Clinical trial tests effectiveness of freezing breast tumors to kill cancer cells

November 6, 2017

Rhode Island Hospital is one of only 10 sites in the nation studying the effectiveness of freezing tumor cells to treat small malignant breast tumors.

Cryoablation – killing cancer cells with extreme cold – is a promising treatment for small, early-stage breast tumors. Most women diagnosed with small malignant breast tumors typically have them removed surgically – before beginning a regimen of other cancer treatments.

"This minimally invasive procedure takes just 15 to 30 minutes, requires very little recovery time and only local anesthesia, is less costly and causes no scarring or tissue deformities," said Robert C. Ward, M.D., a radiologist at the Anne C. Pappas Center for Breast Imaging and the lead investigator for the clinical trial.

Rhode Island Hospital, where the center is located, is the only hospital in New England participating in the so-called FROST clinical trial. The study, expected to span 10 years, is sponsored by Sanarus Technologies, maker of the medical equipment that is being used in the study.

During the research procedure, a small needle guided by ultrasound is inserted through a small incision in the breast and is then used to freeze the tumor, thaw it, and freeze it a second time. The tumor dies and is then naturally resorbed by the body over time. The procedure can be performed in an office setting rather than an operating room.

"Patients leave with a Band-Aid," Dr. Ward said.

Rhode Island Hospital's participation in the study began late this summer. The hospital is recruiting women ages 50 and up whose biopsies have revealed an invasive tumor no greater than 1.5 centimeters in diameter. The malignancy must not have spread into any lymph nodes and must be hormone receptor positive and HER2 negative.

“The National Cancer Institute sponsored a prior study which demonstrated that cryoablation was effective in 92 percent of the lesions targeted,” Dr. Ward said.

While cryoablation is significantly different compared with surgical excision, everything else about a patient's care for breast cancer remains the same, Dr. Ward said. For example, trial patients will undergo hormone (endocrine) therapy, which is typical for women with early-stage breast cancer.

The goal of the study is to enroll about 200 patients in the trial and then check for any sign of the tumor recurring at six-month intervals for five years.
"It has the potential to become the new standard of care for certain women with breast cancer," said Dr. Ward. "Of course, we have to do these studies and see if that will bear out."

For patients or doctors who want to learn more about the trial at Rhode Island Hospital, please contact research coordinator Liz Morrell at (401) 444-2277.

Richard Salit

The Miriam Hospital
401-793-7484
richard.salit@lifespan.org