Real-World Treatment Patterns and Outcomes in HER2-Altered Metastatic Breast Cancer Patients in the United States
NCT07342309 · Status: ACTIVE_NOT_RECRUITING · Type: OBSERVATIONAL · Enrollment: 7933
Last updated 2026-02-10
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
Sponsors & Collaborators
- lead INDUSTRY
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-09-30
- Primary Completion
- 2026-06-30
- Completion
- 2026-06-30
Countries
- United States
Study Locations
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