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Protocol for Women at Increased Risk of Developing Breast Cancer

Sponsor
Carol Fabian, MD (Other)
Overall Status
Recruiting
CT.gov ID
NCT00291096
Collaborator
(none)
3,000
Enrollment
1
Location
448
Anticipated Duration (Months)
6.7
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

    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 Design

    Study Type:
    Observational
    Anticipated Enrollment :
    3000 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
    Actual Study Start Date :
    Aug 1, 1989
    Anticipated Primary Completion Date :
    Dec 1, 2025
    Anticipated Study Completion Date :
    Dec 1, 2026

    Outcome Measures

    Primary Outcome Measures

    1. Prediction of risk for developing breast cancer [ongoing]

      development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    30 Years to 65 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 University of Kansas Medical Center Kansas City Kansas United States 66160

    Sponsors and Collaborators

    • Carol Fabian, MD

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center
    ClinicalTrials.gov Identifier:
    NCT00291096
    Other Study ID Numbers:
    • 4601
    First Posted:
    Feb 13, 2006
    Last Update Posted:
    Oct 25, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Keywords provided by Carol Fabian, MD, Professor, Director Breast Cancer Prevention Unit, University of Kansas Medical Center
    breast atypia
    fine needle aspiration
    high risk for breast cancer
    breast epithelial hyperplasia
    Additional relevant MeSH terms:
    Breast Neoplasms

    Study Results

    No Results Posted as of Oct 25, 2021