drugset / Trial / NCT07405801
A Phase II Study Evaluating the Efficacy and Safety of Inavolisib Plus Ribociclib Plus Fulvestrant Versus Placebo Plus Ribociclib Plus Fulvestrant in Participants With Advanced Breast Cancer
RandomizedParallel-groupQuadruple-blindTreatment
Summary
A study to evaluate the efficacy and safety of triplet combination of inavolisib plus ribociclib and fulvestrant versus placebo plus ribociclib and fulvestrant in the first-line setting in participants with endocrine-therapy-resistant hormone receptor (HR)-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (ABC).
Timeline
- Start
- 2026-04-07
- Primary completion
- 2028-12-19
- Completion
- 2030-02-26
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Inavolisib | Small molecule | — | — |
| Background | Fulvestrant | Small molecule | — | — |
| Background | Ribociclib | Small molecule | — | — |