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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Visica 2 Treatment System
Sponsored by
Sanarus Technologies, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Cryoablation

Eligibility Criteria

50 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Arizona BreastnetRecruiting
  • 90210 Surgery Medical CenterRecruiting
  • City of HopeRecruiting
  • Epic CareRecruiting
  • Diagnostic Center for Women, LLCRecruiting
  • Naples Community HospitalRecruiting
  • Ascension Crittenton HospitalRecruiting
  • Lankenau Medical CenterRecruiting
  • Rhode Island HospitalRecruiting
  • Knoxville Comprehensive Breast CenterRecruiting
  • Texas Tech University Health Sciences CenterRecruiting
  • Ogden Regional HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Low Risk - Age 70+

Moderate Risk - Age 50-69

Arm Description

Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies

Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Local tumor recurrence
Satisfactory breast cosmesis results
Adverse event assessment

Full Information

First Posted
November 6, 2013
Last Updated
April 19, 2018
Sponsor
Sanarus Technologies, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT01992250
Brief Title
Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
Acronym
FROST
Official Title
Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
April 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 2013 (undefined)
Primary Completion Date
December 2021 (Anticipated)
Study Completion Date
June 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sanarus Technologies, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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: Core Biopsy (Pre-Registration) Magnetic Resonance Imaging (Pre-Registration) Tumor Cryoablation Core Biopsy (Post-Cryoablation) Magnetic Resonance Imaging (Post-Cryoablation) Postoperative Follow-up Evaluation of outcomes

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
Cryoablation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Low Risk - Age 70+
Arm Type
Other
Arm Description
Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
Arm Title
Moderate Risk - Age 50-69
Arm Type
Other
Arm Description
Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
Intervention Type
Device
Intervention Name(s)
Visica 2 Treatment System
Other Intervention Name(s)
Visica Breast Therapy
Intervention Description
Cryoablation
Primary Outcome Measure Information:
Title
Tumor ablation occurence
Description
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.
Time Frame
Within 6 months
Secondary Outcome Measure Information:
Title
Local tumor recurrence
Time Frame
Within 5 years
Title
Satisfactory breast cosmesis results
Time Frame
5 Years
Title
Adverse event assessment
Time Frame
5 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age ≥ 50 Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy Maximum tumor size ≤1.5 cm in its greatest diameter Ultrasound visible lesion(s) Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25% intraductal component in the aggregate. Unilateral or bilateral disease meeting study criteria Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease Exclusion Criteria: Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer Ductal carcinoma in-situ with microinvasions (T1mic) Multifocal or multicentric invasive breast carcinoma Prior or planned neoadjuvant systemic therapy for breast cancer Tumor with ≥25% IDC components
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Pamela Ellis
Phone
(925) 460-6080
Email
clinical@sanarus.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dennis R. Holmes, MD, FACS
Organizational Affiliation
90210 Surgery Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Arizona Breastnet
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85260
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tracey Peters
Phone
480-314-7600
Email
tracey@breastnet.net
First Name & Middle Initial & Last Name & Degree
Belinda Barcley-White, MD
Facility Name
90210 Surgery Medical Center
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90210
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Gerald Coronado
Phone
310-651-2050
Email
gerald@drholmesmd.com
First Name & Middle Initial & Last Name & Degree
Dennis R. Holmes, MD, FACS
Facility Name
City of Hope
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Blanca Mendez, BSHS CRCII
Phone
626-218-0433
Ext
80433
Email
blmendez@coh.org
First Name & Middle Initial & Last Name & Degree
Luci Tumyan, MD
Phone
626-218-0433
Ext
80433
Facility Name
Epic Care
City
Emeryville
State/Province
California
ZIP/Postal Code
94608
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shoko Abe, M.D.
Phone
510-629-6682
Email
Shoko.Abe@epic-care.com
Facility Name
Diagnostic Center for Women, LLC
City
Miami
State/Province
Florida
ZIP/Postal Code
33173
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael J Plaza, M.D.
Phone
305-740-5100
First Name & Middle Initial & Last Name & Degree
Cristina Upegui
Phone
305-740-5100
Ext
2004
Facility Name
Naples Community Hospital
City
Naples
State/Province
Florida
ZIP/Postal Code
34109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patricia Prichard
Phone
239-624-8120
Email
Patricia.Pritchard@nchmd.org
First Name & Middle Initial & Last Name & Degree
Sharla Patterson, MD
Facility Name
Ascension Crittenton Hospital
City
Rochester
State/Province
Michigan
ZIP/Postal Code
48307
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michael Cribbs
Phone
248-652-5626
Email
michael.cribbs@ascension.org
First Name & Middle Initial & Last Name & Degree
Colleen Ellis
Email
Colleen.Ellis@ascension.org
First Name & Middle Initial & Last Name & Degree
Peter J. Littrup, M.D.
First Name & Middle Initial & Last Name & Degree
Julie Shultz, M.D.
Facility Name
Lankenau Medical Center
City
Wynnewood
State/Province
Pennsylvania
ZIP/Postal Code
19096
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sharon Steinberg, BS, RN, OCN
Phone
484-476-2395
Email
SteinbergS@MLHS.ORG
First Name & Middle Initial & Last Name & Degree
Elene Turzo, MSN, CRNP
Phone
484-476-2649
First Name & Middle Initial & Last Name & Degree
Ned Z Carp, M.D.
First Name & Middle Initial & Last Name & Degree
Jennifer L Sabol, M.D.
First Name & Middle Initial & Last Name & Degree
Robin Ciocca, D.O.
Facility Name
Rhode Island Hospital
City
Providence
State/Province
Rhode Island
ZIP/Postal Code
02903
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Liz Lorrell
Phone
401-444-2277
Email
emorrell@lifespan.org
First Name & Middle Initial & Last Name & Degree
Robert Ward, M.D>
Facility Name
Knoxville Comprehensive Breast Center
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Miranda Stinnett
Phone
865-583-1014
Email
mstinnett@kcbc-center.com
First Name & Middle Initial & Last Name & Degree
Kamilia Kozlowski, MD
First Name & Middle Initial & Last Name & Degree
Caryn Wunderlich, MD
Facility Name
Texas Tech University Health Sciences Center
City
Lubbock
State/Province
Texas
ZIP/Postal Code
79416
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Melanie Bisbee
Phone
806-775-8597
Email
Melanie.Bisbee@umchealthsystem.com
First Name & Middle Initial & Last Name & Degree
Rakhshanda Rahman, MD
Facility Name
Ogden Regional Hospital
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Kunz
Phone
801-479-2067
Email
joshua.kunz@mountainstarhealth.com
First Name & Middle Initial & Last Name & Degree
Jose Tamayo, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

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