Cryoablation of Low Risk Small Breast Cancer- ICE3 Trial

Not Applicable

Completed

• Conditions: Breast Cancer
• Interventions: Device: Ice-Sense3TM/ ProSenseTM

• Registration Number: NCT02200705
• Lead Sponsor: IceCure Medical Ltd.

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-07-22
• Study First Submitted QC: 2014-07-24
• Study First Posted: 2014-07-25
• Study Start: 2014-10
• Primary Completion: 2024-03-17
• Study Completion: 2024-05-26
• Results First Submitted: 2025-03-17
• Status Verified: 2025-04
• Results First Submitted QC: 2025-04-27
• Last Update Submitted: 2025-04-27
• Results First Posted: 2025-04-30
• Last Update Posted: 2025-04-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 206

Inclusion Criteria

1. Competent to sign informed consent

2. Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria:

   1. 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.
   2. 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.
   3. Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.
   4. Estrogen receptor-positive, progesterone receptor-positive, HER2 negative

3. Age>= 50

4. Breast size adequate for safe cryoablation

5. Lesion must be sonographically visible at the time of treatment.

6. 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.

Exclusion Criteria

1. Presence of lobular carcinoma
2. Presence of luminal B pathology
3. Nottingham score of 3 (specially nuclear and mitotic score>2)
4. Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC)
5. Presence of multifocal and/or multicentric in breast cancer
6. Presence of multifocal calcifications
7. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer
8. Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer
9. Patient that is not suitable to cryoablation procedure according to the physician opinion
10. ER AND PR negative, or Her2 positive noted on pre-cryo biopsy

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
single arm, open label	Ice-Sense3TM/ ProSenseTM	Early stage Breast cancers up to 1.5cm

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Disease-free Survival (DFS)	up to 5 years	DFS from 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, second primary cancer, DCIS or invasive contralateral breast cancer, or death due to any cause
Overall Survival	up to 5 years	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
Breast Cancer Survival.	up to 5 years	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.
Adverse Events	up to 2 years for AEs and up to 5 years for SAEs	Adverse events related to study device or procedure rate
Complete Ablation of Primary Tumor	up to 5 years from procedure date.	Complete ablation of primary tumor up to 60 months after cryoablation
Improvement or Maintenance of Subject's Quality of Life	at 6 months compare to the base line	Quality of life will be assesed using NCCN DISTRESS THERMOMETER
Breast Cosmetics Satisfaction	up to 5 years from procedure data.	subjects and physician satisfaction from the cosmetic results
Regional Recurrence Rate	up to 5 years	Regional Invasive breast tumor recurrence rate.
Distant Metastases Rate	up to 5 years	Distant metastases rate including contralateral Breast cancer

Trial Locations

Locations (19)

Indiana University; 🇺🇸 Indianapolis, Indiana, United States

University hospitals cleveland medical center; 🇺🇸 Cleveland, Ohio, United States

Cincinnati Breast Surgeons Inc.; 🇺🇸 Cincinnati, Ohio, United States

Bridgeport Hospital, Yale Medical School; 🇺🇸 Trumbull, Connecticut, United States

Ironwood Cancer & Research Centers; 🇺🇸 Glendale, Arizona, United States

BreastLink; 🇺🇸 Santa Ana, California, United States

Dalton Surgical Group; 🇺🇸 Dalton, Georgia, United States

Karmanos Cancer Institute; 🇺🇸 Detroit, Michigan, United States

Regional Medical Imaging; 🇺🇸 Flint, Michigan, United States

Comprehensive Breast Care; 🇺🇸 Troy, Michigan, United States

Breast Specialty care/ Presbyterian Hospital; 🇺🇸 Albuquerque, New Mexico, United States

Columbia University/ NY Presbyterian hospital; 🇺🇸 New York, New York, United States

CentraState Medical Center; 🇺🇸 Freehold, New Jersey, United States

Mount Sinai Beth Israel; 🇺🇸 New York, New York, United States

Complete Breast Care; 🇺🇸 Plano, Texas, United States

West Clinic; 🇺🇸 Germantown, Tennessee, United States

Thomas Jefferson University hospital; 🇺🇸 Philadelphia, Pennsylvania, United States

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Montefiore Medical Center; 🇺🇸 New York, New York, United States