About this trial
Italian, multicenter, study aimed at defining the best interval for screening women 45-49 and 70-74 years for Breast Cancer (BC). This research project includes (1) a controlled, prospective randomized non-inferiority trial to determine the optimal screening interval for women aged 45-49, with and without high mammographic density, (2) a retrospective data collection, with the same purpose, on screening performed by women aged 70-74, and (3) a qualitative research to define the best communication strategy.
Eligibility criteria
Qualifiers
Women invited for their first or second mammography (45 or 46 y/o) presenting for screening;
Willingness and ability to comply with scheduled visits;
Written informed consent obtained prior to performing any protocol-related procedures.
Disqualifiers
Pregnancy status;
Personal history of prior breast carcinoma, either invasive or ductal carcinoma in situ (DCIS) diagnosis;
Ascertained heredo-familial risk according to the standard family history used in screening programs;
Participation in another clinical trial on BC screening;
Trial design
Treatments tested in this trial
- screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice