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Cryoablation Offers Hope for Elderly Breast Cancer Patients
21 Aug
Summary
- Study assesses cryoablation for early-stage breast cancer in women 70+.
- ProSense is the only FDA-approved device for this patient group.
- Study to enroll 400 patients across 30 sites in the US.
The West Cancer Center & Research Institute in Germantown, Tennessee, has received Institutional Review Board approval to commence patient enrollment for the ChoICE Study. This clinical trial will investigate the effectiveness of IceCure Medical's ProSense cryoablation system.
The study specifically targets early-stage, low-risk breast cancer in women aged 70 and above. ProSense has received US Food and Drug Administration (FDA) marketing authorization, uniquely positioning it as the sole device suitable for concurrent use with endocrine therapy in this demographic.
This research aims to gather further real-world evidence on ProSense's efficacy for tumors up to 1.5cm, particularly benefiting patients who may not be candidates for surgery. Previous trials, like the ICE3 study, showed a 3.1% local recurrence rate with ProSense followed by endocrine therapy, with high patient and physician satisfaction regarding cosmetic outcomes.
The ChoICE Study will involve 400 patients across 30 sites. This broad participation is designed to increase access to the minimally invasive cryoablation procedure. Dr. Richard Gilmore, a breast surgical oncologist at Margaret West Comprehensive Breast Center, will lead the site's involvement.
