A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

ConditionsMetastatic Breast Cancer Breast Cancer Breast Cancer Stage IV Triple Negative Breast Cancer Triple Negative Breast Neoplasms Metastatic Triple-Negative Breast Carcinoma Locally Advanced Breast Cancer Locally Advanced Triple-Negative Breast Carcinoma

Trial statusRecruiting

Trial phasePhase 1

Trial typeInterventional

Biological sexAll

Age18+

SponsorMemorial Sloan Kettering Cancer Center

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

Qualifiers

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

Treatments tested in this trial

Pembrolizumab
Cryoablation

Treatment groups

30 Participants

are divided into 2 treatment groups

Locations7

Select a site below to view it on the map.

Sponsors and collaborators

Memorial Sloan Kettering Cancer Center

Lead sponsor

Source ClinicalTrials.gov