# Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

> **NCT06757634** · PHASE3 · RECRUITING · sponsor: **Celcuity Inc** · enrollment: 1180 (estimated)

## Conditions studied

- Breast Cancer

## Interventions

- **DRUG:** Arm A: Gedatolisib + Palbociclib + Fulvestrant
- **DRUG:** Arm B: Ribociclib + Fulvestrant
- **DRUG:** Arm C: Gedatolisib + Palbociclib + Letrozole
- **DRUG:** Arm D: Ribociclib + Letrozole

## Key facts

- **NCT ID:** NCT06757634
- **Lead sponsor:** Celcuity Inc
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** RECRUITING
- **Start date:** 2025-07-24
- **Primary completion:** 2029-03-31
- **Final completion:** 2033-07-30
- **Target enrollment:** 1180 (ESTIMATED)
- **Last updated:** 2026-05-18


## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT06757634

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT06757634, "Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)". Retrieved via AI Analytics 2026-07-20 from https://api.ai-analytics.org/clinical/NCT06757634. Licensed CC0.

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