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

• Within-individual mammographic density (MD) longitudinal change and breast cancer risk [ Time Frame: cancer cases diagnosed within the last 3 years (2004-2006). ] [ Designated as safety issue: No ]
• Patterns of within-individual longitudinal change in MD [ Time Frame: cancer cases diagnosed within the last 3 years (2004-2006) ] [ Designated as safety issue: No ]
• Predictors of across-individual differences in MD change [ Time Frame: cancer cases diagnosed within the last 3 years (2004-2006) ] [ Designated as safety issue: No ]

RATIONALE: Studying mammograms for breast density changes over time may help doctors predict breast cancer risk.

PURPOSE: This natural history study is looking at changes in breast density and gathering health information over time to assess breast cancer risk in women with breast cancer and in healthy women.

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.

Breast cancer cases diagnosed after 1994 and equal number of frequency-matched (by age within 2 years and ethnicity) controls. Cases and eligible controls with at least 3 screening mammograms since 1994 will be recruited through the University Hospitals Breast Center, and primary care clinics within the University Hospitals Health System (UHHS). The restriction of 3 or more screening mammograms will allow us to adequately model the longitudinal change patterns.

• Other: physiologic testing
  Urine samples will be assessed for levels of bisphenol-A
• Other: screening questionnaire administration
  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.
• Procedure: breast imaging study
  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.
• Procedure: radiomammography
  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.
• Procedure: study of high risk factors
  • 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.

• Patients
  Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
  Interventions:

  • Other: physiologic testing
  • Other: screening questionnaire administration
  • Procedure: breast imaging study
  • Procedure: radiomammography
  • Procedure: study of high risk factors
• Healthy participants
  Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.
  Interventions:

  • Other: physiologic testing
  • Other: screening questionnaire administration
  • Procedure: breast imaging study
  • Procedure: radiomammography
  • Procedure: study of high risk factors

DISEASE CHARACTERISTICS:

• Meets 1 of the following criteria:

  • Patient at the University Hospitals Breast Center and primary care clinics within the University Hospitals system AND meets the following criteria:

    • Histologically confirmed breast cancer that was diagnosed between the years 2002-2004

      • Known tumor stage
  • Healthy participant who is receiving routine medical care (e.g., screening mammograms) at the University Hospitals Health System
• Underwent ≥ 4 prior screening mammograms at the Breast Center since 1994
• No known carriers of BRCA1 or BRCA2 genes

• Hormone receptor status:

  • Known estrogen and/or progesterone receptor status

PATIENT CHARACTERISTICS:

• Female
• Menopausal status not specified
• No breast implants

PRIOR CONCURRENT THERAPY:

• Not currently taking tamoxifen citrate, raloxifene, or aromatase inhibitors