Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
Purpose
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.
Condition
- Breast Cancer
Eligibility
- Eligible Ages
- Over 50 Years
- Eligible Genders
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 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
- 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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Non-Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Other Low Risk - Age 70+ |
Age 70+. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies |
|
|
Other Moderate Risk - Age 50-69 |
Age between 50-69. Patients treated with the Visica 2 Treatment System, followed by adjuvant therapies |
|
Recruiting Locations
Arizona Breastnet
Scottsdale, Arizona 85260
Scottsdale, Arizona 85260
90210 Surgery Medical Center
Beverly Hills, California 90210
Beverly Hills, California 90210
City of Hope
Duarte, California 91010
Duarte, California 91010
Epic Care
Emeryville, California 94608
Emeryville, California 94608
Diagnostic Center for Women, LLC
Miami, Florida 33173
Miami, Florida 33173
Contact:
Michael J Plaza, M.D.
305-740-5100
Michael J Plaza, M.D.
305-740-5100
Naples Community Hospital
Naples, Florida 34109
Naples, Florida 34109
Ascension Crittenton Hospital
Rochester, Michigan 48307
Rochester, Michigan 48307
Lankenau Medical Center
Wynnewood, Pennsylvania 19096
Wynnewood, Pennsylvania 19096
Rhode Island Hospital
Providence, Rhode Island 02903
Providence, Rhode Island 02903
Knoxville Comprehensive Breast Center
Knoxville, Tennessee 37909
Knoxville, Tennessee 37909
Texas Tech University Health Sciences Center
Lubbock, Texas 79416
Lubbock, Texas 79416
Ogden Regional Hospital
Ogden, Utah 84405
Ogden, Utah 84405
More Details
- NCT ID
- NCT01992250
- Status
- Unknown status
- Sponsor
- Sanarus Technologies, Inc.
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