Validity of Brain Metastasis Risk Predictive Model in Hormone Positive Breast Cancer Patients
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Estrogen Receptor-Positive. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Primary outcome measures
- Validity of prediction model of brain metastases risk for females with HR+ breast cancer [Time frame: 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT06729099 · Predictive model