Clinical trial · Observational
Validity of Brain Metastasis Risk Predictive Model in Hormone Positive Breast Cancer Patients
NCT06729099CI-TRIAL-00083587not yet recruitingClinicalTrials.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)
This study aims to validate a prediction model of brain metastasis risk for females with HR+ breast cancer by using variables collected at diagnosis.
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, Estrogen Receptor-Positive | Malignant Breast Neoplasm | CURATED_EXACT | 0.85 |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (3)
- label
- Low-risk group
- description
- Brain metastasis risk prediction model score 0-4 points.
- label
- Medium-risk group
- description
- Brain metastasis risk prediction model score 5-10 points.
- label
- High-risk group
- description
- Brain metastasis risk prediction model score \>10 points.
Primary outcomes (1)
- measure
- Validity of prediction model of brain metastases risk for females with HR+ breast cancer
- timeFrame
- 2 years
- description
- A Cox regression analysis to assess each group's risk of developing brain metastases. Adjusted hazard ratios (aHRs), 95 % CIs, and p values will be evaluated.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Confirmed diagnosis of HR-positive primary invasive breast cancer. Exclusion Criteria: 1. Patients if they were diagnosed with brain metastases at the time of initial breast cancer diagnosis or within the subsequent three months. 2. Bilateral breast cancer. 3. Synchronic cancer (i.e., lung cancer, melanoma). 4. Paitents presenting neurologic symptoms without follow-up or lacking a contrast-enhanced magnetic resonance image (cMRI). 5. Incomplete clinicopathological information at the time of diagnosis.
References
Publications (0)
Data not yet available
No reference posted for this study.