My Personalized Breast Screening

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

Conditions

• Breast Screening

Interventions

OTHER

Mammogram

Every 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment

OTHER

Ultrasound

As required according to the national/regional guidelines or personalised schedule according to risk assessment

OTHER

MRI

As required according to the national/regional guidelines or personalised schedule according to risk assessment

OTHER

Tomosynthesis

As required according to the national/regional guidelines or personalised schedule according to risk assessment

Sponsors & Collaborators

• UNICANCER

  lead OTHER

Principal Investigators

• Suzette DELALOGE, MD · Gustave Roussy - FRANCE

• Paolo GORGIO-ROSSI, MD · Arcispedale Santa Maria Nuova-IRCCS - ITALY

• Corinne BALLEYGUIER, MD · Gustave Roussy - FRANCE

• Michal GUINDY, MD · ASSUTA Hospital - ISRAEL

• Jean-Benoit BURRION, MD · Institut Jules Bordet - BELGIUM

• Fiona GUILBERT, MD · University of Cambridge - UK

• Marta ROMÁN, PhD · PSMAR - SPAIN

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

40 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2019-07-18

Primary Completion

2027-08-31

Completion

2027-12-31

Countries

• Belgium
• France
• Israel
• Italy
• Spain
• United Kingdom

Study Locations