AzTrials
AzTrials

Breast CancerPhase 3VIKTORIA-1NCT05501886

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)

A Phase 3 study testing Gedatolisib, Palbociclib and Fulvestrant in people with Breast Cancer, run by Celcuity Inc at 235 sites in 23 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Gedatolisib, Palbociclib and Fulvestrant
Could I receive a placebo?
No, everyone receives an active treatment
How many people
701 participants
Where
235 sitesin 23 countries
Study dates
8 Dec 2022to 31 Dec 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
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  • 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

Who cannot join

  • 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
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  • Known and untreated, or active, brain or leptomeningeal metastases
  • 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
  • ii. On screening, inability to determine the corrected QT interval using Fridericia's formula (QTcF) on the ECG (i.e., unreadable or not interpretable) or QTcF >480 msec (determined by mean of triplicate ECGs at screening)
  • Known hypersensitivity to the study drugs or their components
  • Pregnant or breast-feeding women
  • Concurrent participation in another interventional clinical trial
  • Subjects must agree not to participate in another clinical trial (other than observational) at any time during participation in VIKTORIA-1.

Trial locations and contacts

235 sites in 23 countries.

235 sites in 23 countries

United States71 sites

  • New York Oncology Hematology, P.C. - Albany

    Albany, New York, 12206

  • Pacific Cancer Medical Center Inc

    Anaheim, California, 92801

  • Illinois Cancer Specialists - Arlington Heights

    Arlington Heights, Illinois, 60005

  • Texas Oncology - Austin

    Austin, Texas, 78745

  • American Oncology Partners of Maryland, PA

    Bethesda, Maryland, 20817-7847

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02215-5450

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Consultants In Medical Oncology and Hematology, P.C.

    Broomall, Pennsylvania, 19008

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106-1716

  • The James Cancer Hospital and Solove Research Institute

    Columbus, Ohio, 43210

  • Texas Oncology P.A. - Dallas

    Dallas, Texas, 75230

  • Texas Oncology - Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • William Beaumont Army Medical Center

    El Paso, Texas, 79920

  • Sanford Health- Fargo

    Fargo, North Dakota, 58102

  • Fort Belvoir Community Hospital

    Fort Belvoir, Virginia, 22060

  • Fort Wayne Medical Oncology and Hematology

    Fort Wayne, Indiana, 46845

  • Arizona Oncology (US Oncology/McKesson) - Goodyear

    Goodyear, Arizona, 85395

  • Cone Health Cancer Center at Alamance Regional, Hematology/Oncology

    Greensboro, North Carolina, 27403

  • Kaiser Permanente South Bay Medical Center

    Harbor City, California, 90710

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

    Hollywood, Florida, 33021

  • Alliance Cancer Specialists PC

    Horsham, Pennsylvania, 19044

  • Oncology Consultants

    Houston, Texas, 77030

  • University of Texas MD Anderson Cancer Center

    Houston, Texas, 77030

  • Brooke Army Medical Center

    Houston, Texas, 78234

  • Cancer Specialists of North Florida - Jacksonville

    Jacksonville, Florida, 32256

  • Queens Hospital Cancer Center

    Jamaica, New York, 11432

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • University of Kentucky Medical Center

    Lexington, Kentucky, 40536-0293

  • Nebraska Hematology - Oncology, P.C.

