Clinical trial NCT06300125: Percutaneous Cryoablation of Low-risk Early Breast Cancer
Official title: Percutaneous Cryoablation of Low-risk Early Breast Cancer
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Breast Cancer
Keywords: Cryoablation
Ablation
Breast Cancer
Lead sponsor: European Institute of Oncology
Sponsor class: OTHER
Collaborators: name: Fondazione Umberto Veronesi
name: IceCure Medical Ltd.
First posted: 2024-03-08
Enrollment: 234
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients undergone percutaneous cryoablation of early stage breast cancer

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

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

Primary outcomes:
measure: Procedure failure rate
timeFrame: 8 months
Secondary outcomes:
measure: Assessment of subject's quality of life in terms of evaluation of sources of distress
timeFrame: 60 months
measure: Assessment of subject's satisfaction
timeFrame: 60 months
measure: Cost-analysis - evaluation of cost of intervention, hospitalization and re-intervention (if applicable)
timeFrame: 60 months
measure: Ipsilateral breast tumor recurrence
timeFrame: 60 months
measure: Distant metastasis
timeFrame: 60 months
Other outcomes:
Locations:
city: Milan
country: Italy
facility: European Institute of Oncology
Study officials:
affiliation: European Institute of Oncology
name: Franco Orsi, MD
role: PRINCIPAL_INVESTIGATOR
References: