Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
← catalyst calendarNCT06757634 · readout in 955 d
Sponsored by Celcuity Inc (industry) · CELC — their whole pipeline →.
Phase
Phase 3
Status
Recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
1,180estimated
Sites
203
Countries
Argentina, Australia, Belgium +19
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 | 2025-07-24 | actual | When the study began enrolling |
| Primary completion | 2029-03-31 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2033-07-30 | estimated | The whole study's end, after follow-up |
| First posted | 2025-01-03 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-05-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Breast Cancer
Interventions
- Drug: Arm A: Gedatolisib + Palbociclib + Fulvestrant — also filed as PF-05212384, IBRANCE, Faslodex
- Drug: Arm B: Ribociclib + Fulvestrant — also filed as KISQALI®, Faslodex
- Drug: Arm C: Gedatolisib + Palbociclib + Letrozole — also filed as PF-05212384, IBRANCE, FEMARA
- Drug: Arm D: Ribociclib + Letrozole — also filed as KISQALI®, FEMARA
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS)
measured From date of randomization to the date of death due to any cause, up to approximately 48 months
Permalink · CELC's whole pipeline · Catalyst calendar · Every registered study · What changed