RecruitingNCT06300125

Percutaneous Cryoablation of Low-risk Early Breast Cancer

Sponsor

European Institute of Oncology

Enrollment

234 participants

Start Date

Apr 15, 2024

Study Type

OBSERVATIONAL

Conditions

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

Min Age: 50 Years

Plain Language Summary

Simplified for easier understanding

This study evaluates whether a minimally invasive technique called cryoablation — which uses extreme cold to destroy a tumor — can be used as an alternative to surgery for small, early-stage breast cancers. Instead of removing the breast tissue, a probe is inserted through the skin to freeze and destroy the tumor. **You may be eligible if...** - You have a small early-stage breast tumor (up to 15 mm in size) with no spread to lymph nodes or distant sites - Your cancer is a single tumor (not spread across multiple areas of the breast) - Your tumor is a hormone receptor-positive, HER2-negative invasive breast cancer (not lobular type) - Your tumor is not located too close to the skin surface (at least 1 cm deep) **You may NOT be eligible if...** - Your tumor is larger than 15 mm - Cancer has spread to lymph nodes or other organs - You have lobular breast cancer - Your tumor is HER2-positive or hormone receptor-negative - The tumor is located right under the skin Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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