My Personalized Breast Screening

Condition(s) studied

Investigational drug(s) / intervention(s)

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

Study 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

Eligibility

Primary outcome measure(s)

• Incidence rate of stage 2 and plus breast cancer (non-inferiority analysis) — 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.

Trial sites (6)

More UNICANCER trials in France