Breast Cancer Cryoablation: FDA Authorisation and 5-Year Results

Breast cancer cryoablation is a procedure in which a thin, needle-like cryoprobe is guided into the breast under ultrasound and the tumour is enclosed in a ball of ice, frozen and thawed to destroy the cancer cells. The US Food and Drug Administration (FDA) has authorised this type of cryoablation device as a local treatment for low-risk early breast cancers of 1.5 cm or smaller in people aged 70 or older who also take hormone therapy, and US multicentre trials report 5-year same-breast recurrence rates of around 3–4%.

At the European Society of Breast Imaging (EUSOBI) congress in October 2026, hospitals in Italy, Spain and Romania presented their experience of treating older patients who could not easily have surgery, renewing interest in treating breast cancer without surgery. Using the FDA decision document and trial papers from the US and Brazil, this article explains who is eligible, how the procedure is done, what the results show and where it is available.

What is new: FDA authorisation and 2026 congress reports

The FDA granted the ProSense cryoablation system from IceCure Medical (Israel) the first authorisation of a device for local treatment of breast cancer. The De Novo classification order, the pathway for new types of devices, was issued on October 3, 2025, and a corrected order clarifying the post-market study requirements was published on March 20, 2026. The US patient organisation Breastcancer.org also notes that the FDA approved one specific type of cryoablation in October 2025 for people aged 70 or older with certain early hormone receptor-positive cancers.

The authorised use in the FDA document is summarised below, with the conditions copied as written.

Source: FDA De Novo decision DEN220077 (corrected version, March 20, 2026).

As a condition of authorisation, the FDA requires a post-market study of about 400 patients at about 30 sites, following recurrence and serious adverse events for 5 years, so results continue to be checked in routine care. At EUSOBI 2026 in October, presentations covered local control with cryoablation alone or combined with hormone therapy in older patients unfit for surgery, and one-year outcomes from a Romanian centre, showing that more European hospitals are now offering the procedure.

How breast cryoablation is done

Cryoablation is carried out in a procedure room rather than an operating theatre, usually under local anaesthetic. Breastcancer.org and the trial papers describe the following steps.

1. Locating the tumour: ultrasound (occasionally CT or MRI) is used to find the tumour and the skin is numbed. A mild sedative may be offered, but you stay awake.
2. Inserting the probe: a thin cryoprobe is passed through a tiny skin nick into the centre of the tumour.
3. Freezing: liquid nitrogen or argon gas forms an ice ball at the probe tip that covers the tumour and a rim of normal tissue. Two freeze–thaw cycles are commonly used.
4. Finishing: the probe is removed and the site is usually covered with a dressing without stitches. The procedure takes about 30–90 minutes and you go home the same day.

In the Brazilian FIRST trial, the median maximum ice-ball diameter was 4.2 cm, about 3.6 times the tumour size, and ice-ball margins of at least 1 cm beyond the tumour were associated with complete ablation in most cases. The body gradually clears the dead cells, leaving a small painless lump of scar tissue that shrinks over time. Comparing it with heat-based treatment in our RFA (radiofrequency ablation) guide helps explain the principle, and image-guided needle procedures in general are covered in our IVR (interventional radiology) guide.

Who is eligible

In the US the authorised group is low-risk early breast cancer in people aged 70 or older, as shown above. Combining trial criteria and patient information, cryoablation is considered in these situations.

• Small, slow-growing early breast cancer: 1.5 cm or less, hormone receptor-positive, HER2-negative, low grade, and not too close to the skin
• Older patients for whom surgery is a burden: heart disease or other illnesses, age, or treatment for another cancer that make surgery and general anaesthesia difficult
• Patients able to continue hormone therapy: both the US authorisation and the main trials combined cryoablation with hormone therapy
• Clinical trials: people aged 50–69, ductal carcinoma in situ (DCIS) and triple-negative breast cancer are being studied in trials

For larger or multiple tumours, lymph node spread, lobular cancer or extensive intraductal disease, surgery remains the standard treatment. Cryoablation is best understood not as a replacement for surgery for everyone, but as an option that spares suitable patients the burden of an operation.

