Breast CancerPhase 3NCT06757634

Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)

A Phase 3 study testing Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant and Arm C: Gedatolisib + Palbociclib + Letrozole in people with Breast Cancer, run by Celcuity Inc at 239 sites in 25 countries.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

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 and palbociclib plus endocrine therapy for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer. 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?: Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant and Arm C: Gedatolisib + Palbociclib + Letrozole
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,180 participants
Where: 239 sitesin 25 countries
Study dates: 24 Jul 2025to 30 Jul 2033
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 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 endocrine therapy (ET) or progression of disease after 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:

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(neo)adjuvant fulvestrant 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
Study 1: if disease progression was on or within event occurred >6 months of discontinuation after completion of CDK4/6 inhibitor portion of treatment.
Study 2: if disease progression event occurred >12 months after completion of CDK4/6 inhibitor portion of treatment.
Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with nonmeasurable 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.

Who cannot join

Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.
Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting.
Prior treatment with systemic anticancer therapy for ABC
Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy.
Known and untreated, or active, brain or leptomeningeal metastases
History of clinically significant cardiovascular abnormalities
Known, clinically significant ophthalmic conditions
History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis

Trial locations and contacts

239 sites in 25 countries. Contact the study team or a site near you to ask about taking part.

Nadene Zack, MS contact

844-310-3900

viktoria-2_trial@celcuity.com

Country

City, postcode or hospital

Sites recruiting now only

239 sites in 25 countries

United States30 sites, 28 recruiting

University of Colorado Hospital - Cancer Center
Aurora, Colorado, 80045
Not yet recruiting
American Oncology Partners, P.A.
Bethesda, Maryland, 20817
Withdrawn
SCL Health - Cancer Centers of Montana
Billings, Montana, 59102
Recruiting
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114
Not yet recruiting
Stefanie Spielman Comprehensive Breast Center at Olentangy River Road
Columbus, Ohio, 43210
Recruiting
Henry Ford Health System
Detroit, Michigan, 48202
Recruiting
City of Hope Medical Center
Duarte, California, 91010
Not yet recruiting
The Center for Cancer and Blood Disorders - Breast Center
Fort Worth, Texas, 76104
Not yet recruiting
Providence Medical Foundation
Fullerton, California, 92835
Recruiting
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000
Recruiting
St Bernards Medical Center
Jonesboro, Arkansas, 72401
Not yet recruiting
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111-5965
Recruiting
CARTI Cancer Center
Little Rock, Arkansas, 72205
Not yet recruiting
UCLA Hematology Oncology Santa Monica
Los Angeles, California, 90404
Recruiting
Bon Secours St. Francis Medical Oncology Center
Midlothian, Virginia, 23114-3203
Recruiting
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, 10065
Recruiting
Mercy Health-Paducah Cancer Center
Paducah, Kentucky, 42003
Recruiting
Rittenhouse Hematology/Oncology
Philadelphia, Pennsylvania, 19004
Withdrawn
UPMC Hillman Cancer Center
Pittsburgh, Pennsylvania, 15232
Not yet recruiting
BRCR Medical Center, Inc- Internal Medicine
Plantation, Florida, 33322
Recruiting
OHSU Research Integrity
Portland, Oregon, 97239
Not yet recruiting
Cancer Care Associates
Redondo Beach, California, 90277
Not yet recruiting
Mays Cancer Center
San Antonio, Texas, 78229
Recruiting
UC San Diego Moores Cancer Center
San Diego, California, 92093
Not yet recruiting
Christus Saint Vincent Regional Cancer Center
Santa Fe, New Mexico, 87505
Not yet recruiting
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Recruiting
Washington University School of Medicine in Saint Louis
St Louis, Missouri, 63110
Recruiting
BRCR Medical Center, INC
Tamarac, Florida, 33321
Recruiting
Clinical Research Alliance, Inc.
Westbury, New York, 11590
Recruiting
The University of Kansas Cancer Center
Westwood, Kansas, 66205
Recruiting

Other trials in United States

China19 sites, 19 recruiting

Cancer Hospital Chinese Academy of Medical Sciences - Head and Neck Surgery Department
Beijing, Beijing Municipality, 100021
Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Not yet recruiting
Xiangya Hospital Central South University-Breast surgery
Changsha, Hunan, 410008
Not yet recruiting
Hunan Cancer Hospital -Oncology
Changsha, Hunan, 410013
Not yet recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine - Medical Oncology
Hangzhou, Zhejiang, 310009
Not yet recruiting
Shandong Provincial Hospital - Oncology
Jinan, Shandong, 250021
Not yet recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471003
Not yet recruiting
Nanchang People's Hospital
Nanchang, Jiangxi, 330009
Not yet recruiting
Jiangsu Cancer Institute & Hospital
Nanjing, Jiangsu, 210009
Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315041
Not yet recruiting
Fujian Medical University Affiliated Second Hospital
Quanzhou, Fujian, 362002
Not yet recruiting
The Central Hospital of Shaoyang-Breast surgery
Shaoyang, Hunan, 422000
Not yet recruiting
Shengjing Hospital of China Medical University ( Nanhu Campus )
Shenyang, Liaoning, 110004
Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital - Breast Tumor Department
Tianjin, Tianjin Municipality, 300060
Not yet recruiting
Weifang People's Hospital
Weifang, Shandong, 261000
Not yet recruiting
Xi'an International Medical Center Hospital - Oncology
Xi'an, Shaanxi, 710100
Not yet recruiting
The First Affiliated Hospital of Henan Medical University
Xinxiang, Henan, 453199
Not yet recruiting
Yangzhou University - Clinical Medical School - Northern Jiangsu People's Hospital (NJPH) (Subei People's Hospital)
Yangzhou, Jiangsu, 225012
Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Not yet recruiting

