Breast Cancer
Conditions
Keywords
Cryoablation
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.
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
Interventions
DEVICEVisica 2 Treatment System
Cryoablation
Sponsors
Sanarus Technologies, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
50 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Tumor ablation occurence | Within 6 months | 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. |
Secondary
| Measure | Time frame |
|---|---|
| Local tumor recurrence | Within 5 years |
| Satisfactory breast cosmesis results | 5 Years |
| Adverse event assessment | 5 years |
Countries
United States
Contacts
Primary ContactPamela Ellis
Outcome results
None listed