Percutaneous Cryoablation of Low-risk Early Breast Cancer (PRECICE)

January 2, 2026 updated by: European Institute of Oncology
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

PRECICE is a prospective single arm, single centre, observational study which aims to enroll patients ≥50 years old, diagnosed with early-stage luminal A/B, unifocal Breast Cancer (BC), < 15 mm in size, without in situ component detected at imaging (by breast ultrasound, Magnetic Resonance Imaging (MRI), Mammography) and confirmed by needle biopsy, defining histotype and biology. All patients that receive treatment with cryoablation as their standard care for BC followed by RadioTherapy (RT), according to the MultiDisciplinary Tumor Board (MDTB) referral and fulfil the inclusion criteria, will be prospectively included in the study.

Follow-up protocol involved breast imaging with mammography, ultrasound, and MRI, assessment of procedure failure rate, quality of life, psychological impact, oncological outcome and economical efficacy. Adjuvant therapy will be planned after further multidisciplinary discussion

Study Type

Observational

Enrollment (Estimated)

234

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
      • Milan, Italy
        • Recruiting
        • European Institute of Oncology
        • Contact:
          • Franco Orsi

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

Study Population

Patients undergone percutaneous cryoablation of early stage breast cancer

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cryoablation
Percutaneous Cryoablation of Breast Cancer
Procedure: Cryoablation
Percutaneous Cryoablation of Breast Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Procedure failure rate
Time Frame: 8 months
Percentage of patients with residual tumor at the site of cryoablation
8 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of subject's quality of life in terms of evaluation of sources of distress
Time Frame: 60 months
Quality of life will be assessed using National Comprehensive Cancer Network (NCCN) DISTRESS THERMOMETER
60 months
Assessment of subject's satisfaction
Time Frame: 60 months
Satisfaction will be assessed using BreastQ questionnaire
60 months
Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable)
Time Frame: 60 months
Cost will be calculated for all patients considering the cost of the intervention, the cost of hospitalization and cost of eventual re-intervention in case of unsuccessful intervention
60 months
Ipsilateral breast tumor recurrence
Time Frame: 60 months
Percentage of ipsilateral breast tumor recurrence
60 months
Distant metastasis
Time Frame: 60 months
Percentage of distant metastasis
60 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

European Institute of Oncology

Collaborators

Fondazione Umberto Veronesi
IceCure Medical Ltd.

Investigators

  • Principal Investigator: Franco Orsi, MD, European Institute of Oncology

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 15, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2031

Study Registration Dates

First Submitted

February 16, 2024

First Submitted That Met QC Criteria

March 7, 2024

First Posted (Actual)

March 8, 2024

Study Record Updates

Last Update Posted (Actual)

January 6, 2026

Last Update Submitted That Met QC Criteria

January 2, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UID 4037
  • R1881/23 - L2-015 (Other Identifier: Comitato Etico Territoriale Lombardia 2)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe