Cryoablation of Low Risk Small Breast Cancer- Ice3 Trial

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

Official Title
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Cryoablation of Low Risk Breast Cancer Less Than 1.5 cm: An Evaluation of Local Recurrence (Ice3 Trial)

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Ice-Sense3TM/ ProSenseTM


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Competent to sign informed consent Diagnosis of invasive ductal breast carcinoma by core needle biopsy, meeting the following criteria: 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. 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. Nottingham grade 1-2. Specifically, nuclear and mitotic scores must be less than or equal to 2. Estrogen receptor-positive, progesterone receptor-positive, HER2 negative Age>= 50 Breast size adequate for safe cryoablation Lesion must be sonographically visible at the time of treatment. 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: Presence of lobular carcinoma Presence of luminal B pathology Nottingham score of 3 (specially nuclear and mitotic score>2) Presence of microinvasion, or invasive breast carcinoma with extensive intraductal component (EIC) Presence of multifocal and/or multicentric in breast cancer Presence of multifocal calcifications Presence of prior or concurrent neoadjuvant chemotherapy for breast cancer Presence of prior en bloc open surgical biopsy and/or lumpectomy for diagnosis/treatment of the index breast cancer Patient that is not suitable to cryoablation procedure according to the physician opinion ER AND PR negative, or Her2 positive noted on pre-cryo biopsy

Ages Eligible for Study
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Minimum Age: 50 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: single arm, open label<br>Early stage Breast cancers up to 1.5cm | Device: Ice-Sense3TM/ ProSenseTM<br> <br> |

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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cryoablation, cryotherapy, breast cancer