Clinical trial · Observational
Cohort Study of Patients With HER2-negative MBC and BRCA 1/2 Pathogenic Mutation
Epidemiologic Evaluation and Clinical Outcomes for HER2-negative Metastatic Breast Cancer (MBC) Patients With Germline BRCA1 and 2 Pathogenic Mutation in Korea
NCT04368442CI-TRIAL-00044892BRCAmunknownClinicalTrials.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)
The purpose of this study is to investigate the prevalence germline pathogenic BRCA1/2 mutation in a large group of potential candidate of PARP inhibitors, among the unselected patients with HER2-negative unresectable locally advanced or metastatic breast cancer.
Conditions
Conditions (1)
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 Metastatic | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Progression free survival
- timeFrame
- Length of time from the first date of each line of palliative endocrine treatment or chemotherapy until the date of the first documented progression of breast cancer or death of any cause,, assessed up to 60 months
- description
- Progression free survival of each of palliative systemic treatment
Secondary outcomes (3)
- measure
- Overall survival 1
- timeFrame
- Length of time from the date of first neoadjuvant chemotherapy or curative surgery until death for any cause,, assessed up to 60 months
- description
- Overall survival from initial diagnosis
- measure
- Overall survival 2
- timeFrame
- Length of time from the first date of the first line of chemotherapy, assessed up to 60 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Age ≥ 20 years old * Histologically confirmed, unresectable locally advanced or metastatic breast invasive carcinoma * Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer * Germline mutational status of BRCA1 and/or BRCA2 can be known or unknown * Signed written informed consent * The patient is regarded as good candidate for active palliative management at time of enrollment. The patient with terminal cancer which is not appropriate for further endocrine treatment or chemotherapy cannot be enrolled to this study. Exclusion Criteria: * HER2 positive breast cancer * Amenable to curative surgery
References
Publications (0)
Data not yet available
No reference posted for this study.