To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an advanced breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4). To assess the potential effect of age, menopausal and hormonal status, breast density, and family cancer history on the primary endpoint difference between the two arms.
Participants in this trial will be randomized to receive either 2D or 3D mammograms for the first 5 years of the research study, either ever year or every other year depending on personal risk factors. Information will be collected on breast cancer status for 8 years in total.More
Women aged 45-74 years who do not have a personal history of breast cancer.
Detailed Eligibility: Patients must also have a screening mammogram scheduled, or intend to schedule, at either the Anschutz Medical Campus or at Lone Tree. Patients must not have had a screening mammogram within the last 11 months.
III - Research Studies that gather more information about a drug's safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. These studies typically involve more participants.
Highlands Ranch Hospital
University of Colorado Hospital
Dulcy Wolverton, MD
Protocol Number: 18-0392
More information available at ClinicalTrials.gov: NCT03233191
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