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

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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02302742

Acronym

PROGECT

Enrollment

3000

Registered

2014-11-27

Start date

2011-03-22

Completion date

2026-12-01

Last updated

2026-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer, Hereditary Breast and Ovarian Cancer

Keywords

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

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).

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Yes

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"

Design outcomes

Primary

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

Countries

United States

Contacts

CONTACTJoshua Staley

jstaley2@kumc.edu913-588-8548

PRINCIPAL_INVESTIGATORPriyanka Sharma, MD

University of Kansas Medical Center

Outcome results