    Lincoln, Nebraska, 68506

  • CARTI Cancer Center

    Little Rock, Arkansas, 72205

  • Cancer and Blood Specialty Clinic

    Los Alamitos, California, 90720

  • Southeast Regional Cancer Center

    Lumberton, North Carolina, 28359

  • Texas Oncology - McKinney

    McKinney, Texas, 75071

  • Bon Secours St. Francis Medical Oncology Center

    Midlothian, Virginia, 23114

  • Pacific Cancer Care

    Monterey, California, 93940

  • Yale Cancer Center - New Haven

    New Haven, Connecticut, 06520-8028

  • Coleman, Pasmantier & Decter, MDs

    New York, New York, 10021-5302

  • Weill Cornell Medicine/New York-Presbyterian Hospital

    New York, New York, 10021

  • Virginia Oncology Associates - Newport News

    Newport News, Virginia, 23502

  • OU Health Stephenson Cancer Center

    Oklahoma City, Oklahoma, 73104

  • Oncology Hematology West PC dba Nebraska Cancer Specialists

    Omaha, Nebraska, 68130

  • University of Nebraska Medical Center

    Omaha, Nebraska, 68198

  • University of California, Irvine Medical Center

    Orange, California, 92868

  • Ventura County Hematology Oncology Specialists

    Oxnard, California, 93030

  • Mercy Health - Paducah

    Paducah, Kentucky, 42003

  • Redlands Hematology Oncology

    Redlands, California, 92373

  • VCU Massey Cancer Center

    Richmond, Virginia, 23219

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

    Roanoke, Virginia, 24014

  • University of Rochester Medical Center

    Rochester, New York, 14642

  • Maryland Oncology Hematology, P.A. - Rockville

    Rockville, Maryland, 20850

  • Oregon Oncology Specialists

    Salem, Oregon, 97301

  • UCLA Hematology/Oncology-Santa Monica

    Santa Monica, California, 90904

  • Fred Hutchinson Cancer Center

    Seattle, Washington, 98109-1023

  • Sanford Gynecologic Oncology Clinic

    Sioux Falls, South Dakota, 57104

  • Texas Oncology - Gulf Coast

    Sugar Land, Texas, 77479

  • Hematology/Oncology Associates of Central New York

    Syracuse, New York, 13057

  • Northwest Medical Specialties, PLLC - Tacoma

    Tacoma, Washington, 98405

  • H. Lee Moffitt Cancer Center & Research Institute

    Tampa, Florida, 33612

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • John D. Archbold Memorial Hospital

    Thomasville, Georgia, 31792

  • Northwest Cancer Specialists, PC - Tigard

    Tigard, Oregon, 97223

  • Torrance Memorial Physician Network - Cancer Care

    Torrance, California, 90505

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Kaiser Permanente Medical Center - Vallejo

    Vallejo, California, 94589

  • University of Kansas Cancer Center

    Westwood, Kansas, 66205

  • White Plains Hospital

    White Plains, New York, 10601

  • PIH Health Hospital Whittier

    Whittier, California, 90602-1006

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

    Winter Haven, Florida, 33881

  • Cancer Care Associates of York

    York, Pennsylvania, 17403

Other trials in United States

Argentina13 sites

  • CENIT Foundation

    Buenos Aires, C1113

  • Alexander Fleming Institute

    Buenos Aires

  • Buenos Aires British Hospital

    Buenos Aires

  • Center for Medical Education and Clinical Research (CEMIC)

    Buenos Aires

  • Fleischer Medical Center

    Buenos Aires

  • Medical Center Austral

    Buenos Aires

  • Pergamino Clinic

    Buenos Aires

  • Cordoba Oncology Institute (IONC)

    Córdoba

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

    Paraná

  • CEDIT Diagnostic and treatment center

    Salta

  • CER San Juan

    San Juan

  • 9 of July Sanatorium

    San Miguel de Tucumán

  • Rosario's Oncology Institute and Medical Specialities (IOR)

    Santa Fe

Other trials in Argentina

Greece10 sites

  • Metropolitan General Hospital

    Athens, 15562

  • Alexandra General Hospital

    Athens

  • University General Hospital of Ioannina

    Ioannina

  • University General Hospital of Larissa

    Larissa, 41110

  • IASO Thessaly SA

    Larissa

  • Metropolitan Hospital

    Piraeus, 18547

  • Bioclinic Thessalonikis S.A.

