The current age-based Swedish National Breast Cancer Screening Program reduces breast cancer mortality with 40% for those attending. Despite the effectiveness of the program, ≈ 30% of all screening-detected cancers are found to be in stage II of higher which means that they are either large and/or spread outside the breast gland at time of diagnosis. In addition, ≈ 25% of breast cancers diagnosed are so called interval cancers, that is cancers diagnosed in the interval between two mammography rounds. Interval cancers are known to be larger and more aggressive than screening detected cancers at time of diagnosis.
The overarching aim of SMART is to compare the effectiveness of current screening practice with screening based on the individual risk of breast cancer.
The possible benefits of individualised screening will be contrasted to the possible harms defined as unnecessary recalls, biopsies and induced anxiety and worry.
SMART is a Phase III, randomised, non-blinded screening trial. Women who consent to participate in SMART are randomised to either screening based on the individual risk of breast cancer (intervention arm) or screening according to the current Swedish National Breast Cancer Screening Program (control arm).
Women invited for screening according to the Swedish National Breast Cancer Screening Program at Södersjukhuset or S:t Görans sjukhus. The program invites women 40 – 74 years.
Participants will be matched 1:1 with 23,000 women in each arm. Women randomised to screening based on risk will get their 2-year risk of breast cancer assessed and women with an increased short-term risk are offered contrast enhanced mammography and a mammogram at 12 months.
Recruitment is ongoing and planned to end in early 2027. The inclusion phase is followed by a follow-up period of 2 years.