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

NCT ID: NCT00291096

Last Updated: 2025-10-29

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 3000 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 1989-08-31
• Study Completion Date: 2027-12-31

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.

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

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

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Carol Fabian, MD

OTHER

Sponsor Role: lead

Responsible Party

Carol Fabian, MD

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Carol J Fabian, MD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

University of Kansas Medical Center

Kansas City, Kansas, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Bruce Kimler, Ph.D.

Role: CONTACT

bkimler@kumc.edu

913-588-4523

Other Identifiers

4601

Identifier Type: -

Identifier Source: org_study_id