Percutaneous Cryoablation of Low-risk Early Breast Cancer

NCT ID: NCT06300125

Last Updated: 2026-01-06

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 234 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-04-15
• Study Completion Date: 2031-03-01

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.

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

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Cryoablation

Percutaneous Cryoablation of Breast Cancer

Cryoablation

Intervention Type: PROCEDURE

Percutaneous Cryoablation of Breast Cancer

Interventions

Cryoablation

Percutaneous Cryoablation of Breast Cancer

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fondazione Umberto Veronesi

OTHER

Sponsor Role: collaborator

IceCure Medical Ltd.

INDUSTRY

Sponsor Role: collaborator

European Institute of Oncology

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Franco Orsi, MD

Role: PRINCIPAL_INVESTIGATOR

European Institute of Oncology

Locations

European Institute of Oncology

Milan, , Italy

Site Status: RECRUITING

Countries

Italy

Central Contacts

Paolo Della Vigna, MD

Role: CONTACT

paolo.dellavigna@ieo.it

0039 02 57489060

Mara Negri

Role: CONTACT

mara.negri@ieo.it

0039 02 57489536

Facility Contacts

Franco Orsi

Role: primary

Other Identifiers

R1881/23 - L2-015

Identifier Type: OTHER

Identifier Source: secondary_id

UID 4037

Identifier Type: -

Identifier Source: org_study_id