Trial Information

Longitudinal Changes in Mammographic Density and Risk of Breast Cancer

OBJECTIVES:

- Determine the mammographic density (MD) longitudinal change trajectory in women with
breast cancer and in healthy female participants to assess within-individual MD
longitudinal change and breast cancer risk.

- Determine whether these patients or healthy participants manifest different patterns of
within-individual change in MD and evaluate predictors of across-individual
differences.

- Determine whether the developmental profile of MD differs systematically between these
patients and healthy participants.

OUTLINE: This is a prospective, retrospective, controlled study. Patients and healthy
participants are frequency-matched by age (± 2 years) and ethnicity.

- Questionnaire: Patients and healthy participants complete a self-administered
questionnaire providing detailed information on breast cancer risk factors, including
demographics, behavioral and lifestyle factors, reproductive history, family history of
breast cancer, comorbidities, medication and hormone replacement therapy use, and
breast cancer screening history. This information is then cross-validated with
documented data abstracted from medical records to provide a longitudinal and
historical framework for assessing individual risk.

- Mammographic density (MD) assessment: Patients and healthy participants are evaluated
for patterns of longitudinal change in MD and subsequent breast cancer risk by
retrospective review of screening mammograms performed prior to breast cancer
diagnosis.

PROJECTED ACCRUAL: A total of 350 patients and 350 healthy participants will be accrued for
this study.