Cryoablation of Small Breast Tumors in Early Stage Breast Cancer

Status unconfirmed · Not applicable

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT01992250

Run by

Sanarus Technologies, Inc.

People needed

200

Starts

2013-11-01

Expected to finish

2023-06-01

Last updated by the study team

2018-04-20

Who can join

Age: 50 and older. Sex: female. Healthy volunteers: not accepted.

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

Where it is running

• Arizona Breastnet — Scottsdale, Arizona, United States (enrolling)
• 90210 Surgery Medical Center — Beverly Hills, California, United States (enrolling)
• City of Hope — Duarte, California, United States (enrolling)
• Epic Care — Emeryville, California, United States (enrolling)
• Diagnostic Center for Women, LLC — Miami, Florida, United States (enrolling)
• Naples Community Hospital — Naples, Florida, United States (enrolling)
• Ascension Crittenton Hospital — Rochester, Michigan, United States (enrolling)
• Lankenau Medical Center — Wynnewood, Pennsylvania, United States (enrolling)
• Rhode Island Hospital — Providence, Rhode Island, United States (enrolling)
• Knoxville Comprehensive Breast Center — Knoxville, Tennessee, United States (enrolling)
• Texas Tech University Health Sciences Center — Lubbock, Texas, United States (enrolling)
• Ogden Regional Hospital — Ogden, Utah, United States (enrolling)

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.