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

NCT02302742 | Recruiting

• 1 other identifier: KUMC 12614
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 11

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).

Conditions

Breast Cancer; Hereditary Breast and Ovarian Cancer

Keywords

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

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (2)

Triple Negative Breast Cancer patients

No intervention

Germline HBOC Mutation Carriers

No intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Academic Center \& Community Clinics

You may qualify if:

• 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

You may not qualify if:

• 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"

Sponsors & Collaborators

• University of Kansas Medical Center: lead

Study Sites (11)

Hays Medical Center Dreiling-Schmidt Cancer Institute

Hays, Kansas, 67601, United States

RECRUITING

KCCC West

Kansas City, Kansas, 66112, United States

RECRUITING

KCCC Overland Park

Overland Park, Kansas, 66210, United States

RECRUITING

Overland Park Regional Medical Center

Overland Park, Kansas, 66215, United States

RECRUITING

Salina Regional Health Center - Tammy Walker Cancer Center

Salina, Kansas, 67401, United States

RECRUITING

The University of Kansas Cancer Center

Westwood, Kansas, 66205, United States

RECRUITING

Universtiy Health

Kansas City, Missouri, 64108, United States

RECRUITING

KCCC South

Kansas City, Missouri, 64131, United States

RECRUITING

Research Medical Center

Kansas City, Missouri, 64132, United States

RECRUITING

KCCC - North

Kansas City, Missouri, 64154, United States

RECRUITING

KCCC Lee's Summit

Lee's Summit, Missouri, 64064, United States

RECRUITING

Related Publications (2)

• 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.

  PMID: 24807107 BACKGROUND

• 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 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

A baseline blood draw is collected as a part of this registry. If a study participant has a personal history of cancer and a tumor sample is available, the participant may give consent for the tissue to be used as a part of the study. Additional optional specimen collection sub-studies may also be offered to participants.

MeSH Terms

Conditions

Breast Neoplasms; Hereditary Breast and Ovarian Cancer Syndrome; Triple Negative Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Priyanka Sharma, MD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Joshua Staley

CONTACT

913-588-8548; jstaley2@kumc.edu

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine

Study Record Dates

• First Submitted: November 11, 2014
• First Posted: November 27, 2014
• Study Start: March 22, 2011
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: October 6, 2025

Record last verified: 2025-09

Locations

US (11)