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)
VIKTORIA-1
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
2 other identifiers
interventional
701
22 countries
227
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Dec 2022
227 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 12, 2022
CompletedFirst Posted
Study publicly available on registry
August 16, 2022
CompletedStudy Start
First participant enrolled
December 8, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 31, 2026
February 10, 2026
February 1, 2026
3.6 years
August 12, 2022
February 6, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
PFS is defined as the time from randomization to death or the first documented progression, whichever occurs first, confirmed by Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 criteria, as determined based on blinded independent central review (BICR)
Approximately 48 months
Secondary Outcomes (10)
Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
From date of randomization to the date of death due to any cause, up to approximately 48 months
Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Up to approximately 48 months
Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Up to approximately 48 months
Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Up to approximately 48 months
Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer
Up to approximately 48 months
- +5 more secondary outcomes
Study Arms (6)
Arm A - Patients Lacking PIK3CA Mutations (WT)
EXPERIMENTALGedatolisib + Palbociclib + Fulvestrant
Arm B - Patients Lacking PIK3CA Mutations (WT)
EXPERIMENTALGedatolisib + Fulvestrant
Arm C - Patients Lacking PIK3CA Mutations (WT)
ACTIVE COMPARATORFulvestrant
Arm D - Patients with PIK3CA Mutation (MT)
EXPERIMENTALGedatolisib + Palbociclib + Fulvestrant
Arm E - Patients with PIK3CA Mutation (MT)
ACTIVE COMPARATORAlpelisib + Fulvestrant
Arm F - Patients with PIK3CA Mutation (MT)
EXPERIMENTALGedatolisib + Fulvestrant
Interventions
Gedatolisib 180 mg IV given weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Palbociclib 125 mg PO given daily for 3 weeks (21 days), followed by 1 week off
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
Alpelisib 300 mg PO (2 × 150 mg tablets) given daily for 4 weeks (28 days)
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced breast cancer Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue on it for the duration of the study.
- Negative pregnancy test for women of childbearing potential. Female subjects of childbearing potential must use an effective and/or acceptable contraceptive method from screening until 1 year after the last dose of study treatment
- Confirmed diagnosis of estrogen receptor positive and/or progesterone receptor positive, as per American Society of Clinical Oncology/College of American Pathologists (ASCO-CAP) guidelines (2020), based on most recent tumor biopsy utilizing an assay consistent with local standards
- Documented HER2 immunohistochemistry (IHC) negative as per ASCO-CAP 2018 guidance
- Adequate archival or fresh tumor tissue for the analysis of PIK3CA mutational status
- Subject must have documentation of radiological disease progression on or after the last prior treatment and also have radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment. Subjects with bone only disease must have lytic or mixed lytic/blastic lesions that can be accurately assessed; bone only blastic lesions with no soft tissue component is not allowed.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-1
- Life expectancy of at least 3 months
- Progressed during or after CDK4/6 inhibitor combination treatment with non-steroidal aromatase inhibitor (AI)
- Adequate bone marrow, hepatic, renal and coagulation function
You may not qualify if:
- History of malignancies other than adequately treated non-melanoma skin cancer, curatively treated in situ cancer of the cervix, or other solid tumors curatively treated with no evidence of disease for ≥3 years
- Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
- Prior treatment with chemotherapy and antibody drug conjugates for advanced disease is not permitted (prior adjuvant or neoadjuvant chemotherapy is permitted)
- More than 2 lines of prior endocrine therapy treatment
- Bone only disease that is only blastic with no soft tissue component
