Cryoablation of Small Breast Tumors in Early Stage Breast Cancer (FROST)

April 19, 2018 updated by: Sanarus Technologies, Inc.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed 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

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85260
        • Recruiting
        • Arizona Breastnet
        • Contact:
        • Principal Investigator:
          • Belinda Barcley-White, MD
    • California
      • Beverly Hills, California, United States, 90210
        • Recruiting
        • 90210 Surgery Medical Center
        • Contact:
        • Principal Investigator:
          • Dennis R. Holmes, MD, FACS
      • Duarte, California, United States, 91010
        • Recruiting
        • City of Hope
        • Contact:
          • Blanca Mendez, BSHS CRCII
          • Phone Number: 80433 626-218-0433
          • Email: blmendez@coh.org
        • Contact:
          • Luci Tumyan, MD
          • Phone Number: 80433 626-218-0433
      • Emeryville, California, United States, 94608
    • Florida
      • Miami, Florida, United States, 33173
        • Recruiting
        • Diagnostic Center for Women, LLC
        • Contact:
          • Michael J Plaza, M.D.
          • Phone Number: 305-740-5100
        • Contact:
          • Cristina Upegui
          • Phone Number: 2004 305-740-5100
      • Naples, Florida, United States, 34109
        • Recruiting
        • Naples Community Hospital
        • Contact:
        • Principal Investigator:
          • Sharla Patterson, MD
    • Michigan
      • Rochester, Michigan, United States, 48307
    • Pennsylvania
      • Wynnewood, Pennsylvania, United States, 19096
        • Recruiting
        • Lankenau Medical Center
        • Contact:
        • Contact:
          • Elene Turzo, MSN, CRNP
          • Phone Number: 484-476-2649
        • Principal Investigator:
          • Ned Z Carp, M.D.
        • Sub-Investigator:
          • Jennifer L Sabol, M.D.
        • Sub-Investigator:
          • Robin Ciocca, D.O.
    • Rhode Island
      • Providence, Rhode Island, United States, 02903
        • Recruiting
        • Rhode Island Hospital
        • Contact:
        • Principal Investigator:
          • Robert Ward, M.D>
    • Tennessee
      • Knoxville, Tennessee, United States, 37909
        • Recruiting
        • Knoxville Comprehensive Breast Center
        • Principal Investigator:
          • Kamilia Kozlowski, MD
        • Contact:
        • Principal Investigator:
          • Caryn Wunderlich, MD
    • Texas
      • Lubbock, Texas, United States, 79416
        • Recruiting
        • Texas Tech University Health Sciences Center
        • Contact:
        • Principal Investigator:
          • Rakhshanda Rahman, MD
    • Utah
      • Ogden, Utah, United States, 84405

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: Low Risk - Age 70+
Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
Device: Visica 2 Treatment System
Cryoablation
Other Names:
  • Visica Breast Therapy
Other: Moderate Risk - Age 50-69
Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
Device: Visica 2 Treatment System
Cryoablation
Other Names:
  • Visica Breast Therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Tumor ablation occurence
Time Frame: Within 6 months
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 Outcome Measures

Outcome Measure
Time Frame
Local tumor recurrence
Time Frame: Within 5 years
Within 5 years
Satisfactory breast cosmesis results
Time Frame: 5 Years
5 Years
Adverse event assessment
Time Frame: 5 years
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sanarus Technologies, Inc.

Investigators

  • Principal Investigator: Dennis R. Holmes, MD, FACS, 90210 Surgery Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2013

Primary Completion (Anticipated)

December 1, 2021

Study Completion (Anticipated)

June 1, 2023

Study Registration Dates

First Submitted

November 6, 2013

First Submitted That Met QC Criteria

November 18, 2013

First Posted (Estimate)

November 25, 2013

Study Record Updates

Last Update Posted (Actual)

April 20, 2018

Last Update Submitted That Met QC Criteria

April 19, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CP-00-0011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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