Clinical Trial

The Prognostic Impact of HER2 Expression in Non-Metastatic HER2-Positive Breast Cancer Treated With Dual HER2-Targeted Therapy

Recruiting
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Record status
This record was last updated January 29, 2026 (before its estimated June 10, 2026 completion). Its status may not reflect the trial's current state.
Summary
Previous studies suggest that among patients receiving trastuzumab monotherapy, a HER2/CEP17 ratio \>7.0 (ultra-high expression) is associated with poorer disease-free survival (DFS). Dual-target therapy (trastuzumab + pertuzumab) has become the standard treatment for high-risk HER2-positive breast cancer; however, whether it can predict outcomes in patients with ultra-high HER2 expression remains unsupported by clinical data. To analyze the clinicopathological characteristics and prognostic relationship between the HER2 ultra-high expression group and the normal expression group in non-metastatic HER2-positive breast cancer patients who received dual-target therapy.
Trial Details
NCT Number NCT07376174
Lead Sponsor Shandong Cancer Hospital and Institute
Conditions Breast Cancer, HER2/CEP17 Ratio
Enrollment 300 participants
Start Date 2026-01-10
Primary Completion 2026-06-10 (estimated)
Study Completion 2026-06-20 (estimated)
Updated on ClinicalTrials.gov 2026-01-29