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Registry for patients with Triple Negative Breast Cancer and hereditary mutations

PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations

Observational University of Kansas Medical Center · NCT02302742

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 typeObservational
Enrollment1500 (estimated)
SexAll
SponsorUniversity of Kansas Medical Center Academic / other
Locations11 sites (Hays, Kansas and 10 other locations)
Trial IDNCT02302742 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: Other studies have shown success in utilizing registries to gather data on genetic mutations and cancer outcomes, indicating that this approach is promising.

Eligibility criteria

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 this trial is running

Hays, Kansas and 10 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Breast CancerHereditary Breast and Ovarian CancerTriple Negative Breast CancerTNBCHBOCProspective Registry
Last reviewed 2026-06-13 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.