Breast Cancer Clinical Trial

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)

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.

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Full 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.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

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 who are not surgically sterile. Female subjects who are not surgically sterile must use a medically-effective 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 has radiologically evaluable disease (measurable and/or non-measurable) according to RECIST v1.1, per local assessment. Mixed lytic/blastic or lytic lesions with measurable soft tissue component are 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

Exclusion Criteria:

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
More than one prior treatment with chemotherapy for advanced disease (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 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, history of cardiac failure, or history of clinically significant/symptomatic bradycardia
ii. Concomitant medication(s) with a known risk to prolong the QT interval and/or known to cause TdP that cannot be discontinued or replaced by safe alternative medication
iii. Bradycardia (heart rate <50 beats per minute at rest) by electrocardiogram (ECG) or pulse
iv. 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 >450 msec for males and >460 msec for females (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 clinical trial

Subjects must agree not to participate in another clinical trial at any time during participation in VIKTORIA-1.

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

701

Study ID:

NCT05501886

Recruitment Status:

Recruiting

Sponsor:

Celcuity, Inc.

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There are 67 Locations for this study

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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
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
UCSF Helen Diller Family Comprehensive Cancer Center
San Francisco California, 94158, 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, United States
Yale Cancer Center - New Haven
New Haven Connecticut, 06520, 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
Rush University Medical Center
Chicago Illinois, 60612, United States
Fort Wayne Medical Oncology and Hematology
Fort Wayne Indiana, 46845, United States
Mission Cancer and Blood
Des Moines Iowa, 50309, United States
University of Kentucky Medical Center
Lexington Kentucky, 40536, United States
American Oncology Partners of Maryland, PA
Bethesda Maryland, 20817, United States
Maryland Oncology Hematology, P.A. - Rockville
Rockville Maryland, 20850, United States
Dana Farber Cancer Institute
Boston Massachusetts, 02215, 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
Montefiore Medical Center
Bronx New York, 10467, United States
Queens Hospital Cancer Center
Jamaica New York, 11432, United States
Coleman, Pasmantier & Decter, MDs
New York New York, 10021, 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
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
Bon Secours Mercy Health
Cincinnati Ohio, 45237, United States
University Hospitals Cleveland Medical Center
Cleveland Ohio, 44106, United States
OSU Gynecologic Oncology at Mill Run
Hilliard Ohio, 43026, United States
University of Oklahoma Medical 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
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
US Oncology - Denison
Denison Texas, 75020, 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 - Sugar Land
Sugar Land Texas, 77479, United States
Texas Oncology - Tyler
Tyler Texas, 75702, United States
Inova Healthcare Services
Fairfax Virginia, 22031, United States
Fort Belvoir Community Hospital
Fort Belvoir Virginia, 22060, United States
Virginia Oncology Associates - Newport News
Newport News Virginia, 23502, United States
Virginia Cancer Institute
Richmond Virginia, 23235, United States
VCU Massey Cancer Center
Richmond Virginia, 23298, United States
Oncology & Hematology Associates of Southwest Virginia, Inc., DBA Blue Ridge Cancer Care - Roanoke
Roanoke Virginia, 24014, United States
Seattle Cancer Care Alliance
Seattle Washington, 98109, United States
Northwest Medical Specialties, PLLC - Tacoma
Tacoma Washington, 98405, United States
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
Rosario's Oncology Institute and Medical Specialities (IOR)
Santa Fe , , Argentina
9 of July Sanatorium
Tucumán , , 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 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
St. Poelten , , Austria
Hospital Hietzing, Department of Gynecology
Vienna , , Austria
Medical University Vienna, Department of Gynecology and Obstetrics
Vienna , , 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
VITAZ
Sint-Niklaas , , Belgium
Centre Hospitalier Peltzer-la-Tourelle
Verviers , , Belgium
UCL Mont-Godinne University Hospitals
Yvoir , , Belgium
Pronutrir
Fortaleza , , Brazil
ONCOSITE - Clinical Research Center in Oncology
Ijuí , , Brazil
Juiz de Fora Eurolatino Research Center
Minas Gerais , , Brazil
Centro CEMEC Oncologia Para
Pará , , Brazil
Bahia Oncology Center
Salvador de Bahia , , 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
Mount Sinai Hospital
Toronto Ontario, , Canada
CIUSSS du Saguenay Lac St-Jean
Chicoutimi Quebec, , Canada
Hospital du Sacre-Coeur in Montreal
Montréal Quebec, , Canada
Hospital Notre-Dame
Montréal Quebec, , Canada
Maisonneuve-Rosemont Hospital
Montréal Quebec, , Canada
University Hospital Olomouc, Clinic of Oncology
Olomouc , , Czechia
General University Hospital in Prague, Clinic of Oncology
Prague , , Czechia
Thomayer University Hospital, Clinic of Oncology
Prague , , Czechia
University Hospital Motol, Clinic of Oncology
Prague , , Czechia
Bergonie Institute
Bordeaux , , France
CHU La Timone - La Timone Children's Hospital
Marseille , , France
University Hospital Center of Poitiers
Poitiers , , France
Gustave Roussy
Villejuif , , France
Hospital Bayreuth
Bayreuth , , Germany
Vivantes Hospital Am Urban
Berlin , , Germany
University Hospital Schleswig-Holstein
Kiel , , Germany
Private Practice with Focus on Oncology
Luebeck , , Germany
University Hospital Johannes Gutenberg - University of Mainz
Mainz , , Germany
Hospital Suedstadt Rostock
Mecklenburg , , Germany
University Hospital Muenster
Münster , , Germany
Caritas Klinikum
Saarbrücken , , Germany
Helios Clinic Wuppertal
Wuppertal , , Germany
Alexandra General Hospital
Athens , , Greece
University General Hospital of Ioannina
Ioánnina , , Greece
IASO Thessaly SA
Larissa , , Greece
EUROMEDICA General Clinic of Thessaloniki
Thessaloníki , , Greece
Theageneio Anticancer Hospital of Thessaloniki
Thessaloníki , , Greece
National Institute of Oncology, Department of Oncology, Internal Medicine "B" and Clinical Pharmacology
Budapest , , Hungary
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
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
All India Institute of Medical Sciences
Rishīkesh , , 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
Gangnam Severance Hospital
Soeul , , Korea, Republic of
Samsung Medical Center
Soeul , , Korea, Republic of
Severance Hospital, Yonsei University Health System
Soeul , , Korea, Republic of
Ulsan University Hospital
Ulsan , , Korea, Republic of
Clinical Research Center Chapultepec Mexico City
Mexico City , , Mexico
CRYPTEX
Mexico City , , Mexico
ProcliniQ Clinical Research
Mexico City , , 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
Medical Clinic "Komed"
Konin , , Poland
Maria Sklodowska-Curie Institute of Oncology, Branch in Krakow
Kraków , , Poland
St. John Paul 2nd Mazovian Provincial Hospital in Siedlce Limited Liability Company, Siedlce Oncology Centre
Siedlce , , Poland
West Pomeranian Oncology Center
Szczecin , , Poland
Maria Sklodowska-Curie - National Research Institute of Oncology
Warsaw , , Poland
Polish Mother's Memorial Hospital-Research Institute
Łódź , , 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
Cluj-Napoca , , Romania
Onco Clinic Consult S.A.
Craiova , , Romania
Oncology Center "Sf. Nectarie"
Craiova , , 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
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
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung , , 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
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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 3

Estimated Enrollment:

701

Study ID:

NCT05501886

Recruitment Status:

Recruiting

Sponsor:


Celcuity, Inc.

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