Primary end-point.
- Invasive cancer detection rates.
- Interval cancer rates.
- Size and lymph node status of grade 2 and 3 invasive cancers.
- Cost-effectiveness of screening with DBT + 2DDM or S2D vs screening with 2DDM.
Secondary end-point.
- Measurement of invasive cancer detection rates using DBT + S2D vs 2DDM.
- Recall rates.
- Benign biopsy rates at assessment.
- Benign surgical biopsy rates.
- Measurement of cancer detection rates, recall rates in subgroups of women in intervention and control groups defined by breast density, type of screen, age group.
- Development of a method for measurement of reader performance.
- Results of retrospective reader studies to compare different screening strategies including 2DDM + synthetic 2D, DBT alone, 2DDM + limited
tomo views. - Measurement of trial participant experience of DBT + 2DDM vs 2DDM.