NCT06975371

Real-World Outcomes of Patients With Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i

Real-World Outcomes of Patients With HR-Positive HER2-Negative Metastatic Breast Cancer After Treatment With First-Line ET+CDK4/6i in the United States

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,415 (actual)
• Sponsor: Daiichi Sankyo · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to assess the treatment patterns and real-world outcomes of HR+/HER- metastatic breast cancer patients who have progressed on 1L ET + CDK4/6i and started a second line (2L) treatment within a real-world cohort in the United States Flatiron Health Database.

Detailed description

This analysis will assess real-world outcomes in HR+/HER2- mBC patients who initiated a subsequent line of therapy (LOT) (i.e., 2L) after progressing on 1L treatment with ET+CDK4/6i. This study will also characterize the treatment patterns, clinical characteristics, and outcomes in this patient population. No study drug was administered in this non-interventional study.

Conditions

• Advanced/Metastatic HER2-negative Breast Cancer

Interventions

Type	Name	Description
OTHER	No drug	No study drug was administered in this non-interventional study.

Timeline

• Start date: 2025-04-14
• Primary completion: 2025-05-08
• Completion: 2025-08-05
• First posted: 2025-05-16
• Last updated: 2025-10-07

Locations

1 site across 1 country: United States