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

Informazioni relative al progetto

MyPeBS

ID dell’accordo di sovvenzione: 755394

DOI

10.3030/755394

Data della firma CE 5 Dicembre 2017

Data di avvio 1 Gennaio 2018

Data di completamento 31 Dicembre 2027

Finanziato da

• SOCIETAL CHALLENGES - Health, demographic change and well-being

Costo totale

€ 12 498 983,75

Contributo UE

€ 12 436 858,75

Coordinato da

UNICANCER
France

Periodic Reporting for period 5 - MyPeBS (International Randomized Study Comparing personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70)

Periodo di rendicontazione: 2024-01-01 al 2025-06-30

Sintesi del contesto e degli obiettivi generali del progetto

Since the late 1980s, organised breast cancer screening programmes have been introduced in more and more countries across Europe. The aim of mammography screening is to detect breast cancer as early as possible, primarily in order to reduce the number of breast cancer deaths but also to reduce the severity of the disease and the use of heavy invasive cancer treatments.

These programmes have always used a “one size fits all” strategy whereby women in a target age group (typically between 50-69 years old) are invited for a mammography every 2 to 3 years. This approach has demonstrated benefits on specific mortality. However, it also comes with certain side effects, such as false positive findings, overdiagnosis and associated overtreatment. Furthermore, mammography may induce a small lifetime risk of radiation-induced cancer.

A promising approach to improve mammography screening is personalized, individual risk-based screening. Indeed, each woman has her own individual risk of developing breast cancer, depending on many factors like genetic factors, lifestyle, or hormonal exposure.

Recent scientific advances have largely improved our understanding of breast cancer genetics and other risk factors. We now have accurate risk assessment tools and sufficient knowledge to investigate the advantages of using a new screening approach based on individual risk estimation of breast cancer: this is the goal of MyPeBS.

MyPeBS aims to assess the effectiveness, feasibility and safety of a personalised breast cancer screening strategy, where screening interval and methods used are based on the personal risk of developing breast cancer.
To meet such a goal, at MyPeBS’s core is a multi-centre, international, randomised clinical study that aimed at recruiting 56,000 volunteer women aged 40 to 70 years-old and without history of breast cancer, living in Belgium, France, Israel, Italy, the United Kingdom and Spain.
This study will compare two groups of women: half of them will follow the ongoing standard breast screening in their region, and the other half will experiment a personalised strategy where women at higher risk of breast cancer are screened more, and women at a lower risk, less. The incidence of stage 2+ breast cancer after 4 years will be compared in each group to determine if a personalised breast screening is at least equivalent (non-inferiority test), or even more efficient (superiority test), to the standard screening programme.
MyPeBS will also evaluate whether a personalised approach is acceptable for women (psycho-social evaluation), and if the economic resources required for a personalised screening programme justify the results obtained.

Lavoro eseguito dall’inizio del progetto fino alla fine del periodo coperto dalla relazione e principali risultati finora ottenuti

During the first 18 months of the project, the MyPeBS consortium performed the set up activities necessary to launch the clinical trial. This included:
- preparing and translating study related documents, obtaining all required regulatory approvals, implementing all contractual and logistical steps
- building a dedicated GDPR-compliant Web platform for study data collection and flow, and enabling personalisation of the interface for each user depending on their country/region, language, screening schedule etc
- developing all the modules required to run the study and connect them to the platform, e.g. e-learning for investigators, e-signature of participation consents, risk score estimation
- setting the saliva DNA extraction and genotyping activities
- developing a communication plan and multilingual communication tools.

The first study participant was recruited in France on July 18, 2019, followed by Belgium (October 22, 2019) Italy (December 13, 2019), Israel (December 18, 2019) and UK (October 20, 2020). Recruitment was suspended due to the COVID-19 pandemic from March to September 2020 and continued to be hampered by successive epidemic waves thorough 2021-2022.

In order to mitigate the effects of the pandemic, additional recruitment centres were identified in Italy and France, and Spain joined the consortium as an additional recruiting country in 2021 (first participant recruited September 15, 2021). The statistical design of the protocol was also changed to reduce the number of subjects needed to 56,000 and the duration of the project extended by an additional 18 months.

Recruitment concluded on August 4, 2023 (date last participant was randomised). In total 53,143 participants were randomised in the trial.

Following the end of recruitment, the trial entered the follow-up period, with emphasis placed on ensuring the quality of data collection and the publication of research performed with the different work packages.

Notably initial results from WP4 (Modelling MyPeBS to quantify long-term benefits, harms and cost-effectiveness of risk-based screening scenarios) and WP5 (Sociological, ethical and psychological assessments) have been accepted for publication:

• McWilliams et al, Psychol Health 2024 Sep 2:1-23: Women's experiences of risk-stratified breast cancer screening in the MyPeBS trial.
• Quessep et al, Eur J Cancer 2025 Feb 25:217:115220: Subgroups varying in risk and density highlight the potential for stratified breast cancer screening.
• Roux et al, BMC Cancer 2025 Mar 15;25(1):483 : Acceptability of risk-based breast cancer screening among professionals and healthcare providers from 6 countries contributing to the MyPeBS study.

Progressi oltre lo stato dell’arte e potenziale impatto previsto (incluso l’impatto socioeconomico e le implicazioni sociali più ampie del progetto fino ad ora)

MyPeBS first expects to produce clear-cut scientific results and strong recommendations regarding the best-possible screening model between current standard and risk-based screening, in terms of reduction of stage II or higher BC incidence.

Overall with MyPeBS the following impacts are expected:
1. For Women of the general population
• Improve individual patient outcomes and health outcome predictability
• Reduce the overall burden of breast cancer by allowing earlier detection of a breast cancer in women with a higher risk. Such earlier diagnosis is indeed associated with a better prognosis, less treatments needs, less morbidity from the therapies, and lower costs
• Improve the benefit / risk ratio of the of mammography screening by
- reducing the amount of over-diagnosed breast cancers and consequently the overtreatment (unnecessary mammographies and biopsies), by lengthening the screening interval in low risk women;
- obtaining more effective screening in higher risk individuals, especially young women (<40 years old), with a more intensive screening (frequency and exams) allowing earlier detection of advanced stage disease
• Enhance women compliance with organised breast cancer screening by their satisfaction level with screening and prevention measures
• Improve women empowerment towards their personal health
• Pave the way for the development of personalised screening for other types of cancer.

2. For decision makers and health authorities:
• Demonstration of the feasibility, psycho-social acceptability, efficacy and cost-effectiveness of a personalised breast screening program
• Production of recommendations about risk-based screening and associated operational guidelines
• Identification of adequate care pathways models for the delivery of stratified prevention

3. For health care professionals
• Improved awareness on the efficacy of breast cancer prevention
• Better knowledge and understanding of breast cancer risk factors

Overall recruitment rate over time

MyPeBS Study scheme

MyPeBS logo

Final recruitment figures for each country

MyPeBS trial design figure