Clinical Trial

A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)

Recruiting Phase 3
View on ClinicalTrials.gov →
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.
Protocol Amendment History 5 changes
notable Trial sites expanded: 330 -> 338 locations 2026-07-08
notable Trial sites expanded: 327 -> 330 locations 2026-06-24
notable Trial sites expanded: 324 -> 327 locations 2026-06-05
notable Trial sites expanded: 317 -> 323 locations 2026-05-15
notable Trial sites expanded: 307 -> 317 locations 2026-04-18
Trial Details
NCT Number NCT07174336
Lead Sponsor Eli Lilly and Company
Collaborators: Pfizer
Conditions Breast Neoplasms, Neoplasm Metastasis
Enrollment 920 participants
Start Date 2025-12-22
Primary Completion 2029-05 (estimated)
Study Completion 2033-05 (estimated)
Updated on ClinicalTrials.gov 2026-07-07