RECRUITING
Status Verified Date:
2024-06
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:
PembroIORT
Brief Summary:
Assess response to pembrolizumab in both primary tumor normal breast stroma circulating lymphocytes and serum exosomes in treatment naive triple negative breast cancer TNBC patients
Assess for change in tumor-infiltrating lymphocytes TILS both stromal sTILS and intraepithelial iTILS in newly diagnosed early stage TNBC patients treated with two doses of MK-3475 prior to lumpectomy
Assess for change in tumor-infiltrating lymphocytes TILS both stromal sTILS and intraepithelial iTILS in newly diagnosed early stage TNBC patients treated with two doses of MK-3475 prior to lumpectomy
Detailed Description:
This is an open-label single-arm single institution pre-operative window of opportunity study of pembrolizumab in subjects with newly diagnosed triple-negative 3 cm node negative breast cancer Subjects may not have received any prior neoadjuvant chemotherapy definitive surgery or radiation treatment prior to enrollment
The goal of this project is to determine if immune modulation through treatment with MK-3475 Pembrolizumab in triple negative breast cancer TNBC patients will alter expression of immune tolerant markers including PD-L1 within the primary tumor Investigators hope to determine if MK-3475 exposure will change the molecular signature of breast stroma from normal adjacent breast tissue non-tumor tissue obtained prospectively at the time of breast conserving surgery BCS in TNBC patients Finally investigators will investigate how pembrolizumab alters breast stromal response to high dose radiation delivered by intraoperative radiation therapy IORT
The goal of this project is to determine if immune modulation through treatment with MK-3475 Pembrolizumab in triple negative breast cancer TNBC patients will alter expression of immune tolerant markers including PD-L1 within the primary tumor Investigators hope to determine if MK-3475 exposure will change the molecular signature of breast stroma from normal adjacent breast tissue non-tumor tissue obtained prospectively at the time of breast conserving surgery BCS in TNBC patients Finally investigators will investigate how pembrolizumab alters breast stromal response to high dose radiation delivered by intraoperative radiation therapy IORT
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