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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
CHU La Timone
Marseille, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Centre Hospitalier Universitaire de Poitiers - Médico-Chirurgical De Cardiol
Poitiers, France
Institut Gustave Roussy
Villejuif, France
Klinik für Frauenheilkunde und Geburtshilfe
Düsseldorf, Germany
Universitätsmedizin Johannes Gutenberg
Mainz, Germany
CaritasKlinikum Saarbrücken St. Theresia
Saarbrücken, Germany
Helios Klinikum Wuppertal
Wuppertal, Germany
Evgenidion Clinic Agia Trias S.A.
Attiki, Athens, Greece
University General Hospital of Heraklion
Heraklion, Greece
Iaso Thessalia General Clinic Private Obstetrics S.A.
Larissa, Greece
General University Hospital Of Larissa
Larissa, Greece
Metropolitan Hospital
Piraeus, Greece
Athens Medical Center S.A.
Thessaloniki, Greece
Theageneio Cancer Hospital
Thessaloniki, Greece
Debreceni Egyetem Klinikai Központ Nagyerdei Campus - Onkológiai Klinika
Debrecen, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, Hungary
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház - Oncology
Gyula, Hungary
Bacs-Kiskun Varmegyei Oktatakorhaz
Kecskemét, Hungary
University of Pecs- Oncology Dept.
Pécs, Hungary
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, Hungary
Presidio Ospedaliero S. Croce - Oncologia
Fano, Italy
IRCCS Ospedale Policlinico San Martino - Clinica di Oncologia Medica
Genova, Italy
IRST IRCCS - Oncologia Medica
Meldola, Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, Italy
AOU di Modena, Policlinico di Modena - Attività Integrata di Oncologia ed Ematologia
Modena, Italy
Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
Naples, Italy
Ospedale Maggiore, AOU Parma
Parma, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Pavia, Italy
Nuovo Ospedale di Prato S. Stefano - Oncologia Medica
Prato, Italy
Ospedale "Santa Maria delle Croci" di Ravenna - Oncologia
Ravenna, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, Italy
Umberto I Policlinico di Roma, Università La Sapienza
Roma, Italy
Istituto Clinico Humanitas
Rozzano, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, Italy
Ospedale Santa Maria della Misericordia di Udine - Oncologia
Udine, Italy
Borgo Trento, Ospedale Civile Maggiore, AOU Integrata Verona
Verona, Italy
Penang Adventist Hospital
George Town, Malaysia
Hospital Universiti Sains Malaysia
Kota Bharu, Malaysia
Hospital Kuala Lumpur - Surgery
Kuala Lumpur, Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Malaysia
Hospital Umum Sarawak
Kuching, Malaysia
Beacon Hospital
Petaling Jaya, Malaysia
National Cancer Institute - Radiotherapy and Oncology
Putrajaya, Malaysia
San Peregrino Unidad de Investigacion
Aguascalientes, Mexico
Office of Emanuel de la Mora Jimenez, MD/equiv
Guadalajara, Mexico
Clinical Research Center Chapultepec Mexico City
Mexico City, Mexico
Centro de Atencion Oncologica Viva
Mexico City, Mexico
Avix Clinical Research
Monterrey, Mexico
Filios High Medicine
Monterrey, Mexico
Administrative Society of Health Services, SC
Morelia, Mexico
Mazowiecki Szpital Wojewodzki im. sw. Jana Pawla II w Siedlcach Sp. z o.o. - Oddział Onkologii Klinicznej i Radioterapii
Siedlce, Masovian Voivodeship, Poland
Centrum Onkologii im. prof. F. Lukaszczyka - Ambulatorium Chemioterapii
Bydgoszcz, Poland
Przychodnia Lekarska KOMED
Konin, Poland
Pratia MCM Kraków
Krakow, Poland
Instytut Medyczny Santa Familia
Lodz, Poland
SP ZOZ Opolskie Centrum Onkologii - Oddzial Onkologii Klinicznej z Odcinkiem Dziennym
Opole, Poland
Zachodniopomorskie Centrum Onkologii - Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
Szczecin, Poland
LUX MED Onkologia Sp. z o.o., Szpital Szamocka - Oddzial Onkologii Klinicznej/Chemioterapii
Warsaw, Poland
Narodowy Instytut Onkologii im. Marii SkÅ'odowskiej-Curie â€" PaÅ"stwowy Instytut Badawczy - Klinika Nowotworow Piersi i Chirurg
Warsaw, Poland
Centro Hospitalar e Universitário de Coimbra
Coimbra, Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
Lisbon, Portugal
Hospital da Luz de Lisboa - Learning Health
Lisbon, Portugal
H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia
Lisbon, Portugal
Hospital CUF Descobertas
Lisbon, Portugal
Centro Hospitalar Universitario do Porto - H. Santo Antonio
Porto, Portugal
Centrul de Oncologie Sf Nectarie - Medical Oncology
Baia Mare, Romania
Oncopremium Team - Medical Oncology
Baia Mare, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Bucharest, Romania
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
Cluj-Napoca, Romania
Onco Clinic Consult
Craiova, Romania
Radiotherapy Center Cluj
