The ICE3 Clinical Trial: Cryoablation of Early-Stage, Low-Risk Breast Cancer
The ICE3 Clinical Trial is the largest multi-center clinical trial ever completed for liquid-nitrogen (LN2) – based cryoablation for patients with low-risk, early-stage breast cancer without surgically removing the breast tumor.
ProSense® is cleared for the treatment of breast cancer in select markets; please contact us for more information about availability in your region.
The ICE3 Clinical Trial: Cryoablation of Early-Stage, Low-Risk Breast Cancer
The ICE3 Clinical Trial is the largest multi-center clinical trial ever completed for liquid-nitrogen (LN2) – based cryoablation for patients with low-risk, early-stage breast cancer without surgically removing the breast tumor.
ICE3 Trial – Positive 5-Year Results
5-year results from this clinical study provide evidence to assess the safety and efficacy for the ProSense® cryotherapy treatment of low-risk, early-stage breast cancer.
3.1%
Rate of Local Recurrence
Patients treated with cryoablation
and endocrine therapy*
99.1%
Patients
97%
Physicians
Very satisfied or satisfied
with cosmetic outcome
Recovery
To Normal Activity (Median 1 day)
Patients experienced recovery to normal activity within median 1 day recovery time (range of 0-8 days).
READ THE PUBLICATION: Fine, R.E., Gilmore, R.C., Tomkovich, K.R. et al. Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence. Ann Surg Oncol 31, 7273–7283 (2024): https://doi.org/10.1245/s10434-024-16181-0
How was the ICE3
Trial Conducted?
The ICE3 clinical study by IceCure Medical was a prospective, single arm, nonrandomized clinical trial conducted across 19 sites in the United States. The study was designed to evaluate the safety and efficacy of the ProSense® cryoablation system for treatment of women aged 50 and over with early stage, low risk breast cancer.
206 subjects were enrolled and received cryoablation. Out of those patients, 194 patients met the eligibility criteria and received cryoablation treatment as required by the study protocol. The mean age of these patients was 74.9 (±6.9) years (range 55–94 years) with a mean follow-up period of 54.16 (± 13.07) months. 41 patients (21.1%) from the study group were under the age of 70.
The ICE3 clinical study results provide evidence to assess the safety and effectiveness of the ProSense® Cryoablation System for treatment of women aged 70 and over with early stage, low risk breast cancer receiving adjuvant endocrine therapy (also known as hormonal therapy).
3.1% of patients treated with cryoablation and endocrine therapy (also known as hormone or hormonal therapy), are estimated to experience local recurrence of breast cancer within 5-years after treatment, based on the study results.
The recurrence rate is being further evaluated in a larger patient population through an ongoing post-market study. For more information on ICE3 and patient benefits and risks, please read our patient leaflet.
