Percutaneous Cryoablation of Low-risk Early Breast Cancer

Breast Cancer Clinical Trial

— PRECICE  

Official title:

Percutaneous Cryoablation of Low-risk Early Breast Cancer

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06300125
• Other study ID #: R1881/23 - L2-015
• Status: Recruiting
• Start date: April 15, 2024
• Est. completion date: March 1, 2031

Study information

• Verified date: January 2024
• Source: European Institute of Oncology
• Contact: Paolo Della Vigna, MD
• Phone: +390257489060
• Email: paolo.dellavigna[@]ieo.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 234
• Est. completion date: March 1, 2031
• Est. primary completion date: December 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Procedure:
• Cryoablation
Percutaneous Cryoablation of Breast Cancer

Locations

Country	Name	City	State
Italy	European Institute of Oncology	Milan

Sponsors (3)

Lead Sponsor	Collaborator
European Institute of Oncology	Fondazione Umberto Veronesi, IceCure Medical Ltd.

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procedure failure rate	Percentage of patients with residual tumor at the site of cryoablation	8 months
Secondary	Assessment of subject's quality of life in terms of evaluation of sources of distress	Quality of life will be assessed using National Comprehensive Cancer Network (NCCN) DISTRESS THERMOMETER	60 months
Secondary	Assessment of subject's satisfaction	Satisfaction will be assessed using BreastQ questionnaire	60 months
Secondary	Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable)	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
Secondary	Ipsilateral breast tumor recurrence	Percentage of ipsilateral breast tumor recurrence	60 months
Secondary	Distant metastasis	Percentage of distant metastasis	60 months