RecruitingPhase 2NCT03546686

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.


Sponsor

University of Texas Southwestern Medical Center

Enrollment

80 participants

Start Date

Nov 12, 2019

Study Type

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether giving an immune checkpoint drug (pembrolizumab or a similar immunotherapy) before surgery — combined with a freezing treatment called cryoablation that destroys a portion of the tumor — can activate the immune system to fight triple-negative breast cancer more effectively. **You may be eligible if...** - You are a woman 18 years or older - You have been diagnosed with triple-negative breast cancer (meaning the tumor is negative for estrogen receptor, progesterone receptor, and HER2) - Your tumor is at least 1 cm in size and has not spread to distant organs - You are planning to have a mastectomy or lumpectomy - Your tumor can be targeted by the freezing (cryoablation) procedure - Your blood counts and organ function are within acceptable ranges - Your general health is good (ECOG score 0–1) **You may NOT be eligible if...** - Your breast cancer has spread to other parts of the body - Your tumor is too small or not accessible for cryoablation - You have serious immune-related conditions or are on high-dose immune-suppressing medications - Your blood counts or organ function are outside acceptable ranges Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPembrolizumab

Pembro will be administered 1-20 days before the cryoablation date per SOC and q3 weeks after surgery for 9 cycles per SOC.

PROCEDURECore Biopsy/Cryoablation

US-guided core biopsy and cryoablation 7-10 days prior to surgery.

PROCEDUREBreast Surgery

Standard-of-care definitive surgery.

DRUGIpilimumab

ipilimumab 1mg/Kg IV is administered 1-5 days prior to cryoablation.

DRUGNivolumab

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)

Providence Cancer Institute

Portland, Oregon, United States

UT Southwestern Medical Center

Dallas, Texas, United States

Ohio State University Medical Center

Columbus, Ohio, United States

Cedars Sinai Medical Center

Los Angeles, California, United States

View Full Details on ClinicalTrials.gov

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NCT03546686


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