FROST Clinical Study
Freezing Alone Instead of Resection of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer (FROST).The FROST Clinical Study, sponsored by Sanarus Technologies, examines the use of cryoablation as an alternative to surgical resection for the management of primary early stage invasive breast cancer. This study is intended to assess the outcomes of cryoablation alone as an alternative to standard breast surgery (lumpectomy) in malignant tumors ≤1.5 cm. This is a phase ll clinical trial, of the Z1072 trial which showed 100% ablation success in all breast tumors <1.0 cm.
The FROST Study is currently enrolling patients at participating sites nationwide.
How Do I Enroll?
Your physician will evaluate your particular case and determine eligibility as a participant in this study. Pre-study tests will be done as well as post-study MRIs, mammograms, and biopsies throughout a 5-year follow up period.
Participants Must Have the Following:
- Age: 50 and older
- A cancer that is ≤1.5 cm in its greatest diameter
- A cancer that has not spread to other organs
- A cancer that is strongly sensitive to estrogen
- No prior treatment of the current breast cancer
- Neither radiation therapy nor chemotherapy will be routinely performed in subjects of Stratum 1 ≥70 years
Should I Participate in FROST?
For the past 15 years, cryoablation has provided a minimally invasive and highly effective treatment option for both benign breast tumors and other types of cancer outside of the breast. Information from this study will help physicians and researchers understand and learn more about cryoablation as an alternative to surgical treatment for early stage breast cancer.
Should I Participate in a Clinical Study?
Taking part in a clinical study is one way of making a contribution to the advancement of medical technology and to receive the newest forms of treatment. Your decision to participate should be made only with a full understanding of the risks involved. Consult your physician before deciding.
If you would like more information or find a physician near you, please contact us.
You can also find additional information about FROST Clinical Study on clinicaltrials.gov
To view the FROST Brochure, click here