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Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

Sponsor
IceCure Medical Ltd. (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT02200705
Collaborator
(none)
200
Enrollment
19
Locations
1
Arm
122
Anticipated Duration (Months)
10.5
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

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
  • Device: Ice-Sense3TM
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
200 participants
Allocation:
N/A
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 :
Oct 1, 2014
Anticipated Primary Completion Date :
Aug 1, 2024
Anticipated Study Completion Date :
Dec 1, 2024

Arms and Interventions

Arm Intervention/Treatment
Other: single arm, open label

Early stage Breast cancers up to 1.5cm

Device: Ice-Sense3TM

Outcome Measures

Primary Outcome Measures

  1. local Inbreast Breast Tumor Recurrence (IBTR) rate. [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 [up to 5 years from procedure date.]

    Complete ablation of primary tumor

  2. 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

  3. Breast cosmetics satisfaction. [6 months after cryoablation]

    subjects and physician satisfaction from the cosmetic results

  4. Regional and distant Invasive breast tumor recurrence rate. [up to 5 years]

    Regional and distant Invasive breast tumor recurrence rate.

  5. Disease-free Survival (DFS),Overall survival including breast Cancer Survival. [up to 5 years]

    DFS from cryoablation procedure and up to 5 years of FU

Eligibility Criteria

Criteria

Ages Eligible for Study:
50 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:

  1. Competent to sign informed consent

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

  3. 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.

  4. 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.

  5. Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2.

  6. Estrogen receptor positive, progesterone receptor positive, HER2 negative

  7. Age>= 50

  8. Breast size adequate for safe cryoablation

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

  10. 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) 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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Ironwood Cancer & Research Centers Glendale Arizona United States 85306
2 BreastLink Santa Ana California United States 92705
3 Bridgeport Hospital, Yale Medical School Trumbull Connecticut United States 06611
4 Dalton Surgical Group Dalton Georgia United States 30720
5 Indiana University Indianapolis Indiana United States 46202-5116
6 Karmanos Cancer Institute Detroit Michigan United States 48201
7 Regional Medical Imaging Flint Michigan United States 48507
8 Comprehensive Breast Care Troy Michigan United States 48085
9 CentraState Medical Center Freehold New Jersey United States 07728
10 Breast Specialty care/ Presbyterian Hospital Albuquerque New Mexico United States 87114
11 Mount Sinai Beth Israel New York New York United States 10011
12 Columbia University/ NY Presbyterian hospital New York New York United States 10032
13 Weill Cornell Medical College New York New York United States 10065
14 Montefiore Medical Center New York New York United States 10467
15 Cincinnati Breast Surgeons Inc. Cincinnati Ohio United States 45227
16 University hospitals cleveland medical center Cleveland Ohio United States 44106
17 Thomas Jefferson University hospital Philadelphia Pennsylvania United States 19107
18 West Clinic Germantown Tennessee United States 38138
19 Complete Breast Care Plano Texas United States 75075

Sponsors and Collaborators

  • IceCure Medical Ltd.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
IceCure Medical Ltd.
ClinicalTrials.gov Identifier:
NCT02200705
Other Study ID Numbers:
  • ICMBC-02
First Posted:
Jul 25, 2014
Last Update Posted:
Apr 8, 2022
Last Verified:
Mar 1, 2022
Keywords provided by IceCure Medical Ltd.
cryoablation, cryotherapy, breast cancer
Additional relevant MeSH terms:
Breast Neoplasms

Study Results

No Results Posted as of Apr 8, 2022