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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
200

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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 Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sanarus Technologies, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2013

Primary Completion (Anticipated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 1, 2021

Study Completion (Anticipated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 6, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 18, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 25, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 20, 2018

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 19, 2018

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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