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

Last updated: May 8, 2023
Sponsor: University of Kansas Medical Center
Overall Status: Active - Recruiting

Phase

N/A

Condition

Breast Cancer

Cancer

Ovarian Cysts

Treatment

N/A

Clinical Study ID

NCT02302742
KUMC 12614
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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).

Eligibility Criteria

Inclusion

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 Design

Total Participants: 1500
Study Start date:
March 22, 2011
Estimated Completion Date:
December 31, 2025

Study 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.

Connect with a study center

  • Hays Medical Center Dreiling-Schmidt Cancer Institute

    Hays, Kansas 67601
    United States

    Active - Recruiting

  • KCCC West

    Kansas City, Kansas 66112
    United States

    Active - Recruiting

  • KCCC Overland Park

    Overland Park, Kansas 66210
    United States

    Active - Recruiting

  • Menorah Medical Center

    Overland Park, Kansas 66209
    United States

    Active - Recruiting

  • Overland Park Regional Medical Center

    Overland Park, Kansas 66215
    United States

    Active - Recruiting

  • Salina Regional Health Center - Tammy Walker Cancer Center

    Salina, Kansas 67401
    United States

    Active - Recruiting

  • The University of Kansas Cancer Center

    Westwood, Kansas 66205
    United States

    Active - Recruiting

  • Centerpoint Regional Medical Center

    Independence, Missouri 64057
    United States

    Active - Recruiting

  • KCCC - North

    Kansas City, Missouri 64154
    United States

    Active - Recruiting

  • KCCC South

    Kansas City, Missouri 64131
    United States

    Active - Recruiting

  • Research Medical Center

    Kansas City, Missouri 64132
    United States

    Active - Recruiting

  • Truman Medical Center

    Kansas City, Missouri 64108
    United States

    Active - Recruiting

  • KCCC Lee's Summit

    Lee's Summit, Missouri 64064
    United States

    Active - Recruiting

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