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.
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.
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;
Parallel
screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice
Diagnostic testwomen will be screened for breast cancer using tomosynthesis and synthetic 2D mammography with an interval defined according to their randomization arm for a follow-up period of 6 years;
To compare the cumulative incidence of stage 2 or higher breast cancer between different screening intervals
Cumulative breast cancer risk will computed as the ratio between the number of stage 2 or higher cancers and the total number of women in the arm. The comparison between arms will be performed using the two proportion Z-test. 95% confidence intervals will also be computed
Participation in screening
number of participating women within 3 months since invitation)/(total invited women). It will be computed for each screening round and overall as average of round participation
contamination proportion (use of mammography) within two screening rounds (in women referred to 2-year interval)
number of women referred to 2-year interval and performing a mammogram within two screening round)/number of women referred to 2-year interval The indicator will be computed only for women randomized to arm 2 and for women referred to 2-year arm in arm 3
Breast cancer detection
number of women with BC diagnosis at screening / number of total screened women
overall recall rate
number of women recalled for further assessment/ number of total screened women.
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