NCT07377643

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

A Randomized, Multicenter, Open-label Phase 3 Study to Compare IBI354 With or Without Pertuzumab vs. Taxane in Combination With Trastuzumab and Pertuzumab as First-line Treatment in Participants With Unresectable, Locally Advanced or Metastatic HER2-Positive Breast Cancer

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 540 (estimated)
• Sponsor: Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• HER2-positive Breast Cancer

Interventions

Type	Name	Description
DRUG	Trastuzumab	IV infusion
DRUG	IBI354	IV infusion
DRUG	Docetaxel	IV infusion
DRUG	Pertuzumab	IV infusion
DRUG	Paclitaxel	IV infusion

Timeline

• Start date: 2026-02-10
• Primary completion: 2028-04-28
• Completion: 2030-05-31
• First posted: 2026-01-30
• Last updated: 2026-02-25

Locations

1 site across 1 country: China