Cryoablation Without Excision for Low-Risk Early-Stage Breast Cancer: 3-Year Interim Analysis of Ipsilateral Breast Tumor Recurrence in the ICE3 Trial

Summary: 194 eligible patients were treated with cryoablation. At a mean of 34.83 months (about 3 years) following treatment with the ProSense™ Cryoablation System, only 2.06% (4 patients) experienced cancer recurrence. The 36-month local Failure Free Probability is 99.22%. The statistical analysis presented by Dr. Fine indicates that among patients treated with ProSense™, the chance of non-recurrence in a population of patients with low-risk breast cancer, in early stages, and up to 1.5 cm tumor size, for a period of up to three years, is between 94.58%% and 99.89%%, with a statistical significance (confidence level) of 95%. No significant device-related adverse events were reported. 95% percent of patients and 98% of treating physicians reported satisfaction with the cosmetic results.