VIKTORIA-2: Gedatolisib for HR+/HER2- Advanced Breast Cancer

This study is testing new ways to treat advanced breast cancer that is hormone receptor-positive (HR+) and HER2-negative. It compares different combinations of medicines: gedatolisib, palbociclib, fulvestrant, ribociclib, and letrozole. The goal is to see which combinations are most effective and safe as a first treatment. You may be eligible if you are an adult male or female with this type of breast cancer, whether it's metastatic (spread) or locally advanced. The main way we'll know if the treatment is successful is by measuring how long people live without their cancer getting worse (Progression Free Survival). The study is currently recruiting a total of 1180 participants.

Study design
This is a Phase 3, open-label, randomized study. Participants will be assigned to one of four treatment groups to compare different drug combinations.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed from the date of randomization until death or for approximately 48 months to measure how long they live without their cancer getting worse.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06757634

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Celcuity Inc
~1,180 participants
Updated 2026-05-18 on ClinicalTrials.gov
What's tested:Arm A: Gedatolisib + Palbociclib + FulvestrantArm B: Ribociclib + FulvestrantArm C: Gedatolisib + Palbociclib + LetrozoleArm D: Ribociclib + Letrozole

At a glance

Recruiting sites
64 of 203 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Progression Free Survival (PFS)
Measured over From date of randomization to the date of death due to any cause, up to approximately 48 months
Breast Cancer
203 sites across 37 states
Italy15
Turkey (Türkiye)14
Argentina13
South Korea13
Spain13
Brazil11
Taiwan11
France9

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  • Progression Free Survival (PFS)From date of randomization to the date of death due to any cause, up to approximately 48 months

    PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)