Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02200705
Recruitment Status : Active, not recruiting
First Posted : July 25, 2014
Last Update Posted : March 5, 2019
Sponsor:
Information provided by (Responsible Party):
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 .

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Ice-Sense3TM Not Applicable

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)
Actual Study Start Date : October 2014
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : December 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
single arm, open label
Early stage Breast cancers up to 1.5cm
Device: Ice-Sense3TM



Primary Outcome Measures :
  1. local Inbreast Breast Tumor Recurrence (IBTR) rate. [ Time Frame: up to 5 years ]
    6 months post cryoabltion , then annually for 5 years


Secondary Outcome Measures :
  1. Complete ablation of primary tumor up to 60 months after cryoablation [ Time Frame: up to 5 years from procedure date. ]
  2. Improvement or maintenance of subject's quality of life. [ Time Frame: at 6 months compare to the base line ]
  3. Breast cosmetics satisfaction. [ Time Frame: 6 months after cryoablation ]
  4. Regional and distant Invasive breast tumor recurrence rate. [ Time Frame: up to 5 years ]
  5. Disease-free Survival (DFS),Overall survival including breast Cancer Survival. [ Time Frame: up to 5 years ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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)

3. Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC) 4. Presence of multifocal and/or multicentric in breast cancer 5. Presence of multifocal calcifications 6. Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02200705


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

Layout table for additonal information
Responsible Party: IceCure Medical Ltd.
ClinicalTrials.gov Identifier: NCT02200705     History of Changes
Other Study ID Numbers: ICMBC-02
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: March 5, 2019
Last Verified: March 2019

Keywords provided by IceCure Medical Ltd.:
cryoablation, cryotherapy, breast cancer

Additional relevant MeSH terms:
Layout table for MeSH terms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases