Clinical Trial

IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer

Recruiting Phase 3
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Summary
This is a randomized, multicenter, open-label, phase 3 study evaluating the efficacy, safety, and tolerability of IBI354 combined with or without pertuzumab vs. THP as first-line treatment for HER2-positive unresectable, locally advanced or metastatic breast cancer.
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2026-01-22.
Status change: Not Yet Recruiting → Recruiting 2026-02-23
Trial Details
NCT Number NCT07377643
Lead Sponsor Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.
Conditions HER2-positive Breast Cancer
Enrollment 540 participants
Start Date 2026-02-10
Primary Completion 2028-04-28 (estimated)
Study Completion 2030-05-31 (estimated)
Updated on ClinicalTrials.gov 2026-02-25