Study ID: FROST
Freezing alone instead of resection and radiotherapy of small breast tumors: a study of cryoablation in the management of prognostically favorable early-stage breast cancer in elderly women (FROST Trial)
This study is recruiting women age 50 and older who have been diagnosed with breast cancer. The study offers cryoablation as an alternative to surgery. Cryoablation with the Visica® 2 Treatment System “spot-freezes” breast tumors and kills cancer cells. This office/outpatient procedure preserves the natural shape of the breast.
* A modification of ACOSOG Z1072 Protocol
- Age ≥ 50
- Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy
- Maximum tumor size ≤1.5 cm in its greatest diameter
- Ultrasound visible lesion(s)
- Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25 percent intraductal component in the aggregate
- Patient agrees to receive a five-year minimum course of endocrine therapy following cryoablation for control of systemic disease
This study will determine the rate of successful tumor ablation in patients treated with cryoablation and endocrine therapy in a subset of patients with early-stage breast cancer.
The study process includes core biopsy (pre-registration); MRI (pre-registration); tumor cryoablation; core biopsy (post-cryoablation); MRI (post-cryoablation); postoperative follow-up and evaluation of outcomes.
- Must have been diagnosed by your oncologist with clinically node negative, hormone receptor-positive, HER2 negative breast cancer
- Must agree to at least five years of endocrine therapy following cryoblation