Phase 1 Breast Cancer Trial, Recruiting NCT06246968 Sponsor: Memorial Sloan Kettering Cancer Center Condition: Breast Cancer
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Phase 1 Breast Cancer Trial, Recruiting

NCT06246968
Recruiting Phase 1

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • People who are 18 years of age or older
  • People who have been diagnosed with metastatic triple-negative breast cancer (a type of breast cancer confirmed by tissue testing that has spread to other parts of the body)
  • People who have at least one tumour site that is suitable for cryoablation (a procedure that uses extreme cold to destroy tumour tissue), measuring at least 1.5 cm, as determined by a specialist radiologist — eligible sites can include soft tissue, liver, lung, or bone
  • People who are physically well enough to undergo cryoablation, as assessed through standard clinical practice
  • People for whom pembrolizumab (an immunotherapy drug, 200 mg every 3 weeks) is already planned as part of their standard cancer treatment, as a first, second, or third line of therapy — this must be determined by the patient's own cancer specialist
  • People whose cancer specialist has determined they are suitable for a PD-1 inhibitor (a type of immunotherapy) as part of their treatment plan
  • People whose treatment plan may also include certain other chemotherapy medicines, such as paclitaxel, carboplatin, gemcitabine, or others from a specified list — the timing of these medicines alongside pembrolizumab and cryoablation is flexible
  • Women aged 11–50 who have the potential to become pregnant will need to have a pregnancy test within 2 weeks before cryoablation (this requirement does not apply to those who have had certain surgeries, are post-menopausal, or have been surgically sterilised, with supporting documentation)
  • Women of childbearing age are expected to use effective contraception during pembrolizumab treatment and for at least 4 months after the last dose, as monitored by their cancer specialist

Who may not be able to join:

  • People whose cancer specialist has determined they are not suitable for a PD-1 inhibitor
  • People who do not have any tumour sites that a specialist radiologist considers suitable for cryoablation
  • People for whom pembrolizumab is not already planned as part of their standard care

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 19 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Principal Investigator: Yolanda Bryce, MD, Memorial Sloan Kettering Cancer Center

Phone: 212-639-6530

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
29 January 2024
Est. completion
29 January 2027

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change in CD4-PD1 from baseline to post-cryoablation

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 19 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov