Recruiting

Observational Study

Sponsor:

University of Kansas Medical Center

Code:

NCT02302742

Conditions

Breast Cancer

Hereditary Breast and Ovarian Cancer

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

Study Details

Brief 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).

Conditions

Breast Cancer

Hereditary Breast and Ovarian Cancer

Study ID

NCT02302742

Start date

Mar 22, 2011

Status verified date

Sep, 2025

Completion date

Dec, 2026

Anticipated

Primary completion date

Dec, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Accepted

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

Enrollment

3000 participants

Anticipated

Interventions and Outcome Measures

Arms

Triple Negative Breast Cancer patients

No intervention

Germline HBOC Mutation Carriers

No intervention

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Joshua Staley

913-588-8548jstaley2@kumc.edu

Locations

Hays Medical Center Dreiling-Schmidt Cancer Institute

Recruiting

Hays, Kansas, United States, 67601

Contacts

Josette Klaus

785-623-5761

KCCC West

Recruiting

Kansas City, Kansas, United States, 66112

Contacts

Kristina Sharpe-Pringle

913-328-3206

KCCC Overland Park

Recruiting

Overland Park, Kansas, United States, 66210

Contacts

Christy Kuechler

9132340459

Overland Park Regional Medical Center

Recruiting

Overland Park, Kansas, United States, 66215

Contacts

Amy Nelson

913-498-7892

Salina Regional Health Center - Tammy Walker Cancer Center

Recruiting

Salina, Kansas, United States, 67401

Contacts

Melanie Leepers, RN, MBA

785-452-7038

The University of Kansas Cancer Center

Recruiting

Westwood, Kansas, United States, 66205

Contacts

Joshua M Staley

(913) 588-8548jstaley2@kumc.edu

Universtiy Health

Recruiting

Kansas City, Missouri, United States, 64108

Contacts

Nikki Malomo

8164044093

KCCC South

Recruiting

Kansas City, Missouri, United States, 64131

Contacts

Adrienne Harris-Connell

816-823-6640

Research Medical Center

Recruiting

Kansas City, Missouri, United States, 64132

Contacts

Jennifer Feeback

8162764000

KCCC - North

Recruiting

Kansas City, Missouri, United States, 64154

Contacts

Nicole Jenci

816-584-4879

KCCC Lee's Summit

Recruiting

Lee's Summit, Missouri, United States, 64064

Contacts

Jan Ward

816-350-5825

More Information

Sponsor

University of Kansas Medical Center

Last update posted

Aug 18, 2026

Last verified

Sep, 2025

Keywords

  • Triple Negative Breast Cancer
  • TNBC
  • Hereditary Breast and Ovarian Cancer
  • HBOC
  • Prospective Registry

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Kansas Medical Center on 2026-08-18.