FreezIng bReaST Cancer in Brazil: a Before-after Study

Study Overview
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Brief Summary
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Image-guided tumor ablation is a non-surgical, minimally invasive therapy available for local therapy of some carcinomas as an alternative to surgical treatment. This study assesses whether cryoablation can be used as an alternative to surgery in cases of early invasive breast carcinoma.

Detailed Description
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Purpose: To evaluate the effectiveness of cryoablation in the local treatment of breast cancer, through the absence of neoplastic cells (invasive or in situ). Outline Core biopsy Mammogram Magnetic resonance imaging Ultrasound Tumor Cryoablation Mammogram (post-cryoablation) Magnetic resonance imaging (post-cryoablation) Ultrasound (post-cryoablation) Surgery Evaluation of outcomes

Official Title
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Evaluation of Cryoablation in the Local Treatment of Early Breast Cancer

Conditions
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Breast Cancer, Breast Neoplasms

Intervention / Treatment
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* Device: Cryoablation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unifocal primary invasive breast carcinoma Pathological report should be complete (with the result of ER, PR , HER2, KI67 and FISH report of ERBB2 gene if necessary) Maximum tumor size ≤2.5 cm in its greatest diameter Ultrasound visible lesion Exclusion Criteria: Multifocal or multicentric invasive breast carcinoma Ductal carcinoma in-situ Breast cancer with skin involvement Clinically positive axilla (N1, N2 or N3) Distance from lesion and skin less than 5 mm Prior neoadjuvant systemic therapy for breast cancer Distant metastasis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

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 |
| --- | --- |
| Experimental: Early stage breast cancer up to 2.5 cm<br>Patients treated with Cryocare SL followed by traditional surgery, radiotherapy and adjuvant systemic therapy. | Device: Cryoablation<br>* Cryoablation will be performed under ultrasound guidance.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor ablation | Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma in the surgical specimen. | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Negative predictive value of magnetic resonance imaging (MRI) | Magnetic resonance imaging will be conducted between 14 to 28 days after cryoablation. Negative predictive value of MRI will be calculated according to the pathological report after the traditional surgery. Negative predictive value = number of the patients who is pathologically negative divided by the number of patients who is MRI negative. | 14 days and 28 days | 
| Accuracy of conventional imaging methods (mammography and ultrasound) | Mammography and ultrasound will be conducted between 14 to 28 days after cryoablation. Accuracy of conventional imaging methods will be calculated according to the pathological report after the traditional surgery. | 14 days and 28 days | 
| Measurement of the ice ball by ultrasound | To compare the baseline tumor size, ultrasound measurement of the ice ball, and the pathological result. | 14 days and 28 days | 

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