TransPALLAS (NCT02513394)

Novel cancer therapies are increasingly studied internationally to evaluate their impact on treating cancer and adverse events. The drug approval process varies significantly across different countries and regions (e.g. European Union, Latin America). Patient-reported outcomes (PROs) have become integral to trial design, providing valuable insights into patients’ experiences and serving as crucial measures of treatment effects. Research indicates that patients' experiences and attitudes toward cancer treatments and symptom management may be influenced by cultural and societal factors related to their geographic location. However, rigorous studies evaluating how geographical differences affect PROs in cancer care are limited. With the growing number of trials being conducted internationally, understanding of these differences will be critical to guide trial design, and inform regulatory approval and clinical implementation of novel therapies. This study aims to analyze the impact of national and regional variations on PROs such as pain, fatigue, quality of life, and symptom burden among breast cancer survivors receiving endocrine treatments using a large international database.