Floreşti, Romania
Victoria Hospital - Oncology
Iași, Romania
Institutul Regional de Oncologie Iasi - Medical Oncology
Iași, Romania
National Cancer Center - Breast Cancer
Goyang, South Korea
Gachon University Gil Medical Center - Oncology
Incheon, South Korea
CHA Bundang Medical Center - Oncology
Seongnam-si, South Korea
Korea University Anam Hospital - Gastroenterological Surgery
Seoul, South Korea
Seoul National University Hospital
Seoul, South Korea
Yonsei University Health System, Severance hospital
Seoul, South Korea
Asan Medical Center - Oncology
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Samsung Medical Center - Hematology & Oncology
Seoul, South Korea
Korea University Guro Hospital
Seoul, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital - Hematology and Oncology
Seoul, South Korea
Ajou University Hospital - Hematology/Oncology
Suwon, South Korea
Ulsan University Hospital
Ulsan, South Korea
Complexo Hospitalario Universitario A Coruña
A Coruña, Spain
Hospital Universitario de Badajoz
Badajoz, Spain
Hospital Del Mar
Barcelona, Spain
Hospital Clinic De Barcelona
Barcelona, Spain
Caceres Hospital Complex - San Pedro de Alcantara General Hospital
Cáceres, Spain
Hospital Clínico Universitario Virgen De La Arrixaca
El Palmar, Spain
Institut Catala D'oncologia
L'Hospitalet de Llobregat, Spain
H.U Arnau De Vilanova Lleida
Lleida, Spain
Hospital Beata Maria Ana de Jesus
Madrid, Spain
Hospital Universitario Ramon y Cajal - Oncología Médica
Madrid, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, Spain
Complejo Hospitalario Universitario De Santiago
Santiago de Compostela, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, Spain
Changhua Christian Medical Foundation - Changhua Christian Hospital - Neurology
Changhua, Taiwan
National Taiwan University Hospital - Yunlin Branch - Oncology
Douliu, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital - Breast Surgery
Kaohsiung City, Taiwan
China Medical University Hospital - Breast Surgery
Taichung, Taiwan
Taichung Veterans General Hospital - General Surgery
Taichung, Taiwan
National Cheng Kung University Hospital - Gynecology/Obstetrics
Tainan, Taiwan
Chi Mei Medical Center - YongKang - Oncology and Hematology
Tainan, Taiwan
Chi Mei Medical Center - Liouying - Oncology
Tainan, Taiwan
National Taiwan University Hospital - Oncology
Taipei, Taiwan
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare - Nephrology
Taipei, Taiwan
Taipei Veterans General Hospital - Hematology
Taipei, Taiwan
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology
Taipei, Taiwan
King Chulalongkorn Memorial Hospital [Medical Oncology]
Bangkok, Thailand
Rajavithi Hospital
Bangkok, Thailand
Siriraj Hospital - Medical Oncology
Bangkok, Thailand
Prince of Songkla University - Internal Medicine
Hat Yai, Thailand
Banphaeo General Hospital
Samut Sakhon, Thailand
Adana Baskent Practice and Research Hospital - Oncology
Adana, Turkey (Türkiye)
Gulhane Training and Research Hospital - Medical Oncology
Ankara, Turkey (Türkiye)
Hacettepe University Medical Faculty - Hematology
Ankara, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology
Ankara, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, Turkey (Türkiye)
Ankara University Medical Faculty - Oncology
Ankara, Turkey (Türkiye)
Dicle University Medical Faculty Hospital Medical Oncology
Diyarbakır, Turkey (Türkiye)
Trakya University Medical Faculty - Oncology
Edirne, Turkey (Türkiye)
Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya
Istanbul, Turkey (Türkiye)
Medipol Mega Hospital - Medical Oncology
Istanbul, Turkey (Türkiye)
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
Istanbul, Turkey (Türkiye)
Kocaeli Uni Egt ve Uyg Hast
İzmit, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty - Oncology
Konya, Turkey (Türkiye)
VM Medical Park Mersin Hastanesi
Mezitli, Turkey (Türkiye)
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, Cambridgeshire, United Kingdom
NHS Lothian - Western General Hospital
Bathgate, Edinburgh, United Kingdom
East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre
Rickmansworth, Hertfordshire, United Kingdom
Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre
Maidstone, Kent, United Kingdom
Somerset NHS Foundation Trust - Musgrove Park Hospital
Taunton, Somerset, United Kingdom
Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital- Queen's Centre for Oncology & Haematology
Cottingham, United Kingdom
NHS Greater Glasgow and Clyde - The Beatson West of Scotland Cancer Centre
Glasgow, United Kingdom
Leeds Teaching Hospitals NHS Trust - St James' University Hospital
Leeds, United Kingdom