Breast CancerFROSTNCT01992250
Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
A study testing Visica 2 Treatment System in people with Breast Cancer, run by Sanarus Technologies, Inc. at 12 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 50 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Visica 2 Treatment System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 12 sitesUnited States
- Study dates
- Nov 2013to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
United States12 sites, 12 recruiting
- Recruiting
90210 Surgery Medical Center
Beverly Hills, California, 90210
Gerald Coronado, 310-651-2050, gerald@drholmesmd.com
Dennis R. Holmes, MD, FACS
- Recruiting
City of Hope
Duarte, California, 91010
Blanca Mendez, BSHS CRCII, 626-218-0433 ext. 80433, blmendez@coh.org
Luci Tumyan, MD, 626-218-0433 ext. 80433
- Recruiting
Epic Care
Emeryville, California, 94608
Shoko Abe, M.D., 510-629-6682, Shoko.Abe@epic-care.com
- Recruiting
Knoxville Comprehensive Breast Center
Knoxville, Tennessee, 37909
Miranda Stinnett, 865-583-1014, mstinnett@kcbc-center.com
Kamilia Kozlowski, MD
- Recruiting
Texas Tech University Health Sciences Center
Lubbock, Texas, 79416
Melanie Bisbee, 806-775-8597, Melanie.Bisbee@umchealthsystem.com
Rakhshanda Rahman, MD
- Recruiting
Diagnostic Center for Women, LLC
Miami, Florida, 33173
Michael J Plaza, M.D., 305-740-5100
Cristina Upegui, 305-740-5100 ext. 2004
- Recruiting
Naples Community Hospital
Naples, Florida, 34109
Patricia Prichard, 239-624-8120, Patricia.Pritchard@nchmd.org
Sharla Patterson, MD
- Recruiting
Ogden Regional Hospital
Ogden, Utah, 84405
Joshua Kunz, 801-479-2067, joshua.kunz@mountainstarhealth.com
Jose Tamayo, MD
- Recruiting
Rhode Island Hospital
Providence, Rhode Island, 02903
Liz Lorrell, 401-444-2277, emorrell@lifespan.org
Robert Ward, M.D>
- Recruiting
Ascension Crittenton Hospital
Rochester, Michigan, 48307
Michael Cribbs, 248-652-5626, michael.cribbs@ascension.org
Colleen Ellis, Colleen.Ellis@ascension.org
- Recruiting
Arizona Breastnet
Scottsdale, Arizona, 85260
Tracey Peters, 480-314-7600, tracey@breastnet.net
Belinda Barcley-White, MD
- Recruiting
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Sharon Steinberg, BS, RN, OCN, 484-476-2395, SteinbergS@MLHS.ORG
Elene Turzo, MSN, CRNP, 484-476-2649
About this study
Official title: 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.
Read the 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
- Conditions
- Breast Cancer
- Being tested
- Visica 2 Treatment System
- Keywords
- Cryoablation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Visica 2 Treatment SystemDevice
Also called Visica Breast Therapy
Cryoablation
| Study group | Role | What they receive |
|---|---|---|
| Low Risk - Age 70+ | Other | Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies Receives: Device: Visica 2 Treatment System |
| Moderate Risk - Age 50-69 | Other | Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies Receives: Device: Visica 2 Treatment System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Within 6 months
Secondary outcomes (3)
Local tumor recurrence
Measured: Within 5 years
Satisfactory breast cosmesis results
Measured: 5 Years
Adverse event assessment
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2013 (estimated)
- Study startNov 2013
- Primary completionDec 2021 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanarus Technologies, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Dennis R. Holmes, MD, FACS, Principal investigator, 90210 Surgery Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01992250
- Sponsor's protocol ID
- CP-00-0011
- Acronym
- FROST
- Status last verified
- Apr 2018
- First submitted
- 6 Nov 2013
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer
- ClinicalTrials.gov ID
- NCT01992250
- Acronym / sponsor ID
- FROST / CP-00-0011
- Conditions
- Breast Cancer
- Keywords
- Cryoablation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sanarus Technologies, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2013
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 25 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Risk - Age 70+ | Other | Device: Visica 2 Treatment SystemAge 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies |
| Moderate Risk - Age 50-69 | Other | Device: Visica 2 Treatment SystemAge between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies |
Who may qualify
- Ages
- 50 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Visica 2 Treatment SystemAlso: Visica Breast TherapyCryoablation | Device | Low Risk - Age 70+, Moderate Risk - Age 50-69 |
Primary outcome
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.
3 secondary outcomes
Local tumor recurrence
Time frame: Within 5 years
Satisfactory breast cosmesis results
Time frame: 5 Years
Adverse event assessment
Time frame: 5 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Apr 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dennis R. Holmes, MD, FACS principal investigator
90210 Surgery Medical Center
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Visica 2 Treatment System in people with Breast Cancer, run by Sanarus Technologies, Inc. at 12 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Pamela Ellis ((925) 460-6080, clinical@sanarus.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tumor ablation occurence (time frame: Within 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2018.