VIKTORIA-1
14 Sep 2023
Trial Summary
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.
Acronym:
VIKTORIA-1
ACTRN/NCT /ethics:
NCT05501886
Scientific title:
Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)
Sponsor / Cooperative group:
Celcuity, Inc.
Trial & Patient Characteristics
| Cancer Type | Breast Cancer |
|---|---|
| Trial Type | Treatment |
| Phase | Phase III |
| Age Range | 18 years and older |
| Sex | All |
| Tumour Stream | - |
| Cancer Stage | - |
| Anticipated Start Date | 2022-09-30 |
| Anticipated End Date | 2026-09-30 |
Participating Hospitals
| Hospital | The Queen Elizabeth Hospital |
|---|---|
| Clinical Trial Coordinator | Pamela Cooper |
| Pamela.cooper@sa.gov.au | |
| Phone | 08 8222 6140 |
| Principal Investigator | Amanda Townsend |
| Recruitment Status | Recruiting |