A Study of Pembrolizumab and Cryoablation in People With Breast Cancer

Phase 1

Recruiting

• Conditions: Triple Negative Breast Cancer; Metastatic Triple-Negative Breast Carcinoma; Locally Advanced Triple-Negative Breast Carcinoma; Breast Cancer; Metastatic Breast Cancer; Breast Cancer Stage IV; Locally Advanced Breast Cancer; Triple Negative Breast Neoplasms
• Interventions: Drug: Pembrolizumab; Device: Cryoablation

• Registration Number: NCT06246968
• Lead Sponsor: Memorial Sloan Kettering Cancer Center

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-01-29
• Study First Submitted: 2024-01-30
• Study First Submitted QC: 2024-01-30
• Study First Posted: 2024-02-07
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-16
• Last Update Posted: 2025-05-21
• Primary Completion: 2027-01-29
• Study Completion: 2027-01-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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

• 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 cryoablation. 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 cryoablation. 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 cryoablation 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 cryoablation
• Pembrolizumab therapy not planned as part of standard of care

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pembrolizumab + Cryoablation	Cryoablation	Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (cryoablation arm): 1 (no cryoablation arm).
Pembrolizumab + Cryoablation	Pembrolizumab	Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (cryoablation arm): 1 (no cryoablation arm).
Pembrolizumab	Pembrolizumab	Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (cryoablation arm): 1 (no cryoablation arm).

Primary Outcome Measures

Name	Time	Method
Change in CD4-PD1 from baseline to post-cryoablation	6 weeks after cryoablation	Assess changes in CD4-PD1 in the blood after cryoablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).

Trial Locations

Locations (7)

Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities); 🇺🇸 Basking Ridge, New Jersey, United States

Memorial Sloan Kettering Bergen (Limited Protocol Activities); 🇺🇸 Montvale, New Jersey, United States

Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities ); 🇺🇸 Commack, New York, United States

Memorial Sloan Kettering Westchester (Limited Protocol Activities); 🇺🇸 Harrison, New York, United States

Memorial Sloan Kettering Cancer Center (All protocol activites); 🇺🇸 New York, New York, United States

Memorial Sloan Kettering Nassau (Limited Protocol Activites); 🇺🇸 Rockville Centre, New York, United States

Memorial Sloan Kettering Monmouth (Limited protocol activities); 🇺🇸 Middletown, New Jersey, United States