NCT06300125

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
234

participants targeted

Target at P75+ for all trials

Timeline
59mo left

Started Apr 2024

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress30%
Apr 2024Mar 2031

First Submitted

Initial submission to the registry

February 16, 2024

Completed
21 days until next milestone

First Posted

Study publicly available on registry

March 8, 2024

Completed
1 month until next milestone

Study Start

First participant enrolled

April 15, 2024

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2026

Expected
4.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2031

Last Updated

January 6, 2026

Status Verified

September 1, 2025

Enrollment Period

2.7 years

First QC Date

February 16, 2024

Last Update Submit

January 2, 2026

Conditions

Breast Cancer

Keywords

CryoablationAblationBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Procedure failure rate

    Percentage of patients with residual tumor at the site of cryoablation

    8 months

Secondary Outcomes (5)

  • Assessment of subject's quality of life in terms of evaluation of sources of distress

    60 months

  • Assessment of subject's satisfaction

    60 months

  • Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable)

    60 months

  • Ipsilateral breast tumor recurrence

    60 months

  • Distant metastasis

    60 months

Study Arms (1)

Cryoablation

Percutaneous Cryoablation of Breast Cancer

Procedure: Cryoablation

Interventions

CryoablationPROCEDURE

Percutaneous Cryoablation of Breast Cancer

Cryoablation

Eligibility Criteria

Age50 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Patients undergone percutaneous cryoablation of early stage breast cancer

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

European Institute of Oncology

Milan, Italy

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Cryosurgery

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Ablation TechniquesSurgical Procedures, Operative

Study Officials

  • Franco Orsi, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Paolo Della Vigna, MD

CONTACT

0039 02 57489060paolo.dellavigna@ieo.it

Mara Negri

CONTACT

0039 02 57489536mara.negri@ieo.it

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 16, 2024

First Posted

March 8, 2024

Study Start

April 15, 2024

Primary Completion (Estimated)

December 31, 2026

Study Completion (Estimated)

March 1, 2031

Last Updated

January 6, 2026

Record last verified: 2025-09

Locations

IT(1)