ADVANCES SERIES · BREAST CANCER
Freezing Breast Cancer Without Surgery: What Cryoablation Is and Who It Is For
Some technologies sound like science fiction and turn out to already be in hospitals. Cryoablation is one of them: instead of removing the tumor with surgery, it destroys it by freezing, with an image-guided needle-probe. It is not an internet promise: it has a clinical trial with five-year follow-up and, since October 3, 2025, the first FDA authorization for a system of this kind in breast cancer. That said, the authorization is narrow, and in this guide we give you the complete figures and the limits, plainly.
Educational content prepared with official health sources. Professional medical review pending.
No personalized diagnoses: consult your doctor.
📅 Published November 10, 2026 · 2-minute video · Full transcript included
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How does cryoablation work?
A very thin needle reaches the tumor guided by imaging (for example, ultrasound). With liquid nitrogen, the needle's tip forms a ball of ice that brings the tissue down to about −40 °C. The extreme cold, applied in freeze-and-thaw cycles, destroys the tumor cells.
It has one advantage you can see on screen: unlike heat ablation, the ice ball is visible in real time on the image, so the medical team sees exactly what it is treating and what healthy tissue stays outside the frozen zone.
What the ICE3 study measured (the real figures)
The largest trial is called ICE3. It followed 194 women aged 60 and older with a very carefully selected breast cancer: a single tumor up to 1.5 cm, hormone-receptor positive (ER+), HER2-negative, grade 1-2, treated with cryoablation alone, no surgery. At 5 years:
- The cancer had come back in the same breast in only 4.3% of cases — a figure within the range published for breast-conserving surgery (lumpectomy) in similar patients.
- Breast-cancer-specific survival was 96.7%.
- There were no serious adverse events attributed to the device; most effects were mild.
One important nuance: ICE3 was not a randomized trial against surgery. The comparison is with what has been published in similar patients, not a proven equivalence from a head-to-head study.
The FDA authorization: narrow and precise
On October 3, 2025, the FDA granted De Novo marketing authorization (DEN220077) to IceCure's ProSense system (liquid nitrogen): it is the first and only device authorized for the local treatment of breast cancer. The authorized indication is only for:
- Women aged 70 and older.
- A single tumor up to 1.5 cm, biologically low-risk: ER+, PR+, HER2−, and Ki-67 under 15%.
- Accompanied by hormone (endocrine) therapy.
- It includes patients who are not candidates for surgery.
💙 The important care note: the full limits
Stating the limits does not take away hope: it is what lets you ask the right questions at your appointment. For most patients with breast cancer, surgery remains the standard path. Authorized cryoablation is only for the narrow subgroup described above: women aged 70 and older, a single tumor up to 1.5 cm, low-risk (ER+, PR+, HER2−, Ki-67 under 15%), with hormone therapy. It is not an option today in the breast for tumors larger than 1.5 cm, HER2-positive or triple-negative cancer, disease in several spots, or affected lymph nodes. Like any needle procedure, it has risks: cold damage to nearby tissue (nerves or skin), bleeding and infection, and local recurrence if the ice ball does not cover the tumor's full margin. The FDA also requires a post-market study of about 400 patients: long-term results will take years to know. We are not doctors: this is information so you arrive at your appointment prepared.
And in other parts of the body?
The same technique is already a real option in selected cases:
- Kidney: its best-proven indication — small tumors (under 4 cm), accepted in guidelines as an alternative to partial surgery, especially in older people, people with a single kidney, or those at high surgical risk.
- Prostate: whole-gland cryotherapy is an established treatment; focal treatment (only the tumor focus) is still considered investigational.
- Liver and lung: selected cases at specialized centers, when surgery is not the plan (in the lung, the most frequent complication of ablation is pneumothorax).
The question for your appointment
If you or someone in your family is diagnosed with a breast tumor, the concrete question for the oncologist is:
"Does the size and type of my tumor make me a candidate for something like this?"
