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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01992250
Recruitment Status : Unknown
Verified April 2018 by Sanarus Technologies, Inc..
Recruitment status was:  Recruiting
First Posted : November 25, 2013
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sanarus Technologies, Inc.

Study Description
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Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Visica 2 Treatment System Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer
Study Start Date : November 2013
Estimated Primary Completion Date : December 2021
Estimated Study Completion Date : June 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
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 Name: Visica Breast Therapy
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 Name: Visica Breast Therapy


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Local tumor recurrence [ Time Frame: Within 5 years ]
  2. Satisfactory breast cosmesis results [ Time Frame: 5 Years ]
  3. Adverse event assessment [ Time Frame: 5 years ]

Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01992250


Contacts
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Contact: Pamela Ellis (925) 460-6080 clinical@sanarus.com

Locations
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United States, Arizona
Arizona Breastnet Recruiting
Scottsdale, Arizona, United States, 85260
Contact: Tracey Peters    480-314-7600    tracey@breastnet.net   
Principal Investigator: Belinda Barcley-White, MD         
United States, California
90210 Surgery Medical Center Recruiting
Beverly Hills, California, United States, 90210
Contact: Gerald Coronado    310-651-2050    gerald@drholmesmd.com   
Principal Investigator: Dennis R. Holmes, MD, FACS         
City of Hope Recruiting
Duarte, California, United States, 91010
Contact: Blanca Mendez, BSHS CRCII    626-218-0433 ext 80433    blmendez@coh.org   
Contact: Luci Tumyan, MD    626-218-0433 ext 80433      
Epic Care Recruiting
Emeryville, California, United States, 94608
Contact: Shoko Abe, M.D.    510-629-6682    Shoko.Abe@epic-care.com   
United States, Florida
Diagnostic Center for Women, LLC Recruiting
Miami, Florida, United States, 33173
Contact: Michael J Plaza, M.D.    305-740-5100      
Contact: Cristina Upegui    305-740-5100 ext 2004      
Naples Community Hospital Recruiting
Naples, Florida, United States, 34109
Contact: Patricia Prichard    239-624-8120    Patricia.Pritchard@nchmd.org   
Principal Investigator: Sharla Patterson, MD         
United States, Michigan
Ascension Crittenton Hospital Recruiting
Rochester, Michigan, United States, 48307
Contact: Michael Cribbs    248-652-5626    michael.cribbs@ascension.org   
Contact: Colleen Ellis       Colleen.Ellis@ascension.org   
Principal Investigator: Peter J. Littrup, M.D.         
Sub-Investigator: Julie Shultz, M.D.         
United States, Pennsylvania
Lankenau Medical Center Recruiting
Wynnewood, Pennsylvania, United States, 19096
Contact: Sharon Steinberg, BS, RN, OCN    484-476-2395    SteinbergS@MLHS.ORG   
Contact: Elene Turzo, MSN, CRNP    484-476-2649      
Principal Investigator: Ned Z Carp, M.D.         
Sub-Investigator: Jennifer L Sabol, M.D.         
Sub-Investigator: Robin Ciocca, D.O.         
United States, Rhode Island
Rhode Island Hospital Recruiting
Providence, Rhode Island, United States, 02903
Contact: Liz Lorrell    401-444-2277    emorrell@lifespan.org   
Principal Investigator: Robert Ward, M.D>         
United States, Tennessee
Knoxville Comprehensive Breast Center Recruiting
Knoxville, Tennessee, United States, 37909
Contact: Miranda Stinnett    865-583-1014    mstinnett@kcbc-center.com   
Principal Investigator: Kamilia Kozlowski, MD         
Principal Investigator: Caryn Wunderlich, MD         
United States, Texas
Texas Tech University Health Sciences Center Recruiting
Lubbock, Texas, United States, 79416
Contact: Melanie Bisbee    806-775-8597    Melanie.Bisbee@umchealthsystem.com   
Principal Investigator: Rakhshanda Rahman, MD         
United States, Utah
Ogden Regional Hospital Recruiting
Ogden, Utah, United States, 84405
Contact: Joshua Kunz    801-479-2067    joshua.kunz@mountainstarhealth.com   
Principal Investigator: Jose Tamayo, MD         
Sponsors and Collaborators
Sanarus Technologies, Inc.
Investigators
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Principal Investigator: Dennis R. Holmes, MD, FACS 90210 Surgery Medical Center
More Information
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Responsible Party: Sanarus Technologies, Inc.
ClinicalTrials.gov Identifier: NCT01992250    
Other Study ID Numbers: CP-00-0011
First Posted: November 25, 2013    Key Record Dates
Last Update Posted: April 20, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Keywords provided by Sanarus Technologies, Inc.:
Cryoablation
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases