NCT06729099

Validity of Brain Metastasis Risk Predictive Model in Hormone Positive Breast Cancer Patients

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 128 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to validate a prediction model of brain metastasis risk for females with HR+ breast cancer by using variables collected at diagnosis.

Detailed description

1. Data collection: Age at BC diagnosis, tumor size, axillary adenopathy, clinical stage, HER2 status, Ki67 proliferation index and the modified Scarff-Bloom-Richardson grade of differentiation. 2. Analysis Plan: Continuous variables as means and standard deviation (SD) if they follow a normal distribution; if not, as medians and IQR (interquartile range). Numbers and percentages display categorical variables. 3. Model validation: The association between covariates and the diagnosis of brain metastases by performing logistic regression analyses; odds ratio (OR), 95 % confidence intervals (CI), and p-value will be estimated. Variables with a p-value \< 0.05 in the univariate logistic regression analysis will be further assessed in a multivariate logistic regression analysis. For the clinical use of the model, we will use a score to each variable as that designed by Cacho-Díaz B. et. al. then, we will categorize patients into three risk groups according to the sum of the scores. We will employe 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.

Conditions

• Breast Cancer, Estrogen Receptor-Positive

Timeline

• Start date: 2025-01-01
• Primary completion: 2026-12-01
• Completion: 2027-06-01
• First posted: 2024-12-11
• Last updated: 2024-12-11