A Study of Tersolisib (LY4064809/STX-478) With Other Anti-Cancer Treatments in Participants With Advanced Breast Cancer With a Genetic Change (PIK3CA)
← catalyst calendarNCT07174336 · readout ≤ 1,016 d
Sponsored by Eli Lilly and Company (industry) · LLY — their whole pipeline →. With Pfizer.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · Double · Treatment
Enrollment
800estimated
Sites
353
Countries
Argentina, Australia, Belgium +15
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-12-22 | actual | When the study began enrolling |
| Primary completion | May 2029 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | May 2033 | estimated | The whole study's end, after follow-up |
| First posted | 2025-09-15 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-08-06 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Breast Neoplasms
- Neoplasm Metastasis
Interventions
- Drug: LY4064809 — also filed as STX-478, Tersolisib
- Drug: Placebo
- Drug: Ribociclib
- Drug: Palbociclib
- Drug: Abemaciclib — also filed as LY2835219
- Drug: Anastrozole
- Drug: Letrozole
- Drug: Exemestane
- Drug: Fulvestrant
Primary outcomes
what the primary-completion date above is the date OF(Part 1): Overall Response Rate (ORR): Percentage of Participants with Confirmed Complete Response (CR) or Partial Response (PR)
measured Baseline through disease progression or death (Estimated up to 5 years)
(Part 2): Progression-Free Survival
measured Baseline to objective progression or death due to any cause (Estimated up to 5 years)
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