Tomosynthesis as Primary Test for Breast Cancer Screening

Condition(s) studied

Investigational drug(s) / intervention(s)

tomosynthesis + synthetic 2D: Women will be screened for one round with tomosynthesis + synthetic 2D, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

digital mammography: Women will be screened for one round digital mammography, two projections, double reading with consensus or arbitration, according to local protocols, for discordant readings. After two years (one years for women 45-49 yo) women will be re-screened with digital mammography.

Study summary

Randomized trial comparing tomosynthesis plus synthetic 2D Mammography vs Digital Mammography in respect to incidence of advanced cancers (interval and following round) and interval cancers.

Eligibility

Primary outcome measure(s)

• advanced cancer incidence — 2 years (+9 months to complete second round assessment)
  cumulative incidence of T2+ cancers after first screening round
• advanced cancer incidence — 4 years (+9 months to complete third round assessment)
  cumulative incidence of T2+ cancers after first screening round
• interval cancer incidence — 2 years for 50-65 years old women
  incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.
• interval cancer incidence — 1 year for 45-49 years old women
  incidence of cancers occurring after a negative screening test and before the next scheduled screening round. Outcome 3 and 4 will are combined in one single outcome.

Trial sites (4)

More Azienda USL Reggio Emilia - IRCCS trials in Italy

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