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Freeze and unleash: experimental combo aims to boost immune attack on aggressive breast cancer

NCT ID NCT05806385

Disease control Sponsor: Texas Tech University Health Sciences Center Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This early-stage trial tests whether freezing a breast tumor (cryoablation) before giving an immunotherapy drug (PD1 inhibitor) can help the immune system better recognize and attack triple-negative breast cancer. About 36 women with early-stage, high-risk breast cancer will receive the combination before standard chemotherapy. The goal is to see if this approach increases the chance of eliminating all cancer cells by the time of surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PD1 inhibitor (a type of immunotherapy) combined with cryoablation
What this could lead to
If it works, this combination could improve how well the immune system attacks triple-negative breast cancer, potentially leading to better tumor clearance and fewer recurrences.
What could go wrong
This is a very early (Phase 1/2) trial with only 36 participants, so results may not apply broadly. The combination could cause immune-related side effects or fail to improve outcomes over standard treatment.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

About 36 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2029

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Females * Stage I/II Cancer * Age range 18 - 90 years * Diagnoses: Invasive carcinoma, ER -, PR-, HER2- (triple negative) * Radiology findings: Unifocal disease visible on ultrasound Exclusion Criteria: * Additional primary cancer * Inflammatory breast cancer * History of autoimmune disease * History of chronic immunosuppression * Prior immunotherapy * Recent vaccination (within 4 wks.) * Prior radiation therapy * Prior investigational agent therapy within last 1 year * Pregnancy at the time of diagnosis and/ or treatment * Breast feeding

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Triple-negative breast cancer

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

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