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Freezing out breast cancer: new study tests cryoablation for seniors

NCT ID NCT07629206

Disease control Sponsor: IceCure Medical Ltd. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Sep 10, 2026 · Updated 4 times

Summary

This study tracks how well freezing breast tumors (cryoablation) works together with hormone therapy for women aged 70 and older with low-risk, early-stage breast cancer. Researchers will follow 400 participants for up to 5 years to see how often the cancer comes back. The goal is to confirm that this less invasive treatment is safe and effective in everyday medical practice.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 400 people

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

Started

Jul 2026

Expected to finish

Sep 2034

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

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

Ages

70 years and older

Sex

Anyone

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: 1. Provision of a signed and dated informed consent form. 2. Age ≥70 3. Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria: * Unifocal primary disease * Tumor size ≤1.5 cm in greatest diameter * Estrogen receptor positive, Progesterone receptor positive, and HER2 negative * Low-risk tumor biology, defined as Ki67\<15% or confirmed by genomic testing. In cases where Ki67 is ≥15%, low-risk status must be confirmed by genomic testing, which will prevail. 4. Lesions must be sonographically visible at the time of treatment 5. Clinically negative lymph node (N0). Exclusion Criteria: 1. Presence of lobular carcinoma. 2. Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%. 3. Evidence of lymphovascular invasion. 4. Presence of multifocal and/or multicentric breast cancer. 5. Presence of multifocal suspicious calcifications. 6. Presence of inflammatory features. 7. Previous ipsilateral breast radiation 8. Neoadjuvant endocrine treatment is provided to reduce the tumor size. 9. Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies. 10. Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer. 11. Allergy to local anesthesia. 12. Any other reason defined as inoperable declared by a physician.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm neoplasm

As listed by the trial registrant

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

Low-risk, early stage breast cancer

How to take part

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

  1. The places running it

    2 sites. The list below names each one and where it is.

  2. 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 ↗

  3. 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.

Contacts and locations

Locations

  • Glendale Adventist Medical Center d/b/a Adventist Health Glendale

    RECRUITING

    Glendale, California, 91206, United States

  • The West Clinic, PC dba West Cancer Center

    RECRUITING

    Germantown, Tennessee, 38138, United States