Trial results: recurrence and complete ablation

The key figures from the US ICE3 trial, which supported the FDA authorisation, and the US FROST 6-year results and Brazilian FIRST trial published in 2026 are shown below.

All three are single-arm studies without a comparison group. Recurrence rates are the 5-year Kaplan–Meier estimates reported in the papers.

Put simply, of 100 suitable early breast cancer patients treated with cryoablation plus hormone therapy, about 3–4 had cancer return in the same breast within 5 years. In FROST, no patient died of breast cancer during more than 6 years of follow-up, and in FIRST, examination of the removed tissue showed complete destruction of invasive cancer in every tumour of 2 cm or less. Results were best for small tumours, so finding cancer early and discussing options promptly makes the most of cryoablation.

A randomised trial directly comparing cryoablation with surgery (CRYSTAL-SIX, NCT06839001) is also under way and is expected to build evidence for a wider range of patients.

Side effects and recovery

Most reported side effects were mild and settled within days.

In ICE3, minor adverse events were reported in 88.2% and moderate in 9.6%, all resolving without lasting effects, and patient and physician satisfaction with cosmetic results at 5 years was 98.6–100%. Distress scores 6 months after the procedure were also lower than before treatment. With a tiny wound and same-day discharge, most people return to normal activities within a few days. Results are checked with mammography, ultrasound and MRI; in FIRST, MRI was the most accurate test for showing that no cancer remained (negative predictive value 93.0%).

Where it is available

International patients are often not covered by a country's public insurance. Check availability and costs directly with the hospital.

The National Cancer Center Japan explains that, based on the RAFAELO study started in 2013, radiofrequency ablation for breast ductal carcinoma of 15 mm or less entered insured care in December 2023. Freezing and heating work differently, but both treat small early breast cancers with a single needle. Long-term results of cryoablation in kidney cancer, where it has been used for longer, are summarised in our article on kidney cancer cryoablation long-term outcomes.

What to check and questions for your doctor

• Biopsy report: check hormone receptors, HER2, Ki-67 and histology (ductal or lobular).
• Imaging: MRI gives a more accurate check that there is a single tumour of 1.5 cm or less.
• Hormone therapy: consider in advance whether you can take tablets for several years after cryoablation.
• Follow-up plan: if treated abroad, agree which scans to have at home and when.

Questions to ask your doctor:

• Does my tumour meet the FDA criteria (age 70+, 1.5 cm or less, low risk)?
• What are the pros and cons compared with surgery (lumpectomy) in my case?
• Do I still need sentinel lymph node biopsy or radiotherapy?
• How many breast cryoablations has this hospital performed, and which imaging is used to check the result?
• If the cancer comes back, can I have surgery or a repeat procedure?

For consultation tips see five questions before an RFA consultation, and for reading study figures see how to check the study phase of overseas papers.

Frequently asked questions

Can breast cancer cryoablation replace surgery?

For suitable patients it is an alternative to surgery. The FDA has authorised cryoablation with hormone therapy for low-risk breast cancer of 1.5 cm or less in people aged 70 or older, and the 5-year same-breast recurrence rate in the ICE3 trial was 4.3%. For larger tumours or lymph node spread, surgery remains standard.

How long does the procedure take, and do I need to stay in hospital?

It takes about 30–90 minutes under local anaesthetic, and most people go home the same day. The skin nick is small and usually needs no stitches; bruising or swelling may last a few days and normally settles on its own.

I can feel a lump after treatment. Is that normal?

It is scar tissue left where the tumour was frozen. It is painless and often shrinks over time. If it grows or changes shape, tell your care team so it can be checked on follow-up imaging.

Can breast cancer be treated without surgery in Japan?

In Japan, radiofrequency ablation (RFA) for early breast cancer of 15 mm or less has been covered by public insurance since December 2023. It works differently from cryoablation, so check with the hospital which method it uses and the costs for international patients.

Related: for another image-guided local treatment that avoids surgery, see TULSA prostate cancer ablation: a 650-patient meta-analysis.

This article summarises official sources and published studies as general information, not medical advice. Please discuss treatment choices with doctors who have examined you.