About this trial
Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with cryoablation OR pembrolizumab alone. Participants will be randomly assigned.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Patients ≥ 18 years of age
Confirmed histologic diagnosis of metastatic TNBC
1 site amenable cryoablation of at least 1.5 cm in size as determined by an Interventional Radiologist. Eligible cryoablation sites include (but not limited to) soft tissue, liver, lung, and bone as determined by an Interventional Radiologist to be safest and most feasible.
Physically fit (clinically eligible) to undergo cryoablation as per usual clinical practice
Disqualifiers
Patient not eligible for PD-1 inhibitor per the patient's medical oncologist
No disease amenable for cryoablation
Pembrolizumab therapy not planned as part of standard of care
Trial design
Parallel
Treatments tested in this trial
Pembrolizumab
DrugParticipants will receive Pembrolizumab as part of standard of care treatment.
Cryoablation
DeviceCryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection.
Treatment groups
Trial outcomes
Primary outcomes
Change in CD4-PD1 from baseline to post-cryoablation
Assess changes in CD4-PD1 in the blood after cryoablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).
Sponsors and contacts
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