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ACTIVE NOT RECRUITING
NCT05501886
PHASE3

Gedatolisib Plus Fulvestrant With or Without Palbociclib vs Standard-of-Care for the Treatment of Patients With Advanced or Metastatic HR+/HER2- Breast Cancer (VIKTORIA-1)

Sponsor: Celcuity Inc

View on ClinicalTrials.gov

Summary

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant with or without palbociclib for the treatment of patients with locally advanced or metastatic HR+/HER2- breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy.

Official title: Phase 3, Open-Label, Randomized, Study Comparing Gedatolisib Combined With Fulvestrant & With or Without Palbociclib to Standard-of-Care Therapies in Patients With HR-Positive, HER2-Negative Advanced Breast Cancer Previously Treated With a CDK4/6 Inhibitor in Combination w/Non-Steroidal Aromatase Inhibitor Therapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

701

Start Date

2022-12-08

Completion Date

2026-12-31

Last Updated

2026-02-10

Healthy Volunteers

No

Conditions

Interventions

DRUG

Gedatolisib

Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off

DRUG

Palbociclib

Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off

DRUG

Fulvestrant

Fulvestrant 500 mg IM (2 × 5 mL injections) given every 2 weeks during Cycle 1 (Days 1 and 15), then every 4 weeks beginning with Cycle 2 Day 1

DRUG

Alpelisib

Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days)

Locations (235)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Arizona Oncology (US Oncology/McKesson) - Goodyear

Goodyear, Arizona, United States

St. Bernards Medical Center

Jonesboro, Arkansas, United States

CARTI Cancer Center

Little Rock, Arkansas, United States

Pacific Cancer Medical Center Inc

Anaheim, California, United States

Kaiser Permanente South Bay Medical Center

Harbor City, California, United States

Cancer and Blood Specialty Clinic

Los Alamitos, California, United States

Pacific Cancer Care

Monterey, California, United States

University of California, Irvine Medical Center

Orange, California, United States

Ventura County Hematology Oncology Specialists

Oxnard, California, United States

Redlands Hematology Oncology

Redlands, California, United States

UCLA Hematology/Oncology-Santa Monica

Santa Monica, California, United States

Torrance Memorial Physician Network - Cancer Care

Torrance, California, United States

Kaiser Permanente Medical Center - Vallejo

Vallejo, California, United States

PIH Health Hospital Whittier

Whittier, California, United States

Yale Cancer Center - New Haven

New Haven, Connecticut, United States

South Broward Hospital District d/b/a Memorial Healthcare System

Hollywood, Florida, United States

Cancer Specialists of North Florida - Jacksonville

Jacksonville, Florida, United States

H. Lee Moffitt Cancer Center & Research Institute

Tampa, Florida, United States

Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.

Winter Haven, Florida, United States

John D. Archbold Memorial Hospital

Thomasville, Georgia, United States

Illinois Cancer Specialists - Arlington Heights

Arlington Heights, Illinois, United States

Fort Wayne Medical Oncology and Hematology

Fort Wayne, Indiana, United States

University of Kansas Cancer Center

Westwood, Kansas, United States

University of Kentucky Medical Center

Lexington, Kentucky, United States

Mercy Health - Paducah

Paducah, Kentucky, United States

American Oncology Partners of Maryland, PA

Bethesda, Maryland, United States

Maryland Oncology Hematology, P.A. - Rockville

Rockville, Maryland, United States

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Henry Ford Hospital

Detroit, Michigan, United States

Nebraska Hematology - Oncology, P.C.

Lincoln, Nebraska, United States

Oncology Hematology West PC dba Nebraska Cancer Specialists

Omaha, Nebraska, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

New York Oncology Hematology, P.C. - Albany

Albany, New York, United States

Queens Hospital Cancer Center

Jamaica, New York, United States

Coleman, Pasmantier & Decter, MDs

New York, New York, United States

Weill Cornell Medicine/New York-Presbyterian Hospital

New York, New York, United States

University of Rochester Medical Center

Rochester, New York, United States

Hematology/Oncology Associates of Central New York

Syracuse, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

White Plains Hospital

White Plains, New York, United States

Cone Health Cancer Center at Alamance Regional, Hematology/Oncology

Greensboro, North Carolina, United States

Southeast Regional Cancer Center

Lumberton, North Carolina, United States

Sanford Health- Fargo

Fargo, North Dakota, United States

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

The James Cancer Hospital and Solove Research Institute

Columbus, Ohio, United States

OU Health Stephenson Cancer Center

Oklahoma City, Oklahoma, United States

Oregon Oncology Specialists

Salem, Oregon, United States

Northwest Cancer Specialists, PC - Tigard

Tigard, Oregon, United States

Consultants In Medical Oncology and Hematology, P.C.

