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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
53,142
Every 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment
As required according to the national/regional guidelines or personalised schedule according to risk assessment
As required according to the national/regional guidelines or personalised schedule according to risk assessment
As required according to the national/regional guidelines or personalised schedule according to risk assessment
Institut Jules Bordet
Brussels, Belgium
Gustave roussy
Villejuif, France
Assuta Medical Center Ramat HaHayal
Tel Aviv, Israel
AUSL Reggio Emilia
Reggio Emilia, Emilia-Romagna, Italy
Marta Romản
Barcelona, Spain
Cambridge University Hospitals NHS Foundation Trust
Cambridge, Cambridgeshire, United Kingdom
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.
Time frame: 4 years
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.
Time frame: 4 years
Rate of morbidity in each arm
Morbidity is defined as false positive imaging findings and benign breast biopsies
Time frame: 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
Time frame: 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
Time frame: 4 years
Subject quality of life
Subject quality of life will be evaluated using the EQ-5D quality of life questionnaire
Time frame: 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
Time frame: 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
Time frame: 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.
Time frame: 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
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
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