clinical trial · NCT07174336
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
Eli Lilly and Company·phase3·recruiting·n = 920
Breast NeoplasmsNeoplasm MetastasisLY4064809PlaceboRibociclibPalbociclibAbemaciclibAnastrozoleLetrozoleExemestane
brief summary
The purpose of the study is to assess the efficacy and safety of the addition of Tersolisib (LY4064809/STX-478) to other anti-cancer drugs as first treatment for advanced hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative (HER2-) breast cancer. Participants can remain in the study as long as the drug is helping the cancer without unbearable side effects.
started
Dec 22, 2025
primary completion
May 1, 2029
completion
May 1, 2033
last updated
Apr 29, 2026
official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study of 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)
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol