Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

ADAPT-ENRICH will supplement an on-going program (ADAPT) which consists of 2 additional
recruitment plans (ADAPT-SCR and ADAPT-BX) followed by an off-line read of the images and
data collected (ADAPT-BIE). This study involves the comparison of two devices that can
identify abnormalities in routine breast screening and diagnostic mammography. Mammography is
usually done with full-field digital mammography (FFDM), which takes flat, two-dimensional
X-ray images of the breast. Doctors use the two-dimensional images to look for cancers and
other abnormal tissue. The purpose of this study is to learn more about the accuracy of
full-field digital mammography devices and a new mammography device called digital breast
tomosynthesis (DBT). DBT is similar to full-field digital mammography, but can also move
around the breast to get X-ray images from different angles, which provides a
three-dimensional view that doctors can use to look for cancers and abnormal tissue. Subjects
will be recruited from an initially asymptomatic population that have been referred for
clinically indicated breast biopsy based on suspicious DBT screening breast imaging results.
Subjects will undergo a DBT mammogram prior to biopsy. If FFDM was not performed within 30
days, subjects will also undergo FFDM prior to biopsy. Results of biopsy(ies) and
histopathology, including lesion characteristics, will be recorded and considered as truth if
positive for cancer status. Subjects with negative or benign histological findings will be
followed for approximately one year (10-16 months) by FFDM and any additional standard of
care practice.

Inclusion Criteria:

- Women aged 30 years or older (≥30 years old);

- Initially asymptomatic women who underwent routine bilateral screening with Digital
Breast Tomosynthesis (DBT), followed by diagnostic work-up showing one or more
abnormalities and referred for breast biopsy;

- Are able and willing to comply with study procedures;

- Have signed and dated the informed consent form;

- Documented as non-pregnant based on the investigator's medical judgment and in
consideration of local clinical practice standards for evidence of non-pregnancy.

Exclusion Criteria:

- Have been previously included in this study , ADAPT-SCR recruitment plan or ADAPT-BX
recruitment plan;

- Have undergone diagnostic or surgical intervention(s) or procedure(s) on either
breast, including mastectomy and cytopunction, before study-related imaging;

- Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) DBT or
FFDM digital receptor without anatomical cut-off during a DBT or FFDM examination;

- Have participated in (within the prior 30 days) another trial of an investigational
product expected to interfere with study procedures or outcomes;

- Have breast implant(s);

- Have reconstructed breast(s).