Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
NCT06757634
This study is recruiting at 17 US sites in 12 states, according to its ClinicalTrials.gov record last updated .
Summary
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.
Shortened from the sponsor's brief summary. View official record on ClinicalTrials.gov
Conditions studied
- Breast Cancer
Eligibility basics and study details
- Study type
- Interventional
- Phase
- Phase 3
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Sponsor
- Celcuity Inc
- Last updated on ClinicalTrials.gov
- October 9, 2026
These are the basic criteria only. The full inclusion and exclusion criteria are on the official record, and the study team decides who can take part.
US recruiting sites
California · 2
- Providence Medical Foundation · Fullerton, CA
- UCLA Hematology Oncology Santa Monica · Los Angeles, CA
Florida · 2
- BRCR Medical Center, Inc- Internal Medicine · Plantation, FL
- BRCR Medical Center, INC · Tamarac, FL
Kansas · 1
- The University of Kansas Cancer Center · Westwood, KS
Kentucky · 1
- Mercy Health-Paducah Cancer Center · Paducah, KY
Michigan · 1
- Henry Ford Health System · Detroit, MI
Missouri · 2
- Saint Luke's Cancer Institute · Kansas City, MO
- Washington University School of Medicine in Saint Louis · St Louis, MO
Montana · 1
- SCL Health - Cancer Centers of Montana · Billings, MT
New York · 2
- Weill Cornell Medical College - NewYork-Presbyterian Hospital · New York, NY
- Clinical Research Alliance, Inc. · Westbury, NY
Ohio · 1
- Stefanie Spielman Comprehensive Breast Center at Olentangy River Road · Columbus, OH
Texas · 2
- University of Texas MD Anderson Cancer Center · Houston, TX
- Mays Cancer Center · San Antonio, TX
Virginia · 1
- Bon Secours St. Francis Medical Oncology Center · Midlothian, VA
Washington · 1
- Fred Hutchinson Cancer Center · Seattle, WA
Source: ClinicalTrials.gov, data processed . Recruiting US sites filtered by distance and site status; summaries shortened.