drugset / Trial / NCT07377643
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
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
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| 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 |