Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial

NCT02200705 | Completed Results DMC FDA Device

• 1 other identifier: ICMBC-02
• Study Type: interventional
• Target: 206
• Locations: 1 country
• Sites: 19

Brief Summary

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

Conditions

Breast Cancer

Keywords

cryoablation, cryotherapy, breast cancer

Outcome Measures

Primary Outcomes (1)

• Local Inbreast Breast Tumor Recurrence (IBTR) Rate

  6 months post cryoabltion, then annually for 5 years

  up to 5 years

Secondary Outcomes (9)

• Complete Ablation of Primary Tumor

  up to 5 years from procedure date.

• Improvement or Maintenance of Subject's Quality of Life

  at 6 months compare to the base line

• Breast Cosmetics Satisfaction

  up to 5 years from procedure data.

• Regional Recurrence Rate

  up to 5 years

• Distant Metastases Rate

  up to 5 years

Study Arms (1)

single arm, open label

OTHER

Early stage Breast cancers up to 1.5cm

Device: Ice-Sense3TM/ ProSenseTM

Interventions

Ice-Sense3TM/ ProSenseTM DEVICE

single arm, open label

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Age\>= 50
• Breast size adequate for safe cryoablation
• Lesion must be sonographically visible at the time of treatment.

You may not qualify if:

• 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
• 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

Sponsors & Collaborators

• IceCure Medical Ltd.: lead

Study Sites (19)

Ironwood Cancer & Research Centers

Glendale, Arizona, 85306, United States

Location

BreastLink

Santa Ana, California, 92705, United States

Location

Bridgeport Hospital, Yale Medical School

Trumbull, Connecticut, 06611, United States

Location

Dalton Surgical Group

Dalton, Georgia, 30720, United States

Location

Indiana University

Indianapolis, Indiana, 46202-5116, United States

Location

Karmanos Cancer Institute

Detroit, Michigan, 48201, United States

Location

Regional Medical Imaging

Flint, Michigan, 48507, United States

Location

Comprehensive Breast Care

Troy, Michigan, 48085, United States

Location

CentraState Medical Center

Freehold, New Jersey, 07728, United States

Location

Breast Specialty care/ Presbyterian Hospital

Albuquerque, New Mexico, 87114, United States

Location

Mount Sinai Beth Israel

New York, New York, 10011, United States

Location

Columbia University/ NY Presbyterian hospital

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

Montefiore Medical Center

New York, New York, 10467, United States

Location

Cincinnati Breast Surgeons Inc.

Cincinnati, Ohio, 45227, United States

Location

University hospitals cleveland medical center

Cleveland, Ohio, 44106, United States

Location

Thomas Jefferson University hospital

Philadelphia, Pennsylvania, 19107, United States

Location

West Clinic

Germantown, Tennessee, 38138, United States

Location

Complete Breast Care

Plano, Texas, 75075, United States

Location

Related Publications (1)

• 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.

  PMID: 39909175 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Trial Manager
• Organization: IceCure Medical

ronitl@icecure-medical.com

+972-4-623-0333

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: July 22, 2014
• First Posted: July 25, 2014
• Study Start: October 1, 2014
• Primary Completion: March 17, 2024
• Study Completion: May 26, 2024
• Last Updated: April 30, 2025
• Results First Posted: April 30, 2025

Record last verified: 2025-04

Locations

US (19)