ClinicalTrials.gg
RecruitingNCT02302742PROGECTUpdated Aug 18, 2026

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

An observational study in Breast Cancer and Hereditary Breast and Ovarian Cancer, sponsored by University of Kansas Medical Center. Recruiting at 11 sites in United States. Per ClinicalTrials.gov, last updated 2026-08-18.

Primary conditionTriple Negative Breast NeoplasmsRegistry: Breast NeoplasmsReclassifiedWhy we changed it
Registry
Breast Neoplasms — the first condition term the registry derived for this study.
ClinicalTrials.gg
Triple Negative Breast Neoplasms
Why
  1. The study's title name Triple Negative Breast Neoplasms, a narrower term within Breast Neoplasms.
Confidence
High: the new condition is named in the study's own title. Of 46 hand-checked studies reclassified this way, 72% were exactly right and 89% in the right disease family; the registry's first term was right for 4% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by University of Kansas Medical Center · Observational

From the registry’s dates

  • Started Mar 2011; still recruiting 15 years 7 months later.

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Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
3,000
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-14

Among 645 studies in Triple Negative Breast Neoplasms with a site in United States — 163 open to participants now, 264 under way, 16 of them phase 3. Triple Negative Breast Neoplasms · United States.

Planned enrollment
2nd of 38
3,000 · median 90
Started
2011
with 15 others
Observational
38 of 645
13 open now
Primary completion
2026-12
later than 70 of 263 live
Registered
104th of 645
by date

Among the 645 studies in Triple Negative Breast Neoplasms with a site in United States, this one is the 2nd largest by planned enrollment of the 38 observational ones that give a count, is one of 16 that started in 2011, is one of 38 observational ones, reaches primary completion later than 70 of the 263 other live ones, and was the 104th registered.

Triple Negative Breast Neoplasms

1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.

Browse Triple Negative Breast Neoplasms studies →

Open to participants now

163 of the 645 studies in Triple Negative Breast Neoplasms with a site in United States are open now. Recruiting first, the newest first:

158 more — sign in →

All 163 open studies →

A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →

Who these studies take

Of the 331 Triple Negative Breast Neoplasms studies recruiting now, 231 (70%) set no upper age limit and 85 (26%) stop at 75 or younger; 12 take children under 18; 6 take healthy volunteers.

This study: all sexes · healthy volunteers too.

The full table on the hub →

This tab as a report to print or save as PDF → With an account.

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Watch this landscapeDownload CSVNarrow it in search →With an account: a weekly mail of what changed among 645 studies in Triple Negative Breast Neoplasms with a site in United States, or all of them as a file.
02

Study 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 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.

03

Conditions studied

  • Breast Cancer
  • Hereditary Breast and Ovarian Cancer

Keywords

  • Triple Negative Breast Cancer
  • TNBC
  • Hereditary Breast and Ovarian Cancer
  • HBOC
  • Prospective Registry
04

In context

Triple Negative Breast Neoplasms Reclassified

1,219 studies on the registry are indexed under Triple Negative Breast Neoplasms; 445 are open to participants now.

This study's planned enrollment of 3,000 is above the median of 193 across 106 observational studies indexed under Triple Negative Breast Neoplasms.

Browse Triple Negative Breast Neoplasms studies →

Lead sponsor

University of Kansas Medical Center is the lead sponsor of 492 studies on the registry; 110 are open to participants now.

Of its 38 completed or terminated interventional studies of FDA-regulated products, 24 (63%) have results posted.

Compared within Triple Negative Breast Neoplasms, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Breast Neoplasms. The counts are of registry records indexed under each term, refreshed daily. How we classify →

05

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

Academic Center \& Community Clinics

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

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"

06

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
3,000 participants (estimated)
Target follow-up
10 Years
Patient registry
Yes
Biospecimen retention
Samples with dna

Groups and cohorts

  • Triple Negative Breast Cancer patients

    No intervention

  • Germline HBOC Mutation Carriers

    No intervention

07

What researchers measure

Primary outcomes

  1. Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC

    Time frame: 5 years

  2. . Predictors of response to neo/adjuvant chemotherapy in patients with TNBC

    Time frame: 5 years

  3. Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies

    Time frame: 10 years

08

Study locations

11 of 11 sites recruiting
  • Hays Medical Center Dreiling-Schmidt Cancer Institute
    Hays, Kansas 67601, United States
    Recruiting
    • Josette Klaus · Contact785-623-5761
  • KCCC West
    Kansas City, Kansas 66112, United States
    Recruiting
    • Kristina Sharpe-Pringle · Contact913-328-3206
  • KCCC Overland Park
    Overland Park, Kansas 66210, United States
    Recruiting
    • Christy Kuechler · Contact9132340459
  • Overland Park Regional Medical Center
    Overland Park, Kansas 66215, United States
    Recruiting
    • Amy Nelson · Contact913-498-7892
  • Salina Regional Health Center - Tammy Walker Cancer Center
    Salina, Kansas 67401, United States
    Recruiting
    • Melanie Leepers, RN, MBA · Contact785-452-7038
  • The University of Kansas Cancer Center
    Westwood, Kansas 66205, United States
    Recruiting
  • Universtiy Health
    Kansas City, Missouri 64108, United States
    Recruiting
    • Nikki Malomo · Contact8164044093
  • KCCC South
    Kansas City, Missouri 64131, United States
    Recruiting
    • Adrienne Harris-Connell · Contact816-823-6640
  • Research Medical Center
    Kansas City, Missouri 64132, United States
    Recruiting
    • Jennifer Feeback · Contact8162764000
  • KCCC - North
    Kansas City, Missouri 64154, United States
    Recruiting
    • Nicole Jenci · Contact816-584-4879
  • KCCC Lee's Summit
    Lee's Summit, Missouri 64064, United States
    Recruiting
    • Jan Ward · Contact816-350-5825
09

References and documents

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 24807107 ↗
  • 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. PubMed 25266871 ↗
10

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2011 (actual). Primary completion is estimated for Dec 2026, 189 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Nov 11, 2014
First posted
Nov 27, 2014
StartActual
Mar 22, 2011
Primary completionEst.
Dec 2026
CompletionEst.
Dec 2026
Last update
Aug 18, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 18, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT02302742
Responsible party
Priyanka Sharma (Professor of Medicine, University of Kansas) — Principal investigator
First posted
Nov 27, 2014
Start date
Mar 22, 2011
Primary completion
Dec 2026 (estimated)
Completion
Dec 2026 (estimated)
Last update
Aug 18, 2026

Study contacts

Joshua Staley
Contact
jstaley2@kumc.edu
913-588-8548
Priyanka Sharma, MD
principal investigator · University of Kansas Medical Center

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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