Clinical Research Directory

Inclusion Criteria: * Tumour, Node, Metastasis stage (TNM) = dimension up to 15 mm as measured by breast ultrasound, MRI, Mammography, Node negative, absence of distant metastasis * Unifocality * All invasive cancer, except lobular * Biology= luminal A and luminal B\* (Estrogen Receptor (ER) positive/human epidermal growth factor receptor-2 (HER2)negative) (Documented estrogen receptor (ER)-positive tumor assessed locally and defined as ≥10% of tumor cells stained positive. Documented HER2-negative tumor (in accordance to 2018 American Society of Clinical Oncology guidelines, as determined per local assessment) * Any grade (G) * Radiological detection= breast ultrasound, MRI, Mammography * Tumor site= not located superficially (≥1 cm from the skin plane) * Breast size= any, appropriate for the procedure in relation to ultrasound examination * Referral to breast cryoablation by a multidisciplinary tumor board * Planned treatment with cryoablation using IceCure (TM-trade mark) system * Informed consent \*Luminal B and G3 BC: previous specific patients' selection and Oncotype Dx \[31\] on cancer tissue from needle biopsy before procedure and eventual Prediction Analysis of Microarray 50 (PAM50) test. Exclusion Criteria: * Plurifocality * Invasive lobular breast cancer * HER2 overexpressed or Triple Negative Breast Cancer (TNBC) * tumor dimension \>15 mm * Node positive * post NeoAdjuvant ChemoTherapy (NACT) breast cancer * \<50 years * Presence of intraductal component (DCIS) * Absence of psychological compliance in understanding and adhering to rationale of the study * Inability to perform MRI * Breast augmentation with implants