TRIAL OBJECTIVES

The results of the study will be used to enable the NHS Breast Screening Programme decide whether and how to implement tomosynthesis for routine screening

Primary objectives.

To compare the cost – effectiveness of breast cancer screening using DBT + 2DDM or S2D with screening using 2DDM by measuring cancer detection rates, interval cancer rates, size and lymph node status of Grade 2 and 3 invasive cancers in intervention (DBT + 2DDM or S2D) and 2DDM (standard care) groups.

Secondary objectives.

  1. To demonstrate non-inferiority of DBT + S2D compared to DBT + 2DDM.
  2. To measure the impact of DBT + 2DDM screening on screening recall rates, benign biopsy rates at diagnostic assessment and at surgery.
  3. To measure the effect of DBT + 2DDM screening compared to 2DDM in patient groups according to breast density, type of screen, age.
  4. To develop methods for measuring reader performance with DBT + 2DDM screening.
  5. To carry out retrospective reader studies to measure the effect of other  screening strategies – 2DDM vs DBT alone, 2DDM vs DBT + synthetic 2D, 2DDM vs 2DDM + limited tomo views.
  6. To compare patient preferences for breast cancer screening with 2DDM + DBT vs 2DDM.