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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 : February 14, 2024
Sponsor:
Information provided by (Responsible Party):
IceCure Medical Ltd.

Study Description
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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/ ProSenseTM Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 208 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 : October 2014
Estimated Primary Completion Date : March 2024
Estimated Study Completion Date : June 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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


Outcome Measures
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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. ]
    Complete ablation of primary tumor

  2. Improvement or maintenance of subject's quality of life [ Time Frame: at 6 months compare to the base line ]
    Quality of life will be assesed using NCCN DISTRESS THERMOMETER

  3. Breast cosmetics satisfaction [ Time Frame: up to 5 years from procedure data. ]
    subjects and physician satisfaction from the cosmetic results

  4. Regional recurrence rate [ Time Frame: up to 5 years ]
    Regional Invasive breast tumor recurrence rate.

  5. Distant metastases rate [ Time Frame: up to 5 years ]
    Distant metastases rate including contralateral Breast cancer

  6. Disease-free Survival (DFS) [ Time Frame: 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

  7. Overall survival [ Time Frame: 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

  8. Breast Cancer Survival. [ Time Frame: 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.

  9. Adverse events [ Time Frame: up to 2 years for AEs and up to 5 years for SAEs ]
    Adverse events related to study device or procedure rate


Eligibility Criteria
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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)
  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
Contacts and Locations
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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
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Sponsors and Collaborators
IceCure Medical Ltd.
More Information
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Responsible Party: IceCure Medical Ltd.
ClinicalTrials.gov Identifier: NCT02200705    
Other Study ID Numbers: ICMBC-02
First Posted: July 25, 2014    Key Record Dates
Last Update Posted: February 14, 2024
Last Verified: February 2024

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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
Keywords provided by IceCure Medical Ltd.:
cryoablation, cryotherapy, breast cancer
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases