Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

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 .

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Device: Ice-Sense3TM/ ProSenseTM

• Study Type: Interventional
• Enrollment (Actual): 208
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 50 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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 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
Other: single arm, open label; Early stage Breast cancers up to 1.5cm	Device: Ice-Sense3TM/ ProSenseTM

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
local Inbreast Breast Tumor Recurrence (IBTR) rate	6 months post cryoabltion , then annually for 5 years	up to 5 years

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Complete ablation of primary tumor up to 60 months after cryoablation	Complete ablation of primary tumor	up to 5 years from procedure date.
Improvement or maintenance of subject's quality of life	Quality of life will be assesed using NCCN DISTRESS THERMOMETER	at 6 months compare to the base line
Breast cosmetics satisfaction	subjects and physician satisfaction from the cosmetic results	up to 5 years from procedure data.
Regional recurrence rate	Regional Invasive breast tumor recurrence rate.	up to 5 years
Distant metastases rate	Distant metastases rate including contralateral Breast cancer	up to 5 years
Disease-free Survival (DFS)	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	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	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.	up to 5 years
Adverse events	Adverse events related to study device or procedure rate	up to 2 years for AEs and up to 5 years for SAEs

Collaborators and Investigators

• Sponsor: IceCure Medical Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2014
• Primary Completion (Estimated): March 1, 2024
• Study Completion (Estimated): June 1, 2024

Study Registration Dates

• First Submitted: July 22, 2014
• First Submitted That Met QC Criteria: July 24, 2014
• First Posted (Estimated): July 25, 2014

Study Record Updates

• Last Update Posted (Actual): February 14, 2024
• Last Update Submitted That Met QC Criteria: February 13, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: cryoablation, cryotherapy, breast cancer
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: ICMBC-02

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