Hereditary Breast and Ovarian Cancer / Breast Cancer · Observational Study

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

ClinicalTrials.gov · August 18, 2026

Preliminary Why this matters to you Expert discussion

Early or partial results. Treat as a signal, not a conclusion.

AI Summary

This is a clinical trial registry record documenting a planned observational registry (PROGECT) for Triple Negative Breast Cancer patients and germline BRCA mutation carriers. No results have been posted; the record describes only the study protocol, objectives, and planned enrollment. Clinicians should await outcome publication before drawing clinical inferences.

What was studied

Observational. Breast Cancer, Hereditary Breast and Ovarian Cancer; accepts healthy volunteers. Intervention: Triple Negative Breast Cancer patients; Germline HBOC Mutation Carriers. n = 3,000. 11 sites: United States.

Key findings

Safety

Safety was not reported in the material analysed. Check the source before drawing any conclusion about harm.

Who this may help

No clinical impact can be assessed from this registry record, as no results are posted. Clinicians should monitor for publication of outcome data from this registry to inform treatment selection and mutation screening strategies in TNBC.

Plain-language summary

This is a registry study registration with no results reported; it describes planned observational data collection on TNBC and hereditary mutation carriers without outcome data to assess.

Study design

As stated by the source record.

MethodsCohort model. Prospective time perspective. Primary outcome measures: Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC (assessed at 5 years); . Predictors of response to neo/adjuvant chemotherapy in patients with TNBC (assessed at 5 years); Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies (assessed at 10 years)

DesignObservational

PopulationBreast Cancer, Hereditary Breast and Ovarian Cancer; accepts healthy volunteers

Sample size3,000

InterventionTriple Negative Breast Cancer patients; Germline HBOC Mutation Carriers

Setting11 sites: United States

Reported figures

Quoted from the source exactly as published.

Planned enrollment3000

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

Primary outcome measure 2Predictors of response to neo/adjuvant chemotherapy in patients with TNBC

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

Study duration (follow-up)10 years

Clinical bottom line

Caveats

No results reported; this is a study registration only.
Observational design cannot establish causation or definitively guide treatment decisions.
Recruitment status is RECRUITING; enrollment may not have been completed and outcomes not yet mature.
No effect sizes, comparative analyses, or clinical outcomes are provided in this registry record.

Evidence assessment

Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.

Study design

moderate

Observational registry design; prospective data collection on defined cohorts.

Directness

strong

Registry directly measures germline mutation prevalence and clinical outcomes in TNBC.

Consistency

insufficient

Registry record; no results reported to assess internal or external consistency.

Risk of bias

insufficient

No results posted; registry design subject to selection and attrition bias not yet assessable.

Sample adequacy

moderate

3000 estimated participants; adequate for prevalence and association studies if achieved.

What is missing. This record has no key findings. That is a gap in the analysis, not a judgement about the study.

Source abstract

Registry record from ClinicalTrials.gov (NCT02302742). This is a study registration, not published results. Lead sponsor: University of Kansas Medical Center. Recruitment status: RECRUITING. Study type: OBSERVATIONAL. Enrollment: 3000 participants (ESTIMATED). Conditions: Breast Cancer, Hereditary Breast and Ovarian Cancer. Primary outcome measures: 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. 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).

Follow from this

Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.

University of Kansas Medical CenterHereditary Breast and Ovarian CancerNCT02302742Breast Cancer