Digital Tomosynthesis Mammography and Digital Mammography in Screening Patients for Breast Cancer

Inclusion Criteria: * Women of childbearing potential must not be known to be pregnant or lactating * Patients must be scheduled for, or have intent to schedule, a screening mammogram * Patients must be able to tolerate digital breast tomosynthesis and full-field digital mammographic imaging required by protocol. * Patients must be willing and able to provide a written informed consent * Patients must not have symptoms or signs of benign or malignant breast disease (eg, nipple discharge, breast lump) warranting a diagnostic rather than a screening mammogram, and/or other imaging studies (eg, sonogram); patients with breast pain are eligible as long as other criteria are met * Patients must not have had a screening mammogram within the last 11 months prior to date of randomization * Patients must not have previous personal history of breast cancer including ductal carcinoma in situ * Patients must not have breast enhancements (e.g., implants or injections) * ANNUAL SCREENING REGIMEN ELIGIBILITY CHECK * To be eligible for inclusion in the annual screening regimen one of the following three conditions must be met in addition to the eligibility criteria above: * Patients are pre-menopausal; OR * Post-menopausal aged 45-69 with any of the following three risks factors: * Dense breasts (BIRADS density categories c-heterogeneously dense or d-extremely dense), or * Family history of breast cancer (first degree relative with breast cancer), or, positive genetic testing …