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Cryoablation for Breast Cancer – Evidence to date

Cryoablation for breast cancer

Cryoablation, the use of extreme cold to destroy tumors by freezing, is emerging as an innovative treatment for breast cancer*, a disease that impacts approximately one in eight women in their lifetime. Current standards of breast cancer treatment can involve surgery, radiation, chemotherapy, hormone therapy, and targeted therapy.

As a minimally invasive treatment compared to surgery, during a cryoablation procedure a thin needle-like cryoprobe is inserted into a tumor under imaging guidance to create an ultra-cold and lethal ice ball around the target tissue. It is an alternative treatment approach that has been applied to the treatment of cancer since the mid-19th century with growing and well-documented efficacy in the treatment of kidney cancer, lung cancer, and bone cancer.

Approved for use in Europe and several other countries, cryoablation for breast cancer and fibroadenomas (benign breast tumors) has been used for over two decades and is considered a well-tolerated outpatient procedure.

In the United States, cryoablation for breast cancer is currently being investigated in several landmark clinical studies. While FDA clearance exists for cryoablation of various benign and malignant tumors, including fibroadenoma, there is yet to be a specific FDA indication for the treatment of breast cancer.

In this article, we will share some of the latest evidence available for using cryoablation for breast cancer.

Use of Cryoablation for Breast Cancer

The trend in surgical treatment for benign and malignant breast tumors is toward less-invasive techniques. Although total mastectomy is still performed in some patients, breast-conserving surgery followed by radiation therapy has been established as an oncologically safe approach for patients with early breast cancer. Multidisciplinary treatment, including systemic therapy, has also contributed to the trend toward minimally invasive local treatment.

The most common application of cryoablation is to ablate solid tumors found in the lung, liver, breast, kidney, and prostate. Cryoablation is considered a safe and effective procedure with advantages over alternative treatment including:

Minimal scarring as only a small incision is made and usually only closed with a steri-strip.

The size and shape of the breast are maintained.

Can be performed in an office-based setting under local anaesthesia without the need for hospitalization or general anaesthesia, a great benefit for patients at high risk for surgery.

Lower cost secondary to an office-based setting versus an operating room and overnight hospital stays.

The anesthetic effect of cold augments the local anesthesia.

● Possibility to treat multiple lesions in the same session

It is a repeatable procedure in case of local relapse or incomplete ablation.

It acts in synergy with adjuvant and systemic therapies, i.e., chemotherapy, radiation, hormone therapy, immunotherapy

Can create a cryo-immune response via tumor lysates and be considered a weak form of in situ cancer vaccination.

High local control

Growing Experience Treating Fibroadenomas with Cryoablation

Cryoablation for the treatment of fibroadenomas is becoming a well-established procedure and has received FDA and CE clearance

Approximately 500,000 women today undergo surgical resection of FAs each year. Treatment results include a ~ 90% volume reduction with more than 80% of fibroadenomas non-palpable a year after treatment. (1,2,3)

Typical fibroadenoma (FA) changes following cryoablation

Typical fibroadenoma following cryoablation

Fig 1. Ultrasound image of FA (arrow) pre- and 6, 12, 18, and 36 months post-cryoablation. Sheth, M., Lodhi, U., Chen, B., Park, Y., & McElligott, S. (2019). Initial Institutional Experience With Cryoablation Therapy for Breast Fibroadenomas: Technique, Molecular Science, and Post‐Therapy Imaging Follow‐up. Journal of Ultrasound in Medicine, 38(10), 2769-2776.

The American Society of Breast Surgeons (ASBrS) Oct. 2018 Guidelines found cryoablation of fibroadenomas to be similar in efficacy and safety to open surgical excision. According to the guidelines of ASBrS, lesions less than 4 cm in largest diameter can be treated with cryoablation.

IceCure’s liquid nitrogen cryoablation system, ProSense™, has been used for treating fibroadenomas successfully since 2012.

Cryoablation for Breast Cancer: Clinical Trials

There is increasing interest by breast surgeons, breast radiologists, and interventional radiologists in the use of cryoablation for breast cancer. The number of clinical publications and studies on this topic continues to grow. There are several landmark studies that helped to pave the way for clinical trials in the treatment of early stage, low-risk breast cancer.

