NCT07086196

A Study of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer

Retrospective Analysis of Real-World Outcomes of Ribociclib in First-Line Treatment for Metastatic HR+/HER2- Breast Cancer

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 350 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The main aim of this study was to describe the profile of hormone receptor positive/human epidermal growth factor receptor 2 negative (HR+/HER2-) metastatic breast cancer (mBC) patients who received first-line (1L) current treatment options with ribociclib in the United States (US) clinical practice. This study used administrative claims data. De-identified patient-level data of adult patients with HR+/HER2- mBC who initiated 1L treatment with a cyclin dependant kinase 4/6 inhibitor (CDK4/6i) i.e., ribociclib from the Komodo Health Solutions Research Database (KRD; data from 1 January 2016 to 30 June 2023) was used. Data included medical and pharmacy claims for insured patients, which had already been collected (i.e., secondary use of data).

Conditions

• Metastatic HR+/HER2- Breast Cancer

Timeline

• Start date: 2024-05-30
• Primary completion: 2024-08-30
• Completion: 2024-08-30
• First posted: 2025-07-25
• Last updated: 2025-07-25

Locations

1 site across 1 country: United States