NCT07309887

This Clinical Trial is a Retrospective, Multicenter Cohort Study Evaluating the Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer.

Real-world Characteristics and Risk of Disease Recurrence in Hormone Receptor-positive, HER2-negative Early Breast Cancer: a Multi-center Retrospective Cohort Study in Korea

• Status: Not Yet Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 100,000 (estimated)
• Sponsor: Samsung Medical Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

* Primary objective: To describe event-free survival (EFS) in patients with stage I-III HR+/HER2- early breast cancer (EBC) who received curative surgery followed by systemic therapy. * Secondary objectives: Include assessment of relapse-free survival (RFS), distant disease-free survival (DDFS), distant relapse-free survival (DRFS), overall survival (OS), site of distant recurrence, and time-to-next treatment (TTNT), as well as evaluating the association between clinicopathologic/treatment variables and clinical outcomes. * Key inclusion criteria: Adults (≥18 years) with stage I-III HR+/HER2- invasive breast cancer who underwent curative surgery * Key exclusion criteria: HR- or HER2+ tumors, de novo stage IV, or lack of curative-intent surgery

Conditions

• Early Breast Cancer

Timeline

• Start date: 2025-12-17
• Primary completion: 2026-01-31
• Completion: 2026-12-31
• First posted: 2025-12-30
• Last updated: 2025-12-30

Locations

1 site across 1 country: South Korea