Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

Not Applicable

• Conditions: Breast Cancer
• Interventions: Device: Visica 2 Treatment System

• Registration Number: NCT01992250
• Lead Sponsor: Sanarus Technologies, Inc.

Brief Summary

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

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:

1. Core Biopsy (Pre-Registration)

2. Magnetic Resonance Imaging (Pre-Registration)

3. Tumor Cryoablation

4. Core Biopsy (Post-Cryoablation)

5. Magnetic Resonance Imaging (Post-Cryoablation)

6. Postoperative Follow-up

7. Evaluation of outcomes

Study Timeline

• Study Start: 2013-11
• Study First Submitted: 2013-11-06
• Study First Submitted QC: 2013-11-18
• Study First Posted: 2013-11-25
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-19
• Last Update Posted: 2018-04-20
• Primary Completion: 2021-12
• Study Completion: 2023-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 200

Inclusion Criteria

1. Age ≥ 50
2. Unifocal primary invasive breast carcinoma diagnosed by core needle biopsy
3. Maximum tumor size ≤1.5 cm in its greatest diameter
4. Ultrasound visible lesion(s)
5. Clinically node negative, hormone receptor positive (+). HER2 negative (-), with <25% intraductal component in the aggregate.
6. Unilateral or bilateral disease meeting study criteria
7. Physical and emotional ability to undergo baseline and follow-up breast MRIs and serial breast cosmesis analysis
8. Patient agrees to receive a 5 year minimum course of endocrine therapy following cryoablation for control of systemic disease

Exclusion Criteria

1. Prior treatment (e.g., open surgical biopsy, lumpectomy) of index cancer
2. Ductal carcinoma in-situ with microinvasions (T1mic)
3. Multifocal or multicentric invasive breast carcinoma
4. Prior or planned neoadjuvant systemic therapy for breast cancer
5. Tumor with ≥25% IDC components

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Low Risk - Age 70+	Visica 2 Treatment System	Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies
Moderate Risk - Age 50-69	Visica 2 Treatment System	Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies

Primary Outcome Measures

Name	Time	Method
Tumor ablation occurence	Within 6 months	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.

Secondary Outcome Measures

Name	Time	Method
Satisfactory breast cosmesis results	5 Years
Local tumor recurrence	Within 5 years
Adverse event assessment	5 years

Trial Locations

Locations (12)

City of Hope; 🇺🇸 Duarte, California, United States

Diagnostic Center for Women, LLC; 🇺🇸 Miami, Florida, United States

Arizona Breastnet; 🇺🇸 Scottsdale, Arizona, United States

Epic Care; 🇺🇸 Emeryville, California, United States

90210 Surgery Medical Center; 🇺🇸 Beverly Hills, California, United States

Naples Community Hospital; 🇺🇸 Naples, Florida, United States

Ascension Crittenton Hospital; 🇺🇸 Rochester, Michigan, United States

Lankenau Medical Center; 🇺🇸 Wynnewood, Pennsylvania, United States

Knoxville Comprehensive Breast Center; 🇺🇸 Knoxville, Tennessee, United States

Ogden Regional Hospital; 🇺🇸 Ogden, Utah, United States

Texas Tech University Health Sciences Center; 🇺🇸 Lubbock, Texas, United States

Rhode Island Hospital; 🇺🇸 Providence, Rhode Island, United States