VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

Status: Recruiting
Location: See all (181) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- 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 for the duration of the study.

• Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.

• Progression of disease during or within 12 months of completing (neo)adjuvant ET.

• Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.

• Permitted prior therapies:

∙ (neo)adjuvant fulvestrant or any selective ER degrader only if the treatment duration \< 6 months

‣ (neo)adjuvant chemotherapy

‣ (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i

• Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with evaluable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible.

• Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.

• Life expectancy of at least \>6 months.

⁃ Adequate bone marrow, hepatic, renal and coagulation function.

Locations
United States
California
Providence Medical Foundation
NOT_YET_RECRUITING
Fullerton
UCLA Hematology Oncology Ventura
NOT_YET_RECRUITING
Los Angeles
Kansas
The University of Kansas Cancer Center
NOT_YET_RECRUITING
Westwood
Kentucky
Mercy Health-Paducah Cancer Center
RECRUITING
Paducah
Maryland
American Oncology Partners, P.A.
RECRUITING
Bethesda
Michigan
Henry Ford Health System
NOT_YET_RECRUITING
Detroit
Missouri
Saint Luke's Cancer Institute
NOT_YET_RECRUITING
Kansas City
Washington University School of Medicine in Saint Louis
NOT_YET_RECRUITING
St Louis
Montana
SCL Health - Cancer Centers of Montana
NOT_YET_RECRUITING
Billings
New York
Weill Cornell Medical College - NewYork-Presbyterian Hospital
NOT_YET_RECRUITING
New York
University of Rochester Medical Center (URMC) - James P. Wilmot Cancer Center - Pluta Cancer Center (PCC)
NOT_YET_RECRUITING
Rochester
Clinical Research Alliance, Inc.
RECRUITING
Westbury
Ohio
Stefanie Spielman Comprehensive Breast Center at Olentangy River Road
NOT_YET_RECRUITING
Columbus
Pennsylvania
Rittenhouse Hematology/Oncology
NOT_YET_RECRUITING
Philadelphia
South Dakota
Sanford Health
NOT_YET_RECRUITING
Sioux Falls
Texas
University of Texas MD Anderson Cancer Center
NOT_YET_RECRUITING
Houston
Mays Cancer Center
NOT_YET_RECRUITING
San Antonio
Virginia
Bon Secours St. Francis Medical Oncology Center
NOT_YET_RECRUITING
Midlothian
Other Locations
Argentina
Alexander Fleming Institute
NOT_YET_RECRUITING
Buenos Aires
CENIT Foundation
NOT_YET_RECRUITING
Buenos Aires
Center for Medical Education and Clinical Research (CEMIC)
NOT_YET_RECRUITING
Buenos Aires
Centro de Oncologia e Investigacion Buenos Aires COIBA
NOT_YET_RECRUITING
Buenos Aires
Centro Oncológico Korben
NOT_YET_RECRUITING
Buenos Aires
Fleischer Medical Center (Centro Medico Fleischer)
NOT_YET_RECRUITING
Buenos Aires
Fundacion Respirar
NOT_YET_RECRUITING
Buenos Aires
Pergamino Clinic
NOT_YET_RECRUITING
Buenos Aires
Cordoba Oncology Institute (IONC)
NOT_YET_RECRUITING
Córdoba
Centro Oncologico de Excelencia
NOT_YET_RECRUITING
La Plata
Fundación CORI
NOT_YET_RECRUITING
La Rioja
Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
NOT_YET_RECRUITING
Paraná
Rosario's Oncology Institute and Medical Specialities (IOR)
NOT_YET_RECRUITING
Rosario
Australia
GenesisCare - St Andrews
NOT_YET_RECRUITING
Adelaide
Breast Cancer Research Centre
NOT_YET_RECRUITING
Nedlands
Icon Cancer Centre Southport
NOT_YET_RECRUITING
Southport
Sydney Adventist Hospital
NOT_YET_RECRUITING
Wahroonga
Westmead Hospital
NOT_YET_RECRUITING
Westmead
Belgium
Cliniques Universitaires Saint-Luc
NOT_YET_RECRUITING
Brussels
Grand Hopital De Charleroi
