My Personalized Breast Screening

• Mammogram (Other): Every 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment
• Ultrasound (Other): As required according to the national/regional guidelines or personalised schedule according to risk assessment
• MRI (Other): As required according to the national/regional guidelines or personalised schedule according to risk assessment
• Tomosynthesis (Other): As required according to the national/regional guidelines or personalised schedule according to risk assessment

Primary outcomes

• Incidence rate of stage 2 and plus breast cancer (non-inferiority analysis) [4 years]: 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.

Secondary outcomes

• Incidence rate of stage 2 and plus breast cancer (superiority analysis) [4 years]: 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.
• Rate of morbidity in each arm [4 years]: Morbidity is defined as false positive imaging findings and benign breast biopsies
• Subject anxiety in response to risk evaluation [4 years]: Subject anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI) questionaire, and compared between treatment arms
• Socio-psychological characteristics of subjects [4 years]: Socio-psychological characteristics will be evaluated using study specific questions concerning comprehension, information-seeking behavior, satisfaction and socio-demographic and economic status
• Subject quality of life [4 years]: Subject quality of life will be evaluated using the EQ-5D quality of life questionnaire
• Comparison of cost-effectiveness of each strategy [4 years]: 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
• Incidence of stage-specific breast cancer in each arm (including DCIS) [4 years]: Comparison of the overall incidence of breast cancer detected in each arm according to AJCC stage
• Estimates of the rate of detection of clinically non-significant tumours (overdiagnosis) in each study arm [15 years]: 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.
• Rate of false negative images and interval cancers in each arm [4 years]: 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
• 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]

Sex: Female, ages: 40 Years to 70 Years, accepts healthy volunteers

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

• Results publication: 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
• Results publication: 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

• Suzette DELALOGE, MD, Study chair, Gustave Roussy - FRANCE
• Paolo GORGIO-ROSSI, MD, Principal investigator, Arcispedale Santa Maria Nuova-IRCCS - ITALY
• Corinne BALLEYGUIER, MD, Principal investigator, Gustave Roussy - FRANCE
• Michal GUINDY, MD, Principal investigator, ASSUTA Hospital - ISRAEL
• Jean-Benoit BURRION, MD, Principal investigator, Institut Jules Bordet - BELGIUM
• Fiona GUILBERT, MD, Principal investigator, University of Cambridge - UK
• Marta ROMÁN, PhD, Principal investigator, PSMAR - SPAIN