Percutaneous Cryoablation of Low-risk Early Breast Cancer
Expand the current evidence base regarding percutaneous cryoablation of early-stage, low-risk breast tumors, integrated into the standard therapeutic pathway with well-defined follow-up data, as well as data on quality of life. Demonstrate, therefore, that the use of percutaneous cryoablation in the treatment of low-risk breast carcinoma is not inferior to surgery when combined with adjuvant radiotherapy and chemotherapy (when necessary). The hypothesis is that cryoablation, being simple and oncologically effective, ensures a better quality of life for the patient (reduced morbidity, no need for general anesthesia, improved cosmetic outcomes) and consequently has a lesser psychological impact, as well as a better cost-benefit ratio compared to the standard surgical approach.
- EligibilityCriteria: 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 - HealthyVolunteers: No - Gender: All - MinimumAge: 50 Years - StdAgeList: Adult, Older Adult - StudyPopulation: Patients undergone percutaneous cryoablation of early stage breast cancer - SamplingMethod: Probability Sample