Breast CancerPRECICENCT06300125
Percutaneous Cryoablation of Low-risk Early Breast Cancer
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
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. Read more about this study
- Who is it for?
- Ages 50 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Cryoablation
- Type of treatment
- Surgery or procedure
- How many people
- 234 participants
- Where
- 1 siteItaly
- Study dates
- 15 Apr 2024to 1 Mar 2031
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergone percutaneous cryoablation of early stage breast cancer
Who may be able to join
- 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)
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- 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.
Who cannot join
- 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
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- <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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
European Institute of Oncology
Milan
Franco Orsi
About this study
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.
Read the 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
- Being tested
- Cryoablation
- Keywords
- Cryoablation, Ablation, Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CryoablationProcedure or surgery
Percutaneous Cryoablation of Breast Cancer
| Study group | Role | What they receive |
|---|---|---|
| Cryoablation | Percutaneous Cryoablation of Breast Cancer Receives: Procedure: Cryoablation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Procedure failure rate
Percentage of patients with residual tumor at the site of cryoablation
Measured: 8 months
Secondary outcomes (5)
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
Measured: 60 months
Assessment of subject's satisfaction
Satisfaction will be assessed using BreastQ questionnaire
Measured: 60 months
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
Measured: 60 months
Ipsilateral breast tumor recurrence
Percentage of ipsilateral breast tumor recurrence
Measured: 60 months
Distant metastasis
Percentage of distant metastasis
Measured: 60 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2024
- Study start15 Apr 2024
- Primary completion31 Dec 2026 (estimated)
- Study completion1 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by European Institute of OncologyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 234 participants (estimated)
Sponsor and investigators
- Lead sponsor
- European Institute of Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Fondazione Umberto Veronesi, IceCure Medical Ltd.
- Responsible party
- Sponsor
- Investigators
- Franco Orsi, MD, Principal investigator, European Institute of Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06300125
- Sponsor's protocol ID
- UID 4037
- Other IDs
- R1881/23 - L2-015
- Acronym
- PRECICE
- Status last verified
- Sep 2025
- First submitted
- 16 Feb 2024
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Percutaneous Cryoablation of Low-risk Early Breast Cancer
- ClinicalTrials.gov ID
- NCT06300125
- Acronym / sponsor ID
- PRECICE / UID 4037
- Conditions
- Breast Cancer
- Keywords
- Cryoablation, Ablation, Breast Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 234 participants (estimated)
- Lead sponsor
- European Institute of OncologyUniversity, hospital or other
- Collaborators
- Fondazione Umberto Veronesi, IceCure Medical Ltd.
- Study start
- 15 Apr 2024 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 1 Mar 2031 (estimated)
- First posted
- 8 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cryoablation | – | Procedure: CryoablationPercutaneous Cryoablation of Breast Cancer |
Who may qualify
- Ages
- 50 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergone percutaneous cryoablation of early stage breast cancer
Key inclusion criteria (12 listed)
- 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)
Key exclusion criteria (11 listed)
- Plurifocality
- Invasive lobular breast cancer
- HER2 overexpressed or Triple Negative Breast Cancer (TNBC)
- tumor dimension >15 mm
- Node positive
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CryoablationPercutaneous Cryoablation of Breast Cancer | Procedure or surgery | Cryoablation |
Primary outcome
Procedure failure rate
Time frame: 8 months
Percentage of patients with residual tumor at the site of cryoablation
5 secondary outcomes
Assessment of subject's quality of life in terms of evaluation of sources of distress
Time frame: 60 months
Assessment of subject's satisfaction
Time frame: 60 months
Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable)
Time frame: 60 months
Ipsilateral breast tumor recurrence
Time frame: 60 months
Distant metastasis
Time frame: 60 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Jan 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Franco Orsi, MD principal investigator
European Institute of Oncology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by European Institute of Oncology at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Paolo Della Vigna, MD (0039 02 57489060, paolo.dellavigna@ieo.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procedure failure rate (time frame: 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Jan 2026.