FROST Trial

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Background

Cryoablation is available to participants in the Freezing Instead of Removal Of Small Tumors (FROST) Trial, a national study of the use of cryoablation in the treatment of early-stage breast cancer. Dr. Holmes designed and serves as chair of this national trial.  

What is Cryoablation?

Cryoablation is a groundbreaking new treatment for breast tumor freezing.  Cryoablation has been used for many years on liver, skin, and cervical cancers, as well as, benign tumors within the breast.  However, cryoablation has only recently been adapted to treat breast cancer.  

Eligibility and Exclusion Criteria

Study Status: Recruitment and Follow-up Ongoing


Inclusion Criteria:

  1. Age ≥ 50
  2. Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy
  3. Maximum tumor size ≤1.5 cm in its greatest diameter
  4. Ultrasound visible lesion(s)
  5. Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25% intraductal component in the aggregate.
  6. Unilateral or bilateral disease meeting study criteria
  7. Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis
  8. Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease

Exclusion Criteria:

  1. Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer
  2. Ductal carcinoma in-situ with microinvasions (T1mic)
  3. Multifocal or multicentric invasive breast carcinoma
  4. Prior or planned neoadjuvant systemic therapy for breast cancer
  5. Tumor with ≥25% IDC components

Sponsors and Collaborators

Sanarus Technologies, Inc.

Clinical Trials.gov Identifier

NCT01992250

Study Contact

Allison Zimmerman

Research Coordinator and Assistant

(818) 539-1985

450 N Roxbury Drive, Suite 602

Beverly Hills, CA 90210