Neoplasm Metastasis, Breast Neoplasms research hub

J6M-MC-JSGD: A Phase 2, Randomized, Open-Label Dose Optimization and Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of Tersolisib (LY4064809) Combined with a CDK4/6 Inhibitor and Endocrine Therapy in Adults with HR+, HER2- Advanced Breast Cancer with a PIK3CA Mutation Who Received No Prior Treatment for Advanced Breast Cancer (PIKALO-2)

This study is for adults with advanced breast cancer that is HR+, HER2-, and has a specific gene change (PIK3CA mutation), who haven't had previous treatment for advanced disease. It tests a new drug called tersolisib alongside standard hormone therapy and other targeted drugs to see if it can help stop the cancer from growing.