A Study of Pembrolizumab and Ablation (Cryoablation or Histotripsy) in People With Breast Cancer
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.
Metastatic 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
About this study
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.
Interventions
Drug: Pembrolizumab — Participants will receive Pembrolizumab as part of standard of care treatment.
Device: Cryoablation — Cryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection.
Device: Histotripsy — Histotripsy 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.
Primary outcomes
Change in CD4-PD1 from baseline to post-ablation (6 weeks after cryoablation)
Eligibility information
Inclusion Criteria:
* 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
* Per clinical guidelines, women of childbearing age should use effective contraception during treatment with pembrolizumab and for at least 4 months after the last dose of the drug, which will be assessed and monitored by, and the responsibility of, the patient's medical oncologist (not study investigators or research team) as pembrolizumab is standard of care. Memorial Sloan Kettering Cancer Center Pregnancy Standards will be followed prior to ablation. That is, female patients that are 11-50 years of age and of childbearing potential will undergo a pregnancy test within 2 weeks (15 days) before ablation. Pregnancy test will not be required in patients with bilateral oophorectomy, bilateral salpingectomy, bilateral salpingectomy-oophorectomy, hysterectomy, menopause (no menses ≥ 1 year prior to treatment or after completion of all treatment), or surgical sterilization (i.e. tubal ligation or blockage), with documentation of permanent exemptions in CIS ("Pregnancy Testing Exemption").
* Pembrolizumab therapy (200 mg every 3 weeks) planned as part of standard of care as first, second, or third line of therapy
* Eligible for PD-1 inhibitor per the patient's medical oncologist, with planned treatment with PD-1 inhibitor per the patient's medical oncologist. Additional systemic therapy is per the patient's medical oncologist. The following systemic therapy will be accepted (the timing of the systemic therapy relative to pembrolizumab and ablation is not restricted):
* Capecitabine (Xeloda, available as a generic drug)
* Carboplatin (Paraplatin, available as a generic drug)
* Cisplatin (Platinol, available as a generic drug)
* Cyclophosphamide (Cytoxan, available as a generic drug)
* Docetaxel (Taxotere)
* Doxorubicin (Adriamycin, available as a generic drug)
* Pegylated liposomal doxorubicin (Doxil)
* Epirubicin (Ellence, available as a generic drug)
* Eribulin (Halaven)
* Fluorouracil (5-FU, Adrucil, available as a generic drug)
* Gemcitabine (Gemzar, available as a generic drug)
* Ixabepilone (Ixempra)
* Methotrexate (available as a general drug)
* Nab-paclitaxel (Abraxane)
* Paclitaxel (Taxol, available as a generic drug)
* Vinorelbine (Navelbine, available as a generic drug)
Exclusion Criteria:
* 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
Study locations
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities), Basking Ridge, New Jersey 07920 United States
Memorial Sloan Kettering Monmouth (Limited protocol activities), Middletown, New Jersey 07748 United States
Memorial Sloan Kettering Bergen (Limited Protocol Activities), Montvale, New Jersey 07645 United States
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ), Commack, New York 11725 United States
Memorial Sloan Kettering Westchester (Limited Protocol Activities), Harrison, New York 10604 United States
Memorial Sloan Kettering Cancer Center (All protocol activites), New York, New York 10065 United States
Memorial Sloan Kettering Nassau (Limited Protocol Activites), Rockville Centre, New York 11553 United States
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-28.