Program for women at high risk of breast cancer
Official title: High Risk Breast Clinic: Protocol for Women at Increased Risk for Developing Breast Cancer
Run by University of Kansas Medical Center · NCT00291096 · Data updated 2026-11-12
This study is testing a new program to help women at high risk of breast cancer by looking at different factors that might predict their chances of developing the disease.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 30 Years to 65 Years |
| Sex | Women only |
| Enrollment | 3000 (estimated) |
| Sponsor | University of Kansas Medical Center Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Kansas City, Kansas) |
| Status | Recruiting |
| Started | August 1989 |
| Main results expected | December 2027 |
| Study ends | December 2027 |
| Registry record updated | October 29, 2025 |
| Trial ID | NCT00291096 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are women aged 30-65 with at least double the normal risk of developing breast cancer.
✕Probably not a fit
Patients with current breast cancer, metastatic malignancies, or those with certain breast surgeries may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This project aims to create a comprehensive system for assessing breast cancer risk by analyzing various epidemiologic and biological factors. It will correlate established risk biomarkers, such as cytomorphology from fine needle aspiration and mammographic breast density, with long-term risk estimates. The study will also evaluate new potential biomarkers and genetic polymorphisms to enhance predictive capabilities for breast cancer development. Participants will be followed over time to gather data on their health outcomes and risk factors.
Why it matters
Potential benefit: If successful, this study could lead to improved risk assessment and prevention strategies for women at high risk of developing breast cancer.
How similar studies have gone: Other studies have shown promise in using similar biomarker approaches for breast cancer risk assessment, indicating potential for success in this area.
Who can join: the full rules
Show full inclusion / exclusion 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
Where it's running
-
University of Kansas Medical Center
Kansas City, Kansas, United States Recruiting
Study contacts
- Principal investigator: Carol J Fabian, MD — University of Kansas Medical Center
- Study coordinator: Bruce Kimler, Ph.D.
- Email: bkimler@kumc.edu
- Phone: 913-588-4523
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.