Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

Study Overview
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Brief Summary
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This study examines the use of cryoablation as an alternative to surgery in the treatment of early stage invasive breast cancer. The hypothesis is that cryoablation will complete ablation and destroy the tumor in a selected population of women who may otherwise be adequately treated with surgery.

Detailed Description
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PURPOSE: To determine the rate of successful tumor ablation in patients treated with cryoablation and endocrine therapy in a subset of patients with early stage breast cancer. OUTLINE: Core Biopsy (Pre-Registration) Magnetic Resonance Imaging (Pre-Registration) Tumor Cryoablation Core Biopsy (Post-Cryoablation) Magnetic Resonance Imaging (Post-Cryoablation) Postoperative Follow-up Evaluation of outcomes

Official Title
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Freezing Alone Instead of Resection Of Small Breast Tumors: A Study of Cryoablation in the Management of Early Stage Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Visica 2 Treatment System


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 50 Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy Maximum tumor size ≤1.5 cm in its greatest diameter Ultrasound visible lesion(s) Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25% intraductal component in the aggregate. Unilateral or bilateral disease meeting study criteria Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease Exclusion Criteria: Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer Ductal carcinoma in-situ with microinvasions (T1mic) Multifocal or multicentric invasive breast carcinoma Prior or planned neoadjuvant systemic therapy for breast cancer Tumor with ≥25% IDC components

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
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Low Risk - Age 70+<br>Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies | Device: Visica 2 Treatment System<br>* Cryoablation<br>* Other names: Visica Breast Therapy;|
| Other: Moderate Risk - Age 50-69<br>Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies | Device: Visica 2 Treatment System<br>* Cryoablation<br>* Other names: Visica Breast Therapy;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor ablation occurence | Successful tumor ablation will be defined as absence of residual viable invasive or in situ carcinoma. Will be determined at 6-month post-cryoablation biopsy. Residual disease will require surgery. | Within 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local tumor recurrence |  | Within 5 years | 
| Satisfactory breast cosmesis results |  | 5 Years | 
| Adverse event assessment |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cryoablation