Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry
NCT ID: NCT02302742
Last Updated: 2025-10-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
1500 participants
OBSERVATIONAL
2011-03-22
2026-12-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Triple Negative Breast Cancer patients
No intervention
No interventions assigned to this group
Germline HBOC Mutation Carriers
No intervention
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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
Germline mutation Carriers:
-Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"
ALL
Yes
Sponsors
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University of Kansas Medical Center
OTHER
Responsible Party
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Priyanka Sharma
Professor of Medicine
Principal Investigators
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Priyanka Sharma, MD
Role: PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center
Locations
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Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays, Kansas, United States
KCCC West
Kansas City, Kansas, United States
KCCC Overland Park
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, United States
Universtiy Health
Kansas City, Missouri, United States
KCCC South
Kansas City, Missouri, United States
Research Medical Center
Kansas City, Missouri, United States
KCCC - North
Kansas City, Missouri, United States
KCCC Lee's Summit
Lee's Summit, Missouri, United States
Countries
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Central Contacts
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Facility Contacts
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Josette Klaus
Role: primary
Kristina Sharpe-Pringle
Role: primary
Christy Kuechler
Role: primary
Amy Nelson
Role: primary
Melanie Leepers, RN, MBA
Role: primary
Nikki Malomo
Role: primary
Adrienne Harris-Connell
Role: primary
Jennifer Feeback
Role: primary
Nicole Jenci
Role: primary
Jan Ward
Role: primary
References
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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.
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.
Other Identifiers
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KUMC 12614
Identifier Type: -
Identifier Source: org_study_id
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