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)

Summary

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Timeline

Start

2022-12-08

Primary completion

2026-06-30

Completion

2026-12-31

Outcome

Met primary endpoint

paper hazard ratio [HR] for progression or death, 0.24 [95% CI, 0.17 to 0.35]; P < .001 PMID 41802242 ↗

paper 7.4 months in the gedatolisib-doublet group (HR, 0.33 [95% CI, 0.24 to 0.48]; P < .001 v fulvestrant). PMID 41802242 ↗

release “VIKTORIA-1 is the first Phase 3 study to show a significant improvement in median progression-free survival” celcuity.com ↗

release “Phase 3 VIKTORIA-1 trial achieved primary endpoint with clinically meaningful improvement in progression-free survival in PIK3CA mutant cohort” celcuity.com ↗

release “The primary efficacy analysis of gedatolisib combined with fulvestrant and palbociclib (the “gedatolisib triplet”) demonstrated a statistically significant and clinically meaningful improvement in progression-free survival” celcuity.com ↗

release “The Phase 3 PIK3CA mutant cohort of the VIKTORIA-1 trial achieved its primary endpoint” celcuity.com ↗

release “VIKTORIA-1 trial, median progression-free survival (“PFS”) with the gedatolisib triplet was 9.3 months versus 2.0 months with fulvestrant.” celcuity.com ↗

release “PIK3CA mutant cohort of the VIKTORIA-1 trial achieved its primary endpoint by doubling the likelihood of survival without disease progression or death” celcuity.com ↗

Publications

• Hurvitz SA, Layman RM, Curigliano G, Andre F, Cristofanilli M, Kim SB, Martinez Rodriguez JL, Nadal JC, Kim GM, Lo L, Remolina-Bonilla YA, Rosselli G, Emile G, Korbenfeld E, Puig JM, Wesolowski R, Martin M, Ring A, Han HS, Giordano A, Mutka SC, Moss K, Suzuki S, Sullivan B, Gorbatchevsky I, Pistilli B; VIKTORIA-1 Study Group. VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer. J Clin Oncol. 2026 Apr 20;44(12):1108-1119. doi: 10.1200/JCO-25-02643. Epub 2026 Mar 9.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Alpelisib	Small molecule	300 mg	Oral
Subject	Fulvestrant	Small molecule	500 mg	Intramuscular
Subject	Gedatolisib	Small molecule	180 mg	Intravenous
Subject	Palbociclib	Small molecule	125 mg	Oral

Indications