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)
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Phase
Phase 3
Status
Active, not recruiting
Study type
Interventional
Design
Randomized · None · Treatment
Enrollment
701estimated
Sites
235
Countries
Argentina, Australia, Austria +20
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 | 2022-12-08 | actual | When the study began enrolling |
| Primary completion | 2026-06-30 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2026-12-31 | estimated | The whole study's end, after follow-up |
| First posted | 2022-08-16 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-10 | 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: Gedatolisib — also filed as PF-05212384, PKI-587
- Drug: Palbociclib — also filed as IBRANCE, PD-0332991
- Drug: Fulvestrant — also filed as Faslodex
- Drug: Alpelisib — also filed as Piqray, Vijoice, BYL719
Primary outcome
what the primary-completion date above is the date OFProgression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
measured Approximately 48 months
Publications
- PMID 41802242 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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