ECOG-ACRIN tomosynthesis mammographic imaging screening trial (EA1151).

Abstract

TPS1597 Background: This randomized trial is intended to determine whether tomosynthesis (TM) should replace the current standard for breast cancer (BC) screening, digital mammography (DM). It is hypothesized that the population of women assigned TM screening for 3-5 rounds will have fewer advanced cancers than the population assigned to DM screening. Methods: 164,946 women, ages 45 to 74 years who present for screening mammography and consent to participate will be enrolled across 150 sites in the US, Canada and abroad. Women will be randomized to TM or DM. The frequency and number of screening examinations over a five year period will vary based on menopausal status and whether they have specific risk factors, including - hormone use, family history of BC, deleterious genes, prior benign breast biopsy with diagnosis of LCIS or atypia any kind, or dense breasts. Blood and buccal cells will be collected from as many enrolled women as are willing to provide the samples. All breast biopsies during the trial will undergo gene expression analysis for the PAM50 and other progression pathways (PAM50-plus). All subjects enrolled will be followed long term for at least eight years. The primary endpoint is the proportion of participants who have an advanced breast cancer diagnosed at any time within 4.5 years of randomization in to the trial. Secondary endpoints include measures of diagnostic and predictive performance; rates of recall, biopsy, and interval cancers, prevalence of breast cancer subtypes, and tumor subtype based on PAM50-plus analysis. As of January 17th 2020, there are 104 sites open and 21,452 women enrolled in the trial. The DSMC last reviewed the trial in June 2019 and suggested that the trial continue as planned. Clinical trial information: NCT03233191.