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

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).

Recruiting

Interested in participating?

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Key information

Conditions

Breast Cancer Adnexal Diseases Breast Diseases Breast Neoplasms Congenital, Hereditary, and Neonatal Diseases and Abnormalities Endocrine Gland Neoplasms Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genetic Diseases, Inborn Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Hereditary Breast and Ovarian Cancer Hereditary Breast and Ovarian Cancer Syndrome Neoplasms Neoplasms by Site Neoplastic Syndromes, Hereditary Ovarian Diseases Ovarian Neoplasms Skin Diseases Skin and Connective Tissue Diseases Triple Negative Breast Neoplasms Urogenital Diseases Urogenital Neoplasms

Sex eligibility

All sexes

Study type

Observational

Primary location

Hays Medical Center Dreiling-Schmidt Cancer Institute, Hays, Kansas, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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"

Treatment and study plan

Primary outcomes

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

Study contacts

Contact information is provided by the study sponsor or research team.

Joshua Staley

CONTACT

[email protected]

913-588-8548

Sponsors and collaborators

Lead sponsor

University of Kansas Medical Center

Other

Registry information

Official study title

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

Acronym: PROGECT

Important dates

Study start: 2011
Primary completion: 2026
Study completion: 2026
First posted: Nov 27, 2014
Registry last updated: Oct 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed