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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Longitudinal Changes in Mammographic Density and Risk of Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: physiologic testing
* Other: screening questionnaire administration
* Procedure: breast imaging study
* Procedure: radiomammography
* Procedure: study of high risk factors


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>Histologically confirmed breast cancer that was diagnosed between the years 2002-2004 | Other: physiologic testing<br>* Urine samples will be assessed for levels of bisphenol-A<br>Other: screening questionnaire administration<br>* 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.<br>Procedure: breast imaging study<br>* 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.<br>Procedure: radiomammography<br>* 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.<br>Procedure: study of high risk factors<br>* 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.<br>|
| Healthy participants<br>Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity. | Other: physiologic testing<br>* Urine samples will be assessed for levels of bisphenol-A<br>Other: screening questionnaire administration<br>* 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.<br>Procedure: breast imaging study<br>* 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.<br>Procedure: radiomammography<br>* 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.<br>Procedure: study of high risk factors<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Within-individual mammographic density (MD) longitudinal change and breast cancer risk |  | cancer cases diagnosed within the last 3 years (2004-2006). | 
| Patterns of within-individual longitudinal change in MD |  | cancer cases diagnosed within the last 3 years (2004-2006) | 
| Predictors of across-individual differences in MD change |  | cancer cases diagnosed within the last 3 years (2004-2006) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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stage I breast cancer, stage II breast cancer, stage IIIA breast cancer, stage IIIB breast cancer, stage IIIC breast cancer, stage IV breast cancer, recurrent breast cancer, breast cancer in situ