Evolutionary Clinical Trial for Novel Biomarker-Driven Therapies

This Phase 2 adaptive clinical trial uses tumor biomarkers to guide treatment decisions for women with estrogen receptor-positive/HER2-negative or triple-negative metastatic breast cancer who have progressed after first-line therapy and have not yet started second-line treatment. The platform design tests multiple targeted therapies at once, with participants assigned to a standard-of-care therapy based on their specific biomarker profile; those who progress may be reassigned to other sub-trials within the platform. Adults aged 18 or older with confirmed ER+/HER2- or triple-negative metastatic breast cancer, an ECOG performance status of 0–2, and who have not yet started second-line therapy are eligible; HER2-positive patients are excluded. Participation involves biomarker testing, standard treatment, liquid biopsy collection every treatment cycle, and imaging at re-staging visits. This summary was prepared as patient-facing educational content using AI assistance.