Collection of Biological Specimens with or without Fine Needle Aspiration in Predicting Short Term Risk in Patients with High Risk for Breast Cancer

Inclusion Criteria

• DEFINITION OF RISK COHORT FOR CONSIDERATION OF RPFNA
• Should generally be between the ages of 30 and 60; can be older or younger than this range depending on family history, genetic mutation status, or other factors; or as specified by separate protocols for approved intervention trials
• Have a known moderate or high penetrance mutation associated with hereditary breast or ovarian cancer or high polygenic risk score determined by germline genetic testing
• Have one or more first or second degree relatives with breast cancer, with at least one under the age of 60
• Have had a prior biopsy diagnosed atypical lobular hyperplasia, atypical ductal hyperplasia, lobular carcinoma in situ, or ductal carcinoma in situ in the last 10 years; or have had multiple prior breast biopsies, regardless of histology
• Have a 5 year Gail risk of >= 1.67% or 2x risk for age as given in model, or 10 year Tyrer-Cuzick risk 2x population risk as listed in model
• Have a prior diagnosis of T1 or T2 breast cancer diagnosed within the last 10 years
• Have breast density assessed as >= 25% on a prior mammogram (Boyd 1995)
• Obesity (body mass index [BMI] >= 30 kg/m^2)
• MEDICAL ELIGIBILITY CRITERIA FOR PERTAINING TO HIGH RISK GROUPS UNDERGOING RPFNA
• Must be more than six months from ingestion of antihormonal therapy (tamoxifen, raloxifene, other selective estrogen receptor modulators [SERMs], aromatase inhibitors)
• Must be more than 1 year from pregnancy, lactation or chemotherapy
• If undergoing regular screening, subject must have a mammogram performed at the University of Kansas Medical Center or other accredited facility within 1 year prior to their RPFNA procedure; mammograms must be read as not suspicious for breast cancer (American College of Radiology [ACR] class I-III) unless issue resolved with other procedures
• Must be willing to discontinue aspirin, nonsteroidal antiinflammatory drugs (NSAIDS), or supplements such as fish oil 3 weeks prior to the procedure (to decrease soft tissue bleeding)
• Must be willing to have about 40 cc of blood (approximately 8 tablespoons) drawn at each aspiration visit
• Must be willing to complete demographic, family history, personal health and medication history, and informed consent
• Must be willing to keep the clinic informed of their breast health status for 10 years when requested
• Must be willing to have height and weight recorded at each aspiration visit
• If currently menstruating, must know the date of the first day of their latest menstrual cycle
• If applicable, must be willing to collect a urine specimen and bring to the clinic; depending on specific planned uses, this may be a 24-hour collection, a 12-hour fasting collection, or a first morning collection
• If applicable, must be willing to collect a stool specimen and bring to the clinic; special collection kits will be provided

Exclusion Criteria

• Metastatic malignancy to other organs, excluding Hodgkin’s or non-Hodgkins lymphoma
• Women on Coumadin, Xarelto, or other anticoagulants
• Women with bilateral subglandular breast implants (Women with subpectoral implants are eligible if C cup or greater; breast can easily be pulled off the chest wall; and with specific approval of principal investigator [PI])
• Tram flap reconstruction
• Women who have had radiation to both breasts
• Women who cannot give an informed consent in English
• Women with a current mammographic or clinical breast exam mass which is suspicious for breast cancer (ACR class IV), and malignancy has not been ruled out