# 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)

> **NCT05501886** · PHASE3 · ACTIVE_NOT_RECRUITING · sponsor: **Celcuity Inc** · enrollment: 701 (estimated)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** Gedatolisib
- **DRUG:** Palbociclib
- **DRUG:** Fulvestrant
- **DRUG:** Alpelisib

## Key facts

- **NCT ID:** NCT05501886
- **Lead sponsor:** Celcuity Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** ACTIVE_NOT_RECRUITING
- **Start date:** 2022-12-08
- **Primary completion:** 2026-06-30
- **Final completion:** 2026-12-31
- **Target enrollment:** 701 (ESTIMATED)
- **Last updated:** 2026-02-10


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT05501886

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT05501886, "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)". Retrieved via AI Analytics 2026-07-17 from https://api.ai-analytics.org/clinical/NCT05501886. Licensed CC0.

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