Breast ScreeningMyPeBSNCT03672331
My Personalized Breast Screening
A study testing Mammogram, Ultrasound and MRI in people with Breast Screening, run by UNICANCER at 6 sites in 6 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 to 70 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Screening
- What is being tested?
- Mammogram, Ultrasound and MRI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 53,142 participants
- Where
- 6 sitesin 6 countries
- Study dates
- 18 Jul 2019to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
6 sites in 6 countries.
6 sites in 6 countries
United Kingdom1 site
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire
About this study
Official title: 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
- Conditions
- Breast Screening
- Being tested
- Mammogram, Ultrasound, MRI, Tomosynthesis
- Keywords
- standard breast screening - risk-based screening program
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MammogramOther
Every 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment
UltrasoundOther
As required according to the national/regional guidelines or personalised schedule according to risk assessment
MRIOther
As required according to the national/regional guidelines or personalised schedule according to risk assessment
TomosynthesisOther
As required according to the national/regional guidelines or personalised schedule according to risk assessment
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Mammogram; Other: Ultrasound; Other: MRI; Other: Tomosynthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 4 years
Secondary outcomes (15)
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.
Measured: 4 years
Rate of morbidity in each arm
Morbidity is defined as false positive imaging findings and benign breast biopsies
Measured: 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
Measured: 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
Measured: 4 years
Subject quality of life
Subject quality of life will be evaluated using the EQ-5D quality of life questionnaire
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 4 years
10- and 15-year breast cancer specific survival in MyPeBS and in a combined analysis of the Wisdom and MyPeBS studies
Measured: 15 years
Detection rate of stage 2+ breast cancer in women who had screening tomosynthesis (where and when available) and the rate without tomosynthesis
Measured: 4 years
Incidence of all stage and stage 2 + breast cancers at 10- and 15-year follow-up
Measured: 15 years
Incidence of stage 2 + breast cancer in each arm, in women aged 40-49 at inclusion
Measured: 4 years
Rate of breast cancers identified at second reading in each arm
Measured: 4 years
Rate of false positive imaging findings and benign breast biopsies in women classified at low risk in risk-based arm
Measured: 4 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2018
- Study start18 Jul 2019
- Primary completion31 Aug 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast ScreeningStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 53,142 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Suzette DELALOGE, MD, Study chair, Gustave Roussy - FRANCEPaolo GORGIO-ROSSI, MD, Principal investigator, Arcispedale Santa Maria Nuova-IRCCS - ITALYCorinne BALLEYGUIER, MD, Principal investigator, Gustave Roussy - FRANCEMichal GUINDY, MD, Principal investigator, ASSUTA Hospital - ISRAELJean-Benoit BURRION, MD, Principal investigator, Institut Jules Bordet - BELGIUMFiona GUILBERT, MD, Principal investigator, University of Cambridge - UKMarta ROMÁN, PhD, Principal investigator, PSMAR - SPAIN
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03672331
- Sponsor's protocol ID
- UC-0109/1805
- Acronym
- MyPeBS
- Status last verified
- Jul 2026
- First submitted
- 13 Sep 2018
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 40089664Roux 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.
PubMed 35524202
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- International Randomized Study Comparing Personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70
- ClinicalTrials.gov ID
- NCT03672331
- Acronym / sponsor ID
- MyPeBS / UC-0109/1805
- Conditions
- Breast Screening
- Keywords
- standard breast screening - risk-based screening program
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 53,142 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- 18 Jul 2019 (actual)
- Primary completion
- 31 Aug 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 14 Sep 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard arm | Other | Other: Mammogram, Other: Ultrasound, Other: MRI, Other: TomosynthesisParticipants 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. |
| Risk-based arm | Experimental | Other: Mammogram, Other: Ultrasound, Other: MRI, Other: TomosynthesisParticipants 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MammogramEvery 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment | Other | Risk-based arm, Standard arm |
| UltrasoundAs required according to the national/regional guidelines or personalised schedule according to risk assessment | Other | Risk-based arm, Standard arm |
| MRIAs required according to the national/regional guidelines or personalised schedule according to risk assessment | Other | Risk-based arm, Standard arm |
| TomosynthesisAs required according to the national/regional guidelines or personalised schedule according to risk assessment | Other | Risk-based arm, Standard arm |
Primary outcome
Incidence rate of stage 2 and plus breast cancer (non-inferiority analysis)
Time frame: 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.
15 secondary outcomes
Incidence rate of stage 2 and plus breast cancer (superiority analysis)
Time frame: 4 years
Rate of morbidity in each arm
Time frame: 4 years
Subject anxiety in response to risk evaluation
Time frame: 4 years
Socio-psychological characteristics of subjects
Time frame: 4 years
Subject quality of life
Time frame: 4 years
Comparison of cost-effectiveness of each strategy
Time frame: 4 years
Incidence of stage-specific breast cancer in each arm (including DCIS)
Time frame: 4 years
Estimates of the rate of detection of clinically non-significant tumours (overdiagnosis) in each study arm
Time frame: 15 years
Rate of false negative images and interval cancers in each arm
Time frame: 4 years
10- and 15-year breast cancer specific survival in MyPeBS and in a combined analysis of the Wisdom and MyPeBS studies
Time frame: 15 years
Detection rate of stage 2+ breast cancer in women who had screening tomosynthesis (where and when available) and the rate without tomosynthesis
Time frame: 4 years
Incidence of all stage and stage 2 + breast cancers at 10- and 15-year follow-up
Time frame: 15 years
Incidence of stage 2 + breast cancer in each arm, in women aged 40-49 at inclusion
Time frame: 4 years
Rate of breast cancers identified at second reading in each arm
Time frame: 4 years
Rate of false positive imaging findings and benign breast biopsies in women classified at low risk in risk-based arm
Time frame: 4 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2026.
- Derived from this study: PubMed 40089664Roux 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.
- Derived from this study: PubMed 35524202Roux 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.
- Public website of MyPeBSLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
6 sites in 6 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mammogram, Ultrasound and MRI in people with Breast Screening, run by UNICANCER at 6 sites in 6 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Belgium, France, Israel, Italy, Spain and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of stage 2 and plus breast cancer (non-inferiority analysis) (time frame: 4 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03672331, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2026.