Metastatic Breast CancerPhase 1NCT06246968
A Study of Pembrolizumab and Ablation (Cryoablation or Histotripsy) in People With Breast Cancer
A Phase 1 study testing Pembrolizumab, Cryoablation and Histotripsy in people with Metastatic Breast Cancer and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Metastatic Breast Cancer, Breast Cancer, Breast Cancer Stage IV
- What is being tested?
- Pembrolizumab, Cryoablation and Histotripsy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 7 sitesUnited States
- Study dates
- 29 Jan 2024to 29 Jan 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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)
Who cannot join
- 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
Trial locations and contacts
7 sites in 1 country. Contact the study team or a site near you to ask about taking part.
7 sites in 1 country
United States7 sites, 7 recruiting
- Recruiting
Memorial Sloan Kettering Cancer Center at Basking Ridge (Limited Protocol Activities)
Basking Ridge, New Jersey, 07920
Yolanda Bryce, MD, 212-639-6530
- Recruiting
Memorial Sloan Kettering Suffolk-Commack (Limited Protocol Activities )
Commack, New York, 11725
Yolanda Bryce, MD, 212-639-6530
- Recruiting
Memorial Sloan Kettering Westchester (Limited Protocol Activities)
Harrison, New York, 10604
Yolanda Bryce, MD, 212-639-6530
- Recruiting
Memorial Sloan Kettering Monmouth (Limited protocol activities)
Middletown, New Jersey, 07748
Yolanda Bryce, MD, 212-639-6530
- Recruiting
Memorial Sloan Kettering Bergen (Limited Protocol Activities)
Montvale, New Jersey, 07645
Yolanda Bryce, MD, 212-639-6530
- Recruiting
Memorial Sloan Kettering Cancer Center (All protocol activites)
New York, New York, 10065
Yolanda Bryce, MD, 212-639-6530
- Recruiting
Memorial Sloan Kettering Nassau (Limited Protocol Activites)
Rockville Centre, New York, 11553
Yolanda Bryce, MD, 212-639-6530
About this study
Official title: Does Ablation (Cryoablation or Histotripsy) Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative 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.
- Conditions
- Metastatic Breast Cancer, Breast Cancer, Breast Cancer Stage IV, Triple Negative Breast Cancer, Triple Negative Breast Neoplasms, Metastatic Triple-Negative Breast Carcinoma
- Being tested
- Pembrolizumab, Cryoablation, Histotripsy
- Keywords
- metastatic TNBC, metastatic triple negative breast carcinoma, metastatic breast cancer, breast cancer, breast cancer stage IV, triple negative breast cancer, pembrolizumab, cryoablation, Memorial Sloan Kettering Cancer Center, 23-390, locally advanced breast cancer, locally advanced triple negative breast carcinoma, locally advanced triple negative breast cancer
- Medical subject headings
- Breast Neoplasms, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PembrolizumabDrug
Participants will receive Pembrolizumab as part of standard of care treatment.
CryoablationDevice
Cryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection.
HistotripsyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Pembrolizumab + Ablation (Cryoablation or Histotripsy) | Experimental | Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm). Receives: Drug: Pembrolizumab; Device: Cryoablation; Device: Histotripsy |
| Pembrolizumab | Active comparator | Participants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm). Receives: Drug: Pembrolizumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 weeks after cryoablation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2024
- Study start29 Jan 2024
- Primary completion29 Jan 2027 (estimated)
- Study completion29 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yolanda Bryce, MD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06246968
- Sponsor's protocol ID
- 23-390
- Status last verified
- Sep 2026
- First submitted
- 30 Jan 2024
- Last updated
- 14 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Yes: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Ablation (Cryoablation or Histotripsy) Boost Immune Response Improving the Benefits of Pembrolizumab in Patients With Metastatic or Locally Advanced Triple Negative Breast Cancer?
- ClinicalTrials.gov ID
- NCT06246968
- Acronym / sponsor ID
- 23-390
- Conditions
- Metastatic Breast Cancer, Breast Cancer, Breast Cancer Stage IV, Triple Negative Breast Cancer, Triple Negative Breast Neoplasms, Metastatic Triple-Negative Breast Carcinoma
- Keywords
- metastatic TNBC, metastatic triple negative breast carcinoma, metastatic breast cancer, breast cancer, breast cancer stage IV, triple negative breast cancer, pembrolizumab, cryoablation
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 29 Jan 2024 (actual)
- Primary completion
- 29 Jan 2027 (estimated)
- Study completion
- 29 Jan 2027 (estimated)
- First posted
- 7 Feb 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pembrolizumab + Ablation (Cryoablation or Histotripsy) | Experimental | Drug: Pembrolizumab, Device: Cryoablation, Device: HistotripsyParticipants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm). |
| Pembrolizumab | Active comparator | Drug: PembrolizumabParticipants will have a diagnosis of metastatic triple negative breast cancer or locally advanced inoperable triple negative breast cancer. Participants will be randomized 2 (ablation arm): 1 (no ablation arm). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (23 listed)
- 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").
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PembrolizumabParticipants will receive Pembrolizumab as part of standard of care treatment. | Drug | Pembrolizumab, Pembrolizumab + Ablation (Cryoablation or Histotripsy) |
| CryoablationCryoablation is a type of thermal ablation that is a minimally invasive alternative technique to surgical resection. | Device | Pembrolizumab + Ablation (Cryoablation or Histotripsy) |
| HistotripsyHistotripsy 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. | Device | Pembrolizumab + Ablation (Cryoablation or Histotripsy) |
Primary outcome
Change in CD4-PD1 from baseline to post-ablation
Time frame: 6 weeks after cryoablation
Assess changes in CD4-PD1 in the blood after ablation in patients with metastatic or locally advanced triple negative breast cancer (TNBC).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2026.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Yolanda Bryce, MD principal investigator
Memorial Sloan Kettering Cancer Center
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Pembrolizumab, Cryoablation and Histotripsy in people with Metastatic Breast Cancer and Breast Cancer, run by Memorial Sloan Kettering Cancer Center at 7 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 23 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yolanda Bryce, MD (212-639-6530, brycey@mskcc.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in CD4-PD1 from baseline to post-ablation (time frame: 6 weeks after cryoablation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.