Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
NA
53142 participants
INTERVENTIONAL
2019-07-18
2027-12-31
Brief Summary
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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
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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.
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
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.
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
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
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
40 Years
70 Years
FEMALE
Yes
Sponsors
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UNICANCER
OTHER
Responsible Party
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Principal Investigators
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Suzette DELALOGE, MD
Role: STUDY_CHAIR
Gustave Roussy - FRANCE
Paolo GORGIO-ROSSI, MD
Role: PRINCIPAL_INVESTIGATOR
Arcispedale Santa Maria Nuova-IRCCS - ITALY
Corinne BALLEYGUIER, MD
Role: PRINCIPAL_INVESTIGATOR
Gustave Roussy - FRANCE
Michal GUINDY, MD
Role: PRINCIPAL_INVESTIGATOR
ASSUTA Hospital - ISRAEL
Jean-Benoit BURRION, MD
Role: PRINCIPAL_INVESTIGATOR
Institut Jules Bordet - BELGIUM
Fiona GUILBERT, MD
Role: PRINCIPAL_INVESTIGATOR
University of Cambridge - UK
Marta ROMÁN, PhD
Role: PRINCIPAL_INVESTIGATOR
PSMAR - SPAIN
Locations
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Institut Jules Bordet
Brussels, , Belgium
Gustave roussy
Villejuif, , France
Assuta Medical Center Ramat HaHayal
Tel Aviv, , Israel
AUSL Reggio Emilia
Reggio Emilia, Emilia-Romagna, Italy
Marta Romản
Barcelona, , Spain
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
Countries
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References
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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.
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.
Related Links
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Public website of MyPeBS
Other Identifiers
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UC-0109/1805
Identifier Type: -
Identifier Source: org_study_id
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