Participants will have a confirmed diagnosis of metastatic breast cancer and will receive pembrolizumab in combination with ablation (cryoablation or histotripsy) OR pembrolizumab alone. Participants will be randomly assigned.
Patients ≥ 18 years of age
Confirmed histologic diagnosis of metastatic TNBC or locally advanced inoperable 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 ablation as per usual clinical practice
Patient not eligible for PD-1 inhibitor per the patient's medical oncologist
No disease amenable for ablation
Pembrolizumab therapy not planned as part of standard of care
Parallel
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.
Histotripsy
DeviceHistotripsy of the liver is a noninvasive, nonthermal ablation technique that employs high intensity focused ultrasound pulses to mechanically disrupt targeted hepatic tissues- typically liver tumors-via a process known as acoustic cavitation.
Change in CD4-PD1 from baseline to post-ablation
Assess changes in CD4-PD1 in the blood after ablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).
Click on the lead sponsor to view all of their trials.
