Clinical trial NCT03672331: My Personalized Breast Screening
Official title: International Randomized Study Comparing Personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Breast Screening
Keywords: standard breast screening - risk-based screening program
Lead sponsor: UNICANCER
Sponsor class: OTHER
First posted: 2018-09-14
Enrollment: 53142
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


Eligibility criteria: 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

Primary outcomes:
measure: Incidence rate of stage 2 and plus breast cancer (non-inferiority analysis)
timeFrame: 4 years
Secondary outcomes:
measure: Incidence rate of stage 2 and plus breast cancer (superiority analysis)
timeFrame: 4 years
measure: Rate of morbidity in each arm
timeFrame: 4 years
measure: Subject anxiety in response to risk evaluation
timeFrame: 4 years
measure: Socio-psychological characteristics of subjects
timeFrame: 4 years
measure: Subject quality of life
timeFrame: 4 years
measure: Comparison of cost-effectiveness of each strategy
timeFrame: 4 years
measure: Incidence of stage-specific breast cancer in each arm (including DCIS)
timeFrame: 4 years
measure: Estimates of the rate of detection of clinically non-significant tumours (overdiagnosis) in each study arm
timeFrame: 15 years
measure: Rate of false negative images and interval cancers in each arm
timeFrame: 4 years
measure: 10- and 15-year breast cancer specific survival in MyPeBS and in a combined analysis of the Wisdom and MyPeBS studies
timeFrame: 15 years
measure: Detection rate of stage 2+ breast cancer in women who had screening tomosynthesis (where and when available) and the rate without tomosynthesis
timeFrame: 4 years
measure: Incidence of all stage and stage 2 + breast cancers at 10- and 15-year follow-up
timeFrame: 15 years
measure: Incidence of stage 2 + breast cancer in each arm, in women aged 40-49 at inclusion
timeFrame: 4 years
measure: Rate of breast cancers identified at second reading in each arm
timeFrame: 4 years
measure: Rate of false positive imaging findings and benign breast biopsies in women classified at low risk in risk-based arm
timeFrame: 4 years
Other outcomes:
Locations:
city: Bruxelles
country: Belgium
facility: Institut Jules Bordet
city: Villejuif
country: France
facility: Gustave roussy
city: Tel Aviv
country: Israel
facility: Assuta Medical Center Ramat HaHayal
city: Reggio Emilia
country: Italy
facility: AUSL Reggio Emilia
state: Emilia
city: Barcelona
country: Spain
facility: Marta Romản
city: Cambridge
country: United Kingdom
facility: Cambridge University Hospitals NHS Foundation Trust
state: Cambridgeshire
Study officials:
affiliation: Gustave Roussy - FRANCE
name: Suzette DELALOGE, MD
role: STUDY_CHAIR
affiliation: Arcispedale Santa Maria Nuova-IRCCS - ITALY
name: Paolo GORGIO-ROSSI, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Gustave Roussy - FRANCE
name: Corinne BALLEYGUIER, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ASSUTA Hospital - ISRAEL
name: Michal GUINDY, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Institut Jules Bordet - BELGIUM
name: Jean-Benoit BURRION, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Cambridge - UK
name: Fiona GUILBERT, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: PSMAR - SPAIN
name: Marta ROMÁN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Roux A, Cholerton R, Sicsic J, Moumjid N, French DP, Giorgi Rossi P, Balleyguier C, Guindy M, Gilbert FJ, Burrion JB, Castells X, Ritchie D, Keatley D, Baron C, Delaloge S, de Montgolfier S. Study protocol comparing the ethical, psychological and socio-economic impact of personalised breast cancer screening to that of standard screening in the "My Personal Breast Screening" (MyPeBS) randomised clinical trial. BMC Cancer. 2022 May 6;22(1):507. doi: 10.1186/s12885-022-09484-6.