    Thessaloniki, 546 22

  • European Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 57001

  • EUROMEDICA General Clinic of Thessaloniki

    Thessaloniki

  • Theageneio Anticancer Hospital of Thessaloniki

    Thessaloniki

Other trials in Greece

Poland10 sites

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

    Bydgoszcz

  • Medical Clinic "Komed"

    Konin

  • Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow

    Krakow

  • Polish Mother's Memorial Hospital-Research Institute

    Lodz

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

    Opole

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

    Siedlce

  • West Pomeranian Oncology Center

    Szczecin

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

    Warsaw

  • Maria Sklodowska-Curie - National Research Institute of Oncology

    Warsaw

  • Provincial Specialist Hospital in Wroclaw, Department of Chemotherapy

    Wroclaw

Other trials in Poland

Belgium9 sites

  • Saint Luc University Hospital

    Brussels

  • Charleroi Grand Hospital (GHDC)

    Charleroi

  • University Hospital Antwerp (UZA)

    Edegem

  • AZ Groeninge

    Kortrijk

  • University Hospitals Leuven, Campus Gasthuisberg

    Leuven

  • Citadelle Regional Hospital Center

    Liège

  • VITAZ

    Sint-Niklaas

  • Centre Hospitalier Peltzer-la-Tourelle

    Verviers

  • UCL Mont-Godinne University Hospitals

    Yvoir

Other trials in Belgium

Brazil9 sites

  • Oncology Treatment Center

    Belém, Pará

  • Pronutrir

    Fortaleza

  • ONCOSITE - Clinical Research Center in Oncology

    Ijuí

  • Catarina Clinical Research

    Itajaí, Santa Catarina, 88301

  • Juiz de Fora Eurolatino Research Center

    Minas Gerais

  • Bahia Oncology Center

    Salvador

  • Portuguese Sao Paulo Charity / Sao Jose Hospital

    São Paulo, 01323

  • D'OR Institute

    São Paulo

  • Hospital A.C.Camargo

    São Paulo

Other trials in Brazil

Mexico9 sites

  • Clinical Research Center Chapultepec Mexico City

    Mexico City

  • CRYPTEX

    Mexico City

  • ProcliniQ Clinical Research

    Mexico City

  • Filios High Medicine

    Monterrey, 64460

  • Administrative Society of Health Services, SC

    Morelia

  • Avix Clinical Research

    Nuevo León

  • Zambrano Hellion Medical Center

    Nuevo León

  • Inbiomedyc

    Querétaro

  • ONCOR Life Medical Center

    Saltillo

Other trials in Mexico

Australia8 sites

  • Adelaide Oncology & Haematology

    Adelaide

  • St Vincent's Hospital (Melbourne) Ltd

    Fitzroy

  • Peninsula & South Eastern Hematology and Oncology Group (PSEHOG)

    Frankston

  • Hollywood Private Hospital, Breast Cancer Research Centre

    Nedlands

  • Mater Hospital Brisbane, Mater Cancer Care Centre

    South Brisbane

  • Icon Cancer Centre- Southport

    Southport

  • Sydney Adventist Hospital

    Wahroonga

  • The Queen Elizabeth Hospital

    Woodville

Other trials in Australia

Austria8 sites

  • University Hospital Graz, Department of Gynecology and Obstetrics

    Graz

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

    Innsbruck

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

    Linz

  • Salzburg Regional Hospital, Department of Internal Medicine III

    Salzburg

  • University Hospital St. Poelten, Department of Internal Medicine I

    Sankt Pölten

  • Hospital Hietzing, Department of Gynecology

    Vienna

  • Medical University Vienna, Department of Gynecology and Obstetrics

    Vienna

  • Hospital Wels-Grieskirchen, Internal Medicine Department IV

    Wels, 4600

Other trials in Austria

Germany8 sites

  • Hospital Bayreuth

    Bayreuth

  • Vivantes Hospital Am Urban

    Berlin

  • Hospital Suedstadt Rostock

    Dorf Mecklenburg

  • Private Practice with Focus on Oncology

    Lübeck

  • University Hospital Johannes Gutenberg - University of Mainz

    Mainz

  • University Hospital Muenster

    Münster

  • Caritas Klinikum

    Saarbrücken

  • Helios Clinic Wuppertal

    Wuppertal

Other trials in Germany

Italy8 sites

  • European Institute of Oncology (IEO), IRCCS

    Milan

  • University Polyclinic Hospital of Modena

    Modena

  • Local Healthcare Company of Monza (ASST Monza)