NOT_YET_RECRUITING
Charleroi
Universitair Ziekenhuis Gent - Medische Oncologie
NOT_YET_RECRUITING
Ghent
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
NOT_YET_RECRUITING
Hasselt
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
NOT_YET_RECRUITING
Leuven
Brazil
CTO Centro de Tratamento Oncológico
NOT_YET_RECRUITING
Belém
Oncocentro Belo Horizonte
NOT_YET_RECRUITING
Belo Horizonte
Centro Regional Integrado de Oncologia - CRIO
NOT_YET_RECRUITING
Fortaleza
Pronutrir Oncologia e Nutrição
NOT_YET_RECRUITING
Fortaleza
ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA
NOT_YET_RECRUITING
Ijuí
Catarina Pesquisa Clinica
NOT_YET_RECRUITING
Itajaí
Hospital Sao Lucas da PUCRS
NOT_YET_RECRUITING
Porto Alegre
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
NOT_YET_RECRUITING
Ribeirão Preto
Bahia Oncology Center
NOT_YET_RECRUITING
Salvador
Hospital A.C.Camargo
NOT_YET_RECRUITING
São Paulo
Instituto D'or de Pesquisa e Ensino - ONCO STAR
NOT_YET_RECRUITING
São Paulo
Bulgaria
Complex Oncology Center - Burgas
NOT_YET_RECRUITING
Burgas
Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
NOT_YET_RECRUITING
Panagyurishte
Complex Oncological Centre Ruse
NOT_YET_RECRUITING
Rousse
MHAT Nadezhda - Medical Oncology Clinic
NOT_YET_RECRUITING
Sofia
MHAT Serdika EOOD, Base 2 - Second Department of Medical Oncology
NOT_YET_RECRUITING
Sofia
USHAT of Oncology
NOT_YET_RECRUITING
Sofia
France
Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Oncologie Medicale - Cancerolo
NOT_YET_RECRUITING
Amiens
Centre Georges François Baclesse
NOT_YET_RECRUITING
Caen
Centre Georges Francois Leclerc - service d'oncologie médicale
NOT_YET_RECRUITING
Dijon
Clinique Victor Hugo / Centre Jean Bernard
NOT_YET_RECRUITING
Le Mans
APHM Hopital Timone
NOT_YET_RECRUITING
Marseille
Centre Hospitalier Lyon Sud
NOT_YET_RECRUITING
Pierre-bénite
Centre Hospitalier Universitaire de Poitiers - Médico-Chirurgical De Cardiol
NOT_YET_RECRUITING
Poitiers
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau - Oncology
NOT_YET_RECRUITING
Saint-herblain
Institut Gustave Roussy
NOT_YET_RECRUITING
Villejuif
Germany
Universitätsklinikum Düsseldorf - Gynecology
NOT_YET_RECRUITING
Düsseldorf
Universitätsmedizin Johannes Gutenberg
NOT_YET_RECRUITING
Mainz
CaritasKlinikum Saarbrücken St. Theresia
NOT_YET_RECRUITING
Saarbrücken
Helios Klinikum Wuppertal
NOT_YET_RECRUITING
Wuppertal
Greece
Areteio Hospital
NOT_YET_RECRUITING
Athens
University General Hospital of Heraklion
NOT_YET_RECRUITING
Heraklion
General University Hospital Of Larissa
NOT_YET_RECRUITING
Larissa
Iaso Thessalia General Clinic Private Obstetrics S.A.
NOT_YET_RECRUITING
Larissa
Metropolitan Hospital
NOT_YET_RECRUITING
Piraeus
Athens Medical Center S.A.
NOT_YET_RECRUITING
Thessaloniki
Theageneio Cancer Hospital
NOT_YET_RECRUITING
Thessaloniki
Hungary
Debreceni Egyetem Klinikai Központ Nagyerdei Campus - Onkológiai Klinika
NOT_YET_RECRUITING
Debrecen
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
NOT_YET_RECRUITING
Győr
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaza
NOT_YET_RECRUITING
Gyula
Bacs-Kiskun Varmegyei Oktatakorhaz
NOT_YET_RECRUITING
Kecskemét
Pecsi Tudomanyegyetem Klinikai Kozpont
NOT_YET_RECRUITING
Pécs
Tolna Varmegyei Balassa Janos Korhaz
NOT_YET_RECRUITING
Szekszárd
Italy
Ospedale San Martino IRCSS - Oncologia Medica 1
NOT_YET_RECRUITING
Genova
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L
NOT_YET_RECRUITING
Meldola
IEO - Istituto Europeo di Oncologia, IRCCS
NOT_YET_RECRUITING
Milan
Istituto Clinico Humanitas
NOT_YET_RECRUITING
Milan
AOU di Modena, Policlinico di Modena - Attività Integrata di Oncologia ed Ematologia