ACOSOG trial (2008) (completed in 2013)

The ACOSOG multicenter phase II clinical trial showed cryoablation was highly effective for treating tumors <1 cm. In this study, patients underwent surgical resection of the primary tumor within 28 days of the cryoablation. Results showed that when multifocal disease outside of the targeted cryoablation zone was not defined as ablation failure, 92% of the lesions were completely ablated (100% of the lesions <1 cm; 8% Ipsilateral breast tumor recurrence (IBTR).

FROST – Freezing Instead of Removal of Small Tumors (2013) (completed in 2021)

The FROST trial aimed to investigate the use of cryoablation in place of surgical excision for patients aged 50 and above with early stage, invasive breast cancer. Criteria for Inclusion in the FROST trial were a primary invasive breast carcinoma ≤1.5 cm in diameter, hormone receptor-positive, Her2 negative, with <25% intraductal component. The primary goal was to evaluate successful tumor ablation, defined as absence of residual viable invasive or in situ carcinoma at 6-months post-cryoablation biopsy. Patients underwent US-guided cryoablation followed by adjuvant hormonal therapy and serial imaging exams.

ICE3 trial (2014 – will be complete in 2024)

The ICE3 trial was the first ever cryoablation trial that did not involve follow-up surgical excision of the tumor. The trial has completed the recruitment of 206 patients in 19 hospitals and medical centers across the US, including Columbia University Medical Center and Mount Sinai Beth Israel.

An interim analysis performed in July 2022 studied 194 patients 60 years of age or older with unifocal invasive ductal cancers measuring ≤1.5 cm. Tumors were all low-grade (Nottingham grade 1-2 tumors), HR+, HER2-, consistent with a low-risk form of the disease. Women were treated with a cryoablation freeze-thaw-freeze cycle for 20 to 40 minutes. ​Patients are followed up with mammograms every 6 months and then annually for up to five years.

As of July 2022, 96.91% of patients were recurrence free (188 out of the 194 eligible patients did not have recurrence). No significant device related adverse events were reported, and 100% of patients and treating physicians reported satisfaction with the cosmetic results.

ICE3 case report #3: After 8 months necrotic tissue completely covering lesion

fig 2. ICE3 case report #3: After 8 months necrotic tissue completely covering lesion

New hope for breast cancer patients

For over 70 years, cryoablation has been used to treat a wide variety of cancers, including musculoskeletal, lung, liver, breast, kidney and prostate. The treatment has been found to significantly reduce tumor size and pain in patients.

The interim results of the ICE3 clinical trial on cryoablation of small, low-risk breast cancers present a promising new minimally invasive and minimal risk breast cancer treatment option – no severe device related adverse events were reported (4), 96.91% of patients were recurrence free, and 100% of patients and physicians were satisfied with the cosmetic results.

The ProSense™ Cryoablation System is considered an optimal solution for treating a selected group of early stage, low risk breast cancer patients. In Europe and many other countries, cryoablation is approved for breast cancer treatment. ProSense has received FDA clearance for the treatment of fibroadenoma and has been granted FDA Breakthrough Device Designation. While the US still awaits FDA clearance for the breast cancer procedure, ASBrS guidelines recommend participation in breast cryoablation registries and clinical trials to evaluate the use of percutaneous ablative technology with or without surgical excision of a breast malignancy, as early data suggests its efficacy.

With promising results and the potential for more accessible and less invasive treatment options, cryoablation treatment offers new hope for appropriately selected low risk breast cancer patients.

To receive a demo or to learn more about the ProSense™ liquid nitrogen cryoablation system currently under investigation in the landmark ICE3 trial, visit here.


  1. Niu L. et al. Cryosurgery for breast fibroadenomas. Gland Surg. 2012 Aug; 1(2): 128–131.
  2. Littrup P. J. et al. Cryotherapy for breast fibroadenomas. Radiology. 2005 Jan;234(1):63-72.
  3. Golatta M. et al. Ultrasound-guided cryoablation of breast fibroadenoma: a pilot trial. Arch Gynecol Obstet. 2015 Jun;291(6):1355-60.
  4. Fine, R.E. et al. Cryoablation without excision for low-risk early-stage breast cancer: 3-year interim analysis of ipsilateral breast tumor recurrence in the ICE3 Trial. Ann Surg Oncol. 2021 Aug; 28(10): 5525-5534

* IceCure Medical, LTD’s cryoablation systems are not currently cleared for breast cancer treatment in the United States. Please check that the clinical indications discussed in this article have regulatory clearance for you use in your country.