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Study identifier: NCT06757634 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

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

Condition: Breast Cancer  ·  Sponsor: Celcuity Inc

PhasePhase 3
Planned participants1180
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

This description comes directly from the study's public registry record.

Talk to the study team

Nadene Zack, MS  ·  844-310-3900  ·  viktoria-2_trial@celcuity.com

Always discuss trial participation with your own doctor first.

Locations (203)

City of Hope Medical CenterDuarte, California, United StatesNot Yet Recruiting
Providence Medical FoundationFullerton, California, United StatesRecruiting
UCLA Hematology Oncology Santa MonicaLos Angeles, California, United StatesRecruiting
BRCR Medical Center, Inc- Internal MedicinePlantation, Florida, United StatesRecruiting
BRCR Medical Center, INCTamarac, Florida, United StatesRecruiting
The University of Kansas Cancer CenterWestwood, Kansas, United StatesRecruiting
Mercy Health-Paducah Cancer CenterPaducah, Kentucky, United StatesRecruiting
American Oncology Partners, P.A.Bethesda, Maryland, United StatesRecruiting
Massachusetts General Hospital Cancer CenterBoston, Massachusetts, United StatesNot Yet Recruiting
Henry Ford Health SystemDetroit, Michigan, United StatesRecruiting
Saint Luke's Cancer InstituteKansas City, Missouri, United StatesRecruiting
Washington University School of Medicine in Saint LouisSt Louis, Missouri, United StatesRecruiting

+ 191 more locations — full list on the registry record.

Follow this study

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Source record: clinicaltrials.gov/study/NCT06757634