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

Source: https://onco.cc/trials/nct06757634/  
OnCo record `nct06757634` (Trial). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

A phase 3 trial of Fulvestrant, Gedatolisib, Palbociclib and Ribociclib in HR-positive / HER2-negative breast cancer, run by Celcuity Inc, now recruiting.

## Summary

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2) is a phase 3 interventional study registered as NCT06757634 by Celcuity Inc, with 1180 participants planned, started 2025-07-24 and due to reach its primary completion in 2029-03-31. Interventions recorded: Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole and Arm D: Ribociclib + Letrozole.

## Fields

- Kind: Trial
- Status: recruiting
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT06757634
- Phase: 3
- Setting: VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer
- Sponsor: Celcuity Inc
- Enrolled: 1180

## Sources

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

## Connected records

- cancers: [HR-positive / HER2-negative breast cancer](https://onco.cc/cancers/breast-hr-positive/)
- drugs: [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Gedatolisib](https://onco.cc/drugs/gedatolisib/), [Palbociclib](https://onco.cc/drugs/palbociclib/), [Ribociclib](https://onco.cc/drugs/ribociclib/)
- companies: [Celcuity](https://onco.cc/companies/celcuity/)

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