Actively Recruiting

All Genders
Healthy Volunteers
ID02302742

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

Led by University of Kansas Medical Center · Updated on 2025-10-06

1500

Participants Needed

11

Research Sites

N/A

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are collecting detailed cancer-related information from patients with Triple Negative Breast Cancer (TNBC) and those who carry hereditary genetic mutations linked to breast and ovarian cancer, such as mutations in the BRCA1 or BRCA2 genes. The study aims to improve understanding of how these genetic changes affect cancer outcomes in these patients. Participants include those diagnosed with TNBC within the past five years and individuals who carry germline mutations in hereditary breast and ovarian cancer (HBOC) genes, regardless of cancer history. No treatments or interventions are provided as part of this observational registry study. During the study, participants' medical and genetic information will be collected and analyzed to determine mutation prevalence, predict chemotherapy responses, and assess long-term survival rates over periods up to ten years. This ongoing registry enables researchers to track disease outcomes and treatment effects without requiring active treatment or intervention from participants.

CONDITIONS

Brief Title

Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry

Who Can Participate

All Genders
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosed with Triple Negative Breast Cancer (ER/PR <10% and HER2 negative) at any stage (I-IV)
  • Diagnosed with Triple Negative Breast Cancer within the last 5 years
  • Eligible regardless of genetic testing status
  • Genetic testing recommended if meeting NCCN and Medicare guidelines
  • Patients with deleterious or uncertain germline mutations in hereditary breast and ovarian cancer genes (BRCA, PTEN, P53, PALB2, etc.) regardless of cancer type or site
  • Healthy individuals carrying germline mutations are eligible
  • No time limit since cancer diagnosis for germline mutation carriers
  • Eligible regardless of personal history of cancer
Not Eligible

You will not qualify if you...

  • Patients with Triple Negative Breast Cancer diagnosed more than 5 years ago
  • Individuals carrying only germline mutations classified as "polymorphism" or "favor polymorphism"

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Long-term Monitoring

Duration - Up to 10 years

Participants are observed over time to collect cancer-related information and understand the link between genetic changes and cancer outcomes.

Trial Site Locations

Total: 11 locations

1

Hays Medical Center Dreiling-Schmidt Cancer Institute

Hays, Kansas, United States, 67601

Actively Recruiting

2

KCCC West

Kansas City, Kansas, United States, 66112

Actively Recruiting

3

KCCC Overland Park

Overland Park, Kansas, United States, 66210

Actively Recruiting

4

Overland Park Regional Medical Center

Overland Park, Kansas, United States, 66215

Actively Recruiting

5

Salina Regional Health Center - Tammy Walker Cancer Center

Salina, Kansas, United States, 67401

Actively Recruiting

6

The University of Kansas Cancer Center

Westwood, Kansas, United States, 66205

Actively Recruiting

7

Universtiy Health

Kansas City, Missouri, United States, 64108

Actively Recruiting

8

KCCC South

Kansas City, Missouri, United States, 64131

Actively Recruiting

9

Research Medical Center

Kansas City, Missouri, United States, 64132

Actively Recruiting

10

KCCC - North

Kansas City, Missouri, United States, 64154

Actively Recruiting

11

KCCC Lee's Summit

Lee's Summit, Missouri, United States, 64064

Actively Recruiting

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Research Team

J

Joshua Staley

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Frequently Asked Questions

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Published Research Related To This Trial

Germline BRCA mutation evaluation in a prospective triple-negative breast cancer registry: implications for hereditary breast and/or ovarian cancer syndrome testing.

Priyanka Sharma, Jennifer R Klemp, Bruce F Kimler...

https://pubmed.ncbi.nlm.nih.gov/24807107

Impact of neoadjuvant chemotherapy on axillary nodal involvement in patients with clinically node negative triple negative breast cancer.

Carol S Connor, Bruce F Kimler, Joshua M V Mammen...

https://pubmed.ncbi.nlm.nih.gov/25266871