Breast CancerNCT02200705

Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial

A study testing Ice-Sense3TM/ ProSenseTM in people with Breast Cancer, run by IceCure Medical Ltd. at 19 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer . 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?: Ice-Sense3TM/ ProSenseTM
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 206 participants
Where: 19 sitesUnited States
Study dates: Oct 2014to 26 May 2024
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Competent to sign informed consent
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
Unifocal primary disease NOTE: Patients with multifocal and/or multicentric in breast cancer, or evidence of EIC are NOT eligible. Patients with contralateral disease will remain eligible.
Tumor size ≤1.5 cm in greatest diameter in the axis parallel to the treatment probe AND ≤1.5 cm in the axis anti-parallel to the treatment probe AND ≤1.5 cm in Anterior/ Posterior dimension. Tumor size ≤1.5 cm in greatest diameter as measured by breast ultrasound, mammogram and/or MRI. The largest dimension measured will be used to determine eligibility.
Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.
Estrogen receptor-positive, progesterone receptor-positive, HER2 negative

Show all 10Show fewer

Age>= 50
Breast size adequate for safe cryoablation
Lesion must be sonographically visible at the time of treatment.
History of previously treated ipsilateral or contralateral breast carcinoma is not an exclusion criteria if the investigator is certain newly diagnosed carcinoma is new unifocal primary tumor.

Who cannot join

Presence of lobular carcinoma
Presence of luminal B pathology
Nottingham score of 3 (specially nuclear and mitotic score>2)
Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)
Presence of multifocal and/or multicentric in breast cancer
Presence of multifocal calcifications

Show all 10Show fewer

Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
Patient that is not suitable to cryoablation procedure according to the physician opinion
ER AND PR negative, or Her2 positive noted on pre-cryo biopsy

Trial locations and contacts

19 sites in 1 country.

City, postcode or hospital

19 sites in 1 country

United States19 sites

Breast Specialty care/ Presbyterian Hospital
Albuquerque, New Mexico, 87114
Cincinnati Breast Surgeons Inc.
Cincinnati, Ohio, 45227
University hospitals cleveland medical center
Cleveland, Ohio, 44106
Dalton Surgical Group
Dalton, Georgia, 30720
Karmanos Cancer Institute
Detroit, Michigan, 48201
Regional Medical Imaging
Flint, Michigan, 48507
CentraState Medical Center
Freehold, New Jersey, 07728
West Clinic
Germantown, Tennessee, 38138
Ironwood Cancer & Research Centers
Glendale, Arizona, 85306
Indiana University
Indianapolis, Indiana, 46202-5116
Mount Sinai Beth Israel
New York, New York, 10011
Columbia University/ NY Presbyterian hospital
New York, New York, 10032
Weill Cornell Medical College
New York, New York, 10065
Montefiore Medical Center
New York, New York, 10467
Thomas Jefferson University hospital
Philadelphia, Pennsylvania, 19107
Complete Breast Care
Plano, Texas, 75075
BreastLink
Santa Ana, California, 92705
Comprehensive Breast Care
Troy, Michigan, 48085
Bridgeport Hospital, Yale Medical School
Trumbull, Connecticut, 06611

Other trials in United States

About this study

Official title: Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .

Conditions: Breast Cancer
Being tested: Ice-Sense3TM/ ProSenseTM
Keywords: cryoablation, cryotherapy, breast cancer
Medical subject headings: Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Ice-Sense3TM/ ProSenseTMDevice

Study groups in NCT02200705
Study group	Role	What they receive
single arm, open label	Other	Early stage Breast cancers up to 1.5cm Receives: Device: Ice-Sense3TM/ ProSenseTM

What is being measured

The primary outcome is the main question the study is designed to answer.

Local Inbreast Breast Tumor Recurrence (IBTR) Rate
6 months post cryoabltion, then annually for 5 years
Measured: up to 5 years

Secondary outcomes (8)

Complete Primary Tumor Ablation Rate
Complete ablation of primary tumor up to 60 months after cryoablation, reported as the percentage of patients with complete tumor ablation.
Measured: up to 5 years from procedure date.
Improvement or Maintenance of Subject's Quality of Life
Quality of life will be assessed using the NCCN Distress Thermometer, a 0-10 scale measuring patient distress (0 = no distress, 10 = extreme distress; higher scores indicate worse distress), collected at baseline and at 6 months follow-up visit.
Measured: Baseline and 6 months
Breast Cosmetics Satisfaction
Participants and treating physicians rated satisfaction with cosmetic outcomes following breast cryoablation.
Measured: Up to 5 years following procedure
Regional Recurrence Rate
Regional Invasive breast tumor recurrence rate.
Measured: up to 5 years following procedure
Distant Metastases Survival Rate
Distant metastases survival rate, including contralateral Breast cancer
Measured: up to 5 years following procedure
Disease-free Survival (DFS)
DFS from the date of complete ablation of the primary tumor until the first disease event, where the disease event is defined as local (DCIS or invasive), regional, or distant breast cancer recurrence, or DCIS or invasive contralateral breast cancer.
Measured: up to 5 years
Overall Survival
Overall survival from the date of the cryoablation until the date of death from any cause or up to the 60 months follow up visit
Measured: up to 5 years
Breast Cancer Survival.
Breast Cancer Survival from the date of cryoablation until the date of death from breast cancer or up to the 60 months follow-up visit.
Measured: up to 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Oct 201426 May 2024

