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Recruiting Observational

Percutaneous Cryoablation of Low-risk Early Breast Cancer

NCT06300125 · tracked via the Priya Life Science Italy tracker
Phase
Observational
Started
2024-04-15
Last updated
2026-01-06

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

Cryoablation

Cryoablation: Percutaneous Cryoablation of Breast Cancer

Study 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

Sex
ALL
Min age
50 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Procedure failure rate — 8 months
    Percentage of patients with residual tumor at the site of cryoablation

Trial sites (1)

FacilityCityRegionStatus
European Institute of Oncology Milan Italy Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06300125 on ClinicalTrials.gov ↗ ← All trials in Italy