This Phase 2/3 trial in California and Texas aims to test the effectiveness of cyroablation for the treatment of breast cancer. The main outcome measures will include biopsy (sample of tissue is removed to test for prescence of cancer) and magnetic resonance imaging (MRI, scan that uses magnetic fields to image body tissues).
The details
Cryoablation uses extreme cold to destroy tissue. The most common use is to treat solid tumors, for example small breast tumors. An advantage of the technique is that it does not require surgery. However, more research is needed before it can replace surgical tumor removal. The investigators would like to test the success of cryoablation in removing small breast tumors.
Who are they looking for?
This study will recruit 200 female participants aged 50 years and older with a diagnosis of a small primary breast cancer tumor. Participants must be able to undergo MRI scans and agree to receive a 5-year course of hormone therapy after cryoablation (normal procedure following breast cancer treatment).
The study is not enrolling subjects who have had previous surgical removal of breast cancer or those who have already had pre-treatment for breast cancer (for example to shrink the tumor before surgery).
How will it work
Participants will receive a core biopsy (where a special needle is inserted into the breast to take a sample of tissue) followed by an MRI scan to visualize the tumor. Participants will then have tumor cryoablation using the Visica 2 Treatment System.
Follow-up tests over 6 months include another core biopsy and MRI to check the effectiveness of the procedure to remove the tumor.
