Clinical trial · Observational
Brain Monitoring for High Risk of Brain Metastases in Metastatic Breast Cancer
NCT03617341CI-TRIAL-00047942unknownClinicalTrials.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)
In general, brain metastases found after development of neurologic symptoms have poor prognosis. Therefore, the investigators aim to investigate whether regular brain MRI (Magnetic Resonance Imaging) can detect early brain metastases and influence survival through early brain management in HER2-positive and triple negative breast cancer.
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 |
|---|---|---|---|
| Metastatic Breast Cancer With HER2 Positive | — | UNRESOLVED | — |
| Triple Negative Breast Cancer | Triple-Negative Breast Carcinoma | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Brain MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Brain MRI
- description
- Regular brain MRI can detect early brain metastases in metastatic Breast cancer with high risk subgroups, such as HER2-positive and triple negative.
- interventionNames
- Procedure: Brain MRI
Primary outcomes (1)
- measure
- The incidence rates of brain metastases with high risk patients in metastatic breast cancer
- timeFrame
- 5 years
- description
- The incidence rates of brain metastases with high risk patients in metastatic breast cancer at initial diagnosis and failure of first- and second-line treatments confirmed by brain MRI
Secondary outcomes (5)
- measure
- The incidence rate of brain oligometastasis (≤ 4) confirmed by brain MRI
- timeFrame
- 5 years
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 19 Years
Show eligibility criteria text
Inclusion Criteria: * Patients over 19 years * Pathologically documented breast cancer that: 1. is unresectable or metastatic ; 2. has confirmed HER2 positive expression according to American Society of Clinical Oncology- College of American Pathologists (ASCO-CAP) guidelines or triple negative breast cancer * No prior systemic palliative treatment of metastatic breast cancer * Must have provided informed consent for study participation before performance of any study-specific procedures or tests Exclusion Criteria: * History of prior treatments about brain metastases or leptomeningeal metastases * Symptomatic brain metastases at screening period * Has received more than second-line systemic treatments (including endocrine therapy) * For subjects who have difficulty lying down or who have claustrophobia, they can undergo sedation during brain MRI * History of hypersensitivity reaction to contrast or drug allergic reaction * Patients who inserted metallic prosthesis (pacemaker, denture, hearing aid, aneurysm clip, metallic material of eyeball, artificial joint, insulin pump, chemo-port, temporary tissue expander for breast reconstruction, etc) can be conducted after consultation with investigator before MRI. * Has known psychiatric or substance abuse disorders that would interfere with cooperation with the requirements of the trial. * Social, familial, or geographical factors that would interfere with study participation or follow-up
References
Publications (0)
Data not yet available
No reference posted for this study.