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My Personalized Breast Screening
My Personalized Breast Screening

NCT03672331

Active Not RecruitingNA

Sponsor: UNICANCER

Conditions: Breast Screening

Interventions: Mammogram, Ultrasound, MRI, Tomosynthesis

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

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 overview

Sex: FEMALE

Age: 40 Years to 70 Years

Healthy volunteers: Yes

Study type: INTERVENTIONAL

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
Locations (6)
  • Brussels, Belgium
  • Villejuif, France
  • Tel Aviv, Israel
  • Reggio Emilia, Emilia-Romagna, Italy
  • Barcelona, Spain
  • Cambridge, Cambridgeshire, United Kingdom