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

Case Comprehensive Cancer Center (Case CCC)

Status: Completed

Conditions: Breast Cancer

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

Study type: Observational

Funder types: Other; NIH

Identifiers

NCT00445445

P30CA043703 (U.S. NIH Grant/Contract)

CASE1105 (Other Identifier)

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 2,201 patients

Sex: Female

Ages: 40+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

2,201 participants in 2 patient groups

Patients

Description:

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

Treatment:

Procedure: breast imaging study

Other: screening questionnaire administration

Procedure: radiomammography

Procedure: study of high risk factors

Other: physiologic testing

Healthy participants

Description:

Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.

Treatment:

Procedure: breast imaging study

Other: screening questionnaire administration

Procedure: radiomammography

Procedure: study of high risk factors

Other: physiologic testing