Cryoablation treatment for low-risk early breast cancer

Percutaneous Cryoablation of Low-risk Early Breast Cancer

This study is testing whether a new freezing treatment for early-stage, low-risk breast cancer can be a safer and more effective option for women aged 50 and older compared to traditional surgery.

Quick facts

• Study type: Observational
• Enrollment: 234 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: European Institute of Oncology (Academic / other)
• Drugs / interventions: ChemoTherapy
• Locations: 1 site (Milan)
• Trial ID: NCT06300125 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are women aged 50 and older with early-stage luminal A/B breast cancer tumors that are unifocal and less than 15 mm in size.

Not a fit: Patients with lobular breast cancer or those with tumors larger than 15 mm or with distant metastasis may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a less invasive treatment option with improved quality of life for patients with low-risk early breast cancer.

How similar studies have performed: While there is emerging evidence supporting cryoablation for breast cancer, this specific approach is novel and has not been extensively tested in similar studies.

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

Where this trial is running

Milan

• European Institute of Oncology — Milan, Italy (Recruiting)

Study contacts

• Principal investigator: Franco Orsi, MD — European Institute of Oncology
• Study coordinator: Paolo Della Vigna, MD

Conditions Breast Cancer; Cryoablation; Ablation