NCT07476170

Real-World Treatment Pattern and Clinical Outcome With Influential Factors of HR+/HER2-aBC 1L Patients in China

Real-World Treatment Pattern and Clinical Outcome With Influential Factors of HR+/HER2-aBC 1L Patients in China: A Retrospective Analysis Based on a Database

• Status: Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 14,000 (estimated)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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

Conditions

• HR+/HER2- Advanced or Metastatic Breast Cancer

Timeline

• Start date: 2026-03-20
• Primary completion: 2027-04-01
• Completion: 2027-04-01
• First posted: 2026-03-17
• Last updated: 2026-04-02

Locations

1 site across 1 country: China