Clinical Research Directory
Browse clinical research sites, groups, and studies.
Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
Sponsor: Celcuity Inc
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.
Official title: VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
1180
Start Date
2025-07-24
Completion Date
2033-07-30
Last Updated
2026-10-09
Healthy Volunteers
No
Conditions
Interventions
Arm A: Gedatolisib + Palbociclib + Fulvestrant
Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Other Names: • PF-05212384 Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Other Names: • IBRANCE Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks Other Names: • Faslodex
Arm B: Ribociclib + Fulvestrant
Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant approximately every 2 weeks during Cycle 1 then approximately every 4 weeks Other Names: • Faslodex
Arm C: Gedatolisib + Palbociclib + Letrozole
Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Drug: Letrozole Participants will receive oral letrozole daily.
Arm D: Ribociclib + Letrozole
Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Drug: Letrozole Participants will receive oral letrozole daily.
Locations (239)
St Bernards Medical Center
Jonesboro, Arkansas, United States
CARTI Cancer Center
Little Rock, Arkansas, United States
City of Hope Medical Center
Duarte, California, United States
Providence Medical Foundation
Fullerton, California, United States
UCLA Hematology Oncology Santa Monica
Los Angeles, California, United States
Cancer Care Associates
Redondo Beach, California, United States
UC San Diego Moores Cancer Center
San Diego, California, United States
University of Colorado Hospital - Cancer Center
Aurora, Colorado, United States
BRCR Medical Center, Inc- Internal Medicine
Plantation, Florida, United States
BRCR Medical Center, INC
Tamarac, Florida, United States
The University of Kansas Cancer Center
Westwood, Kansas, United States
Mercy Health-Paducah Cancer Center
Paducah, Kentucky, United States
American Oncology Partners, P.A.
Bethesda, Maryland, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, United States
Henry Ford Health System
Detroit, Michigan, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, United States
Washington University School of Medicine in Saint Louis
St Louis, Missouri, United States
SCL Health - Cancer Centers of Montana
Billings, Montana, United States
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, United States
Clinical Research Alliance, Inc.
Westbury, New York, United States
Stefanie Spielman Comprehensive Breast Center at Olentangy River Road
Columbus, Ohio, United States
OHSU Research Integrity
Portland, Oregon, United States
Rittenhouse Hematology/Oncology
Philadelphia, Pennsylvania, United States
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, United States
The Center for Cancer and Blood Disorders - Breast Center
Fort Worth, Texas, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, United States
Mays Cancer Center
San Antonio, Texas, United States
Bon Secours St. Francis Medical Oncology Center
Midlothian, Virginia, United States
Fred Hutchinson Cancer Center
Seattle, Washington, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA
Buenos Aires, Argentina
Pergamino Clinic
Buenos Aires, Argentina
Centro de Investigaciones Médicas y Desarrollo LC
Buenos Aires, Argentina
Fleischer Medical Center (Centro Medico Fleischer)
Buenos Aires, Argentina
Fundacion Respirar
Buenos Aires, Argentina
Centro Oncológico Korben
Buenos Aires, Argentina
Alexander Fleming Institute
Buenos Aires, Argentina
Center for Medical Education and Clinical Research (CEMIC)
Buenos Aires, Argentina
Cordoba Oncology Institute (IONC)
Córdoba, Argentina
Fundación CORI
La Rioja, Argentina
Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
Paraná, Argentina
Rosario's Oncology Institute and Medical Specialities (IOR)
Rosario, Argentina
Centro Oncologico de Excelencia
San Juan, Argentina
Sunshine Coast University Private Hospital-Coastal Cancer Care
Birtinya, Queensland, Australia
Austin Health
Heidelberg, Victoria, Australia
GenesisCare - St Andrews
Adelaide, Australia
Breast Cancer Research Centre
Nedlands, Australia
Icon Cancer Centre Southport
Southport, Australia
Sydney Adventist Hospital
Wahroonga, Australia
Westmead Hospital
Westmead, Australia
The Queen Elizabeth Hospital
Woodville, Australia
Cliniques Universitaires Saint-Luc
Brussels, Belgium
Grand Hopital De Charleroi
Charleroi, Belgium
Universitair Ziekenhuis Gent - Medische Oncologie
Ghent, Belgium
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
Hasselt, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium
Complex Oncology Center - Burgas
Burgas, Bulgaria
Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, Bulgaria
Complex Oncological Centre Ruse
Rousse, Bulgaria
MHAT Nadezhda - Medical Oncology Clinic
Sofia, Bulgaria
MHAT "Serdika" EOOD, Base 2 - Second Department of Medical Oncology
Sofia, Bulgaria
USHAT of Oncology
Sofia, Bulgaria
Cancer Hospital Chinese Academy of Medical Sciences - Head and Neck Surgery Department
Beijing, Beijing Municipality, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, China
Fujian Medical University Affiliated Second Hospital
Quanzhou, Fujian, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Xiangya Hospital Central South University-Breast surgery
Changsha, Hunan, China
Hunan Cancer Hospital -Oncology
Changsha, Hunan, China
The Central Hospital of Shaoyang-Breast surgery
Shaoyang, Hunan, China
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, China
Yangzhou University - Clinical Medical School - Northern Jiangsu People's Hospital (NJPH) (Subei People's Hospital)
Yangzhou, Jiangsu, China
Nanchang People's Hospital
Nanchang, Jiangxi, China
Shengjing Hospital of China Medical University ( Nanhu Campus )
Shenyang, Liaoning, China
Xi'an International Medical Center Hospital - Oncology
Xi'an, Shaanxi, China
Shandong Provincial Hospital - Oncology
Jinan, Shandong, China
Weifang People's Hospital
Weifang, Shandong, China
Tianjin Medical University Cancer Institute & Hospital - Breast Tumor Department
Tianjin, Tianjin Municipality, China
The Second Affiliated Hospital Zhejiang University School of Medicine - Medical Oncology
Hangzhou, Zhejiang, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China
Masarykuv onkologicky ustav - Oddeleni klinickych hodnoceni
Brno, Czechia
Multiscan s.r.o. - Ambulance klinicke onkologie se stacionarem
Hořovice, Czechia
FN Hradec Kralove - Klinika onkologie a radioterap
Hradec Králové, Czechia
Fakultni nemocnice Olomouc - Onkologicka klinika
Olomouc, Czechia
FN Kralovske Vinohrady - Radioterapeuticka a onkologicka klinika
Prague, Czechia
Fakultni Thomayerova Nemocnice - Onkologicka klinika
Prague, Czechia
Fakultni Nemocnice v Motole
Prague, Czechia
Rigshospitalet
Copenhagen, Capital Region of Denmark, Denmark
Region Hovedstaden
Hillerød, Capital Region of Denmark, Denmark
Aalborg Universitetshospital - Oncology
Aalborg, North Denmark, Denmark
Odense Universitetshospital - Oncology
Odense, Region of South Denmark, Denmark
Vaasa Central Hospital
Vaasa, Lapland, Finland
Turku University Hospital - Oncology And Radiotherapy
Turku, Länsi-Suomen Lääni, Finland
Comprehensive Cancer Center, Helsinki University Hospital
Helsinki, Uusimaa, Finland
Tampere University Hospital Department of Oncology
Tampere, Uusimaa, Finland
Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Oncologie Medicale - Cancerolo
Amiens, France
Centre Georges François Baclesse
Caen, France
Centre Georges Francois Leclerc - service d'oncologie médicale
Dijon, France
Clinique Victor Hugo / Centre Jean Bernard
Le Mans, France