Cancerify Logo
Log inSign up
Back to clinical trials
RecruitingObservational

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

NCT ID: NCT02302742Sponsor: University of Kansas Medical CenterLast updated: 2025-10-06

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.

Arms & interventions

Outcome measures

Primary

  • 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

Eligibility criteria

Sex: AllAge: All agesHealthy 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"

Study locations (11)

Hays Medical Center Dreiling-Schmidt Cancer Institute

Hays, Kansas, 67601

Recruiting
Josette Klaus · Contact

KCCC West

Kansas City, Kansas, 66112

Recruiting
Kristina Sharpe-Pringle · Contact

KCCC Overland Park

Overland Park, Kansas, 66210

Recruiting
Christy Kuechler · Contact

Overland Park Regional Medical Center

Overland Park, Kansas, 66215

Recruiting
Amy Nelson · Contact

Salina Regional Health Center - Tammy Walker Cancer Center

Salina, Kansas, 67401

Recruiting
Melanie Leepers, RN, MBA · Contact

The University of Kansas Cancer Center

Westwood, Kansas, 66205

Recruiting
Joshua M Staley · Contact

Universtiy Health

Kansas City, Missouri, 64108

Recruiting
Nikki Malomo · Contact

KCCC South

Kansas City, Missouri, 64131

Recruiting
Adrienne Harris-Connell · Contact

Research Medical Center

Kansas City, Missouri, 64132

Recruiting
Jennifer Feeback · Contact

KCCC - North

Kansas City, Missouri, 64154

Recruiting
Nicole Jenci · Contact

KCCC Lee's Summit

Lee's Summit, Missouri, 64064

Recruiting
Jan Ward · Contact

References

  • Sharma P, Klemp JR, Kimler BF, Mahnken JD, Geier LJ, Khan QJ, Elia M, Connor CS, McGinness MK, Mammen JM, Wagner JL, Ward C, Ranallo L, Knight CJ, Stecklein SR, Jensen RA, Fabian CJ, Godwin AK. Germline BRCA mutation evaluation in a prospective triple-negative breast cancer registry: implications for hereditary breast and/or ovarian cancer syndrome testing. Breast Cancer Res Treat. 2014 Jun;145(3):707-14. doi: 10.1007/s10549-014-2980-0. Epub 2014 May 7.(PubMed)
  • Connor CS, Kimler BF, Mammen JM, McGinness MK, Wagner JL, Alsop SM, Ward C, Fabian CJ, Khan QJ, Sharma P. Impact of neoadjuvant chemotherapy on axillary nodal involvement in patients with clinically node negative triple negative breast cancer. J Surg Oncol. 2015 Feb;111(2):198-202. doi: 10.1002/jso.23790. Epub 2014 Sep 29.(PubMed)