What is the Best Interval to Screen Women 45-49 and 70-74 for Breast Cancer?

Condition(s) studied

Investigational drug(s) / intervention(s)

screening for breast cancer with tomosynthesis and synthetic 2D mammography performed at different interval compared to actual clinical practice: women 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;

Study summary

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

Primary outcome measure(s)

• To compare the cumulative incidence of stage 2 or higher breast cancer between different screening intervals — 6 years
  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

Trial sites (4)

More Istituto Romagnolo per lo Studio dei Tumori Dino Amadori IRST S.r.l. IRCCS trials in Italy

Other trials for the same condition