High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer

October 27, 2025 updated by: Carol Fabian, MD
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.

Study Overview

Status

Recruiting

Conditions

Detailed Description

  1. To correlate established risk biomarkers such as cytomorphology obtained from random periareolar fine needle aspiration ( RPFNA), mammographic breast density, serum bioavailable estradiol and IGF-1/IGFBP-3 with each other and with 5-10 year Gail risk estimates. Where available, and with appropriate safe guards to maintain status for breast cancer susceptibility genes may be included.
  2. To determine the relative predictive value of established risk biomarkers for the development of DCIS and/or invasive cancer.
  3. To evaluate potential new breast tissue-based biomarkers including Ki-67, PCNA, ER, COX-2, aromatase, methylation of key tumor suppressor genes (i.e., RAR, p16, etc), proteomic patterns in RPFNA and nipple aspirate fluid (NAF), as well as NAF hormone levels, and correlate them with other risk biomarkers listed in 1.
  4. To determine the prevalence of polymorphisms of a panel of genes important in hormone and xenobiotic metabolism as well as DNA repair and correlate these polymorphisms with established risk biomarkers listed in 1, as well as with development of DCIS and invasive cancer.
  5. To maintain contact with this initially identified cohort of high risk women, acquire demographic data, biologic specimens and data and follow them prospectively for the development.

Study Type

Observational

Enrollment (Estimated)

3000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Kansas City, Kansas, United States, 66160
        • Recruiting
        • University of Kansas Medical Center
        • Principal Investigator:
          • Bruce Kimler, PhD
        • Principal Investigator:
          • Carol J Fabian, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Self-identified women at high risk for development of breast cancer

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prediction of risk for developing breast cancer
Time Frame: ongoing
development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.
ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Carol Fabian, MD

Investigators

  • Principal Investigator: Carol J Fabian, MD, University of Kansas Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 1989

Primary Completion (Estimated)

December 1, 2027

Study Completion (Estimated)

December 1, 2027

Study Registration Dates

First Submitted

February 10, 2006

First Submitted That Met QC Criteria

February 10, 2006

First Posted (Estimated)

February 13, 2006

Study Record Updates

Last Update Posted (Estimated)

October 29, 2025

Last Update Submitted That Met QC Criteria

October 27, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 4601

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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