- Subjects with type 1 diabetes or uncontrolled type 2 diabetes
- Known and untreated, or active, brain or leptomeningeal metastases
- a. Subjects with previously treated central nervous system (CNS) metastases may be enrolled in the study if they meet the following criteria: do not require supportive therapy with steroids; do not have seizures and do not exhibit uncontrolled neurological symptoms; stable disease confirmed by radiographic assessment within at least 4 weeks prior to enrollment
- Patients with advanced, symptomatic, visceral spread that are at risk of life-threatening complication in the short-term
- History of clinically significant cardiovascular abnormalities such as: Congestive heart failure (New York Heart Association (NYHA) classification ≥ II within 6 months of study entry
- Myocardial infarction within 12 months of study entry
- History of any uncontrolled (or untreated) clinically significant cardiac arrhythmias, (e.g., ventricular tachycardia), complete left bundle branch block, high grade AV block (e.g., bifascicular block, Mobitz type II and third degree AV block), supraventricular, nodal arrhythmias, or conduction abnormality in the previous 12 months
- Uncontrolled hypertension defined by systolic blood pressure (SBP) ≥160 mmHg and/or diastolic blood pressure (DBP) ≥100 mmHg, with or without antihypertensive medication (initiation or adjustment of antihypertensive medication\[s\] is allowed prior to screening)
- Long QT syndrome, family history of idiopathic sudden death or congenital long QT syndrome, or any of the following:
- i. Risk factors for Torsades de Pointes (TdP) including uncorrected hypokalemia or hypomagnesemia, or history of clinically significant/symptomatic bradycardia
- +5 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celcuity Inclead
Study Sites (235)
University of Alabama at Birmingham
Birmingham, Alabama, 35294, United States
Arizona Oncology (US Oncology/McKesson) - Goodyear
Goodyear, Arizona, 85395, United States
St. Bernards Medical Center
Jonesboro, Arkansas, 72401, United States
CARTI Cancer Center
Little Rock, Arkansas, 72205, United States
Pacific Cancer Medical Center Inc
Anaheim, California, 92801, United States
Kaiser Permanente South Bay Medical Center
Harbor City, California, 90710, United States
Cancer and Blood Specialty Clinic
Los Alamitos, California, 90720, United States
Pacific Cancer Care
Monterey, California, 93940, United States
University of California, Irvine Medical Center
Orange, California, 92868, United States
Ventura County Hematology Oncology Specialists
Oxnard, California, 93030, United States
Redlands Hematology Oncology
Redlands, California, 92373, United States
UCLA Hematology/Oncology-Santa Monica
Santa Monica, California, 90904, United States
Torrance Memorial Physician Network - Cancer Care
Torrance, California, 90505, United States
Kaiser Permanente Medical Center - Vallejo
Vallejo, California, 94589, United States
PIH Health Hospital Whittier
Whittier, California, 90602-1006, United States
Yale Cancer Center - New Haven
New Haven, Connecticut, 06520-8028, United States
South Broward Hospital District d/b/a Memorial Healthcare System
Hollywood, Florida, 33021, United States
Cancer Specialists of North Florida - Jacksonville
Jacksonville, Florida, 32256, United States
H. Lee Moffitt Cancer Center & Research Institute
Tampa, Florida, 33612, United States
Bond & Steele Clinic, P.A. d/b/a Bond Clinic, P.A.
Winter Haven, Florida, 33881, United States
John D. Archbold Memorial Hospital
Thomasville, Georgia, 31792, United States
Illinois Cancer Specialists - Arlington Heights
Arlington Heights, Illinois, 60005, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne, Indiana, 46845, United States
University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
University of Kentucky Medical Center
Lexington, Kentucky, 40536-0293, United States
Mercy Health - Paducah
Paducah, Kentucky, 42003, United States
American Oncology Partners of Maryland, PA
Bethesda, Maryland, 20817-7847, United States
Maryland Oncology Hematology, P.A. - Rockville
Rockville, Maryland, 20850, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02215-5450, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215, United States
Henry Ford Hospital
Detroit, Michigan, 48202, United States
Nebraska Hematology - Oncology, P.C.
