Protocol for Women at Increased Risk of Developing Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00291096
• Other study ID #: 4601
• Status: Recruiting
• Start date: August 1989
• Est. completion date: December 2026

Study information

• Verified date: February 2023
• Source: University of Kansas Medical Center
• Contact: Bruce Kimler, Ph.D.
• Phone: 913-588-4523
• Email: bkimler[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3000
• Est. completion date: December 2026
• Est. primary completion date: December 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 30 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
United States	University of Kansas Medical Center	Kansas City	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
Carol Fabian, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Prediction of risk for developing breast cancer	development of algorithm for predicting risk for developing breast cancer based on random sampling of benign breast tissue.	ongoing