First posted25 Jul 2014 (estimated)
Study startOct 2014
Primary completion17 Mar 2024
Study completion26 May 2024

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 206 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02200705
Sponsor's protocol ID: ICMBC-02
Status last verified: Jun 2026
First submitted: 22 Jul 2014
Last updated: 7 Jul 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes

Publications

Jean J, Jochelson MS, Moo TA, Solomon SB, Bryce Y. Breast Cancer Recurrence after Cryoablation in Patients Who Are Poor Surgical Candidates or Who Refuse Surgery. J Vasc Interv Radiol. 2025 Jun;36(6):971-978. doi: 10.1016/j.jvir.2025.01.048. Epub 2025 Feb 3.
PubMed 39909175

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 7 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)
ClinicalTrials.gov ID: NCT02200705
Acronym / sponsor ID: ICMBC-02
Conditions: Breast Cancer
Keywords: cryoablation, cryotherapy, breast cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 206 participants (actual)
Lead sponsor: IceCure Medical Ltd.Industry (pharma, biotech, devices)
Study start: Oct 2014 (actual)
Primary completion: 17 Mar 2024 (actual)
Study completion: 26 May 2024 (actual)
First posted: 25 Jul 2014 (estimated)
Results: Posted 30 Apr 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

To evaluate the efficacy of cryoablation without lumpectomy and its impact on local and distant recurrence of early stage breast cancer .

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
single arm, open label	Other	Device: Ice-Sense3TM/ ProSenseTMEarly stage Breast cancers up to 1.5cm

Who may qualify

Ages: 50 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Competent to sign informed consent
Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:
Age>= 50
Breast size adequate for safe cryoablation
Lesion must be sonographically visible at the time of treatment.

Key exclusion criteria (10 listed)

Presence of lobular carcinoma
Presence of luminal B pathology
Nottingham score of 3 (specially nuclear and mitotic score>2)
Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)
Presence of multifocal and/or multicentric in breast cancer

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
Ice-Sense3TM/ ProSenseTM	Device	single arm, open label

Primary outcome

Local Inbreast Breast Tumor Recurrence (IBTR) Rate
Time frame: up to 5 years
6 months post cryoabltion, then annually for 5 years

8 secondary outcomes

Complete Primary Tumor Ablation Rate
Time frame: up to 5 years from procedure date.
Improvement or Maintenance of Subject's Quality of Life
Time frame: Baseline and 6 months
Breast Cosmetics Satisfaction
Time frame: Up to 5 years following procedure
Regional Recurrence Rate
Time frame: up to 5 years following procedure
Distant Metastases Survival Rate
Time frame: up to 5 years following procedure
Disease-free Survival (DFS)
Time frame: up to 5 years
Overall Survival
Time frame: up to 5 years
Breast Cancer Survival.
Time frame: up to 5 years

Results and safety

Results posted to the registry on 30 Apr 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Single Arm, Open Label	206	131

Primary outcome: Local Inbreast Breast Tumor Recurrence (IBTR) Rate

Time frame: up to 5 years. Number (95% Confidence Interval). Unit: Percentage of participants with IBTR

Measure	Single Arm, Open Label n = 194
Value	4.3 (2.1 to 8.7)

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were collected through 2 years post-procedure, and serious adverse events (SAEs) were collected through the final follow-up (5 years post-procedure).. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Single Arm, Open Label	0 of 206 (0%)	97 of 206 (47.1%)	21 of 206

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Jul 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 39909175Jean J, Jochelson MS, Moo TA, Solomon SB, Bryce Y. Breast Cancer Recurrence after Cryoablation in Patients Who Are Poor Surgical Candidates or Who Refuse Surgery. J Vasc Interv Radiol. 2025 Jun;36(6):971-978. doi: 10.1016/j.jvir.2025.01.048. Epub 2025 Feb 3.

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Not yet recruitingObservational study
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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.

The record lists no contact. Use the official record to reach the sponsor.

19 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Ice-Sense3TM/ ProSenseTM in people with Breast Cancer, run by IceCure Medical Ltd. at 19 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 10 inclusion and 10 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: finished, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 19 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?

Yes. Results are posted in the registry (first posted 30 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Local Inbreast Breast Tumor Recurrence (IBTR) Rate (time frame: up to 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02200705, which also lists 1 linked publication.

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 7 Jul 2026.