NOT_YET_RECRUITING
Modena
Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
NOT_YET_RECRUITING
Napoli
Ospedale Maggiore, AOU Parma
NOT_YET_RECRUITING
Parma
IRCCS Policlinico San Matteo, Università degli studi di Pavia
NOT_YET_RECRUITING
Pavia
Fondazione PU Campus Biomedico
NOT_YET_RECRUITING
Roma
Umberto I Policlinico di Roma, Università La Sapienza
NOT_YET_RECRUITING
Roma
Istituto Clinico Humanitas
NOT_YET_RECRUITING
Rozzano
Azienda Ospedaliera Santa Maria di Terni
NOT_YET_RECRUITING
Terni
Ospedale Santa Maria delle Croci di Ravenna - Oncologia
NOT_YET_RECRUITING
Terni
Borgo Trento, Ospedale Civile Maggiore, AOU Integrata Verona
NOT_YET_RECRUITING
Verona
Malaysia
Hospital Universiti Sains Malaysia
NOT_YET_RECRUITING
Kota Bharu
Hospital Kuala Lumpur - Surgery
NOT_YET_RECRUITING
Kuala Lumpur
Pantai Hospital Kuala Lumpur
NOT_YET_RECRUITING
Kuala Lumpur
Hospital Umum Sarawak
NOT_YET_RECRUITING
Kuching
Institut Kanser Negara
NOT_YET_RECRUITING
Putrajaya
Mexico
San Peregrino Unidad de Investigacion
NOT_YET_RECRUITING
Aguascalientes
Office of Emanuel de la Mora Jimenez, MD/equiv
NOT_YET_RECRUITING
Guadalajara
Centro de Atencion Oncologica Viva
NOT_YET_RECRUITING
Mexico City
Clinical Research Center Chapultepec Mexico City
NOT_YET_RECRUITING
Mexico City
Avix Clinical Research
NOT_YET_RECRUITING
Monterrey
Filios High Medicine
NOT_YET_RECRUITING
Monterrey
Administrative Society of Health Services, SC
NOT_YET_RECRUITING
Morelia
Poland
Centrum Onkologii im. prof. F. Lukaszczyka - Ambulatorium Chemioterapii
NOT_YET_RECRUITING
Bydgoszcz
Przychodnia Lekarska KOMED
NOT_YET_RECRUITING
Konin
Pratia MCM Kraków
NOT_YET_RECRUITING
Krakow
Instytut Medyczny Santa Familia
NOT_YET_RECRUITING
Lodz
SP ZOZ Opolskie Centrum Onkologii - Oddzial Onkologii Klinicznej z Odcinkiem Dziennym
NOT_YET_RECRUITING
Opole
Zachodniopomorskie Centrum Onkologii - Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
NOT_YET_RECRUITING
Szczecin
LUX MED Onkologia Sp. z o.o., Szpital Szamocka - Oddzial Onkologii Klinicznej/Chemioterapii
NOT_YET_RECRUITING
Warsaw
Narodowy Instytut Onkologii im. Marii SkÅ'odowskiej-Curie †PaÅstwowy Instytut Badawczy - Klinika Nowotworow Piersi i Chirurg
NOT_YET_RECRUITING
Warsaw
Portugal
Centro Hospitalar e Universitário de Coimbra
NOT_YET_RECRUITING
Coimbra
H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia
NOT_YET_RECRUITING
Lisbon
Hospital CUF Descobertas
NOT_YET_RECRUITING
Lisbon
Hospital da Luz de Lisboa - Learning Health
NOT_YET_RECRUITING
Lisbon
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
NOT_YET_RECRUITING
Lisbon
ULS de Santo Antonio E.P.E.
NOT_YET_RECRUITING
Porto
Republic of Korea
Asan Medical Center - Oncology
RECRUITING
Seoul
Gangnam Severance Hospital
NOT_YET_RECRUITING
Seoul
Korea University Anam Hospital - Gastroenterological Surgery
NOT_YET_RECRUITING
Seoul
Korea University Guro Hospital
NOT_YET_RECRUITING
Seoul
Samsung Medical Center - Hematology & Oncology
NOT_YET_RECRUITING
Seoul
Seoul National University Hospital
NOT_YET_RECRUITING
Seoul
Yonsei University Health System, Severance hospital
NOT_YET_RECRUITING
Seoul
Ajou University Hospital - Hematology/Oncology
NOT_YET_RECRUITING
Suwon
Ulsan University Hospital
RECRUITING
Ulsan
Romania
Centrul de Oncologie Sf Nectarie - Medical Oncology
NOT_YET_RECRUITING
Baia Mare
Oncopremium Team - Medical Oncology
NOT_YET_RECRUITING
Baia Mare
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
NOT_YET_RECRUITING
Bucharest
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
NOT_YET_RECRUITING
Cluj-napoca
Onco Clinic Consult
NOT_YET_RECRUITING
Craiova
