Actively Recruiting
Percutaneous Cryoablation of Low-risk Early Breast Cancer
Led by European Institute of Oncology · Updated on 2026-01-06
234
Participants Needed
1
Research Sites
358 weeks
Total Duration
On this page
Sponsors
E
European Institute of Oncology
Lead Sponsor
F
Fondazione Umberto Veronesi
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Percutaneous Cryoablation of Low-risk Early Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 50 years or older
- Breast cancer tumor up to 15 mm in size by ultrasound, MRI, or mammography
- Tumor must be unifocal
- Invasive breast cancer, excluding lobular type
- Tumor biology must be luminal A or luminal B subtype (ER positive and HER2 negative)
- Any tumor grade
- Tumor not located within 1 cm of the skin surface
- Breast size suitable for the procedure
- Referral for cryoablation by a multidisciplinary tumor board
- Planned treatment with IceCure system cryoablation
- Informed consent given
You will not qualify if you...
- Multiple tumors in the breast (plurifocality)
- Invasive lobular breast cancer
- HER2 positive or triple negative breast cancer
- Tumor larger than 15 mm
- Node positive breast cancer
- Breast cancer treated with neoadjuvant chemotherapy
- Age younger than 50 years
- Presence of intraductal carcinoma component
- Psychological inability to understand or follow study procedures
- Unable to undergo MRI
- Breast augmentation with implants
AI-Screening
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Trial Site Locations
Total: 1 location
1
European Institute of Oncology
Milan, Italy
Actively Recruiting
Research Team
P
Paolo Della Vigna, MD
CONTACT
M
Mara Negri
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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