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Clinical Trials in Italy / NCT03672331
Active, not recruiting Not applicable

My Personalized Breast Screening

NCT03672331 · tracked via the Priya Life Science Italy tracker
Sponsor
UNICANCER
Phase
Not applicable
Started
2019-07-18
Last updated
2026-07-22

Condition(s) studied

Breast Screening

Investigational drug(s) / intervention(s)

MammogramUltrasoundMRITomosynthesis

Mammogram: Every 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment

Ultrasound: As required according to the national/regional guidelines or personalised schedule according to risk assessment

MRI: As required according to the national/regional guidelines or personalised schedule according to risk assessment

Tomosynthesis: As required according to the national/regional guidelines or personalised schedule according to risk assessment

Study summary

MyPeBS is an international randomized, open-label, multicentric, study assessing the effectiveness of a risk-based breast cancer screening strategy (using clinical risk scores and polymorphisms) compared to standard screening (according to the current national guidelines in each participating country) in detecting stage 2 or higher breast cancers.

Women will be differentially screened for 4 years and then, after an end-of-study mammogram, they will return to the routine screening practice. The main study endpoint will be measured at the end of the four years of intervention.

Furthermore, follow up data will be collected for 15 years from study entry for evaluation of long-term cumulative breast cancer incidence and breast cancer-specific survival

Eligibility

Sex
FEMALE
Min age
40 Years
Max age
70 Years
Healthy volunteers
Accepted
Inclusion Criteria: 1. Female (whether born female or not) 2. Aged 40 to 70 years old (inclusive) 3. Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures 4. Able to provide written informed consent obtained prior to performing any protocol-related procedures 5. Sufficient understanding of any of the languages used in the study 6. Affiliated to a social security/national healthcare system Exclusion Criteria: 1. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) 2. Prior history of atypical breast lesion, lobular carcinoma in situ or chest wall irradiation 3. Known condition or suspicion of a very high risk predisposition to breast cancer: germline mutation of BRCA1/2, PALB2, TP53 or equivalent 4. History of bilateral mastectomy 5. Recent abnormal breast finding under work-up (clinically suspect lesion or BI-RADS 4 or 5 image) 6. Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up 7. Women who do not intend to be followed-up for 4 years

Primary outcome measure(s)

Trial sites (6)

FacilityCityRegionStatus
Institut Jules Bordet Brussels Belgium
Gustave roussy Villejuif France
Assuta Medical Center Ramat HaHayal Tel Aviv Israel
AUSL Reggio Emilia Reggio Emilia Emilia-Romagna
Marta Romản Barcelona Spain
Cambridge University Hospitals NHS Foundation Trust Cambridge Cambridgeshire

More UNICANCER trials in Italy

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ADT +/- Darolutamide in de Novo Metastatic Prostate Cancer Patients With Vulnerable Functional Ability (PEACE6-Vulnerable) Recruiting
Chemotherapy De-escalation in HR +, HER2-, Intermediate-risk Early Breast Cancer Treated With Adjuvant Ribociclib Recruiting
Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests Recruiting
Evaluation of an Online Intervention to Educate Women at High Risk of Breast Cancer on How to Help Reduce Their Risk. Recruiting

Other trials for the same condition

Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03672331 on ClinicalTrials.gov ↗ ← All trials in Italy