A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
A phase 3 trial testing Tersolisib in HR-positive / HER2-negative breast cancer, now recruiting.
Overview
A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA) is a phase 3 interventional study registered as NCT07174336, led by Eli Lilly and with Pfizer, and recruiting when checked on 2026-09-11. Official title: A Phase 2, Randomised, Open-Label Dose Optimization and Phase 3, Randomised, 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). Planned enrolment is 800 participants (estimated). The study started in 2025-12-22 and primary completion is expected in 2029-05. No results have been posted on ClinicalTrials.gov.
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