Ignite Creation Date:
2024-05-06 @ 11:33 AM
Last Modification Date:
2024-10-26 @ 12:47 PM
Study NCT ID:
NCT03546686
Status:
RECRUITING
Last Update Posted:
2024-05-28
First Post:
2018-05-23
Brief Title:
Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women with Triple-negative Breast Cancer
Sponsor:
University of Texas Southwestern Medical Center
Organization:
University of Texas Southwestern Medical Center
Study Overview
Official Title:
A Single Arm Phase 2 Study of Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women with Hormone Receptor-Negative HER2-Negative Early StageResectable Breast Cancer
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
The purpose of this study is to determine the impact of pre-operative cryoablation and immune checkpoint inhibition ICI on on 3-year Event Free Survival EFS in women with residual hormone receptor negative HER2-negative triple negative resectable breast cancer after taxane-based neoadjuvant chemotherapy
Detailed Description:
The purpose of this study is to determine the impact of pre-operative cryoablation immune checkpoint inhibition ICI on 3-year Event Free Survival EFS in women with triple negative breast cancer after taxane-based neoadjuvant chemotherapy Our strategy combines two interventions induced activation and maturation of dendritic cells and tumor-specific T cells by cross-presentation of tumor antigens via local destruction of tumor tissue by cryoablation Second we administer Pembrolizumab an antibody that inhibits lymphocyte programmed death 1 PD-1 receptors and interferes with PD-1 mediated T-cell regulatory signaling and was recently US FDA approved as curative-intent standard-of-care treatment for triple negative breast cancer Women with residual triple negative resectable breast cancer after neoadjuvant chemotherapy will be treated with tumor cryoablation and pre-operative immune checkpoint inhibition ICI Women undergoing either mastectomy or breast conserving surgery are eligible
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