Track this trial free. DataLookout checks ClinicalTrials.gov daily and emails you which fields changed on NCT07174336 (status, enrollment, completion dates, endpoints, sites) when this record is updated. Free accounts track up to 5 trials.

Track this trial

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

StatusRecruiting
PhasePhase 3
Started2025-12-22
View on ClinicalTrials.gov ↗
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.

Amendment history 9 changes detected by DataLookout

2026-08-22
Trial sites expanded: 353 → 359 locations
2026-08-07
Trial sites expanded: 346 → 353 locations
2026-07-31
Enrollment reduced: 920 → 800 participants
2026-07-31
Trial sites expanded: 338 → 346 locations
2026-07-08
Trial sites expanded: 330 → 338 locations
2026-06-24
Trial sites expanded: 327 → 330 locations
2026-06-05
Trial sites expanded: 324 → 327 locations
2026-05-15
Trial sites expanded: 317 → 323 locations
2026-04-18
Trial sites expanded: 307 → 317 locations
Trial Details
NCT Number NCT07174336
Lead Sponsor Eli Lilly and Company
Collaborators: Pfizer
Conditions Breast Neoplasms, Neoplasm Metastasis
Enrollment 800 participants
Start Date 2025-12-22
Primary Completion 2029-05 (estimated)
Study Completion 2033-05 (estimated)
Updated on ClinicalTrials.gov 2026-09-08