drugset / 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)
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2025-12-22
- Primary completion
- 2029-05
- Completion
- 2033-05
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | STX-478 | Small molecule | — | Oral |
| Background | Abemaciclib | Small molecule | — | Oral |
| Background | Anastrozole | Other / unclassified | — | Oral |
| Background | Exemestane | Small molecule | — | Oral |
| Background | Fulvestrant | Small molecule | — | Intramuscular |
| Background | Letrozole | Other / unclassified | — | Oral |
| Background | Palbociclib | Small molecule | — | Oral |
| Background | Ribociclib | Small molecule | — | Oral |