Recruiting
Percutaneous Cryoablation of Low-risk Early Breast Cancer
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…
ClinicalTrials.gov IDNCT06300125
PhaseNot Applicable
Enrollment234
SponsorEuropean Institute of Oncology
Age50 Years
SexALL
Conditions studied
Breast Cancer
About this study
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.
Interventions
- Procedure: Cryoablation — Percutaneous Cryoablation of Breast Cancer
Primary outcomes
- Procedure failure rate (8 months)
Eligibility information
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
Study locations
- European Institute of Oncology, Milan, Italy
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.