Asking commits you to nothing, and sometimes it opens a door you did not know existed.
Frequently asked questions
Does cryoablation replace surgery?
For most patients, no: surgery remains the standard path. The FDA authorization covers only a narrow subgroup (women aged 70 and older, a single tumor up to 1.5 cm, low-risk, with hormone therapy), which includes patients who are not candidates for surgery.
What exactly did the ICE3 study measure?
It followed 194 women aged 60 and older treated with cryoablation alone, no surgery. At 5 years, the cancer had come back in the same breast in 4.3% of cases and breast-cancer-specific survival was 96.7%, with no serious adverse events attributed to the device. It was not a randomized trial against surgery.
What risks does the procedure have?
Like any needle procedure: cold damage to nearby tissue (nerves or skin), bleeding and infection, and local recurrence if the ice ball does not cover the tumor's full margin. In ICE3, most effects were mild.
Is it offered at any hospital yet?
No. The initial rollout is tied to a small number of centers, with broad reimbursement still unresolved. The FDA also requires a post-market study of about 400 patients (the ChoICE study).
References
- ICE3 trial: 194 women aged 60 and older with a single tumor ≤1.5 cm, ER+, HER2−, grade 1-2, treated with cryoablation alone; at 5 years, recurrence in the same breast of 4.3% (95% CI: 2.1–8.7) and breast-cancer-specific survival of 96.7%; no serious adverse events attributed to the device. ICE3 was not a randomized trial against surgery: the comparison is with what has been published in similar patients.
- FDA (October 3, 2025): De Novo authorization DEN220077 for IceCure's ProSense system, the first device authorized for the local treatment of breast cancer; indication in women aged 70 and older with a low-risk tumor ≤1.5 cm (ER+, PR+, HER2−, Ki-67 <15%), with adjuvant endocrine therapy; required post-market study of ~400 patients.
- Cryoablation in other indications: kidney (T1a tumors <4 cm, an accepted alternative in guidelines), prostate (whole gland established; focal investigational), liver and lung in selected cases at specialized centers.
How to read this guide: real numbers with their limits — this is a verified advance from a published trial with 5-year follow-up, not a general cure for breast cancer; the final word on your case belongs to your oncologist, with your studies in hand.
Full video transcript
What you are watching is a ball of ice forming inside a tumor. This is not science fiction: it is a real technology that destroys cancer cells by freezing them, and in October 2025 it received the first authorization to treat breast cancer this way.
It is called cryoablation. A very thin needle reaches the tumor guided by imaging, and with liquid nitrogen it forms a ball of ice that brings the tissue down to about forty degrees below zero. The extreme cold, applied in freeze-and-thaw cycles, destroys the tumor cells. And it has one advantage you can see on screen: the ice ball is visible in real time, so the medical team sees exactly what it is treating and what healthy tissue stays outside.
The serious question is whether it works without surgery. The largest study, called ICE3, followed one hundred ninety-four women aged sixty and older with small, low-risk tumors, treated with cryoablation alone. At five years, the cancer had come back in the same breast in only four point three percent of cases, a figure within the range published for breast-conserving surgery in similar patients. And there were no serious adverse events attributed to the device.
That is why the health authority authorized the first system of this kind for the breast. Now, the part to hear in full, because it is care, not discouragement: that authorization covers a very precise group. Women aged seventy or older, with a tumor up to one and a half centimeters, low-risk, hormone-responsive, and accompanied by hormone therapy. For most patients, surgery remains the standard path, and saying that clearly is also part of good care.
The same technique is already a proven option in other parts of the body, in selected cases: small kidney tumors, for example, especially in people for whom surgery carries a high risk.
If you or someone in your family is diagnosed with a breast tumor, this is the question you can take to the appointment: does the size and type of my tumor make me a candidate for something like this? Asking commits you to nothing, and sometimes it opens a door you did not know existed. If you want the complete guide to this technology, with its figures and its limits, write INFO and we will send it to you.
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