Cryoablation treatment for low-risk early breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational study aims to evaluate the effectiveness of percutaneous cryoablation for treating early-stage, low-risk breast cancer in patients aged 50 and older. It will assess the procedure's oncological outcomes, quality of life, and economic efficacy compared to traditional surgical methods. Patients with unifocal luminal A/B breast tumors under 15 mm will receive cryoablation followed by adjuvant radiotherapy as needed, with comprehensive follow-up data collected to ensure thorough evaluation. The study seeks to demonstrate that cryoablation is a viable alternative to surgery, offering reduced morbidity and improved cosmetic results.

Why it matters

Who can join: the full rules

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

Where it's running

• European Institute of Oncology
  Milan, Italy Recruiting

Study contacts

• Principal investigator: Franco Orsi, MD — European Institute of Oncology
• Study coordinator: Paolo Della Vigna, MD
• Email: paolo.dellavigna@ieo.it
• Phone: 0039 02 57489060

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.