Breast CancerPROGECTNCT02302742
Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry
An observational study of Breast Cancer and Hereditary Breast and Ovarian Cancer, run by University of Kansas Medical Center at 11 sites in United States.
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). Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Hereditary Breast and Ovarian Cancer
- How many people
- 3,000 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Mar 2011to Dec 2026
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Academic Center \& Community Clinics
Who may be able to join
- 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
Show all 13Show fewer
- 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
Who cannot join
- 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"
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Hays Medical Center Dreiling-Schmidt Cancer Institute
Hays, Kansas, 67601
Josette Klaus, 785-623-5761
- Recruiting
KCCC West
Kansas City, Kansas, 66112
Kristina Sharpe-Pringle, 913-328-3206
- Recruiting
Universtiy Health
Kansas City, Missouri, 64108
Nikki Malomo, 8164044093
- Recruiting
KCCC South
Kansas City, Missouri, 64131
Adrienne Harris-Connell, 816-823-6640
- Recruiting
Research Medical Center
Kansas City, Missouri, 64132
Jennifer Feeback, 8162764000
- Recruiting
KCCC - North
Kansas City, Missouri, 64154
Nicole Jenci, 816-584-4879
- Recruiting
KCCC Lee's Summit
Lee's Summit, Missouri, 64064
Jan Ward, 816-350-5825
- Recruiting
KCCC Overland Park
Overland Park, Kansas, 66210
Christy Kuechler, 9132340459
- Recruiting
Overland Park Regional Medical Center
Overland Park, Kansas, 66215
Amy Nelson, 913-498-7892
- Recruiting
Salina Regional Health Center - Tammy Walker Cancer Center
Salina, Kansas, 67401
Melanie Leepers, RN, MBA, 785-452-7038
- Recruiting
The University of Kansas Cancer Center
Westwood, Kansas, 66205
Joshua M Staley, (913) 588-8548, jstaley2@kumc.edu
About this study
Official title: PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations
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).
Read the 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.
- Keywords
- Triple Negative Breast Cancer, TNBC, Hereditary Breast and Ovarian Cancer, HBOC, Prospective Registry
- Medical subject headings
- Breast Neoplasms, Hereditary Breast and Ovarian Cancer Syndrome, Triple Negative Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Triple Negative Breast Cancer patients | No intervention | |
| Germline HBOC Mutation Carriers | No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC
Measured: 5 years
. Predictors of response to neo/adjuvant chemotherapy in patients with TNBC
Measured: 5 years
Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Nov 2014 (estimated)
- Study start22 Mar 2011
- Primary completionDec 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 3,000 participants (estimated)
- Target duration
- 10 Years
Sponsor and investigators
- Lead sponsor
- University of Kansas Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Priyanka Sharma, University of Kansas
- Investigators
- Priyanka Sharma, MD, Principal investigator, University of Kansas Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02302742
- Sponsor's protocol ID
- KUMC 12614
- Acronym
- PROGECT
- Status last verified
- Sep 2025
- First submitted
- 11 Nov 2014
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
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):707-14. doi: 10.1007/s10549-014-2980-0. Epub 2014 May 7.
PubMed 24807107Connor 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.
PubMed 25266871
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations
- ClinicalTrials.gov ID
- NCT02302742
- Acronym / sponsor ID
- PROGECT / KUMC 12614
- Keywords
- Triple Negative Breast Cancer, TNBC, Hereditary Breast and Ovarian Cancer, HBOC, Prospective Registry
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 3,000 participants (estimated)
- Lead sponsor
- University of Kansas Medical CenterUniversity, hospital or other
- Study start
- 22 Mar 2011 (actual)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 27 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Triple Negative Breast Cancer patients | – | –No intervention |
| Germline HBOC Mutation Carriers | – | –No intervention |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Academic Center \& Community Clinics
Key inclusion criteria (13 listed)
- 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
Key exclusion criteria (3 listed)
- Triple Negative Breast Cancer -Patient is not within five years of diagnosis
- -Patient only carries a HBOC mutation that is classified as "polymorphism" of "favor polymorphism"
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Results publication: PubMed 24807107Sharma 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.
- Results publication: PubMed 25266871Connor 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Priyanka Sharma, MD principal investigator
University of Kansas Medical Center
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Hereditary Breast and Ovarian Cancer, run by University of Kansas Medical Center at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 13 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Joshua Staley (913-588-8548, jstaley2@kumc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC (time frame: 5 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02302742, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.