Lincoln, Nebraska, 68506, United States
Oncology Hematology West PC dba Nebraska Cancer Specialists
Omaha, Nebraska, 68130, United States
University of Nebraska Medical Center
Omaha, Nebraska, 68198, United States
New York Oncology Hematology, P.C. - Albany
Albany, New York, 12206, United States
Queens Hospital Cancer Center
Jamaica, New York, 11432, United States
Coleman, Pasmantier & Decter, MDs
New York, New York, 10021-5302, United States
Weill Cornell Medicine/New York-Presbyterian Hospital
New York, New York, 10021, United States
University of Rochester Medical Center
Rochester, New York, 14642, United States
Hematology/Oncology Associates of Central New York
Syracuse, New York, 13057, United States
Montefiore Medical Center
The Bronx, New York, 10467, United States
White Plains Hospital
White Plains, New York, 10601, United States
Cone Health Cancer Center at Alamance Regional, Hematology/Oncology
Greensboro, North Carolina, 27403, United States
Southeast Regional Cancer Center
Lumberton, North Carolina, 28359, United States
Sanford Health- Fargo
Fargo, North Dakota, 58102, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106-1716, United States
The James Cancer Hospital and Solove Research Institute
Columbus, Ohio, 43210, United States
OU Health Stephenson Cancer Center
Oklahoma City, Oklahoma, 73104, United States
Oregon Oncology Specialists
Salem, Oregon, 97301, United States
Northwest Cancer Specialists, PC - Tigard
Tigard, Oregon, 97223, United States
Consultants In Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, 19008, United States
Alliance Cancer Specialists PC
Horsham, Pennsylvania, 19044, United States
Cancer Care Associates of York
York, Pennsylvania, 17403, United States
Sanford Gynecologic Oncology Clinic
Sioux Falls, South Dakota, 57104, United States
Texas Oncology - Austin
Austin, Texas, 78745, United States
Texas Oncology P.A. - Dallas
Dallas, Texas, 75230, United States
Texas Oncology - Baylor Charles A. Sammons Cancer Center
Dallas, Texas, 75246, United States
William Beaumont Army Medical Center
El Paso, Texas, 79920, United States
Oncology Consultants
Houston, Texas, 77030, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Brooke Army Medical Center
Houston, Texas, 78234, United States
Texas Oncology - McKinney
McKinney, Texas, 75071, United States
Texas Oncology - Gulf Coast
Sugar Land, Texas, 77479, United States
Texas Oncology - Tyler
Tyler, Texas, 75702, United States
Fort Belvoir Community Hospital
Fort Belvoir, Virginia, 22060, United States
Bon Secours St. Francis Medical Oncology Center
Midlothian, Virginia, 23114, United States
Virginia Oncology Associates - Newport News
Newport News, Virginia, 23502, United States
VCU Massey Cancer Center
Richmond, Virginia, 23219, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke
Roanoke, Virginia, 24014, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109-1023, United States
Northwest Medical Specialties, PLLC - Tacoma
Tacoma, Washington, 98405, United States
CENIT Foundation
Buenos Aires, C1113, 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, 4600, 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, 88301, 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, 01323, 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, L2S 0A9, 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, 14076, France
La Roche-sur-Yon Hospital
La Roche-sur-Yon, 85925, 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, 15562, Greece
Alexandra General Hospital
Athens, Greece
University General Hospital of Ioannina
Ioannina, Greece
University General Hospital of Larissa
Larissa, 41110, Greece
IASO Thessaly SA
Larissa, Greece
Metropolitan Hospital
Piraeus, 18547, Greece
Bioclinic Thessalonikis S.A.
Thessaloniki, 546 22, Greece
European Interbalkan Medical Center of Thessaloniki
Thessaloniki, 57001, 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, 302022, 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, 64460, 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, 400015, 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, 407280, 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, 28034, 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, 500209, 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, 632, 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, SM2 5PT, United Kingdom
Related Publications (1)
Hurvitz SA, Layman RM, Curigliano G, Andre F, Cristofanilli M, Kim SB, Martinez Rodriguez JL, Nadal JC, Kim GM, Lo L, Remolina-Bonilla YA, Rosselli G, Emile G, Korbenfeld E, Puig JM, Wesolowski R, Martin M, Ring A, Han HS, Giordano A, Mutka SC, Moss K, Suzuki S, Sullivan B, Gorbatchevsky I, Pistilli B; VIKTORIA-1 Study Group. VIKTORIA-1 Trial of Gedatolisib Plus Fulvestrant With or Without Palbociclib in Hormone Receptor-Positive/HER2-/PIK3CA Wild-Type Advanced Breast Cancer. J Clin Oncol. 2026 Mar 9:JCO2502643. doi: 10.1200/JCO-25-02643. Online ahead of print.
PMID: 41802242DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Nadene Zack
Celcuity Inc
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 12, 2022
First Posted
August 16, 2022
Study Start
December 8, 2022
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
December 31, 2026
Last Updated
February 10, 2026
Record last verified: 2026-02