    Monza

  • University Hospital of Parma

    Parma

  • New Hospital of Prato (NOP)

    Prato

  • University Hospital Campus Bio-Medico

    Rome

  • University Polyclinic Foundation "Agostino Gemelli" - IRCCS

    Rome

  • Santa Maria della Misericordia University Hospital of Udine

    Udine

Other trials in Italy

Romania8 sites

  • S.C. Oncopremium-Team SRL

    Baia Mare

  • Prof. Dr. Alexandru Trestioreanu Institute of Oncology

    Bucharest

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

    Cluj-Napoca, 400015

  • Prof. Dr. Ion Chiricuta Institute of Oncology

    Cluj-Napoca

  • Onco Clinic Consult S.A.

    Craiova

  • Oncology Center "Sf. Nectarie"

    Craiova

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

    Floreşti, 407280

  • S.C. Topmed Medical Center SRL

    Târgu Mureş

Other trials in Romania

Spain8 sites

  • Infanta Cristina Hospital

    Badajoz

  • Catalan Institute of Oncology, Hospital Duran i Reynals

    Barcelona

  • Caceres Hospital Complex - San Pedro de Alcantara General Hospital

    Cáceres

  • University Hospital Ramon y Cajal

    Madrid, Madrid, 28034

  • Hospital Ruber Internacional

    Madrid

  • University Hospital Foundation Jimenez Diaz

    Madrid

  • University Clinical Hospital Virgen de la Arrixaca, Department of Oncology

    Murcia

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

    Santiago de Compostela

Other trials in Spain

Taiwan8 sites

  • Changhua Christian Hospital

    Changhua, 500209

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • Taipei Medical University - Shuang Ho Hospital

    New Taipei City

  • China Medical University Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Veterans General Hospital

    Taipei

  • National Taiwan University Hospital - Yunlin Branch (Huwei District)

    Yuanlin, 632

Other trials in Taiwan

France7 sites

  • Bergonie Institute

    Bordeaux

  • Francois Baclesse Center

    Caen, 14076

  • La Roche-sur-Yon Hospital

    La Roche-sur-Yon, 85925

  • CHU La Timone - La Timone Children's Hospital

    Marseille

  • University Hospital Center of Poitiers

    Poitiers

  • Saint Anne Clinic

    Strasbourg

  • Gustave Roussy

    Villejuif

Other trials in France

United Kingdom7 sites

  • Royal United Hospital, Department of Oncology/Hematology

    Bath

  • Velindre Cancer Centre

    Cardiff

  • Guy's Hospital

    London

  • Royal Marsden Hospital - London, Department of Medical Oncology

    London

  • The Christie NHS Foundation Trust

    Manchester

  • Nottingham City Hospital

    Nottingham

  • Royal Marsden Hospital - Sutton

    Sutton, SM2 5PT

Other trials in United Kingdom

India6 sites

  • HCG Cancer Centre

    Bangalore

  • Postgraduate Institute of Medical Education and Research (PGIMER)

    Chandigarh

  • Shri Ram Cancer Centre, Mahatma Gandhi Medical College & Hospital

    Jaipur, Rajasthan, 302022

  • Tata Medical Center

    Kolkata

  • Tata Memorial Hospital

    Navi Mumbai

  • Christian Medical College, Department of Medical Oncology

    Vellore

Other trials in India

South Korea6 sites

  • Asan Medical Center

    Seoul

  • Gangnam Severance Hospital

    Soeul

  • Korea University Anam Hospital

    Soeul

  • Samsung Medical Center

    Soeul

  • Severance Hospital, Yonsei University Health System

    Soeul

  • Ulsan University Hospital

    Ulsan

Other trials in South Korea

Bulgaria5 sites

  • Multiprofile Hospital for Active Treatment - Uni Hospital, Panagyurishte

    Panagyurishte

  • MHAT for Women's Health "Nadezhda"

