# 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)

Source: https://onco.cc/trials/nct05501886/  
OnCo record `nct05501886` (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 Gedatolisib, Palbociclib, Fulvestrant and Alpelisib in advanced solid tumours, run by Celcuity Inc, active and no longer recruiting.

## Summary

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) is a phase 3 interventional study registered as NCT05501886 by Celcuity Inc, with 701 participants enrolled, started 2022-12-08 and due to reach its primary completion in 2026-06-30. Interventions recorded: Gedatolisib, Palbociclib, Fulvestrant and Alpelisib.

## Fields

- Kind: Trial
- Status: active
- Last checked: 2026-09-16
- Tags: pipeline; ctgov-ingest
- Registry id: NCT05501886
- Phase: 3
- Setting: Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy
- Sponsor: Celcuity Inc
- Enrolled: 701

## Sources

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

## Connected records

- cancers: [Metastatic cancer (cancer that has spread)](https://onco.cc/cancers/metastatic-cancer/)
- drugs: [Alpelisib](https://onco.cc/drugs/alpelisib/), [Fulvestrant](https://onco.cc/drugs/fulvestrant/), [Gedatolisib](https://onco.cc/drugs/gedatolisib/), [Palbociclib](https://onco.cc/drugs/palbociclib/)
- companies: [Celcuity](https://onco.cc/companies/celcuity/)

---
JSON: https://onco.cc/api/v1/entities/nct05501886.json