TRI-SERVICE GENERAL HOSPITAL

EVER-132-002 study, compliant with Helsinki and ICH GCP guidelines, was approved by national authorities and ethics committees. It enrolled HR+HER2- metastatic or locally recurrent BC patients from China, Korea, and Taiwan, requiring prior chemotherapy and measurable disease. Patients were randomized 1:1 to receive SG or chemotherapy, with PFS as the primary endpoint. Secondary endpoints included OS, ORR, DoR, CBR, safety, and QoL. Assessments involved tumor measurements, safety evaluations, and QoL questionnaires. Statistical analysis included sample size calculation, HR estimation, and safety summaries. The study design details are available in the Nature Portfolio Reporting Summary.