clinical trial · NCT07377643
IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.·phase3·recruiting·n = 540
HER2-positive Breast CancerTrastuzumabIBI354DocetaxelPertuzumabPaclitaxel
brief 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.
started
Feb 10, 2026
primary completion
Apr 28, 2028
completion
May 31, 2030
last updated
Feb 25, 2026
official title
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
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol