Balancing Efficacy and Safety in HER2+ Breast Cancer Trials

In both early and metastatic HER2-positive breast cancer, evaluating clinical trial data requires careful consideration of efficacy alongside safety. In early breast cancer, high response rates and improvements in disease-free survival must be weighed against potential toxicities and long-term impacts, particularly when considering changes to established neoadjuvant or adjuvant regimens. For metastatic disease, overall survival, progression-free survival, and durability of response are key efficacy measures, while safety, tolerability, and quality of life remain critical. To alter current practice patterns, clinicians look for robust, reproducible data demonstrating meaningful improvements over the existing standard of care without introducing prohibitive toxicity. Trials that combine strong efficacy signals with manageable safety profiles, ideally across diverse patient populations, provide the confidence needed to adopt new therapeutic strategies and optimize outcomes across the continuum of HER2-positive