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My Personalized Breast Screening (MyPeBS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03672331
Recruitment Status : Suspended (Temporary suspension since March 13 due to COVID-19 pandemic)
First Posted : September 14, 2018
Last Update Posted : May 5, 2020
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Tracking Information
First Submitted Date  ICMJE September 13, 2018
First Posted Date  ICMJE September 14, 2018
Last Update Posted Date May 5, 2020
Actual Study Start Date  ICMJE July 18, 2019
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 22, 2019)
  • 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.
  • Rate of morbidity in each arm [ Time Frame: 4 years ]
    Morbidity is defined as false positive imaging findings and benign breast biopsies
  • 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
  • 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
  • Subject quality of life [ Time Frame: 4 years ]
    Subject quality of life will be evaluated using the EQ-5D quality of life questionnaire
  • 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
  • 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
  • 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.
  • 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- 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 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: September 13, 2018)
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.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE My Personalized Breast Screening
Official Title  ICMJE International Randomized Study Comparing Personalized, Risk-Stratified to Standard Breast Cancer Screening In Women Aged 40-70
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

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Breast Screening
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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.
    Interventions:
    • Other: Mammogram
    • Other: Ultrasound
    • Other: MRI
    • Other: Tomosynthesis
  • 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.
    Interventions:
    • Other: Mammogram
    • Other: Ultrasound
    • Other: MRI
    • Other: Tomosynthesis
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Suspended
Estimated Enrollment  ICMJE
 (submitted: September 13, 2018)
85000
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2025
Estimated Primary Completion Date December 31, 2025   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 40 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Israel,   Italy,   United Kingdom
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03672331
Other Study ID Numbers  ICMJE UC-0109/1805
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: 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.
Responsible Party UNICANCER
Study Sponsor  ICMJE UNICANCER
Collaborators  ICMJE Not Provided
Investigators  ICMJE
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
PRS Account UNICANCER
Verification Date May 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP