My Personalized Breast Screening (MyPeBS)

International Randomized Study Comparing Personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70

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

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Screening
• Intervention / Treatment: Other: Mammogram; Other: Ultrasound; Other: MRI; Other: Tomosynthesis

• Study Type: Interventional
• Enrollment (Actual): 53142
• Phase: Not Applicable

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 40 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Standard arm; 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; Every 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment; Other: Ultrasound; As required according to the national/regional guidelines or personalised schedule according to risk assessment; Other: MRI; As required according to the national/regional guidelines or personalised schedule according to risk assessment; Other: Tomosynthesis; As required according to the national/regional guidelines or personalised schedule according to risk assessment
Experimental: Risk-based arm; 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; Every 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment; Other: Ultrasound; As required according to the national/regional guidelines or personalised schedule according to risk assessment; Other: MRI; As required according to the national/regional guidelines or personalised schedule according to risk assessment; Other: Tomosynthesis; As required according to the national/regional guidelines or personalised schedule according to risk assessment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence rate of stage 2 and plus breast cancer (superiority analysis)	The key secondary objective, if non-inferiority is shown, is to demonstrate superiority of the risk-based screening arm to reduce the incidence rate of stage 2+ breast cancer, compared to standard screening.	4 years
Rate of morbidity in each arm	Morbidity is defined as false positive imaging findings and benign breast biopsies	4 years
Subject anxiety in response to risk evaluation	Subject anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI) questionaire, and compared between treatment arms	4 years
Socio-psychological characteristics of subjects	Socio-psychological characteristics will be evaluated using study specific questions concerning comprehension, information-seeking behavior, satisfaction and socio-demographic and economic status	4 years
Subject quality of life	Subject quality of life will be evaluated using the EQ-5D quality of life questionnaire	4 years
Comparison of cost-effectiveness of each strategy	Crude costs, defined as full real costs per stage 2 cancer diagnosis, will be estimated in each arm. The cost-effectiveness of mammographic screening will be calculated by comparing estimated life-years and costs of breast cancer in each arm	4 years
Incidence of stage-specific breast cancer in each arm (including DCIS)	Comparison of the overall incidence of breast cancer detected in each arm according to AJCC stage	4 years
Estimates of the rate of detection of clinically non-significant tumours (overdiagnosis) in each study arm	Overdiagnosed breast cancer cases are defined as cancers that would never have been detected clinically, if women had not been screened. Differential overdiagnosis will be measured comparing the cumulative incidence of breast cancer in each arm 15 years after the end of the interventional period of the study.	15 years
Rate of false negative images and interval cancers in each arm	False negative images: in case of diagnosis of breast cancer in women whose last screening images (including mammogram +/- US and MRI) were considered as Breast Imaging- Reporting and Data System 1 or 2 (BI-RADS 1 or 2) at 6 months maximum before diagnosis. Interval cancers are defined as a breast cancers diagnosed between a negative screening episode - [mammogram classified as normal (BI-RADS ACR 1 or 2 or equivalent) or abnormal mammogram but negative assessment] and the next planned mammogram	4 years
10- and 15-year breast cancer specific survival in MyPeBS and in a combined analysis of the Wisdom and MyPeBS studies		15 years
Detection rate of stage 2+ breast cancer in women who had screening tomosynthesis (where and when available) and the rate without tomosynthesis		4 years
Incidence of all stage and stage 2 + breast cancers at 10- and 15-year follow-up		15 years
Incidence of stage 2 + breast cancer in each arm, in women aged 40-49 at inclusion		4 years
Rate of breast cancers identified at second reading in each arm		4 years
Rate of false positive imaging findings and benign breast biopsies in women classified at low risk in risk-based arm		4 years

Collaborators and Investigators

• Sponsor: UNICANCER
• Investigators: Study Chair: Suzette DELALOGE, MD, Gustave Roussy - FRANCE; Principal Investigator: 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

Publications and helpful links

General Publications

• 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.
• 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.

Helpful Links

• Public website of MyPeBS

Study record dates

Study Major Dates

• Study Start (Actual): July 18, 2019
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: September 13, 2018
• First Submitted That Met QC Criteria: September 13, 2018
• First Posted (Actual): September 14, 2018

Study Record Updates

• Last Update Posted (Estimated): September 18, 2025
• Last Update Submitted That Met QC Criteria: September 17, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: standard breast screening - risk-based screening program
• Additional Relevant MeSH Terms: Physical Phenomena; Radiation; Radiation, Nonionizing; Ultrasonic Waves; Sound; High-Energy Shock Waves
• Other Study ID Numbers: UC-0109/1805

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
• IPD Sharing 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.
• IPD Sharing 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.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No