Changes in Breast Density and Breast Cancer Risk in Women With Breast Cancer and in Healthy Women - Full Text View

Sponsors and Collaborators:	Case Comprehensive Cancer Center National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00445445

Purpose

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.

Condition	Intervention
Breast Cancer	Other: physiologic testing Other: screening questionnaire administration Procedure: breast imaging study Procedure: mammography Procedure: study of high risk factors

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer Mammography

U.S. FDA Resources

Study Type:	Observational
Official Title:	Longitudinal Changes in Mammographic Density and Risk of Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Within-individual mammographic density (MD) longitudinal change and breast cancer risk
Patterns of within-individual longitudinal change in MD
Predictors of across-individual differences in MD change

Estimated Enrollment:	700
Study Start Date:	January 2007
Estimated Primary Completion Date:	January 2009 (Final data collection date for primary outcome measure)

Detailed Description:

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.

Eligibility

Ages Eligible for Study:	50 Years and older
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00445445

Locations

United States, Ohio
Case Comprehensive Cancer Center	Recruiting
Cleveland, Ohio, United States, 44106-5065
Contact: Clinical Trials Office - Case Comprehensive Cancer Center 800-641-2422

Sponsors and Collaborators

Case Comprehensive Cancer Center

National Cancer Institute (NCI)

Investigators

Principal Investigator:

Li Li, MD, PhD

Case Comprehensive Cancer Center

More Information

Additional Information:

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

No publications provided

Study ID Numbers:	CDR0000533036, CASE-1105
Study First Received:	March 7, 2007
Last Updated:	February 6, 2009
ClinicalTrials.gov Identifier:	NCT00445445 History of Changes
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

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

Study placed in the following topic categories:

Skin Diseases
Breast Neoplasms
Healthy
Breast Diseases
Recurrence

Additional relevant MeSH terms:

Neoplasms
Neoplasms by Site
Skin Diseases
Breast Neoplasms
Breast Diseases

ClinicalTrials.gov processed this record on May 06, 2009