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.
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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
200
Cryoablation
Arizona Breastnet
Scottsdale, Arizona, United States
RECRUITING90210 Surgery Medical Center
Beverly Hills, California, United States
RECRUITINGTumor 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.
Time frame: Within 6 months
Local tumor recurrence
Time frame: Within 5 years
Satisfactory breast cosmesis results
Time frame: 5 Years
Adverse event assessment
Time frame: 5 years
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
City of Hope
Duarte, California, United States
RECRUITINGEpic Care
Emeryville, California, United States
RECRUITINGDiagnostic Center for Women, LLC
Miami, Florida, United States
RECRUITINGNaples Community Hospital
Naples, Florida, United States
RECRUITINGAscension Crittenton Hospital
Rochester, Michigan, United States
RECRUITINGLankenau Medical Center
Wynnewood, Pennsylvania, United States
RECRUITINGRhode Island Hospital
Providence, Rhode Island, United States
RECRUITINGKnoxville Comprehensive Breast Center
Knoxville, Tennessee, United States
RECRUITING...and 2 more locations