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Trial record 1 of 1 for:    mypebs
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My Personalized Breast Screening (MyPeBS)

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ClinicalTrials.gov Identifier: NCT03672331
Recruitment Status : Recruiting
First Posted : September 14, 2018
Last Update Posted : April 14, 2022
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Study Description
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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


Condition or disease Intervention/treatment Phase
Breast Screening Other: Mammogram Other: Ultrasound Other: MRI Other: Tomosynthesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 85000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: International Randomized Study Comparing Personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70
Actual Study Start Date : July 18, 2019
Estimated Primary Completion Date : December 31, 2025
Estimated Study Completion Date : December 31, 2025

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Standard arm
Participants will be screened for breast cancer according to current national/regional guidelines and procedures: with a mammogram and/or tomosynthesis (TS) every 1-3 years starting at age 40-50 years, up to age 69-74 years, with or without ultrasound and MRI depending on breast mammographic density and current recommendations. The national/regional guidelines in use in the including center may be subjected to changes during the study. Guidelines and procedures in the standard arm will be updated accordingly.
 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
Experimental: Risk-based arm
Participants will be screened according to a personalised timetable based on their estimated 5-year risk of developing breast cancer: with a mammography and/or tomosynthesis every 1-4 years with or without ultrasound depending on breast density. Risk estimation will be performed using the following variables: age, family history, previous history of benign breast biopsy, personal hormone and reproductive history, breast mammographic density and genotyping (polygenic risk score). Risk assessment will be conducted using Mammorisk™ for women with at most one first-degree relative with breast or ovarian cancer and using Tyrer-Cuzick™ risk score for those women with more than one first-line first degree relative with breast or ovarian cancer.
 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


Outcome Measures
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Primary Outcome Measures :
  1. Incidence rate of stage 2 and plus breast cancer (non-inferiority analysis) [ Time Frame: 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 Outcome Measures :
  1. Incidence rate of stage 2 and plus breast cancer (superiority analysis) [ Time Frame: 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.

  2. Rate of morbidity in each arm [ Time Frame: 4 years ]
    Morbidity is defined as false positive imaging findings and benign breast biopsies

  3. Subject anxiety in response to risk evaluation [ Time Frame: 4 years ]
    Subject anxiety will be evaluated using the State-Trait Anxiety Inventory (STAI) questionaire, and compared between treatment arms

  4. Socio-psychological characteristics of subjects [ Time Frame: 4 years ]
    Socio-psychological characteristics will be evaluated using study specific questions concerning comprehension, information-seeking behavior, satisfaction and socio-demographic and economic status

  5. Subject quality of life [ Time Frame: 4 years ]
    Subject quality of life will be evaluated using the EQ-5D quality of life questionnaire

  6. Comparison of cost-effectiveness of each strategy [ Time Frame: 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

  7. Incidence of stage-specific breast cancer in each arm (including DCIS) [ Time Frame: 4 years ]
    Comparison of the overall incidence of breast cancer detected in each arm according to AJCC stage

  8. Estimates of the rate of detection of clinically non-significant tumours (overdiagnosis) in each study arm [ Time Frame: 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.

  9. Rate of false negative images and interval cancers in each arm [ Time Frame: 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

  10. 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 ]
  11. 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 ]
  12. Incidence of all stage and stage 2 + breast cancers at 10- and 15-year follow-up [ Time Frame: 15 years ]
  13. Incidence of stage 2 + breast cancer in each arm, in women aged 40-49 at inclusion [ Time Frame: 4 years ]
  14. Rate of breast cancers identified at second reading in each arm [ Time Frame: 4 years ]
  15. Rate of false positive imaging findings and benign breast biopsies in women classified at low risk in risk-based arm [ Time Frame: 4 years ]

Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03672331


Contacts
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Contact: Cécile VISSAC SABATIER, PhD +33 (0)1 73 79 77 58 ext +330142114293 contact@mypebs.eu
Contact: Suzette DELALOGE, MD +33 (0)1 42 11 42 93 ext +330142114293 Suzette.delaloge@gustaveroussy.fr

Locations
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Belgium
Institut Jules Bordet Recruiting
Bruxelles, Belgium
Contact: Jean-Benoît Burrion, MD    +32 (0)2 541 35 00    jeanbenoit.burrion@bordet.be   
France
Gustave roussy Recruiting
Villejuif, France
Contact: Corinne Balleyguier, MD    +33 (0)142116074    corinne.balleyguier@gustaveroussy.fr   
Israel
Assuta Medical Center Ramat HaHayal Recruiting
Tel Aviv, Israel
Contact: Michal Guindy, MD       michalgu@assuta.co.il   
Italy
AUSL Reggio Emilia Recruiting
Reggio Emilia, Emilia, Italy
Contact: Paolo Giorgi Rossi, MD    +39 (0)522 335490    paolo.giorgirossi@ausl.re.it   
Spain
Marta Romản Recruiting
Barcelona, Spain
Contact: Marta Romản, PhD       mroman@parcdesalutmar.cat   
United Kingdom
Cambridge University Hospitals NHS Foundation Trust Recruiting
Cambridge, Cambridgeshire, United Kingdom
Contact: Fiona Guilbert, MD       fjg28@medschl.cam.ac.uk   
Sponsors and Collaborators
UNICANCER
Investigators
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Study Chair: Suzette DELALOGE, MD Gustave Roussy - FRANCE
Principal Investigator: Paolo GORGIO-ROSSI, MD Arcispedale Santa Maria Nuova-IRCCS - ITALY
Principal Investigator: Corinne BALLEYGUIER, MD Gustave Roussy - FRANCE
Principal Investigator: Michal GUINDY, MD ASSUTA Hospital - ISRAEL
Principal Investigator: Jean-Benoit BURRION, MD Institut Jules Bordet - BELGIUM
Principal Investigator: Fiona GUILBERT, MD University of Cambridge - UK
Principal Investigator: Marta ROMÁN, PhD PSMAR - SPAIN
More Information
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Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03672331    
Other Study ID Numbers: UC-0109/1805
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: April 14, 2022
Last Verified: April 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Time Frame: The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.
Access Criteria: Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by UNICANCER:
standard breast screening - risk-based screening program