Percutaneous Cryoablation for the Treatment of Breast Cancer

Percutaneous Cryoablation for the Treatment of Breast Cancer: A Prospective Study of Clinical Effectiveness, Safety, and CEM-Based Imaging Surveillance

The goal of this clinical trial is to study cryoablation as a treatment for selected adults with localized breast cancer. Cryoablation uses very low temperatures to destroy the tumor through thin needles placed through the skin under ultrasound guidance.

The main questions this study aims to answer are:

• Can cryoablation completely destroy the treated breast tumor?
• Is the procedure safe and well tolerated?
• Can ultrasound and contrast-enhanced mammography be used to monitor the treated area after cryoablation?

The study will include participants with breast cancer who cannot undergo surgery or choose not to have surgery, as well as selected postmenopausal participants with small, low-risk breast cancers.

Participants will undergo ultrasound-guided cryoablation instead of surgical removal of the breast tumor. They will then have clinical examinations and imaging follow-up, including ultrasound and contrast-enhanced mammography, to assess the treated area over time. A biopsy will be performed if follow-up findings are suspicious or unclear.

Other cancer treatments, such as radiation therapy or hormone therapy, will be given when indicated according to standard clinical practice.

Inclusion Criteria:

General criteria:

• Female participants aged 18 years or older.
• Histologically confirmed invasive breast carcinoma diagnosed by core needle biopsy.
• Unifocal and unilateral tumor.
• Tumor clearly visible and accessible by ultrasound.
• Tumor considered technically suitable for ultrasound-guided cryoablation, with the possibility of achieving adequate ice-ball coverage and safety margins.
• No known distant metastatic disease.
• Ability to understand the study procedures and provide written informed consent.

Cohort A:

- Participants considered unsuitable for breast surgery because of age, comorbidities, or other clinical conditions, or participants who decline surgical treatment after appropriate multidisciplinary evaluation.

Cohort B:

• Postmenopausal participants with early-stage, low-risk invasive breast cancer.
• Invasive tumor preferably 15 mm or smaller.
• Hormone receptor-positive (estrogen receptor and/or progesterone receptor positive).
• HER2-negative.
• Histological grade 1 or 2.
• Clinically node-negative disease.
• Invasive carcinoma of no special type or another favorable low-risk histological subtype

Exclusion Criteria:

• Multifocal or multicentric breast cancer.
• Bilateral breast cancer requiring treatment.
• Tumor not adequately visible or accessible by ultrasound.
• Tumor location or anatomy preventing safe cryoablation or achievement of an adequate ablation margin.
• Known distant metastatic disease.
• HER2-positive invasive breast cancer for Cohort B.
• Predominantly extensive intraductal disease or other findings considered unsuitable for cryoablation.
• Contraindication to the planned cryoablation procedure.
• Inability to provide informed consent or comply with study follow-up.