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NCT Number: NCT03672331

My Personalized Breast Screening

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

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Breast Screening

Age range

40 year–70 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Institut Jules Bordet, Brussels, Belgium

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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

  1. 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.

Secondary outcomes

  1. Incidence rate of stage 2 and plus breast cancer (superiority analysis)

    Time frame: 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.

  2. Rate of morbidity in each arm

    Time frame: 4 years

    Morbidity is defined as false positive imaging findings and benign breast biopsies

  3. Subject anxiety in response to risk evaluation

    Time frame: 4 years

    Subject anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI) questionaire, and compared between treatment arms

  4. Socio-psychological characteristics of subjects

    Time frame: 4 years

    Socio-psychological characteristics will be evaluated using study specific questions concerning comprehension, information-seeking behavior, satisfaction and socio-demographic and economic status

  5. Subject quality of life

    Time frame: 4 years

    Subject quality of life will be evaluated using the EQ-5D quality of life questionnaire

  6. Comparison of cost-effectiveness of each strategy

    Time frame: 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

  7. Incidence of stage-specific breast cancer in each arm (including DCIS)

    Time frame: 4 years

    Comparison of the overall incidence of breast cancer detected in each arm according to AJCC stage

  8. Estimates of the rate of detection of clinically non-significant tumours (overdiagnosis) in each study arm

    Time frame: 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.

  9. Rate of false negative images and interval cancers in each arm

    Time frame: 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. 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

  11. 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

  12. Incidence of all stage and stage 2 + breast cancers at 10- and 15-year follow-up

    Time frame: 15 years

  13. Incidence of stage 2 + breast cancer in each arm, in women aged 40-49 at inclusion

    Time frame: 4 years

  14. Rate of breast cancers identified at second reading in each arm

    Time frame: 4 years

  15. Rate of false positive imaging findings and benign breast biopsies in women classified at low risk in risk-based arm

    Time frame: 4 years

Sponsors and collaborators

Lead sponsor

UNICANCER

Other

Registry information

Official study title

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

Acronym: MyPeBS

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Sep 14, 2018
Registry last updated
Jul 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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