Discussion
ERBB2-positive
ADVERSE EVENTS, EVENTS
The phase 3 TROIKA study in patients with ERBB2-positive EBC is the conclusive step in the investigation of HD201 and the referent trastuzumab in the extensive comparison of the two supporting the development of the biosimilar candidate [The overall safety profile of HD201 and trastuzumab at the 3-year follow-up remains consistent with the safety profiles observed in previous studies, post-treatment adverse events are unrelated or unlikely to the study drug, and rarely, events related to the study drug occurred in the post-treatment follow-up period.Limitations of the study include the use of newer anti-HER2 agents, which could impact survival in patients with relapse and were not assessed in this study. In addition, subgroup analyses are limited by their small and unbalanced sample sizes.