    Sofia

  • Multiprofile Hospital for Active Treatment "Serdika", Sofia

    Sofia

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

    Sofia

  • University Multiprofile Hospital for Active Treatment "Sveta Marina"

    Varna

Other trials in Bulgaria

Canada5 sites

  • CIUSSS du Saguenay Lac St-Jean

    Chicoutimi, Quebec

  • Hospital Notre-Dame

    Montreal, Quebec

  • Maisonneuve-Rosemont Hospital

    Montreal, Quebec

  • Walker Family Cancer Center

    St. Catharines, Ontario, L2S 0A9

  • BC Cancer - Vancouver, Medical Oncology

    Vancouver, British Columbia

Other trials in Canada

Singapore5 sites

  • Curie Oncology

    Singapore

  • ICON SOC Farrer Park Medical Clinic

    Singapore

  • OncoCare Cancer Centre

    Singapore

  • Raffles Hospital

    Singapore

  • Tan Tock Seng Hospital

    Singapore

Other trials in Singapore

Czechia4 sites

  • University Hospital Olomouc, Clinic of Oncology

    Olomouc

  • Thomayer University Hospital, Clinic of Oncology

    Prague

  • University Hospital Bulovka, Institute of Radiation Oncology

    Prague

  • University Hospital Motol, Clinic of Oncology

    Prague

Other trials in Czechia

Hungary3 sites

  • University of Debrecen Clinical Center, Institute of Oncology

    Debrecen

  • Bacs-Kiskun County Hospital, Center for Oncoradiology

    Kecskemét

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

    Nyíregyháza

Other trials in Hungary

About this study

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

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.

Read the detailed description

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 advanced (inoperable) or metastatic Hormone Receptor Positive, Human Epidermal Growth Factor Receptor 2 Negative (HR+/HER2-) breast cancer following progression on or after CDK4/6 and aromatase inhibitor therapy. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Subjects will be assessed for PIK3CA status and then randomized to treatment arms according to their confirmed PIK3CA mutation status.

Conditions
Breast Cancer
Being tested
Gedatolisib, Palbociclib, Fulvestrant, Alpelisib
Keywords
Breast Cancer, Advanced or Metastatic, gedatolisib, HR Positive, ER Positive, HER2 Negative, PIK3CA MT, PI3K
Medical subject headings
Breast Neoplasms, Neoplasm Metastasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GedatolisibDrug

    Also called PF-05212384, PKI-587

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

  • PalbociclibDrug

    Also called IBRANCE, PD-0332991

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

  • FulvestrantDrug

    Also called Faslodex

    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

  • AlpelisibDrug

    Also called Piqray, Vijoice, BYL719

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

Study groups in NCT05501886
Study groupRoleWhat they receive
Arm A - Patients Lacking PIK3CA Mutations (WT)ExperimentalGedatolisib + Palbociclib + Fulvestrant
Receives: Drug: Gedatolisib; Drug: Palbociclib; Drug: Fulvestrant
Arm B - Patients Lacking PIK3CA Mutations (WT)ExperimentalGedatolisib + Fulvestrant
Receives: Drug: Gedatolisib; Drug: Fulvestrant
Arm C - Patients Lacking PIK3CA Mutations (WT)Active comparatorFulvestrant
Receives: Drug: Fulvestrant
Arm D - Patients with PIK3CA Mutation (MT)ExperimentalGedatolisib + Palbociclib + Fulvestrant
Receives: Drug: Gedatolisib; Drug: Palbociclib; Drug: Fulvestrant
Arm E - Patients with PIK3CA Mutation (MT)Active comparatorAlpelisib + Fulvestrant
Receives: Drug: Fulvestrant; Drug: Alpelisib
Arm F - Patients with PIK3CA Mutation (MT)ExperimentalGedatolisib + Fulvestrant
Receives: Drug: Gedatolisib; Drug: Fulvestrant

What is being measured

The primary outcome is the main question the study is designed to answer.

