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

Completed

• Conditions: Breast Cancer
• Interventions: Other: physiologic testing; Other: screening questionnaire administration; Procedure: breast imaging study; Procedure: radiomammography; Procedure: study of high risk factors

• Registration Number: NCT00445445
• Lead Sponsor: Case Comprehensive Cancer Center

Brief Summary

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

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.

Study Timeline

• Study Start: 2007-01-10
• Study First Submitted: 2007-03-07
• Study First Submitted QC: 2007-03-07
• Study First Posted: 2007-03-09
• Primary Completion: 2014-07-21
• Study Completion: 2014-07-21
• Status Verified: 2020-02
• Last Update Submitted: 2020-02-10
• Last Update Posted: 2020-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 2201

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

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Healthy participants	screening questionnaire administration	Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.
Healthy participants	radiomammography	Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.
Patients	physiologic testing	Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
Patients	breast imaging study	Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
Healthy participants	breast imaging study	Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.
Healthy participants	physiologic testing	Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.
Patients	screening questionnaire administration	Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
Patients	radiomammography	Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
Patients	study of high risk factors	Histologically confirmed breast cancer that was diagnosed between the years 2002-2004
Healthy participants	study of high risk factors	Healthy participant who is receiving routine medical care (e.g., screening mammograms. Healthy participants are frequency-matched by age (± 2 years) and ethnicity.

Primary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (8)

University Hospitals Cleveland Medical Center, Seidman Cancer Center, Case Comprehensive Cancer Center; 🇺🇸 Cleveland, Ohio, United States

UH-LUICC; 🇺🇸 Mentor, Ohio, United States

UH-Chagrin Highlands Orange Village Ohio 44122; 🇺🇸 Orange Village, Ohio, United States

UH-Monarch; 🇺🇸 Mayfield Heights, Ohio, United States

UH-Southwest; 🇺🇸 Middleburg Heights, Ohio, United States

UH-Firelands; 🇺🇸 Sandusky, Ohio, United States

UH-Green Road; 🇺🇸 South Euclid, Ohio, United States

UH-Westlake; 🇺🇸 Westlake, Ohio, United States