My Personalized Breast Screening

Breast Screening Clinical Trial

— MyPeBS  

Official title:

International Randomized Study Comparing Personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03672331
• Other study ID #: UC-0109/1805
• Status: Active, not recruiting
• Phase: N/A
• Start date: July 18, 2019
• Est. completion date: December 31, 2027

Study information

• Verified date: August 2023
• Source: UNICANCER
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 53142
• Est. completion date: December 31, 2027
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Screening

Intervention

Other:
• 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

Locations

Country	Name	City	State
Belgium	Institut Jules Bordet	Bruxelles
France	Gustave roussy	Villejuif
Israel	Assuta Medical Center Ramat HaHayal	Tel Aviv
Italy	AUSL Reggio Emilia	Reggio Emilia	Emilia
Spain	Marta Rom?n	Barcelona
United Kingdom	Cambridge University Hospitals NHS Foundation Trust	Cambridge	Cambridgeshire

Sponsors (1)

Lead Sponsor	Collaborator
UNICANCER

Countries where clinical trial is conducted

Belgium,  France,  Israel,  Italy,  Spain,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 years
Secondary	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.	4 years
Secondary	Rate of morbidity in each arm	Morbidity is defined as false positive imaging findings and benign breast biopsies	4 years
Secondary	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	4 years
Secondary	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	4 years
Secondary	Subject quality of life	Subject quality of life will be evaluated using the EQ-5D quality of life questionnaire	4 years
Secondary	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	4 years
Secondary	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	4 years
Secondary	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.	15 years
Secondary	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	4 years
Secondary	10- and 15-year breast cancer specific survival in MyPeBS and in a combined analysis of the Wisdom and MyPeBS studies		15 years
Secondary	Detection rate of stage 2+ breast cancer in women who had screening tomosynthesis (where and when available) and the rate without tomosynthesis		4 years
Secondary	Incidence of all stage and stage 2 + breast cancers at 10- and 15-year follow-up		15 years
Secondary	Incidence of stage 2 + breast cancer in each arm, in women aged 40-49 at inclusion		4 years
Secondary	Rate of breast cancers identified at second reading in each arm		4 years
Secondary	Rate of false positive imaging findings and benign breast biopsies in women classified at low risk in risk-based arm		4 years

External Links

•   Public website of MyPeBS