Broomall, Pennsylvania, United States

Alliance Cancer Specialists PC

Horsham, Pennsylvania, United States

Cancer Care Associates of York

York, Pennsylvania, United States

Sanford Gynecologic Oncology Clinic

Sioux Falls, South Dakota, United States

Texas Oncology - Austin

Austin, Texas, United States

Texas Oncology P.A. - Dallas

Dallas, Texas, United States

Texas Oncology - Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

William Beaumont Army Medical Center

El Paso, Texas, United States

Oncology Consultants

Houston, Texas, United States

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Brooke Army Medical Center

Houston, Texas, United States

Texas Oncology - McKinney

McKinney, Texas, United States

Texas Oncology - Gulf Coast

Sugar Land, Texas, United States

Texas Oncology - Tyler

Tyler, Texas, United States

Fort Belvoir Community Hospital

Fort Belvoir, Virginia, United States

Bon Secours St. Francis Medical Oncology Center

Midlothian, Virginia, United States

Virginia Oncology Associates - Newport News

Newport News, Virginia, United States

VCU Massey Cancer Center

Richmond, Virginia, United States

Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke

Roanoke, Virginia, United States

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Northwest Medical Specialties, PLLC - Tacoma

Tacoma, Washington, United States

CENIT Foundation

Buenos Aires, Argentina

Alexander Fleming Institute

Buenos Aires, Argentina

Buenos Aires British Hospital

Buenos Aires, Argentina

Center for Medical Education and Clinical Research (CEMIC)

Buenos Aires, Argentina

Fleischer Medical Center

Buenos Aires, Argentina

Medical Center Austral

Buenos Aires, Argentina

Pergamino Clinic

Buenos Aires, Argentina

Cordoba Oncology Institute (IONC)

Córdoba, Argentina

Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)

Paraná, Argentina

CEDIT Diagnostic and treatment center

Salta, Argentina

CER San Juan

San Juan, Argentina

9 of July Sanatorium

San Miguel de Tucumán, Argentina

Rosario's Oncology Institute and Medical Specialities (IOR)

Santa Fe, Argentina

Adelaide Oncology & Haematology

Adelaide, Australia

St Vincent's Hospital (Melbourne) Ltd

Fitzroy, Australia

Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)

Frankston, Australia

Hollywood Private Hospital, Breast Cancer Research Centre

Nedlands, Australia

Mater Hospital Brisbane, Mater Cancer Care Centre

South Brisbane, Australia

Icon Cancer Centre- Southport

Southport, Australia

Sydney Adventist Hospital

Wahroonga, Australia

The Queen Elizabeth Hospital

Woodville, Australia

University Hospital Graz, Department of Gynecology and Obstetrics

Graz, Austria

University Hospital Innsbruck - Tyrolean Hospital, Department of Gynaecology and Obstetrics

Innsbruck, Austria

Order Hospital Linz Ltd. - Hospital of Sisters of Mercy, Department of Internal Medicine I

Linz, Austria

Salzburg Regional Hospital, Department of Internal Medicine III

Salzburg, Austria

University Hospital St. Poelten, Department of Internal Medicine I

Sankt Pölten, Austria

Hospital Hietzing, Department of Gynecology

Vienna, Austria

Medical University Vienna, Department of Gynecology and Obstetrics

Vienna, Austria

Hospital Wels-Grieskirchen, Internal Medicine Department IV

Wels, Austria

Saint Luc University Hospital

Brussels, Belgium

Charleroi Grand Hospital (GHDC)

Charleroi, Belgium

University Hospital Antwerp (UZA)

