Loading clinical trials...

UNKNOWNNA

Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

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

NCT01992250•Sanarus Technologies, Inc.

View on ClinicalTrials.gov

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

Eligibility

Age

50 - No limit years

Sex

FEMALE

Healthy Volunteers

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

Locations (12)

Arizona Breastnet

Scottsdale, Arizona, United States

90210 Surgery Medical Center

Beverly Hills, California, United States

City of Hope

Duarte, California, United States

Epic Care

Emeryville, California, United States

Diagnostic Center for Women, LLC

Miami, Florida, United States

Naples Community Hospital

Naples, Florida, United States

Ascension Crittenton Hospital

Rochester, Michigan, United States

Lankenau Medical Center

Wynnewood, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Knoxville Comprehensive Breast Center

Knoxville, Tennessee, United States

Key Dates

Start Date

November 1, 2013

Primary Completion Date

December 1, 2021

Completion Date

June 1, 2023

Last Updated

April 20, 2018

Enrollment

200

ESTIMATED participants

Conditions

Breast Cancer

Interventions

Visica 2 Treatment System

DEVICE

Contacts

Pamela Ellis

CONTACT

(925) 460-6080 clinical@sanarus.com

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

NCT04550494

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

View study

RECRUITINGPHASE1

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

NCT05372640

Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+6 more

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: April 20, 2018Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

Inclusion Criteria

Exclusion Criteria

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

Testing the Safety and Efficacy of the Combination of Two Anti-cancer Drugs, ZEN003694 and Abemaciclib, for Adult and Pediatric Patients (12-17 Years) With Metastatic or Unresectable NUT Carcinoma, Breast Cancer and Other Solid Tumors

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Testing the Addition of an Anti-cancer Drug, ASTX727 (Cedazuridine, Decitabine), to Chemotherapy (Paclitaxel) and Immunotherapy (Pembrolizumab) for Metastatic Triple-Negative Breast Cancer

Testing the Combination of Two Anti-cancer Drugs, DS-8201a and AZD6738, for The Treatment of Advanced Solid Tumors Expressing the HER2 Protein or Gene, The DASH Trial

A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer