Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

Breast Cancer Clinical Trial

— FROST  

Official title:

Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01992250
• Other study ID #: CP-00-0011
• Status: Recruiting
• Phase: N/A
• First received: November 6, 2013
• Last updated: April 19, 2018
• Start date: November 2013
• Est. completion date: June 2023

Study information

• Verified date: April 2018
• Source: Sanarus Technologies, Inc.
• Contact: Pamela Ellis
• Phone: (925) 460-6080
• Email: clinical[@]sanarus.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.

Description:

PURPOSE:

To 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.

OUTLINE:

1. Core Biopsy (Pre-Registration)

2. Magnetic Resonance Imaging (Pre-Registration)

3. Tumor Cryoablation

4. Core Biopsy (Post-Cryoablation)

5. Magnetic Resonance Imaging (Post-Cryoablation)

6. Postoperative Follow-up

7. Evaluation of outcomes

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2023
• Est. primary completion date: December 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Visica 2 Treatment System
Cryoablation

Locations

Country	Name	City	State
United States	90210 Surgery Medical Center	Beverly Hills	California
United States	City of Hope	Duarte	California
United States	Epic Care	Emeryville	California
United States	Knoxville Comprehensive Breast Center	Knoxville	Tennessee
United States	Texas Tech University Health Sciences Center	Lubbock	Texas
United States	Diagnostic Center for Women, LLC	Miami	Florida
United States	Naples Community Hospital	Naples	Florida
United States	Ogden Regional Hospital	Ogden	Utah
United States	Rhode Island Hospital	Providence	Rhode Island
United States	Ascension Crittenton Hospital	Rochester	Michigan
United States	Arizona Breastnet	Scottsdale	Arizona
United States	Lankenau Medical Center	Wynnewood	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Sanarus Technologies, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor ablation occurence	Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma. Will be determined at 6-month post-cryoablation biopsy. Residual disease will require surgery.	Within 6 months
Secondary	Local tumor recurrence		Within 5 years
Secondary	Satisfactory breast cosmesis results		5 Years
Secondary	Adverse event assessment		5 years