NCT01992250

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for not_applicable breast-cancer

Timeline
Completed

Started Nov 2013

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

12 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2013

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

November 6, 2013

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 25, 2013

Completed
8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2021

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2023

Completed
Last Updated

April 20, 2018

Status Verified

April 1, 2018

Enrollment Period

8.1 years

First QC Date

November 6, 2013

Last Update Submit

April 19, 2018

Conditions

Breast Cancer

Keywords

Cryoablation

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (3)

  • Local tumor recurrence

    Within 5 years

  • Satisfactory breast cosmesis results

    5 Years

  • Adverse event assessment

    5 years

Study Arms (2)

Low Risk - Age 70+

OTHER

Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies

Device: Visica 2 Treatment System

Moderate Risk - Age 50-69

OTHER

Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies

Device: Visica 2 Treatment System

Interventions

Visica 2 Treatment SystemDEVICE

Cryoablation

Also known as: Visica Breast Therapy
Low Risk - Age 70+Moderate Risk - Age 50-69

Eligibility Criteria

Age50 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (12)

Arizona Breastnet

Scottsdale, Arizona, 85260, United States

RECRUITING

90210 Surgery Medical Center

Beverly Hills, California, 90210, United States

RECRUITING

City of Hope

Duarte, California, 91010, United States

RECRUITING

Epic Care

Emeryville, California, 94608, United States

RECRUITING

Diagnostic Center for Women, LLC

Miami, Florida, 33173, United States

RECRUITING

Naples Community Hospital

Naples, Florida, 34109, United States

RECRUITING

Ascension Crittenton Hospital

Rochester, Michigan, 48307, United States

RECRUITING

Lankenau Medical Center

Wynnewood, Pennsylvania, 19096, United States

RECRUITING

Rhode Island Hospital

Providence, Rhode Island, 02903, United States

RECRUITING

Knoxville Comprehensive Breast Center

Knoxville, Tennessee, 37909, United States

RECRUITING

Texas Tech University Health Sciences Center

Lubbock, Texas, 79416, United States

RECRUITING

Ogden Regional Hospital

Ogden, Utah, 84405, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Dennis R. Holmes, MD, FACS

    90210 Surgery Medical Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Pamela Ellis

CONTACT

(925) 460-6080clinical@sanarus.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 6, 2013

First Posted

November 25, 2013

Study Start

November 1, 2013

Primary Completion

December 1, 2021

Study Completion

June 1, 2023

Last Updated

April 20, 2018

Record last verified: 2018-04

Locations

US(12)