Clinical trial Recruiting at 11 sites Observational

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.

More Breast Cancer trials

Quick facts

Study typeObservational
SexAll
Enrollment3000 (estimated)
SponsorUniversity of Kansas Medical Center
Academic / other
Locations11 sites (Hays, Kansas and 10 other locations)
StatusRecruiting
StartedMarch 22, 2011
Main results expectedDecember 2026
Study endsDecember 2026
Registry record updatedAugust 18, 2026
Trial IDNCT02302742 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

  • 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
  • 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.