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Clinical Trial Summary

The purpose of this study is to determine the impact of peri-operative cryoablation, ipilimumab and nivolumab versus standard pre-operative care on 3-year Distant Disease-Free Survival (DDFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuvant chemotherapy.


Clinical Trial Description

The purpose of this study is to determine the impact of peri-operative cryoablation, ipilimumab and nivolumab versus standard pre-operative care on 3-year Distant Disease-Free Survival (DDFS), in women with residual hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after taxane-based neoadjuvant chemotherapy. Our strategy combines two interventions: first we induce 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 ipilimumab, a CTLA4 blocking antibody that enhances the magnitude and potency of the tumor specific T cell response, with nivolumab, a PD-1 blocking antibody that interferes with PD-1 mediated T-cell regulatory signaling. In this study, women with hormone receptor negative, HER2-negative ("triple negative") resectable breast cancer after neoadjuvant chemotherapy will be randomized to standard peri-operative management versus tumor cryoablation with peri-operative nivolumab and ipilimumab. Women undergoing either mastectomy or breast conserving surgery are eligible. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03546686
Study type Interventional
Source Cedars-Sinai Medical Center
Contact Christina Abaya
Phone 310-423-5489
Email Christina.Abaya@cshs.org
Status Not yet recruiting
Phase Phase 2
Start date July 2018
Completion date May 2023

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