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Could freezing breast cancer replace the knife? major trial launches

NCT ID NCT07483996

Disease control Sponsor: Franciscus Gasthuis & Vlietland (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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares freezing breast tumors (cryoablation) to standard surgery (lumpectomy) in women over 60 with early-stage, hormone-positive breast cancer. The goal is to see if cryoablation can control the disease just as well, with fewer side effects. About 938 participants will be followed for 5 years to check for cancer return.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 938 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

Dec 2038

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

60 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: 1. Women 2. Age \> 60 years 3. Postmenopausal (no menstrual period for at least 12 months or in case of an intra-uterine device (IUD) hormone levels that indicate the menopause: follicle stimulating hormone (FSH) \> 20 IE/l and estradiol \< 100 pmol/l) 4. Histopathological confirmed primary invasive ER+/HER2- type breast cancer 5. Bloom Richardson grade 1 or 2 (low or intermediate malignancy grade) 6. Unilateral and unifocal breast cancer 7. A clinical T1N0M0 tumor (≤ 2cm and N0 on US and/or MRI), without distant metastases. The largest diameter measured will be used to determine eligibility. 8. Tumor should be visible and well delineated (all borders of the tumor should be visible) on ultrasound at diagnosis and during the procedure. 9. Sufficient knowledge of the Dutch language to complete the questionnaires 10. To be able to give written informed consent Exclusion Criteria: 1. History of invasive breast cancer 2. Breast augmentation 3. BRCA-1 or 2 gene mutation carrier 4. Lobular carcinoma 5. Triple negative breast cancer 6. Multifocality 7. HER2-neu overexpressing tumors 8. Lymph vascular invasion (LVI) on core needle biopsy or histopathological confirmed after lumpectomy 9. Indication for neoadjuvant systemic therapy 10. Intraductal component \> 25% of the diameter of the invasive tumor on MRI, complete area of the primary tumor should not exceed 2cm. 11. Allergic to local anesthetics 12. Electrical devices and/or implants that are not compatible with MRI 13. Current severe breast infection 14. Uncorrectable coagulopathy 15. Hemodynamic instability 16. Respiratory instability 17. Refraining from adjuvant radiotherapy 18. Indication for oncoplastic surgery (surgical volume replacement techniques e.g. LICAP)

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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.

Early-stage breast cancer

How to take part

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  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

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More trials for these conditions

Other studies related to the condition(s) this trial covers.