Cryoablation of Small Breast Tumors in Early Stage Breast Cancer
Inclusion Criteria
- 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
Exclusion Criteria
- 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
California
Duarte
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
Trial Phase Phase NA
Trial Type Treatment
Lead Organization
Sanarus Technologies, Inc.
- Primary ID CP-00-0011
- Secondary IDs NCI-2017-00241
- Clinicaltrials.gov ID NCT01992250