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

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ClinicalTrials.gov Identifier: NCT01992250
Recruitment Status : Recruiting
First Posted : November 25, 2013
Last Update Posted : April 20, 2018
Sponsor:
Information provided by (Responsible Party):
Sanarus Technologies, Inc.

Tracking Information
First Submitted Date  ICMJE November 6, 2013
First Posted Date  ICMJE November 25, 2013
Last Update Posted Date April 20, 2018
Study Start Date  ICMJE November 2013
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Tumor Ablation [ Time Frame: Within 2 years ]
The rate of tumor ablation will be assessed by determining the number of patients in whom residual viable invasive or in situ carcinoma is detected by mammography, ultrasound, or MRI within the zone of cryoablation within 2 years of cryoablation.
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 28, 2015)
  • Local tumor recurrence [ Time Frame: Within 5 years ]
  • Satisfactory breast cosmesis results [ Time Frame: 5 Years ]
  • Adverse event assessment [ Time Frame: 5 years ]
Original Secondary Outcome Measures  ICMJE
 (submitted: November 18, 2013)
Axillary Failure [ Time Frame: Within 5 years ]
The axillary failure rate will be assessed by determining the number of patients who develop histologically-confirmed ipsilateral axillary node recurrence within 5 years of cryoablation.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures
 (submitted: November 18, 2013)
Local Recurrence [ Time Frame: Up to 2 years ]
The local recurrence rate will be assessed by determining the number of patients who develop a histologically-confirmed recurrence of cancer within the index quadrant, further defined as any recurrence within 5 cm of the biopsy site marker (i.e., microclip).
 
Descriptive Information
Brief Title  ICMJE Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
Official Title  ICMJE Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer
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:

  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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE Device: Visica 2 Treatment System
Cryoablation
Other Name: Visica Breast Therapy
Study Arms  ICMJE
  • Low Risk - Age 70+
    Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
    Intervention: Device: Visica 2 Treatment System
  • Moderate Risk - Age 50-69
    Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
    Intervention: Device: Visica 2 Treatment System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: May 28, 2015)
200
Original Estimated Enrollment  ICMJE
 (submitted: November 18, 2013)
99
Estimated Study Completion Date  ICMJE June 2023
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 50 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pamela Ellis (925) 460-6080 clinical@sanarus.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01992250
Other Study ID Numbers  ICMJE CP-00-0011
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party Sanarus Technologies, Inc.
Study Sponsor  ICMJE Sanarus Technologies, Inc.
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dennis R. Holmes, MD, FACS 90210 Surgery Medical Center
PRS Account Sanarus Technologies, Inc.
Verification Date April 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP