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

Breast Cancer Clinical Trial

— PROGECT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02302742
• Other study ID #: KUMC 12614
• Status: Recruiting
• Start date: March 22, 2011
• Est. completion date: December 2025

Study information

• Verified date: May 2023
• Source: University of Kansas Medical Center
• Contact: Joshua Staley
• Phone: 913-588-8548
• Email: jstaley2[@]kumc.edu
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1500
• Est. completion date: December 2025
• Est. primary completion date: December 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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"

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Carcinoma, Ovarian Epithelial
• Hereditary Breast and Ovarian Cancer
• Hereditary Breast and Ovarian Cancer Syndrome
• Ovarian Neoplasms
• Triple Negative Breast Neoplasms

Locations

Country	Name	City	State
United States	Hays Medical Center Dreiling-Schmidt Cancer Institute	Hays	Kansas
United States	Centerpoint Regional Medical Center	Independence	Missouri
United States	KCCC - North	Kansas City	Missouri
United States	KCCC South	Kansas City	Missouri
United States	KCCC West	Kansas City	Kansas
United States	Research Medical Center	Kansas City	Missouri
United States	Truman Medical Center	Kansas City	Missouri
United States	KCCC Lee's Summit	Lee's Summit	Missouri
United States	KCCC Overland Park	Overland Park	Kansas
United States	Menorah Medical Center	Overland Park	Kansas
United States	Overland Park Regional Medical Center	Overland Park	Kansas
United States	Salina Regional Health Center - Tammy Walker Cancer Center	Salina	Kansas
United States	The University of Kansas Cancer Center	Westwood	Kansas

Sponsors (1)

Lead Sponsor	Collaborator
University of Kansas Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

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 Onco — View Citation

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-neg — View Citation

Outcome

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