Registry for patients with Triple Negative Breast Cancer and hereditary mutations
Official title: PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations
Run by University of Kansas Medical Center · NCT02302742 · Data updated 2026-11-12
This study is collecting information from people with Triple Negative Breast Cancer and genetic mutations to see how these factors affect their cancer outcomes and help improve future treatments.
Quick facts
| Study type | Observational |
|---|---|
| Sex | All |
| Enrollment | 3000 (estimated) |
| Sponsor | University of Kansas Medical Center Academic / other |
| Locations | 11 sites (Hays, Kansas and 10 other locations) |
| Status | Recruiting |
| Started | March 22, 2011 |
| Main results expected | December 2026 |
| Study ends | December 2026 |
| Registry record updated | August 18, 2026 |
| Trial ID | NCT02302742 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals diagnosed with Triple Negative Breast Cancer within the last five years or those who are carriers of hereditary mutations related to breast and ovarian cancer.
✕Probably not a fit
Patients who are not within five years of their TNBC diagnosis or who carry mutations classified as 'polymorphism' 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 registry collects cancer-related information from patients diagnosed with Triple Negative Breast Cancer (TNBC) and those with hereditary genetic mutations linked to breast and ovarian cancer. The goal is to better understand the relationship between genetic changes and cancer outcomes in these patients. Participants can include individuals with TNBC or germline mutations, regardless of their cancer history or genetic testing status. The study aims to gather data that could inform future treatment and management strategies for these conditions.
Why it matters
Potential benefit: If successful, this registry could enhance understanding of genetic factors influencing cancer outcomes, leading to improved patient care and targeted therapies.
How similar studies have gone: Other studies have shown success in utilizing registries to gather data on genetic mutations and cancer outcomes, indicating that this approach is promising.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion criteria include: Triple Negative Breast Cancer * ER/PR \<10% and HER negative per current ASCO/CAP guidelines * Stages I-IV * Any age at diagnosis * Patient must be within 5 years of diagnosis * Eligible regardless of genetic testing status * Genetic testing recommended for patients meeting NCCN and Medicare guidelines AND/OR Germline mutation Carriers * Patients with deleterious or uncertain mutations in HBOC genes (BRCA, PTEN, P53, -PALB2 etc) are eligible regardless of type/site of cancer * Healthy patients harboring mutations also eligible * There is no time limit from the time of diagnosis of cancer and enrollment. * Eligible regardless of personal history of cancer Exclusion Criteria include: Triple Negative Breast Cancer -Patient is not within five years of diagnosis Germline mutation Carriers: -Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"
Where it's running
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Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays, Kansas, United States Recruiting -
KCCC West
Kansas City, Kansas, United States Recruiting -
KCCC Overland Park
Overland Park, Kansas, United States Recruiting -
Overland Park Regional Medical Center
Overland Park, Kansas, United States Recruiting -
Salina Regional Health Center - Tammy Walker Cancer Center
Salina, Kansas, United States Recruiting -
The University of Kansas Cancer Center
Westwood, Kansas, United States Recruiting
Show 5 more locations
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Universtiy Health
Kansas City, Missouri, United States Recruiting -
KCCC South
Kansas City, Missouri, United States Recruiting -
Research Medical Center
Kansas City, Missouri, United States Recruiting -
KCCC - North
Kansas City, Missouri, United States Recruiting -
KCCC Lee's Summit
Lee's Summit, Missouri, United States Recruiting
Study contacts
- Principal investigator: Priyanka Sharma, MD — University of Kansas Medical Center
- Study coordinator: Joshua Staley
- Email: jstaley2@kumc.edu
- Phone: 913-588-8548
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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.