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

NCT07629206 | Not Yet Recruiting FDA Device

• 1 other identifier: ICM-BC-003
• Study Type: interventional
• Target: 400
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Low-Risk, Early Stage Breast Cancer

Keywords

Cancer; Breast Cancer; Cryoabalation

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (16)

• Complete Primary Tumor Ablation Rate

  6 Months

• Procedure duration (minutes)

  The day of the procedure

• Number of hospitalization days following the procedure

  6 Months

• Days to resume normal activity

  6 Months

• Number of procedure-related outpatient visits

  6 Months

Study Arms (1)

Low-risk, Early satge breast cancer

EXPERIMENTAL

FDA-Approved cryoablation procedure for the indicated population

Device: Cryoablation

Interventions

Cryoablation DEVICE

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.

Low-risk, Early satge breast cancer

Eligibility Criteria

• Age: 70 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Older Adult (65+)

You may qualify if:

• Provision of a signed and dated informed consent form.
• Age ≥70
• 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.
• Lesions must be sonographically visible at the time of treatment
• Clinically negative lymph node (N0).

You may not qualify if:

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

Sponsors & Collaborators

• IceCure Medical Ltd.: lead

Related Publications (1)

• 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.

  PMID: 39283572 BACKGROUND

MeSH Terms

Conditions

Neoplasms; Breast Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation Techniques; Surgical Procedures, Operative

Central Study Contacts

Eidan Loushi Clinical Research Associate

CONTACT

+972-548118632; eidanl@icecure-medical.com

Ronit Lipson, Clinical Trial Manager

CONTACT

+972-522337768; ronitl@Icecure-medical.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2026
• First Posted: June 5, 2026
• Study Start (Estimated): July 1, 2026
• Primary Completion (Estimated): July 1, 2034
• Study Completion (Estimated): September 1, 2034
• Last Updated: June 5, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share