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Freezing, not cutting: new study tests cryoablation for breast cancer in seniors

NCT ID NCT07398118

Disease control Sponsor: St. Antonius Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Updated 1 time

Summary

This study tests a freezing technique called cryoablation as a main treatment for early-stage breast cancer in adults aged 70 and older. Instead of surgery or long-term hormone pills, doctors use imaging to guide a needle that freezes and destroys the tumor. The goal is to see if this less invasive approach is safe and effective, potentially offering a quicker recovery with fewer side effects.

What this could mean

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

Active substance
cryoablation (freezing procedure)
What this could lead to
If successful, cryoablation could offer a less invasive, single-session treatment option for older adults with early-stage breast cancer, avoiding surgery or long-term hormone therapy.
What could go wrong
This is a small, early feasibility study (61 participants) with no control group. The procedure may not fully destroy the tumor, requiring additional treatment, and long-term outcomes are unknown.

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 61 people

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

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

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

70 years and older

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: * Age ≥ 70 years * Histologically confirmed invasive breast cancer * Clinical stage cT1N0M0 based on mammography and ultrasound ER-positive, HER2-negative (IHC 0-1+ or 2+ with negative ISH), any PR status * Presence of concurrent DCIS is allowed if limited to \<25% of the pre-NST biopsy, with no radiologic suspicion of an extensive component * Unifocal disease \<2 cm, well visualized on ultrasound, with a minimum distance of ≥5 mm from the skin, nipple and thoracic wall * Ability and willingness to comply with project requirements * Preoperative endocrine therapy is allowed * Written informed consent given by the subject Exclusion Criteria: * Pure DCIS lesions without invasive component * Extensive calcifications on imaging suggestive of widespread disease * Invasive lobular carcinoma (as assessed by IHC) * Triple-negative or HER2-positive subtype (defined as (IHC 3+ or ISH positive) * History of ipsilateral breast cancer or DCIS * Prior ipsilateral radiotherapy * Inability to communicate in Dutch or English language * Planned (e)migration or long-term stay abroad within one year after inclusion

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm

As listed by the trial registrant

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

Breast cancer early stage breast cancer (stage 1-3) Breast cancer stage I

How to take part

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

  1. The places running it

    3 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

  • Amphia Hospital

    Breda, North Brabant, 4818 CK, Netherlands

  • Antoni van Leeuwenhoek - Nederlands Kanker Instituut

    Amsterdam, North Holland, 1066 CX, Netherlands

  • Rijnstate Hospital

    Arnhem, Gelderland, 6836 BH, Netherlands

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