NCT06300125 Percutaneous Cryoablation of Low-risk Early Breast Cancer
| NCT ID | NCT06300125 |
| Status | Recruiting |
| Phase | — |
| Sponsor | European Institute of Oncology |
| Condition | Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 234 participants |
| Start Date | 2024-04-15 |
| Primary Completion | 2026-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 234 participants in total. It began in 2024-04-15 with a primary completion date of 2026-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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 Criteria
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
Contact & Investigator
Franco Orsi, MD
PRINCIPAL INVESTIGATOR
European Institute of Oncology
Frequently Asked Questions
Who can join the NCT06300125 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06300125 currently recruiting?
Yes, NCT06300125 is actively recruiting participants. Contact the research team at paolo.dellavigna@ieo.it for enrollment information.
Where is the NCT06300125 trial being conducted?
This trial is being conducted at Milan, Italy.
Who is sponsoring the NCT06300125 clinical trial?
NCT06300125 is sponsored by European Institute of Oncology. The principal investigator is Franco Orsi, MD at European Institute of Oncology. The trial plans to enroll 234 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.