Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Triple-negative Breast Cancer
A Single Arm Phase 2 Study of Peri-Operative Immune Checkpoint Inhibition and Cryoablation in Women With Hormone Receptor-Negative, HER2-Negative Early Stage/Resectable Breast Cancer.
University of Texas Southwestern Medical Center
80 participants
Nov 12, 2019
INTERVENTIONAL
Conditions
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.
Eligibility
Plain Language Summary
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Interventions
Pembro will be administered 1-20 days before the cryoablation date per SOC and q3 weeks after surgery for 9 cycles per SOC.
US-guided core biopsy and cryoablation 7-10 days prior to surgery.
Standard-of-care definitive surgery.
ipilimumab 1mg/Kg IV is administered 1-5 days prior to cryoablation.
nivolumab 240mg IV flat dose is administered 1-5 days prior to cryoablation and 240mg IV every 2 weeks ± 3 days starting 3 (+/-1) weeks after surgery.
Locations(4)
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NCT03546686