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

Trial Status: Active

This randomized clinical trial studies the collection of biological specimens with or without fine needle aspiration in predicting short term risk in patients with high risk for breast cancer. Studying samples of tissue collected using a procedure called fine needle aspiration, where a a few cells and breast fluid are removed from two different areas of the breast, with or without collection of blood, saliva, urine, and / or stool, may help doctors predict the likelihood of developing breast cancer over a five year period.

Inclusion Criteria

  • Should generally be between the ages of 30 and 55; 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 high penetrance mutation associated with hereditary breast or ovarian cancer (including BRCA1, BRCA2, p53, PTRN, ATM, PALB2, mutations associated with the Lynch Syndrome, etc.)
  • 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)
  • 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 breast implants or 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


Kansas City
University of Kansas Cancer Center
Status: ACTIVE
Contact: Carol J. Fabian
Phone: 913-588-7791
University of Kansas Hospital-Westwood Cancer Center
Status: ACTIVE
Contact: Carol J. Fabian
Phone: 913-588-7791


I. To correlate established risk biomarkers such as cytomorphology of specimens obtained by random periareolar fine needle aspiration (RPFNA), estimated mammographic breast density, body mass index, serum biomarkers with each other and with short-term risk estimates such as the Gail or Tyrer-Cuzick models.

II. To determine the relative predictive value of established risk biomarkers for the development of ductal breast carcinoma in situ (DCIS) and/or invasive cancer.

III. To evaluate potential new tissue-based biomarkers including nuclear morphometry, proliferation markers (e.g., Ki-67), hormones, growth factors, cytokines, adipokines, other proteins, macrophage markers, and genetic markers (e.g., single nucleotide polymorphisms [SNPs] and micro ribonucleic acid [microRNAs]).

IV. To periodically repeat biological specimen acquisitions and risk assessments; contact subjects to update demographic data; and follow subjects prospectively for the development of breast cancer.

V. To develop and then utilize techniques for assessment of biologic specimens so as to provide additional information that may contribute to our understanding of the process of breast cancer development.

OUTLINE: Patients are randomized to 1 of 2 groups.

GROUP I: Patients undergo RPFNA procedure for 30 minutes, and collection of blood at the time of the RPFNA procedure. Patients may also undergo standard of care collection of blood, saliva, urine, and/or stool.

GROUP II: Patients may undergo standard of care collection of blood, saliva, urine, and/or stool.

After completion of study intervention, patients are followed up yearly.

Trial Phase Phase NA

Trial Type Screening

Lead Organization
University of Kansas Cancer Center

Principal Investigator
Carol J. Fabian

  • Primary ID 4601
  • Secondary IDs NCI-2017-00818
  • ID NCT00291096