drugset / Trial / NCT06757634
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
RandomizedParallel-groupOpen-labelTreatment
Summary
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
Timeline
- Start
- 2025-07-24
- Primary completion
- 2029-03-31
- Completion
- 2033-07-30
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Fulvestrant | Small molecule | — | Intramuscular |
| Subject | Gedatolisib | Small molecule | — | Intravenous |
| Subject | Letrozole | Other / unclassified | — | Oral |
| Subject | Palbociclib | Small molecule | — | Oral |
| Comparator | Ribociclib | Small molecule | — | Oral |