Study of Breast Tissue in Women Not Previously Diagnosed With Breast Cancer Who Are Undergoing Fine Needle Aspiration

OBJECTIVES:

Primary

- To determine if breast tissue DNA methylation profile and hormone concentration change
across follicular and luteal phase, or across menopause, in random fine needle
aspiration samples of women with no prior diagnosis or treatment for breast cancer.

- To determine if DNA methylation profile and breast hormone levels correlate with
mammographic density, cytomorphology, or Gail risk estimates.

- To develop a high throughput commercial assay for DNA methylation profiling for
assessing breast cancer risk.

- To develop a highly sensitive, specific, and novel nanoassay for estradiol and
progesterone.

OUTLINE: This is a multicenter study.

Premenopausal women are stratified by menstrual cycle phase (mid-follicular [day 5-10] vs
mid-luteal [day 20-25]), based on an adjusted 28-day cycle.

Patients undergo breast density measurement by digital mammography. Blood samples are
obtained and analyzed for estradiol, progesterone, and follicle-stimulating hormone
measurements, to define menstrual/menopausal status, and for DNA extraction. Patients also
undergo random fine needle aspiration. Biopsy material from aspiration is analyzed for
cytomorphology, steroid radioimmunoassay (RIA), steroid nanoassay, and DNA methylation
studies (via polymerase chain reaction). The aspiration samples are also analyzed for
estradiol and progesterone levels using high-pressure liquid chromatography and RIA.

DISEASE CHARACTERISTICS:

- Women meeting one of the following requirements:

- Regularly cycling premenopausal women under 45 years of age

- Perimenopausal women 45-55 years of age who have had ≥ two periods in the past 6
months

- Postmenopausal women under 60 years of age (no menstrual period for 12 months and
follicle-stimulating hormone (FSH) levels > 25 IU/dL)

- No history of breast cancer diagnosis or prior treatment for breast cancer

- Negative breast evaluation within the past 3 months

PATIENT CHARACTERISTICS:

- See Disease Characteristics

PRIOR CONCURRENT THERAPY:

- No concurrent oral contraceptives

- At least 2 weeks since prior aspirin, non-steroidal anti-inflammatory drugs, and
vitamin E