Inclusion Criteria:

- Women 25 years of age or older;

- No history of breast cancer;

- Group A only: Asymptomatic and scheduled for screening mammography;

- Group B only: Asymptomatic and recalled for diagnostic testing due to positive
findings on recent screening using FFDM, completed within 30 days prior to
registration (BI-RADS 0: additional imaging needed);

- Willing to provide a written informed consent.

Exclusion Criteria:

- Pregnancy or intent to become pregnant;

- Unable or unwilling to tolerate compression associated with mammography;

- Breast implants;

- Breasts too large to allow for adequate positioning for the DBT examination;

- Group B only: Patients with FFDM taken at screening who are unwilling or unable to
submit images to ACRIN;

- Group B only: Unwilling to undergo tomosynthesis on both breasts as well as
potentially additional diagnostic imaging based on tomosynthesis findings;

- Unable or unwilling to complete screening and (as necessary) diagnostic imaging at
same facility;

- Tomosynthesis or mammography within 11 months prior to registration (excluding the
screening mammography required for Group B).