Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women

OBJECTIVES:

- Characterize each woman's individual 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.

- Examine 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 1500 patients and 1500 healthy participants will be accrued for
this study.

Inclusion Criteria:

- Patient at the University Hospitals Breast Center and primary care clinics within the
University Hospitals system

- Have at least 3 screening mammograms since 1994

- for cases, diagnosis with breast cancer between 2004-2006

Exclusion criteria:

- having had irregular screening (less than 3 mammorgrams since 1994)

- Having breast implants

- Known carriers of BRCA1/BRCA2 genes

- Unable to give written consent