The current standard of care for early-stage breast cancers is lumpectomy. For decades, the question has not been whether more can be done, but whether the evidence supports doing less.

The six-year outcomes of the Freezing Instead of Resection of Small Tumors (FROST) trial, recently published in the Annals of Surgical Oncology, represent a meaningful step toward answering that question.

Freezing tumors, or cryoablation, is an FDA-approved procedure used for many types of cancers, including liver, kidney, prostate and lung. However, its use for breast cancer has been in clinical trials for the past two decades.¹

Each year, I publish the latest developments on cryoablation for breast cancer, as it was the procedure I chose in 2019, at the age of 54, for my early-stage invasive ductal carcinoma. I remain cancer-free today and am an advocate for this less invasive procedure as an accepted “standard of care” for many early stage breast cancers.

First FDA approval

On October 3, 2025, the FDA approved the ProSense (IceCure) cryoprobe for cryoablation treatment of early-stage breast cancer based on the favorable results of the ICE3 Trial, a second clinical trial that established the safety and effectiveness of cryoablation in the management of early-stage invasive breast cancer.² This landmark FDA approval applies specifically to women 70 years of age or older with low-risk, estrogen-sensitive and HER2-negative invasive ductal carcinoma, and a tumor size equal to or less than 1.5 cm.³

While this approval is limited, it opens the door to future progress, says leading advocate and FROST study investigator Dennis R. Holmes, MD, FACS. “This approval represents an important first step toward expanding access to breast cancer cryoablation nationwide.” He adds that insurance coverage is not yet guaranteed and that establishing reimbursement pathways, such as dedicated billing codes, will be essential to achieving widespread coverage.

Follow-up study seeking participants

As a condition of FDA approval, IceCure will conduct a multicenter post-market study involving approximately 400 patients to further evaluate the safety and effectiveness of breast cancer cryoablation. The study, known as the ChoICE Trial, is expected to open in Southern California this month (July) and will continue enrollment and follow-up over the next 2–3 years.

The cost of the cryoablation procedure will be billed to insurance when coverage is available. For eligible patients whose insurance does not cover the procedure, treatment may be provided at no cost through the study.

Holmes, a breast cancer surgeon and cryoablation researcher with more than
20 years of experience in breast cryoablation, will serve as a participating investigator in the ChoICE Trial.

Participant inclusion criteria include:

70 years of age or older
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
- A single site of disease
- Tumor size equal to or smaller than 1.5 cm in greatest diameter as measured by breast ultrasound
- Estrogen receptor positive (ER+), progesterone receptor positive (PR+) and HER2 negative (HER2-)
- Low-risk tumor biology
- No evidence of lymph node involvement

All study participants will be required to receive endocrine (anti-estrogen) therapy as part of the treatment protocol. Sentinel lymph node biopsy and radiation therapy will be optional and may be performed at the discretion of the patient and treating physicians.

Participants will be followed closely after treatment, with follow-up visits every six months during the first year and annually thereafter for a total follow-up period of five years. Follow-up evaluations will include physical examination and breast imaging to monitor treatment outcomes and detect any evidence of recurrence.

If you feel you meet these criteria and are interested in participating in the trial, reach out to Dr. Holmes’ office at Sam and Grace Carvajal Comprehensive Breast Cancer, Adventist Health Glendale, 1-800-508-CRYO (2796).

FROST trial results published

The FROST trial represented a minimally invasive alternative for early-stage breast cancers. On January 15, 2026, outcomes for the six-year clinical trial were published in the Annals of Surgical Oncology.³ The prospective study evaluated the effectiveness and safety of cryoablation for stage I breast cancer in women 50 years and older with estrogen-sensitive, HER2-negative invasive ductal carcinoma. All participants received anti-estrogen therapy; radiation therapy was recommended only for women younger than 70 years; and lymph node surgery was optional for all patients.

Holmes, the principal investigator of this national, multicenter clinical trial, summarizes the key study findings as such:⁴

5-year local recurrence rate: 3.6%
- Demonstrating cryoablation is as effective as lumpectomy in similar women
5-year local recurrence rate in women 70 and older: 2.1%
97.5% of participants safely avoided lymph node surgery.
Side effects were mild for both cryoablation and radiation therapy.
No breast cancer–related deaths and no distant recurrences were observed.
Anti-estrogen therapy remains essential after cryoablation for reducing the risk of recurrence in the breast, lymph nodes, and beyond, just as it is
following lumpectomy.
Radiation therapy benefits women under 70, reducing recurrence risk similarly to its role after lumpectomy.

As stated, the trial demonstrated that cryoablation is as effective as lumpectomy in women with similar tumor characteristics. These findings are significant and contribute to the growing consensus that surgical de-escalation—when matched to appropriate tumor biology and patient profile—does not compromise outcomes.

“Special thanks to the pioneering women who participated in this study and made this research possible,” says Holmes.

With these advances, cryoablation for breast cancer is finally evolving from a fringe alternative to an increasingly legitimate option. Holmes, who offers cryoablation outside of trials for those who do not qualify, has written a book that launches this fall with pre-orders available at
www.globepequot.com. His goal is to help patients understand the treatment and whether cryoablation is right for them.

Lauren Del Sarto is founder/publisher of Desert Health. For more information on cryoablation for breast cancer, visit Dr. Holmes website at www.cryoablation.com. For more information on Lauren’s cancer journey, search ‘cryoablation’.

References: 1) https://pmc.ncbi.nlm.nih.gov/articles/PMC4805614/; 2) https://pubmed.ncbi.nlm.nih.gov/39283572/; 3) https://ir.icecure-medical.com/news-events/press-releases/detail/191/icecure-medicals-prosense-cryoablation-granted-fda-marketing-authorization-for-treatment-of-low-risk-breast-cancer-in-women-aged-70-and-above-significant-development-in-giving-women-with-breast-cancer-minimally-invasive-care; 4) Holmes DR, Manoian S, Layeequr Rahman R, et al. Cryoablation: A Minimally Invasive Alternative for Early-Stage Breast Cancer: 6-Year Outcomes of the FROST Clinical Trial. Ann Surg Oncol. 2026;33:3374–3382; 5) L.A. Breast Chronicles newsletter, Dennis R. Holmes, MD, F.A.C.S, January 18, 2026.