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.

  1. Measurement of invasive cancer detection rates using DBT + S2D vs 2DDM.
  2. Recall rates.
  3. Benign biopsy rates at assessment.
  4. Benign surgical biopsy rates.
  5. 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.
  6. Development of a method for measurement of reader performance.
  7. Results of retrospective reader studies to compare different screening strategies including 2DDM + synthetic 2D, DBT alone, 2DDM + limited tomo views.
  8. Measurement of trial participant experience of DBT + 2DDM vs 2DDM.