drugset / Trial / NCT07377643

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

NCT07377643

RandomizedParallel-groupOpen-labelTreatment

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.

Timeline

Start
2026-02-10
Primary completion
2028-04-28
Completion
2030-05-31

Drugs

EvaluationDrugModalityDoseRoute
Comparator Docetaxel Small molecule Intravenous
Subject IBI354 Monoclonal antibody Intravenous
Comparator Paclitaxel Small molecule Intravenous
Subject Pertuzumab Monoclonal antibody Intravenous
Comparator Trastuzumab Monoclonal antibody Intravenous