Defining Success in Metastatic Breast Cancer Trial Design

A successful clinical trial in metastatic breast cancer is built on thoughtful design, meaningful endpoints, and a patient-centered approach. Strong studies clearly define the target population, use appropriate comparators, and ensure broad representation to reflect real-world practice. Key design features include biomarker-driven enrollment, rational combination strategies, and attention to safety and quality-of-life measures. While progression-free and overall survival remain essential endpoints, patient-reported outcomes and durability of response are increasingly recognized as equally important. Looking ahead, future antibody-drug conjugate (ADC) trials in HER2-positive disease should explore earlier-line use, novel payloads, resistance-overcoming strategies, and combinations with targeted or immune-modulating agents. These efforts will help refine sequencing, personalize therapy, and further extend meaningful outcomes for patients.