NCT07342309

Real-World Treatment Patterns and Outcomes in HER2-Altered Metastatic Breast Cancer Patients in the United States

Real-World Treatment Patterns and Outcomes of Patients With HER2-Altered Metastatic Breast Cancer in the United States

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 7,933 (estimated)
• Sponsor: Boehringer Ingelheim · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to address the following key objectives in patients with HER2-altered mBC: Primary objectives * Estimate the prevalence of human epidermal growth factor receptor 2 positive (HER2+), human epidermal growth factor receptor 2 (HER2) mutation, cooccurrence of HER2+ and HER2 mutation among adult patients with metastatic breast cancer (mBC) * Among mBC patients with HER2+ and HER2 mutation, describe the following: * Baseline demographic and clinical characteristics * Treatment patterns during follow-up including 1L through fifth-line (5L) settings * Real-world overall survival (rwOS) for 1L through 5L Secondary objectives \- Among mBC patients with HER2+ and HER2 mutation, examine the following (as permissible in the study data): * Real-world progression-free survival (rwPFS) * Real-world time to discontinuation (rwTTD) * Real-world time to next treatment (rwTTNT) * Real-world overall response rate (rwORR)

Conditions

• Metastatic Breast Cancer

Timeline

• Start date: 2025-09-30
• Primary completion: 2026-06-30
• Completion: 2026-06-30
• First posted: 2026-01-15
• Last updated: 2026-02-10

Locations

1 site across 1 country: United States