NCT07148505

A Study of Real-world Outcomes Among Patients Treated With Ribociclib

Assessment of Real-world Outcomes Among Patients Treated With Kisqali (Ribociclib)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 373 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of the study was to evaluate the real-world tolerability and safety of ribociclib as a first-line (1L) treatment among adults with hormone receptor-positive/human epidermal growth factor receptor-2 negative (HR+/HER2-) metastatic breast cancer (mBC). This study used data from the Flatiron Health Research Database (FHRD). The FHRD is a longitudinal database derived from electronic health records (EHRs) and other real-world data (RWD) sources from cancer care providers across the United States. The dataset generated for this study included de-identified patient-level data for eligible individuals between 1 January 2015 up to the data cutoff date, 30 November 2022.

Conditions

• Metastatic Breast Cancer

Timeline

• Start date: 2024-04-24
• Primary completion: 2024-11-07
• Completion: 2024-11-07
• First posted: 2025-08-29
• Last updated: 2025-08-29

Locations

1 site across 1 country: United States