Post-Marketing Study for Early-Stage Low-Risk Breast Cancer Treatment Using ProSense® Cryoablation (ChoICE Trial)

Post Marketing Data Collection on Use of ProSense® Cryoablation System With Adjuvant Endocrine Therapy for the Treatment of Patients With Low-Risk, Early-Stage Breast Cancer (ChoICE Trial)

The FDA has granted marketing authorization for the ProSense® Cryoablation System for the local treatment of patients aged 70 years or older with low-risk early-stage breast cancer who are also receiving adjuvant hormone therapy.

This clinical trial is designed to collect additional data on the safety and effectiveness of cryoablation when used as part of routine clinical care. Specifically, the study will evaluate recurrence rates following the procedure for up to 5 years post-treatment.

In addition, linkage to claims data will be used to assess long-term outcomes, including breast cancer-related surgeries, mammograms and other breast imaging procedures, breast biopsies, and all-cause mortality.

Study Overview

• Status: Not yet recruiting
• Conditions: Low-Risk, Early Stage Breast Cancer
• Intervention / Treatment: Device: Cryoablation

• Study Type: Interventional
• Enrollment (Estimated): 400
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Eidan Loushi Clinical Research Associate; Phone Number: +972-548118632; Email: eidanl@icecure-medical.com
• Study Contact Backup: Name: Ronit Lipson, Clinical Trial Manager; Phone Number: +972-522337768; Email: ronitl@Icecure-medical.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Provision of a signed and dated informed consent form.
2. Age ≥70

3. Diagnosis of invasive ductal breast carcinoma (IDC) by core needle biopsy, meeting the following criteria:

   • Unifocal primary disease
   • Tumor size ≤1.5 cm in greatest diameter
   • Estrogen receptor positive, Progesterone receptor positive, and HER2 negative
   • Low-risk tumor biology, defined as Ki67<15% or confirmed by genomic testing. In cases where Ki67 is ≥15%, low-risk status must be confirmed by genomic testing, which will prevail.
4. Lesions must be sonographically visible at the time of treatment
5. Clinically negative lymph node (N0).

Exclusion Criteria:

