Identification of Biomarkers in Women at High Risk or Average Risk of Breast Cancer

OBJECTIVES:

Primary

• Identify and validate serum biomarkers that can distinguish malignant from benign and normal breast conditions in women at high risk or average risk for breast cancer.

Secondary

• Standardize procedures for recruitment, characterization, and follow-up of participants and collection, processing, storage, and analysis of specimens.
• Assess marker variability over time in healthy controls.
• Develop a shared specimen resource to support ongoing early detection research.

OUTLINE: Blood samples are collected every 6 months and assayed for the presence of biomarkers.

PROJECTED ACCRUAL: A total of 625 participants will be accrued for this study.

DISEASE CHARACTERISTICS:

• Planning to undergo outpatient annual mammogram or biopsy AND meets 1 of the following criteria:

• High risk for breast cancer
• High risk with newly-diagnosed* breast cancer
• Average risk for breast cancer
• Average risk with newly-diagnosed* breast cancer
• Benign breast disease NOTE: * Diagnosed at time of study enrollment
• No other breast cancer diagnosis within the past year
• Hormone receptor status:

• Not specified

PATIENT CHARACTERISTICS:

Age

• 25 and over

Sex

• Female

Menopausal status

• Not specified

Performance status

• Not specified

Life expectancy

• Not specified

Hematopoietic

• No hemophilia
• No other bleeding disorders

Hepatic

• Not specified

Renal

• Not specified

Other

• Not pregnant or nursing
• At least 6 months postpartum
• No planned pregnancy within the next year
• No history of medical conditions that would increase participant risk of blood draws
• No psychiatric, psychological, or other condition that would preclude giving informed consent

PRIOR CONCURRENT THERAPY:

Biologic therapy

• Not specified

Chemotherapy

• Not specified

Endocrine therapy

• Not specified

Radiotherapy

• Not specified

Surgery

• No prior double mastectomy

Other

• No concurrent treatment for breast cancer