My Personalized Breast Screening

  • STATUS
    Recruiting
  • End date
    Dec 31, 2025
  • participants needed
    85000
  • sponsor
    UNICANCER
Updated on 3 September 2021

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 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

Details
Condition Breast Screening
Treatment MRI, ultrasound, Mammogram, Tomosynthesis
Clinical Study IdentifierNCT03672331
SponsorUNICANCER
Last Modified on3 September 2021

Eligibility

Yes No Not Sure

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
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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