RecruitingNot Applicable

Percutaneous Cryoablation of Low-risk Early Breast Cancer

Italy234 participantsStarted 2024-04-15

Plain-language 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.

Who can participate

Age range50 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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 (DCI…

What they're measuring

Procedure failure rate

Timeframe: 8 months

Trial details

NCT IDNCT06300125

SponsorEuropean Institute of Oncology

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-12-31

Contact for this trial

Paolo Della Vigna, MD

0039 02 57489060 paolo.dellavigna@ieo.it