  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)

    Measured: Approximately 48 months

Secondary outcomes (10)

  1. Overall Survival (OS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

    OS is defined as the length of time from randomization until the date of death from any cause method, where 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)

    Measured: From date of randomization to the date of death due to any cause, up to approximately 48 months

  2. Overall Response Rate (ORR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

    Percentage of subjects who achieved an objective response according to RECIST v1.1 criteria (complete response [CR] or partial response [PR]) as assessed by BICR)

    Measured: Up to approximately 48 months

  3. Duration of Response (DOR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

    Time from the assessment of initial response (PR or better) to death or first documented disease progression as assessed by BICR, whichever occurs first

    Measured: Up to approximately 48 months

  4. Time to Response (TTR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

    Time form randomization to the first assessment of PR or better as assessed by BICR, whichever comes first

    Measured: Up to approximately 48 months

  5. Clinical Benefit Rate (CBR) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

    Percentage of subjects with CR, PR, or stable disease (SD) >24 weeks as assessed by BICR

    Measured: Up to approximately 48 months

  6. Quality of Life (QOL)Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI) Questions in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

    The FACT-B TOI is an abbreviated (24-item) version of the full FACT-B which focuses only on the patient's Physical Well-being (PWB), Functional Well-being (FWB), and Breast Cancer Subscale (BCS) components using a 5-level scale, (Not at all, A little bit, Some-what, Quite a bit, Very much).

    Measured: From baseline to 30 Day Safety Follow-up

  7. Quality of Life (QOL) NCCN-FACT Breast Symptom Index -16 (NFBSI-16) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

    NCCN-FACT is derived from the FACT-B and only 4 additional items will be administered to enable optional scoring of the NFBSI subscales and total score using a 5-level scale (Not at all, A little bit, Some-what, Quite a bit, Very much).

    Measured: From baseline to 30 Day Safety Follow-up

  8. Patient-Reported Outcomes in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

    Patient-Reported Outcomes Measurement Information System (PROMIS®) Short Form v2.0 - Physical Function 8c using a 5-level scale (Without any difficulty, With a little difficulty, With some difficulty, With much difficulty, Unable to do)

    Measured: From baseline to 30 Day Safety Follow-up

  9. EuroQol 5 in Patients with PIK3CA WT and PIK3CA MT Breast Cancer

    EuroQol 5 Dimension 5 Level (EQ-5D-5L) - This is a 5 question, self-administered visual analog scale (VAS) where patients use 0 (worst health) to 100 (best health) to indicate how they view their health.

    Measured: From baseline to 30 Day Safety Follow-up

  10. Adverse Events

    Safety and tolerability will be evaluated by review of type, incidence, severity (as graded by the National Cancer Institute Common Terminology Criteria for Adverse Events [NCI CTCAE] v5.0), seriousness, and relationship to study medications of adverse events (AEs) and any laboratory abnormalities

    Measured: Up to approximately 48 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Aug 2022
  2. Study start8 Dec 2022
  3. Primary completion30 Jun 2026 (estimated)
  4. Study completion31 Dec 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
701 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05501886
Sponsor's protocol ID
CELC-G-301
Other IDs
2021-005235-24
Acronym
VIKTORIA-1
Status last verified
Feb 2026
First submitted
12 Aug 2022
Last updated
10 Feb 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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 Apr 20;44(12):1108-1119. doi: 10.1200/JCO-25-02643. Epub 2026 Mar 9.

    PubMed 41802242

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Gedatolisib, Palbociclib and Fulvestrant in people with Breast Cancer, run by Celcuity Inc at 235 sites in 23 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 10 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 10 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 235 sites in United States, Argentina, Greece, Poland, Belgium and 18 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) in Patients with PIK3CA WT and PIK3CA MT Breast Cancer (time frame: Approximately 48 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05501886, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2026.

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