My Personalized Breast Screening

NCT03672331 | Active Not Recruiting DMC

• 1 other identifier: UC-0109/1805
• Study Type: interventional
• Target: 53,142
• Locations: 6 countries
• Sites: 6

Brief 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

Conditions

Breast Screening

Keywords

standard breast screening - risk-based screening program

Outcome Measures

Primary Outcomes (1)

• Incidence rate of stage 2 and plus breast cancer (non-inferiority analysis)

  The study primary objective is to show non-inferiority of the risk-stratified screening strategy in terms of incidence rate of breast cancer of stage 2 and higher (2+), compared to standard screening.

  4 years

Secondary Outcomes (15)

• Incidence rate of stage 2 and plus breast cancer (superiority analysis)

  4 years

• Rate of morbidity in each arm

  4 years

• Subject anxiety in response to risk evaluation

  4 years

• Socio-psychological characteristics of subjects

  4 years

• Subject quality of life

  4 years

Study Arms (2)

Standard arm

OTHER

Participants will be screened for breast cancer according to current national/regional guidelines and procedures: with a mammogram and/or tomosynthesis (TS) every 1-3 years starting at age 40-50 years, up to age 69-74 years, with or without ultrasound and MRI depending on breast mammographic density and current recommendations. The national/regional guidelines in use in the including center may be subjected to changes during the study. Guidelines and procedures in the standard arm will be updated accordingly.

Other: Mammogram; Other: Ultrasound; Other: MRI; Other: Tomosynthesis

Risk-based arm

EXPERIMENTAL

Participants will be screened according to a personalised timetable based on their estimated 5-year risk of developing breast cancer: with a mammography and/or tomosynthesis every 1-4 years with or without ultrasound depending on breast density. Risk estimation will be performed using the following variables: age, family history, previous history of benign breast biopsy, personal hormone and reproductive history, breast mammographic density and genotyping (polygenic risk score). Risk assessment will be conducted using Mammorisk™ for women with at most one first-degree relative with breast or ovarian cancer and using Tyrer-Cuzick™ risk score for those women with more than one first-line first degree relative with breast or ovarian cancer.

Other: Mammogram; Other: Ultrasound; Other: MRI; Other: Tomosynthesis

Interventions

Mammogram OTHER

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

Risk-based arm; Standard arm

Ultrasound OTHER

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

Risk-based arm; Standard arm

MRI OTHER

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

Risk-based arm; Standard arm

Tomosynthesis OTHER

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

Risk-based arm; Standard arm

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female (whether born female or not)
• Aged 40 to 70 years old (inclusive)
• Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures
• Able to provide written informed consent obtained prior to performing any protocol-related procedures
• Sufficient understanding of any of the languages used in the study
• Affiliated to a social security/national healthcare system

You may not qualify if:

• Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS)
• Prior history of atypical breast lesion, lobular carcinoma in situ or chest wall irradiation
• Known condition or suspicion of a very high risk predisposition to breast cancer: germline mutation of BRCA1/2, PALB2, TP53 or equivalent
• History of bilateral mastectomy
• Recent abnormal breast finding under work-up (clinically suspect lesion or BI-RADS 4 or 5 image)
• Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up
• Women who do not intend to be followed-up for 4 years

Sponsors & Collaborators

• UNICANCER: lead

Study Sites (6)

Institut Jules Bordet

Brussels, Belgium

Location

Gustave roussy

Villejuif, France

Location

Assuta Medical Center Ramat HaHayal

Tel Aviv, Israel

Location

AUSL Reggio Emilia

Reggio Emilia, Emilia-Romagna, Italy

Location

Marta Romản

Barcelona, Spain

Location

Cambridge University Hospitals NHS Foundation Trust

Cambridge, Cambridgeshire, United Kingdom

Location

Related Publications (2)

• Roux A, Hervouet L, Stefano FD, French DP, Giordano L, Ritchie D, Bugat MR, Keatley D, Cholerton R, McWilliams L, Rossi PG, Balleyguier C, Guindy M, Gilbert FJ, Burrion JB, Roman M, Vissac-Sabatier C, Couch D, Delaloge S, Montgolfier S; MyPeBS Investigators and the MyPeBS Consortium. Acceptability of risk-based breast cancer screening among professionals and healthcare providers from 6 countries contributing to the MyPeBS study. BMC Cancer. 2025 Mar 15;25(1):483. doi: 10.1186/s12885-025-13848-z.

  PMID: 40089664 DERIVED

• Roux A, Cholerton R, Sicsic J, Moumjid N, French DP, Giorgi Rossi P, Balleyguier C, Guindy M, Gilbert FJ, Burrion JB, Castells X, Ritchie D, Keatley D, Baron C, Delaloge S, de Montgolfier S. Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial. BMC Cancer. 2022 May 6;22(1):507. doi: 10.1186/s12885-022-09484-6.

  PMID: 35524202 DERIVED

Related Links

• Public website of MyPeBS

MeSH Terms

Interventions

High-Energy Shock Waves

Intervention Hierarchy (Ancestors)

Ultrasonic Waves; Sound; Radiation, Nonionizing; Radiation; Physical Phenomena

Study Officials

• Suzette DELALOGE, MD

  Gustave Roussy - FRANCE

  STUDY CHAIR

• Paolo GORGIO-ROSSI, MD

  Arcispedale Santa Maria Nuova-IRCCS - ITALY

  PRINCIPAL INVESTIGATOR

• Corinne BALLEYGUIER, MD

  Gustave Roussy - FRANCE

  PRINCIPAL INVESTIGATOR

• Michal GUINDY, MD

  ASSUTA Hospital - ISRAEL

  PRINCIPAL INVESTIGATOR

• Jean-Benoit BURRION, MD

  Institut Jules Bordet - BELGIUM

  PRINCIPAL INVESTIGATOR

• Fiona GUILBERT, MD

  University of Cambridge - UK

  PRINCIPAL INVESTIGATOR

• Marta ROMÁN, PhD

  PSMAR - SPAIN

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 13, 2018
• First Posted: September 14, 2018
• Study Start: July 18, 2019
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
• Access Criteria: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.

Locations

BE (1); IT (1); IL (1); FR (1); ES (1); GB (1)