Breast Screening
Conditions
Keywords
standard breast screening - risk-based screening program
Brief 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
Interventions
OTHERMammogram
Every 1-4 years according to the national/regional guidelines or personalised schedule according to risk assessment
OTHERUltrasound
As required according to the national/regional guidelines or personalised schedule according to risk assessment
OTHERMRI
As required according to the national/regional guidelines or personalised schedule according to risk assessment
OTHERTomosynthesis
As required according to the national/regional guidelines or personalised schedule according to risk assessment
Sponsors
UNICANCER
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
40 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
1. Female (whether born female or not) 2. Aged 40 to 70 years old (inclusive) 3. Willing and able to comply with scheduled visits, laboratory tests, and other trial procedures 4. Able to provide written informed consent obtained prior to performing any protocol-related procedures 5. Sufficient understanding of any of the languages used in the study 6. Affiliated to a social security/national healthcare system
Exclusion criteria
1. Personal history of breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) 2. Prior history of atypical breast lesion, lobular carcinoma in situ or chest wall irradiation 3. Known condition or suspicion of a very high risk predisposition to breast cancer: germline mutation of BRCA1/2, PALB2, TP53 or equivalent 4. History of bilateral mastectomy 5. Recent abnormal breast finding under work-up (clinically suspect lesion or BI-RADS 4 or 5 image) 6. Psychiatric or other disorders that are not compatible with compliance to the protocol requirements and follow-up 7. Women who do not intend to be followed-up for 4 years
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Rate of morbidity in each arm | 4 years | Morbidity is defined as false positive imaging findings and benign breast biopsies |
| Subject anxiety in response to risk evaluation | 4 years | Subject anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI) questionaire, and compared between treatment arms |
| Socio-psychological characteristics of subjects | 4 years | Socio-psychological characteristics will be evaluated using study specific questions concerning comprehension, information-seeking behavior, satisfaction and socio-demographic and economic status |
| Subject quality of life | 4 years | Subject quality of life will be evaluated using the EQ-5D quality of life questionnaire |
| Comparison of cost-effectiveness of each strategy | 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 |
| Incidence of stage-specific breast cancer in each arm (including DCIS) | 4 years | Comparison of the overall incidence of breast cancer detected in each arm according to AJCC stage |
| Estimates of the rate of detection of clinically non-significant tumours (overdiagnosis) in each study arm | 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. |
| Incidence rate of stage 2 and plus breast cancer (superiority analysis) | 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. |
| 10- and 15-year breast cancer specific survival in MyPeBS and in a combined analysis of the Wisdom and MyPeBS studies | 15 years | — |
| Detection rate of stage 2+ breast cancer in women who had screening tomosynthesis (where and when available) and the rate without tomosynthesis | 4 years | — |
| Incidence of all stage and stage 2 + breast cancers at 10- and 15-year follow-up | 15 years | — |
| Incidence of stage 2 + breast cancer in each arm, in women aged 40-49 at inclusion | 4 years | — |
| Rate of breast cancers identified at second reading in each arm | 4 years | — |
| Rate of false positive imaging findings and benign breast biopsies in women classified at low risk in risk-based arm | 4 years | — |
| Rate of false negative images and interval cancers in each arm | 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 |
Countries
Belgium, France, Israel, Italy, Spain, United Kingdom
Outcome results
None listed