In 2019, I had cyroablation for my invasive ductal breast cancer. The 45-minute procedure was performed at City of Hope, one of the many facilities that took part in the FROST trial conducted by lead investigator Dennis Holmes, MD. The goal of the trial was to determine if this minimally invasive procedure, which freezes the tumor, was a viable alternative to lumpectomy and a new standard of care for smaller invasive tumors.

Then COVID hit, and the trial was discontinued as cancer hospitals turned their focus towards saving lives during the pandemic.

While the trial was sidelined, early studies showed very promising results (over 99% efficacy rates)¹ and Dr. Holmes and others across the country continued to perform the procedure on invasive ductal carcinomas with significant results. You may have read the story about my new-found friend, Leith Sharp, (Desert Health Sept/Oct 2023) who flew from Australia to have the procedure performed by Holmes.

Holmes has now launched a new clinical trial on ductal carcinoma in situ (DCIS) which aims to prevent stage 0 breast cancer from becoming stage 1 by treating it with cryoablation before it has had a chance to progress. The procedure is performed at no charge to trial participants thanks to support from the Helen Rey Breast Cancer Research Foundation which covers the equipment cost. As lead investigator, Holmes volunteers his time for the treatment which is performed in his Glendale, CA office.

Cryoablation creates an “iceball” that engulfs the tumor and kills it.

Cryoablation is currently FDA approved for other cancers such as prostate, liver and kidney, but has yet to be federally approved for breast cancers. The technology uses a needle-sized, ultrasound-guided probe that circulates liquid nitrogen within a targeted area creating an “iceball” that engulfs the tumor and kills it. The minimally invasive procedure takes less than an hour and is done on an outpatient basis using local anesthesia. Recovery time is days versus weeks, and the patient’s breasts are left intact with no change in structure and little to no scarring.

This is great news for those seeking less invasive options. The procedure worked well for me, and this year will be my fifth, and hopefully last, year of returning to City of Hope for follow up imaging, which to date has shown no signs of returning cancer.

And it is important to note that I only did cryoablation with no follow up radiation or hormone therapy which was required to participate in the FROST trial. I selected not to do those therapies and to focus on holistic modalities. City of Hope agreed to do the procedure off protocol (outside of the trial) and it was covered by insurance.

It is my understanding that City of Hope is not currently offering cryoablation for breast cancer. For this article, I was eager to get information out about this new trial and did not research facilities currently offering cryoablation for different types of breast cancer. So, if you are seeking that information, please speak with your current medical team, or contact Holmes’ office.

Following is a synopsis of the new trial as provided by Holmes in a recent newsletter:

Trial study name: Prevention of Invasive Breast Cancer with Cryoablation

Nearly every invasive breast cancer begins its life as ductal carcinoma in situ (DCIS), which is commonly called pre-invasive breast cancer or non-invasive breast cancer. If not for the risk of invasive cancer and its potential to metastasize, surgical removal of DCIS would be completely unnecessary.

Cryoablation (tumor freezing) is a minimally invasive office procedure that has the potential to replace surgery as the main invasive cancer prevention option for women with small areas of DCIS. In this study, cryoablation will provide a minimally-invasive breast cancer treatment option for women with DCIS measuring 2 cm or less based on standard breast imaging (ultrasound, mammogram, +/- optional breast MRI).

In this study, eligible women will undergo cryoablation of DCIS instead of surgery. Six months after cryoablation, all participants will undergo a repeat needle biopsy of the original site to confirm complete killing of the DCIS. In addition, prior to cryoablation, most women will require insertion of an ultrasound-visible biopsy site marker to make it easier to accurately target the site of DCIS at the time of the procedure.

The need for radiation and/or anti-cancer medications will be determined by your personal oncologist. All study participants are expected to continue annual mammograms.

Patients will not be charged for the cryoablation procedure. All other standard breast procedures will be billed to the insurer. Usual insurance deductibles may still apply.

Eligibility:

Women age 18 and older.
DCIS spanning 2 cm or less based on its radiographic appearance by mammography and/or breast contrast-enhanced MRI.
Diagnosis of DCIS by needle biopsy.
No prior history of DCIS or invasive breast cancer in the same breast.
No history of surgical biopsy and/or lumpectomy for diagnosis/treatment in the same breast.
Adequate breast volume and skin clearance to permit cryoablation as assessed by Dr. Holmes. (This excludes male and females with breasts too small to allow safe cryoablation.)
Non-pregnant, non-lactating and no history of pregnancy within the preceding
six months.
No history of breast radiation in the same breast.

What’s involved in the study?

To be evaluated for the study, you must have an initial consultation with Dr. Holmes.
The initial consultation and follow-up visits may be performed via telehealth.
Cryoablation will be performed in Glendale, CA by Dr. Holmes.
Radiology procedures may be performed by your local radiologist.

More information about the trial can be found at www.clinicaltrials.gov. To learn more about cryoablation, visit www.cryoablation.com. If you have done your research and feel you may be a candidate for the trial, contact research coordinator Allison Zimmerman at [email protected]. (818) 539.1985.

Lauren Del Sarto is founder/publisher of Desert Health and may be reached at
[email protected]. For more information on Lauren’s cancer journey, visit www.deserthealthnews.com/health-categories/laurens-cancer-journey.

Reference: 1) https://press.rsna.org/timssnet/media/pressreleases/14_pr_target.cfm?id=2053