Edegem, Belgium

AZ Groeninge

Kortrijk, Belgium

University Hospitals Leuven, Campus Gasthuisberg

Leuven, Belgium

Citadelle Regional Hospital Center

Liège, Belgium

VITAZ

Sint-Niklaas, Belgium

Centre Hospitalier Peltzer-la-Tourelle

Verviers, Belgium

UCL Mont-Godinne University Hospitals

Yvoir, Belgium

Oncology Treatment Center

Belém, Pará, Brazil

Catarina Clinical Research

Itajaí, Santa Catarina, Brazil

Pronutrir

Fortaleza, Brazil

ONCOSITE - Clinical Research Center in Oncology

Ijuí, Brazil

Juiz de Fora Eurolatino Research Center

Minas Gerais, Brazil

Bahia Oncology Center

Salvador, Brazil

Portuguese Sao Paulo Charity / Sao Jose Hospital

São Paulo, Brazil

D'OR Institute

São Paulo, Brazil

Hospital A.C.Camargo

São Paulo, Brazil

Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

Panagyurishte, Bulgaria

MHAT for Women's Health "Nadezhda"

Sofia, Bulgaria

Multiprofile Hospital for Active Treatment "Serdika", Sofia

Sofia, Bulgaria

Specialized Hospital for Active Treatment in Oncology, Clinic of Medicial Oncology (Chemotherapy)

Sofia, Bulgaria

University Multiprofile Hospital for Active Treatment "Sveta Marina"

Varna, Bulgaria

BC Cancer - Vancouver, Medical Oncology

Vancouver, British Columbia, Canada

Walker Family Cancer Center

St. Catharines, Ontario, Canada

CIUSSS du Saguenay Lac St-Jean

Chicoutimi, Quebec, Canada

Hospital Notre-Dame

Montreal, Quebec, Canada

Maisonneuve-Rosemont Hospital

Montreal, Quebec, Canada

University Hospital Olomouc, Clinic of Oncology

Olomouc, Czechia

Thomayer University Hospital, Clinic of Oncology

Prague, Czechia

University Hospital Bulovka, Institute of Radiation Oncology

Prague, Czechia

University Hospital Motol, Clinic of Oncology

Prague, Czechia

Bergonie Institute

Bordeaux, France

Francois Baclesse Center

Caen, France

La Roche-sur-Yon Hospital

La Roche-sur-Yon, France

CHU La Timone - La Timone Children's Hospital

Marseille, France

University Hospital Center of Poitiers

Poitiers, France

Saint Anne Clinic

Strasbourg, France

Gustave Roussy

Villejuif, France

Hospital Bayreuth

Bayreuth, Germany

Vivantes Hospital Am Urban

Berlin, Germany

Hospital Suedstadt Rostock

Dorf Mecklenburg, Germany

Private Practice with Focus on Oncology

Lübeck, Germany

University Hospital Johannes Gutenberg - University of Mainz

Mainz, Germany

University Hospital Muenster

Münster, Germany

Caritas Klinikum

Saarbrücken, Germany

Helios Clinic Wuppertal

Wuppertal, Germany

Metropolitan General Hospital

Athens, Greece

Alexandra General Hospital

Athens, Greece

University General Hospital of Ioannina

Ioannina, Greece

University General Hospital of Larissa

Larissa, Greece

IASO Thessaly SA

Larissa, Greece

Metropolitan Hospital

Piraeus, Greece

Bioclinic Thessalonikis S.A.

Thessaloniki, Greece

European Interbalkan Medical Center of Thessaloniki

Thessaloniki, Greece

EUROMEDICA General Clinic of Thessaloniki

Thessaloniki, Greece

Theageneio Anticancer Hospital of Thessaloniki

Thessaloniki, Greece

University of Debrecen Clinical Center, Institute of Oncology

Debrecen, Hungary

Bacs-Kiskun County Hospital, Center for Oncoradiology

Kecskemét, Hungary

Szabolcs-Szatmar-Bereg County Hospitals and University Teaching Hospital, Department of Oncology

Nyíregyháza, Hungary

Shri Ram Cancer Centre, Mahatma Gandhi Medical College & Hospital

Jaipur, Rajasthan, India

HCG Cancer Centre

Bangalore, India

Postgraduate Institute of Medical Education and Research (PGIMER)

Chandigarh, India

Tata Medical Center

Kolkata, India

Tata Memorial Hospital

Navi Mumbai, India

Christian Medical College, Department of Medical Oncology

Vellore, India

European Institute of Oncology (IEO), IRCCS

Milan, Italy

University Polyclinic Hospital of Modena

Modena, Italy

Local Healthcare Company of Monza (ASST Monza)

Monza, Italy

University Hospital of Parma

Parma, Italy

New Hospital of Prato (NOP)

