Clinical trial · Observational
Percutaneous Cryoablation of Low-risk Early Breast Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Cryoablation | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Cryoablation
- description
- Percutaneous Cryoablation of Breast Cancer
- interventionNames
- Procedure: Cryoablation
Primary outcomes (1)
- measure
- Procedure failure rate
- timeFrame
- 8 months
- description
- Percentage of patients with residual tumor at the site of cryoablation
Secondary outcomes (5)
- measure
- Assessment of subject's quality of life in terms of evaluation of sources of distress
- timeFrame
- 60 months
- description
- Quality of life will be assessed using National Comprehensive Cancer Network (NCCN) DISTRESS THERMOMETER
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available