A Study of Pembrolizumab and Cryoablation in People With Breast Cancer
NCT ID: NCT06246968
Last Updated: 2025-05-21
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
30 participants
INTERVENTIONAL
2024-01-29
2027-01-29
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pembrolizumab + 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
Participants will receive Pembrolizumab as part of standard of care treatment.
Cryoablation
Cryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection.
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
Participants will receive Pembrolizumab as part of standard of care treatment.
Interventions
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Pembrolizumab
Participants will receive Pembrolizumab as part of standard of care treatment.
Cryoablation
Cryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection.
Eligibility Criteria
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Inclusion Criteria
* 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
* No disease amenable for cryoablation
* Pembrolizumab therapy not planned as part of standard of care
18 Years
ALL
No
Sponsors
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Memorial Sloan Kettering Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Yolanda Bryce, MD
Role: PRINCIPAL_INVESTIGATOR
Memorial Sloan Kettering Cancer Center
Locations
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Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, United States
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, 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
Countries
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Central Contacts
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Facility Contacts
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Yolanda Bryce, MD
Role: primary
Yolanda Bryce, MD
Role: primary
Yolanda Bryce, MD
Role: primary
Yolanda Bryce, MD
Role: primary
Yolanda Bryce, MD
Role: primary
Yolanda Bryce, MD
Role: primary
Yolanda Bryce, MD
Role: primary
Related Links
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Memorial Sloan Kettering Cancer Center
Other Identifiers
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23-390
Identifier Type: -
Identifier Source: org_study_id
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