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

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

Tracking Information

• First Submitted Date: November 6, 2013
• First Posted Date: November 25, 2013
• Last Update Posted Date: April 20, 2018
• Study Start Date: November 2013
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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 (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.

Current Secondary Outcome Measures (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 (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: Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
• Official Title: 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: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Non-Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Breast Cancer

Intervention

Device: Visica 2 Treatment System

Cryoablation

Other Name: Visica Breast Therapy

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: May 28, 2015): 200
• Original Estimated Enrollment (submitted: November 18, 2013): 99
• Estimated Study Completion Date: June 2023
• Estimated Primary Completion Date: December 2021 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 50 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

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

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01992250
• Other Study ID Numbers: CP-00-0011
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: Undecided

• Responsible Party: Sanarus Technologies, Inc.
• Study Sponsor: Sanarus Technologies, Inc.
• Collaborators: Not Provided

Investigators

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

• PRS Account: Sanarus Technologies, Inc.
• Verification Date: April 2018