Percutaneous Cryoablation of Low-risk Early Breast Cancer (PRECICE)

European Institute of Oncology

Status

Enrolling

Conditions

Breast Cancer

Treatments

Procedure: Cryoablation

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT06300125

UID 4037

R1881/23 - L2-015

Details and patient eligibility

About

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.

Full 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

Enrollment

234 estimated patients

Sex

All

Ages

50+ years old

Volunteers

No Healthy Volunteers

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