Percutaneous Cryoablation of Low-risk Early Breast Cancer

Summary

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.

Eligibility

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

Conditions2

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