This study aims to fill the current gap in data regarding HR+/HER2- ABC 1L treatment patterns and outcomes in the real-world setting in China, especially in the context of the widespread application of CDK4/6is and the lack of sufficient evidence for ribociclib as a most recently marketed drug in the real-world setting.
This study is a longitudinal, non-interventional, retrospective, and observational study based on secondary real-world data in the National Anti-Tumor Drug Surveillance System (NATDSS) database. The study will not involve any active intervention, randomization, or control group. All analyses will be conducted using Electronic Health Record (EHR) routinely collected in clinical practice and additional secondary data sources
Study Type
OBSERVATIONAL
Enrollment
14,000
Novartis Investigative SIte
Bingjie, Beijing Municipality, China
RECRUITINGDistribution of first-line treatment regimens
Proportion of patients receiving each first line treatment category and specific regimen
Time frame: Up to 39 months
Proportion of patients with treatment changes
Proportion of patients who discontinue or switch first line treatment
Time frame: Up to 39 months
Time to treatment initiation, time to discontinuation, and time to next line therapy
Time to treatment initiation (TTI), time to discontinuation (TTD), and time to next-line therapy (TTNT)
Time frame: Up to 39 months
Proportion of patients by initial CDK4 6 inhibitor dose
Proportion of patients treated with a CDK4 6 inhibitor, stratified by initial dose level
Time frame: Up to 39 months
Proportion of patients with dose modifications of CDK4/6 inhibitor therapy
Proportion of patients treated with CDK4/6 inhibitor who experience any dose modification (including dose reduction and interruption)
Time frame: Up to 39 months
Time to first dose modification of CDK4/6 inhibitor therapy
Time from initiation of CDK4/6 inhibitor therapy to the first dose modification, including dose reduction or interruption
Time frame: Up to 39 months
rwPFS of 1L treatment patterns
rwPFS is defined as the duration from the initiation date of 1L treatment to documented disease progression or death from any cause. If a patient has not experienced disease progression or death, the last confirmed survival time will be used as the censoring time to calculate the rwPFS censoring duration
Novartis Pharmaceuticals
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Time frame: Up to 39 months
rwPFS of HR+/HER2- ABC patients
rwPFS of HR+/HER2- ABC patients adhering or not adhering to the highest level of first-line treatment recommendation in the guidelines in the real-world setting based on the NATDSS database
Time frame: Up to 39 months
rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens
rwPFS of HR+/HER2- ABC patients receiving ribociclib-based 1L treatment regimens in the real-world setting based on the NATDSS database
Time frame: Up to 39 months
Number of subjects with AESIs
AESIs under different treatment patterns, including: * Hematology: neutropenia, leukopenia, anemia, and thrombocytopenia; * Gastrointestinal tract: diarrhea, nausea, vomiting, stomatitis/mucositis; * QTc prolongation; * Hepatotoxicity: alanine transaminase (ALT)/aspartate transaminase (AST) increased, and total bilirubin increased.
Time frame: Up to 39 months
Baseline demographics
Time frame: Baseline