Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry (PROGECT)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02302742 |
Recruitment Status :
Recruiting
First Posted : November 27, 2014
Last Update Posted : April 5, 2022
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Condition or disease |
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Breast Cancer Hereditary Breast and Ovarian Cancer |
Study Type : | Observational [Patient Registry] |
Estimated Enrollment : | 1500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Target Follow-Up Duration: | 10 Years |
Official Title: | PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations |
Actual Study Start Date : | March 22, 2011 |
Estimated Primary Completion Date : | March 2024 |
Estimated Study Completion Date : | March 2025 |

Group/Cohort |
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Triple Negative Breast Cancer patients
No intervention
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Germline HBOC Mutation Carriers
No intervention
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- 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 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | Child, Adult, Older Adult |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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"

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02302742
Contact: Joshua Staley | 913-588-8548 | jstaley2@kumc.edu |
United States, Kansas | |
Hays Medical Center Dreiling-Schmidt Cancer Institute | Recruiting |
Hays, Kansas, United States, 67601 | |
Contact: Josette Klaus 785-623-5761 | |
KCCC West | Recruiting |
Kansas City, Kansas, United States, 66112 | |
Contact: Kristina Sharpe-Pringle 913-328-3206 | |
Menorah Medical Center | Recruiting |
Overland Park, Kansas, United States, 66209 | |
Contact: Amy Nelson 913-498-7892 | |
KCCC Overland Park | Recruiting |
Overland Park, Kansas, United States, 66210 | |
Contact: Christy Kuechler 913-234-0459 | |
Overland Park Regional Medical Center | Recruiting |
Overland Park, Kansas, United States, 66215 | |
Contact: Amy Nelson 913-498-7892 | |
Salina Regional Health Center - Tammy Walker Cancer Center | Recruiting |
Salina, Kansas, United States, 67401 | |
Contact: Melanie Leepers, RN, MBA 785-452-7038 | |
The University of Kansas Cancer Center | Recruiting |
Westwood, Kansas, United States, 66205 | |
Contact: Joshua M Staley 913-588-8548 jstaley2@kumc.edu | |
United States, Missouri | |
Centerpoint Regional Medical Center | Recruiting |
Independence, Missouri, United States, 64057 | |
Contact: Amy Nelson 816-698-8249 | |
Truman Medical Center | Recruiting |
Kansas City, Missouri, United States, 64108 | |
Contact: Nikki Malomo 816-404-4093 | |
KCCC South | Recruiting |
Kansas City, Missouri, United States, 64131 | |
Contact: Adrienne Harris-Connell 816-823-6640 | |
Research Medical Center | Recruiting |
Kansas City, Missouri, United States, 64132 | |
Contact: Jennifer Feeback 816-276-4000 | |
KCCC - North | Recruiting |
Kansas City, Missouri, United States, 64154 | |
Contact: Nicole Jenci 816-584-4879 | |
KCCC Lee's Summit | Recruiting |
Lee's Summit, Missouri, United States, 64064 | |
Contact: Jan Ward 816-350-5825 |
Principal Investigator: | Priyanka Sharma, MD | The University of Kansas Medical Center |
Publications of Results:
Responsible Party: | Priyanka Sharma, Professor of Medicine, University of Kansas |
ClinicalTrials.gov Identifier: | NCT02302742 |
Other Study ID Numbers: |
KUMC 12614 |
First Posted: | November 27, 2014 Key Record Dates |
Last Update Posted: | April 5, 2022 |
Last Verified: | April 2022 |
Triple Negative Breast Cancer TNBC Hereditary Breast and Ovarian Cancer HBOC Prospective Registry |
Breast Neoplasms Ovarian Neoplasms Carcinoma, Ovarian Epithelial Triple Negative Breast Neoplasms Hereditary Breast and Ovarian Cancer Syndrome Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Endocrine Gland Neoplasms Ovarian Diseases |
Adnexal Diseases Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases Gonadal Disorders Carcinoma Neoplasms, Glandular and Epithelial Neoplasms by Histologic Type Neoplastic Syndromes, Hereditary Genetic Diseases, Inborn |