Menu
Recruiting NCT02302742

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

— Observational Breast Cancer Hereditary Breast and Ovarian Cancer

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Breast Cancer, Hereditary Breast and Ovarian Cancer. Basic parameters: No limits · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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.

Primary outcome measures

  • 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

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"

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Observational model
Cohort

Study locations

United States · 11 centers
  • Hays Medical Center Dreiling-Schmidt Cancer Institute — Hays
  • KCCC West — Kansas City
  • KCCC Overland Park — Overland Park
  • Overland Park Regional Medical Center — Overland Park
  • Salina Regional Health Center - Tammy Walker Cancer Center — Salina
  • The University of Kansas Cancer Center — Westwood
  • Universtiy Health — Kansas City
  • KCCC South — Kansas City
  • … and 3 more centers

Publications

  • 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) PMID 24807107
  • 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. PMID 25266871

Identifiers

NCT: NCT02302742 · KUMC 12614

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