FROST Clinical Study for Nonsurgical Treatment of Early Stage Breast Cancer Recruiting Patients

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Sponsored by Sanarus Technologies, the FROST study examines the use of cryoablation as an alternative to surgery for management of primary early stage breast cancer.

Dr. Dennis Holmes

Cryoablation is a very promising alternative to traditional surgery for early stage breast cancer.

Sanarus Technologies, developers of the Visica® 2 Treatment System, is currently enrolling patients for the FROST clinical study, “Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer.” The FROST study is a phase II single-arm multicenter clinical trial that examines the use of cryoablation as an alternative to surgical resection for the management of primary early stage invasive breast cancer.

Cryoablation, also called percutaneous cryotherapy, is a minimally invasive treatment that uses extreme cold to destroy diseased tissue, including cancer cells. During breast cryoablation with the Visica 2 Treatment System, a hollow-tipped probe is placed into the tumor under ultrasound guidance. Liquid nitrogen passes through the probe and forms an ice ball around the lesion in a closed-loop system. The intense cold freezes the tumor, causing cell destruction. The procedure generally takes about 30 minutes and is done under local anesthesia in a physician’s office or outpatient setting. Cryoablation is often used to treat skin conditions, as well as tumors in the lungs, kidneys, prostate and liver. The primary goal of the FROST study is to determine the rate of complete tumor ablation (destruction) and absence of residual breast carcinoma as a result of treatment with cryoablation alone.

Breast cryoablation has already been shown to be a safe and effective minimally invasive alternative to lumpectomy in earlier studies. The current clinical study is a follow-up to the landmark National Cancer Institute-sponsored study “ACOSOG (Alliance) Z1072” trial which showed 100% ablation success in all breast tumors less than 1.0 cm and was effective in 92% of all targeted tumors. The Visica 2 Treatment System was the exclusive device used in the Z1072 study.

FROST investigators are actively recruiting 200 female patients, 50+ years of age, at 20 locations nationwide. The study will track the breast tumor recurrence rates, assess breast cosmesis post-treatment, record adverse events and provide 5-year follow-up. To date, nine centers are participating in the study, with 50 centers requesting inclusion in the 11 slots remaining. Patient eligibility requirements include unifocal primary invasive breast cancer diagnosed by core needle biopsy; maximum tumor size less than or equal to 1.5 cmI; adequate breast size with 0.5 cm margins between the ablated lesion and the skin; tumor distance greater than 3mm from the chest wall or muscle. Cryoablation will be done with the Visica 2 Treatment System.

“Cryoablation is a very promising alternative to traditional surgery for early stage breast cancer,” said Dennis R. Holmes, M.D., FACS, lead investigator of the FROST study. “Cryoablation minimizes changes in breast volume and nipple position, avoids prominent scars, and eliminates many of the side effects of breast cancer surgery. The outstanding results of Z1072 inspired me to start the FROST clinical study, which will eliminate the need for surgery for many women with early stage breast cancer.”

Currently, the standard of care for early stage breast cancer is surgery and sentinel node biopsy, followed by radiotherapy and endocrine and/or chemotherapy. Cryoablation is a minimally invasive alternative to lumpectomy that can destroy early stage tumors, often mitigating the need for adjuvant treatment. In addition, preliminary studies suggest that cryoablation may initiate an anti-cancer immune response, leading to a reduction in the rate of recurrence. After treatment with cryoablation, there is virtually no scarring or disfigurement of the breast. Discomfort following the procedure is mild, with most patients resuming normal activity relatively quickly.

“Less is more with cryoablation of breast cancers,” said Dr. Michael Plaza, breast radiologist and FROST trial investigator at the Diagnostic Center for Women in Miami. “This study is an important step that may lead to a new era in which we treat early stage breast cancer with minimally invasive cryoablation, rather than lumpectomy or mastectomy. We hope that cryoablation will prove to be as effective as surgery, but without the need for general anesthesia and prolonged recovery time.”

To find out more about the FROST clinical study, visit clinicaltrials.gov. To find a physician who specializes in this procedure, contact Sanarus Technologies at 800-909-3060 or send an email to: support@sanarus.com.

About Sanarus Technologies 
In 2001, the Visica® 2 Treatment System was the first device available for cryoablation of fibroadenomas. Since then, our system has been used to successfully treat thousands of patients. The Visica 2 Treatment System is FDA-cleared for the ablation of cancerous or malignant tissue and benign tumors. At Sanarus, we develop innovative solutions for the nonsurgical treatment of breast tumors. We are headquartered in Pleasanton, CA, and all our products are manufactured in the USA. Find out more at http://www.sanarus.com.

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Karen Hambly
@SanarusTech
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