Validity of Brain Metastasis Risk Predictive Model in Hormone Positive Breast Cancer Patients
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 128
- Primary Endpoint
- Validity of prediction model of brain metastases risk for females with HR+ breast cancer
Study Overview
Brief 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
- 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of HR-positive primary invasive breast cancer.
Exclusion Criteria
- •Patients if they were diagnosed with brain metastases at the time of initial breast cancer diagnosis or within the subsequent three months.
- •Bilateral breast cancer.
- •Synchronic cancer (i.e., lung cancer, melanoma).
- •Paitents presenting neurologic symptoms without follow-up or lacking a contrast-enhanced magnetic resonance image (cMRI).
- •Incomplete clinicopathological information at the time of diagnosis.
Outcomes
Primary Outcomes
Validity of prediction model of brain metastases risk for females with HR+ breast cancer
Time Frame: 2 years
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Moheb Ibrahim Melek
Clinical oncology specialist
Assiut University