Radiotherapy Center Cluj
NOT_YET_RECRUITING
Floreşti
Centrul de Oncologie Euroclinic
NOT_YET_RECRUITING
Iași
Institutul Regional de Oncologie Iasi - Medical Oncology
NOT_YET_RECRUITING
Iași
Spain
Complexo Hospitalario Universitario A Coruña
NOT_YET_RECRUITING
A Coruña
Hospital Universitario de Badajoz
NOT_YET_RECRUITING
Badajoz
Hospital Clinic De Barcelona
NOT_YET_RECRUITING
Barcelona
Hospital Del Mar
NOT_YET_RECRUITING
Barcelona
Hospital San Pedro de Alcántara
NOT_YET_RECRUITING
Cáceres
Hospital Clínico Universitario Virgen De La Arrixaca
NOT_YET_RECRUITING
El Palmar
Institut Catala D'oncologia
NOT_YET_RECRUITING
L'hospitalet De Llobregat
H.U Arnau De Vilanova Lleida
NOT_YET_RECRUITING
Lleida
Hospital Beata Maria Ana
NOT_YET_RECRUITING
Madrid
Hospital Universitario Fundacion Jimenez Diaz
NOT_YET_RECRUITING
Madrid
Hospital Universitario Ramon y Cajal - Oncología Médica
NOT_YET_RECRUITING
Madrid
Complejo Hospitalario Universitario De Santiago
NOT_YET_RECRUITING
Santiago De Compostela
Fundacion Instituto Valenciano de Oncologia
NOT_YET_RECRUITING
Valencia
Taiwan
Changhua Christian Medical Foundation - Changhua Christian Hospital - Neurology
NOT_YET_RECRUITING
Changhua
Kaohsiung Medical University - Chung-Ho Memorial Hospital - Breast Surgery
NOT_YET_RECRUITING
Kaohsiung City
China Medical University Hospital - Breast Surgery
NOT_YET_RECRUITING
Taichung
National Cheng Kung University Hospital - Gynecology/Obstetrics
NOT_YET_RECRUITING
Tainan City
National Taiwan University Hospital - Oncology
NOT_YET_RECRUITING
Taipei
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare - Nephrology
NOT_YET_RECRUITING
Taipei
Taipei Veterans General Hospital - Hematology
NOT_YET_RECRUITING
Taipei
Thailand
King Chulalongkorn Memorial Hospital [Medical Oncology]
NOT_YET_RECRUITING
Bangkok
Rajavithi Hospital
NOT_YET_RECRUITING
Bangkok
Siriraj Hospital - Medical Oncology
NOT_YET_RECRUITING
Bangkok
Prince of Songkla University - Internal Medicine
NOT_YET_RECRUITING
Hat Yai
Banphaeo General Hospital
NOT_YET_RECRUITING
Samut Sakhon
Turkey
Medical Park Seyhan Hastanesi
NOT_YET_RECRUITING
Adana
Ankara University Medical Faculty - Oncology
NOT_YET_RECRUITING
Ankara
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi
NOT_YET_RECRUITING
Ankara
Gulhane Egitim Arastirma Hastanesi
NOT_YET_RECRUITING
Ankara
Hacettepe University Medical Faculty - Hematology
NOT_YET_RECRUITING
Ankara
Memorial Ankara Hastanesi
NOT_YET_RECRUITING
Ankara
Dicle Universitesi Hastanesi
NOT_YET_RECRUITING
Diyarbakır
Trakya Univ Hastanesi Ic Hastal
NOT_YET_RECRUITING
Edirne
Goztepe SuleymanYalcin Sehir Hast
NOT_YET_RECRUITING
Istanbul
Medical Park Florya Hastanesi
NOT_YET_RECRUITING
Istanbul
Medipol Mega Hospital - Medical Oncology
NOT_YET_RECRUITING
Istanbul
Izmir Medical Park Hospital - Medical Oncology
NOT_YET_RECRUITING
Izmir
Kocaeli Uni Uyg ve Ars Hst
NOT_YET_RECRUITING
İzmit
Necmettin Erbakan University Meram Medical Faculty - Oncology
NOT_YET_RECRUITING
Konya
VM Medical Park Mersin Hastanesi
NOT_YET_RECRUITING
Mersin
Contact Information
Primary
Nadene Zack, MS
viktoria-2_eligibility@celcuity.com
844-310-3900
Time Frame
Start Date: 2025-06-30
Estimated Completion Date: 2028-12-30
Participants
Target number of participants: 674
Treatments
Experimental: Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant
Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Active_comparator: Arm B: Palbociclib or Ribociclib + Fulvestrant
Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle
Related Therapeutic Areas
Sponsors
Leads: Celcuity Inc

This content was sourced from clinicaltrials.gov

Similar Clinical Trials