Protocol for Women at Increased Risk of Developing Breast Cancer

The overall goal of this project is to develop an integrative system of breast cancer risk
assessment based on epidemiologic and biologic risk variables, as well as to develop or
refine risk biomarkers which may be useful in predicting and monitoring response to
prevention interventions.

Eligibility Criteria

Inclusion Criteria:

- women with at least 2 times the normal risk of developing breast cancer

- between the ages of 30-65 (or within 10 years of youngest age at diagnosis in first
degree relative)

- greater than six months from ingestion of antihormonal therapy

- greater than 1 year from pregnancy, lactation, or chemotherapy

- willing to have a mammogram within six months prior to RPFNA

- willing to discontinue NSAIDS or herbal supplements

- willing to have blood drawn

Exclusion Criteria:

- no metastatic malignancy of any kind

- no breast implants or tram flap reconstructions

- no radiation to both breasts

- no women who have a current mammogram or clinical breast exam suspicious for cancer

Principal Investigator

Carol J Fabian, MD

Study Contact

ctnursenav@kumc.edu, 913-945-7552

Estimated Completion Date

Tuesday, December 1, 2020

ClinicalTrials.gov #

NCT00291096
05/17/2015