1. Presence of lobular carcinoma.
2. Presence of microinvasion or invasive breast carcinoma with extensive intraductal component (EIC), defined as DCIS component comprising ≥25%.
3. Evidence of lymphovascular invasion.
4. Presence of multifocal and/or multicentric breast cancer.
5. Presence of multifocal suspicious calcifications.
6. Presence of inflammatory features.
7. Previous ipsilateral breast radiation
8. Neoadjuvant endocrine treatment is provided to reduce the tumor size.
9. Prior or concurrent neoadjuvant chemotherapy, biological therapy, or other targeted neo-therapies.
10. Prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer.
11. Allergy to local anesthesia.
12. Any other reason defined as inoperable declared by a physician.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Low-risk, Early satge breast cancer; FDA-Approved cryoablation procedure for the indicated population	Device: Cryoablation; Cryoablation procedure, without resection, using the IceCure Medical ProSense® Cryoablation System. Patients will be also provided with adjuvant endocrine therapy for 5 years post-treatment. The IceCure ProSense® cryoablation system is intended for cryogenic destruction of tissue by the application of extreme cold temperatures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Confirmed Ipsilateral Breast Tumor Recurrence (IBTR) Rate	The percentage of patients who develop confirmed Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.	5 Years
Confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR) Rate	The percentage of patients who develop confirmed and suspected Ipsilateral Breast Tumor Recurrence (IBTR), up to 5 years after cryoablation.	5 Years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete Primary Tumor Ablation Rate	The percentage of patients with complete tumor ablation, defined by adequate iceball coverage of the target tumor during the cryoablation procedure and absence of residual tumor at the 6-month follow-up.	6 Months
Procedure duration (minutes)	Procedure duration, defined as the time from procedure initiation to procedure completion, measured in minutes	The day of the procedure
Number of hospitalization days following the procedure	Length of post-procedural hospitalization (If needed), measured as the number of days from the procedure until hospital discharge.	6 Months
Days to resume normal activity	Number of days after cryoablation until return to routine daily activities, as reported by the patient.	6 Months
Number of procedure-related outpatient visits	Number of procedure-related outpatient visits post the procedure, which are unplanned in the study schedule of activities	6 Months
Physician's satisfaction with the breast's cosmetic results	Assessed using the Sneeuw Questionnaire, an observer-rated assessment of cosmetic changes following treatment. Items are scored on a 4-point scale ranging from 1 (None) to 4 (Severe), with the overall cosmetic result rated from 1 (Poor) to 4 (Excellent).	6 Months
Non-serious adverse events (related/non-related to device and procedure) and procedure-related complications.	Number, nature, and percentage of patients with non-serious adverse events (related/nonrelated to device and procedure) and procedure-related complications up to 6 months.	6 Months
Local recurrence and Second primary breast cancer rates	The percentage of patients with local breast cancer recurrence or second primary breast cancer.	5 Years
Patient's satisfaction with cosmetic outcomes	Patients' satisfaction will be assessed at 6-month follow-up and subsequent visits through 5 years using the 'Satisfaction with Breasts' scale from the BREAST-Q 2.0 Patient-Reported Outcome (PRO) Breast-Conserving Surgery module. Scores are reported on a 0 (Worst) to 100 (Best) scale.	5 Years
Patients' Quality of life (QoL)	Improvement or maintenance of patient's quality of life will be evaluated at 6-month follow-up and subsequent visits through 5 years, compared to baseline, using two scales from the BREAST-Q 2.0 PRO Breast-Conserving Surgery module: Physical Well-Being: Chest, and Psychosocial Well-Being. BREAST-Q has domain scores reported on a 0 (Worst) to 100 (Best) scale.	5 Years
Locoregional recurrence (LRR) rate	The percentage of patients who develop locoregional recurrence within 5 years post-procedure.	5 Years
Disease-Free Survival (DFS) rate	The percentage of patients without evidence of IBTR, regional, or distant breast cancer recurrence, contralateral breast cancer, or death due to breast cancer.	5 Years
Overall Survival (OS) rate	The percentage of participants who did not experience death due to any cause up to 5 years.	5 Years
Breast cancer survival rate	The percentage of patients who did not experience death due to breast cancer up to 5 years.	5 Years
Rate of discontinuation of routine follow-up procedures	The percentage of patients who discontinue routine breast-related follow-up procedures.	5 Years
Serious adverse events (related/non-related to device and procedure).	The number, nature, and percentage of patients experiencing serious adverse events (SAEs), related and non-related to the device and procedure.	5 Years

Collaborators and Investigators

• Sponsor: IceCure Medical Ltd.

Publications and helpful links

General Publications

• Fine RE, Gilmore RC, Tomkovich KR, Dietz JR, Berry MP, Hernandez LE, Columbus KS, Seedman SA, Fisher CS, Han LK, Manahan ER, Hicks RD, Vaidya RP, Curcio LD, Sevrukov AB, Kenler AS, Taback B, Chen M, Miller ME, Gold L, Anglin BV, Aoun HD, Simmons RM, Feldman SM, Boolbol SK. Cryoablation Without Excision for Early-Stage Breast Cancer: ICE3 Trial 5-Year Follow-Up on Ipsilateral Breast Tumor Recurrence. Ann Surg Oncol. 2024 Oct;31(11):7273-7283. doi: 10.1245/s10434-024-16181-0. Epub 2024 Sep 16.

Study record dates

Study Major Dates

• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): September 1, 2034

Study Registration Dates

• First Submitted: May 12, 2026
• First Submitted That Met QC Criteria: June 1, 2026
• First Posted (Actual): June 5, 2026

Study Record Updates

• Last Update Posted (Actual): June 5, 2026
• Last Update Submitted That Met QC Criteria: June 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Cancer; Cryoabalation
• Additional Relevant MeSH Terms: Neoplasms by Site; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Neoplasms; Breast Neoplasms; Surgical Procedures, Operative; Ablation Techniques; Cryosurgery
• Other Study ID Numbers: ICM-BC-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No