Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry (PROGECT)

May 8, 2023 updated by: Priyanka Sharma, University of Kansas Medical Center

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

PROGECT is a registry for patients with Triple Negative breast cancer (TNBC) or patients who have an identified germline mutations (such as a mutation on the BRCA1 or BRCA2 genes).

Study Overview

Status

Recruiting

Conditions

Detailed Description

This study is being done to collect cancer-related information from patients with triple negative breast cancer and patients with hereditary genetic mutations. This information will help us better understand the link between genetic changes and cancer outcome in patients with triple negative breast cancer.

Study Type

Observational

Enrollment (Anticipated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Kansas
      • Hays, Kansas, United States, 67601
        • Recruiting
        • Hays Medical Center Dreiling-Schmidt Cancer Institute
        • Contact:
          • Josette Klaus
          • Phone Number: 785-623-5761
      • Kansas City, Kansas, United States, 66112
        • Recruiting
        • KCCC West
        • Contact:
          • Kristina Sharpe-Pringle
          • Phone Number: 913-328-3206
      • Overland Park, Kansas, United States, 66209
        • Recruiting
        • Menorah Medical Center
        • Contact:
          • Amy Nelson
          • Phone Number: 913-498-7892
      • Overland Park, Kansas, United States, 66215
        • Recruiting
        • Overland Park Regional Medical Center
        • Contact:
          • Amy Nelson
          • Phone Number: 913-498-7892
      • Overland Park, Kansas, United States, 66210
        • Recruiting
        • KCCC Overland Park
        • Contact:
          • Christy Kuechler
          • Phone Number: 913-234-0459
      • Salina, Kansas, United States, 67401
        • Recruiting
        • Salina Regional Health Center - Tammy Walker Cancer Center
        • Contact:
          • Melanie Leepers, RN, MBA
          • Phone Number: 785-452-7038
      • Westwood, Kansas, United States, 66205
        • Recruiting
        • The University of Kansas Cancer Center
        • Contact:
    • Missouri
      • Independence, Missouri, United States, 64057
        • Recruiting
        • Centerpoint Regional Medical Center
        • Contact:
          • Amy Nelson
          • Phone Number: 816-698-8249
      • Kansas City, Missouri, United States, 64132
        • Recruiting
        • Research Medical Center
        • Contact:
          • Jennifer Feeback
          • Phone Number: 816-276-4000
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Truman Medical Center
        • Contact:
          • Nikki Malomo
          • Phone Number: 816-404-4093
      • Kansas City, Missouri, United States, 64131
        • Recruiting
        • KCCC South
        • Contact:
          • Adrienne Harris-Connell
          • Phone Number: 816-823-6640
      • Kansas City, Missouri, United States, 64154
        • Recruiting
        • KCCC - North
        • Contact:
          • Nicole Jenci
          • Phone Number: 816-584-4879
      • Lee's Summit, Missouri, United States, 64064
        • Recruiting
        • KCCC Lee's Summit
        • Contact:
          • Jan Ward
          • Phone Number: 816-350-5825

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

Academic Center & Community Clinics

Description

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"

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Triple Negative Breast Cancer patients
No intervention
Germline HBOC Mutation Carriers
No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC
Time Frame: 5 years
5 years
. Predictors of response to neo/adjuvant chemotherapy in patients with TNBC
Time Frame: 5 years
5 years
Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies
Time Frame: 10 years
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Kansas Medical Center

Investigators

  • Principal Investigator: Priyanka Sharma, MD, The University of Kansas Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 22, 2011

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2025

Study Registration Dates

First Submitted

November 11, 2014

First Submitted That Met QC Criteria

November 24, 2014

First Posted (Estimate)

November 27, 2014

Study Record Updates

Last Update Posted (Actual)

May 9, 2023

Last Update Submitted That Met QC Criteria

May 8, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • KUMC 12614

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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