09 Jun Nonsurgical Clinical Study for Early Stage Breast Cancer Now Recruiting Patients
The FROST clinical study examines the use of cryoablation as an alternative to surgery to treat primary early stage invasive breast cancer. 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” is now recruiting patients for its phase ll clinical trial. A phase II trial means that the procedure has already been shown to be safe in earlier studies. The FROST study is a follow-up to the Z1072 trial which showed 100% ablation success in all breast tumors <1.0 cm.
Cryoablation, or tumor freezing, is a minimally invasive alternative to lumpectomy that destroys the cancer without changing the shape of the breast and is used to treat early stage breast cancers. The hypothesis is that this method will dissipate and destroy the tumor in a select population of women who may otherwise be treated with surgery.
In addition to its no-disfigurement, virtually no-scar advantages, studies indicate that cryoablation may trigger an anti-cancer immune response. That means that the immune system begins to seek out and destroy cancer cells, helping to reduce the rate of recurrence. Other benefits of cryoablation include procedure time being less than an hour and light/ normal activity can be resumed right away.
The study is sponsored by Sanarus Technologies, an advanced cryoablation company that produces the Visica® 2 Treatment System.
Who can join this study?
• Female age 50 or older
• Unifocal primary invasive breast cancer diagnosed by core needle biopsy
• Maximum tumor size ≤1.5 cm based on mammography, ultrasound and MRI
• Adequate breast size with 1 cm margins between the ablated lesion and the skin
• Tumor distance > 3mm from chest wall or muscle
To find out more about the FROST clinical study visit sanarus.com or send an email to FROST@sanarus.com