Prato, Italy

University Hospital Campus Bio-Medico

Rome, Italy

University Polyclinic Foundation "Agostino Gemelli" - IRCCS

Rome, Italy

Santa Maria della Misericordia University Hospital of Udine

Udine, Italy

Clinical Research Center Chapultepec Mexico City

Mexico City, Mexico

CRYPTEX

Mexico City, Mexico

ProcliniQ Clinical Research

Mexico City, Mexico

Filios High Medicine

Monterrey, Mexico

Administrative Society of Health Services, SC

Morelia, Mexico

Avix Clinical Research

Nuevo León, Mexico

Zambrano Hellion Medical Center

Nuevo León, Mexico

Inbiomedyc

Querétaro, Mexico

ONCOR Life Medical Center

Saltillo, Mexico

Prof. Franciszek Lukaszczyk Oncology Center in Bydgoszcz, Chemotherapy Outpatient Clinic

Bydgoszcz, Poland

Medical Clinic "Komed"

Konin, Poland

Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow

Krakow, Poland

Polish Mother's Memorial Hospital-Research Institute

Lodz, Poland

Independent Public Healthcare Facility Prof. Tadeusz Koszarowski Opole Oncology Center in Opole, Clinical Oncology Department and Day Hospitalization Unit

Opole, Poland

St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre

Siedlce, Poland

West Pomeranian Oncology Center

Szczecin, Poland

LUX MED Oncology LLC, Szamocka Hospital, Department of Clinical Oncology/Chemotherapy

Warsaw, Poland

Maria Sklodowska-Curie - National Research Institute of Oncology

Warsaw, Poland

Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy

Wroclaw, Poland

S.C. Oncopremium-Team SRL

Baia Mare, Romania

Prof. Dr. Alexandru Trestioreanu Institute of Oncology

Bucharest, Romania

"Prof. Dr. Ion Chiricuta" Institute of Oncology, Radiotherapy Department I

Cluj-Napoca, Romania

Prof. Dr. Ion Chiricuta Institute of Oncology

Cluj-Napoca, Romania

Onco Clinic Consult S.A.

Craiova, Romania

Oncology Center "Sf. Nectarie"

Craiova, Romania

S.C. Radiotherapy Center Cluj SRL, Department of Medical Oncology

Floreşti, Romania

S.C. Topmed Medical Center SRL

Târgu Mureş, Romania

Curie Oncology

Singapore, Singapore

ICON SOC Farrer Park Medical Clinic

Singapore, Singapore

OncoCare Cancer Centre

Singapore, Singapore

Raffles Hospital

Singapore, Singapore

Tan Tock Seng Hospital

Singapore, Singapore

Asan Medical Center

Seoul, South Korea

Gangnam Severance Hospital

Soeul, South Korea

Korea University Anam Hospital

Soeul, South Korea

Samsung Medical Center

Soeul, South Korea

Severance Hospital, Yonsei University Health System

Soeul, South Korea

Ulsan University Hospital

Ulsan, South Korea

University Hospital Ramon y Cajal

Madrid, Madrid, Spain

Infanta Cristina Hospital

Badajoz, Spain

Catalan Institute of Oncology, Hospital Duran i Reynals

Barcelona, Spain

Caceres Hospital Complex - San Pedro de Alcantara General Hospital

Cáceres, Spain

Hospital Ruber Internacional

Madrid, Spain

University Hospital Foundation Jimenez Diaz

Madrid, Spain

University Clinical Hospital Virgen de la Arrixaca, Department of Oncology

Murcia, Spain

University Hospital Complex of Santiago (CHUS), Department of Oncology

Santiago de Compostela, Spain

Changhua Christian Hospital

Changhua, Taiwan

Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, Taiwan

Taipei Medical University - Shuang Ho Hospital

New Taipei City, Taiwan

China Medical University Hospital

Taichung, Taiwan

National Cheng Kung University Hospital

Tainan, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Taipei Veterans General Hospital

Taipei, Taiwan

National Taiwan University Hospital - Yunlin Branch (Huwei District)

Yuanlin, Taiwan

Royal United Hospital, Department of Oncology/Hematology

Bath, United Kingdom

Velindre Cancer Centre

Cardiff, United Kingdom

Guy's Hospital

London, United Kingdom

Royal Marsden Hospital - London, Department of Medical Oncology

London, United Kingdom

The Christie NHS Foundation Trust

Manchester, United Kingdom

Nottingham City Hospital

Nottingham, United Kingdom

Royal Marsden Hospital - Sutton

Sutton, United Kingdom