Clinical trial · Observational
Triple Negative Breast Cancer and Germline Hereditary Breast and Ovarian Cancer Mutation Carrier Registry
PROspective Evaluation of GErmline Mutations, Cancer Outcome and Tissue Biomarkers: A Registry for Patients With Triple Negative Breast Cancer and Germline Mutations
NCT02302742CI-TRIAL-00122477PROGECTrecruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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).
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Hereditary Breast and Ovarian Cancer | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- Triple Negative Breast Cancer patients
- description
- No intervention
- label
- Germline HBOC Mutation Carriers
- description
- No intervention
Primary outcomes (3)
- measure
- Prevalence of germline mutations (such as BRCA1/2 mutations) in patients with TNBC
- timeFrame
- 5 years
- measure
- . Predictors of response to neo/adjuvant chemotherapy in patients with TNBC
- timeFrame
- 5 years
- measure
- Long term Disease free and overall survival rates in TNBC patients treated with different systemic therapies
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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"
References
Publications (2)
- RESULTSharma 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. PMID 24807107
- RESULTConnor 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. PMID 25266871