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My Personalized Breast Screening (MyPeBS)

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ClinicalTrials.gov Identifier: NCT03672331
Recruitment Status : Not yet recruiting
First Posted : September 14, 2018
Last Update Posted : September 14, 2018
Sponsor:
Information provided by (Responsible Party):
UNICANCER

Brief Summary:

MyPeBS is a European 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 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
Estimated Study Start Date : December 31, 2018
Estimated Primary Completion Date : February 1, 2026
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Standard arm
In the standard arm of MyPeBS, women will be screened for breast cancer according to the current national guidelines and procedures: with a mammogram and/or tomosynthesis (TS) every two or three years starting at age 40-50 years, up to age 69-74 years according to countries, with or without ultrasound (US) according to breast mammographic density and ongoing guidelines. The current 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
Frequency of the mammogram according to the national guidelines (every one, two or 3 years)

Other: Ultrasound
According the country and if needed

Other: MRI
According the country and if needed

Other: Tomosynthesis
According the country

Experimental: Risk-based arm
Saliva samples will be centrally genotyped. The patients risk will be estimated by a dedicated centralized risk-evaluation software. The following variables will be used: age, family history, previous history of benign breast biopsy, personal hormonal and reproductive history, breast mammographic density, and genotyping results (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. Depending on the risk estimation a personal screening program will be proposed. The personal screening program will include mammographies, MRIs, ultrasounds, and/or tomosytheses.
Other: Mammogram
Frequency of the mammogram according to the national guidelines (every one, two or 3 years)

Other: Ultrasound
According the country and if needed

Other: MRI
According the country and if needed

Other: Tomosynthesis
According the country




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.



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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

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
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

Sponsors and Collaborators
UNICANCER
Investigators
Study Chair: Suzette DELALOGE Gustave Roussy

Additional Information:
Responsible Party: UNICANCER
ClinicalTrials.gov Identifier: NCT03672331     History of Changes
Other Study ID Numbers: UC-0109/1805
First Posted: September 14, 2018    Key Record Dates
Last Update Posted: September 14, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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