Other trials in China

Italy16 sites, 16 recruiting

Presidio Ospedaliero S. Croce - Oncologia
Fano, 61032
Not yet recruiting
IRCCS Ospedale Policlinico San Martino - Clinica di Oncologia Medica
Genova, 16132
Not yet recruiting
IRST IRCCS - Oncologia Medica
Meldola, 47014
Not yet recruiting
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, 20141
Not yet recruiting
AOU di Modena, Policlinico di Modena - Attività Integrata di Oncologia ed Ematologia
Modena, 41124
Not yet recruiting
Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
Naples, 80131
Not yet recruiting
Ospedale Maggiore, AOU Parma
Parma, 43126
Not yet recruiting
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Pavia, 27100
Not yet recruiting
Nuovo Ospedale di Prato S. Stefano - Oncologia Medica
Prato, 59100
Not yet recruiting
Ospedale "Santa Maria delle Croci" di Ravenna - Oncologia
Ravenna, 48121
Not yet recruiting
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128
Not yet recruiting
Umberto I Policlinico di Roma, Università La Sapienza
Roma, 00161
Not yet recruiting
Istituto Clinico Humanitas
Rozzano, 20089
Not yet recruiting
Azienda Ospedaliera Santa Maria di Terni
Terni, 05100
Not yet recruiting
Ospedale Santa Maria della Misericordia di Udine - Oncologia
Udine, 33100
Not yet recruiting
Borgo Trento, Ospedale Civile Maggiore, AOU Integrata Verona
Verona, 37126
Not yet recruiting

Other trials in Italy

Turkey (Türkiye)14 sites, 14 recruiting

Adana Baskent Practice and Research Hospital - Oncology
Adana, 1120
Recruiting
Gulhane Training and Research Hospital - Medical Oncology
Ankara, 06010
Recruiting
Hacettepe University Medical Faculty - Hematology
Ankara, 06100
Recruiting
Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology
Ankara, 06200
Recruiting
Memorial Ankara Hastanesi
Ankara, 06520
Recruiting
Ankara University Medical Faculty - Oncology
Ankara, 06590
Recruiting
Dicle University Medical Faculty Hospital Medical Oncology
Diyarbakır, 21280
Recruiting
Trakya University Medical Faculty - Oncology
Edirne, 22030
Recruiting
Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya
Istanbul, 34153
Recruiting
Medipol Mega Hospital - Medical Oncology
Istanbul, 34214
Recruiting
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
Istanbul, 34722
Recruiting
Kocaeli Uni Egt ve Uyg Hast
İzmit, 41001
Recruiting
Necmettin Erbakan University Meram Medical Faculty - Oncology
Konya, 42080
Recruiting
VM Medical Park Mersin Hastanesi
Mezitli, 33200
Recruiting

Other trials in Turkey (Türkiye)

Argentina13 sites, 13 recruiting

Centro de Oncologia e Investigacion Buenos Aires COIBA
Buenos Aires, B1884BBF
Not yet recruiting
Pergamino Clinic
Buenos Aires, B2700CPM
Not yet recruiting
Centro de Investigaciones Médicas y Desarrollo LC
Buenos Aires, C1113 AEE
Not yet recruiting
Fleischer Medical Center (Centro Medico Fleischer)
Buenos Aires, C1414
Not yet recruiting
Fundacion Respirar
Buenos Aires, C1426ABP
Not yet recruiting
Centro Oncológico Korben
Buenos Aires, C1426AGE
Not yet recruiting
Alexander Fleming Institute
Buenos Aires, C1426ANZ
Not yet recruiting
Center for Medical Education and Clinical Research (CEMIC)
Buenos Aires
Not yet recruiting
Cordoba Oncology Institute (IONC)
Córdoba, X5006HBF
Not yet recruiting
Fundación CORI
La Rioja
Not yet recruiting
Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
Paraná, E3100HYB
Not yet recruiting
Rosario's Oncology Institute and Medical Specialities (IOR)
Rosario
Not yet recruiting
Centro Oncologico de Excelencia
San Juan, 5400
Not yet recruiting

Other trials in Argentina

South Korea13 sites, 13 recruiting

National Cancer Center - Breast Cancer
Goyang, 10408
Not yet recruiting
Gachon University Gil Medical Center - Oncology
Incheon, 21565
Not yet recruiting
CHA Bundang Medical Center - Oncology
Seongnam-si, 13496
Not yet recruiting
Korea University Anam Hospital - Gastroenterological Surgery
Seoul, 02841
Recruiting
Seoul National University Hospital
Seoul, 03080
Recruiting
Yonsei University Health System, Severance hospital
Seoul, 03722
Recruiting
Asan Medical Center - Oncology
Seoul, 05505
Recruiting
Gangnam Severance Hospital
Seoul, 06273
Recruiting
Samsung Medical Center - Hematology & Oncology
Seoul, 06351
Recruiting
Korea University Guro Hospital
Seoul, 08308
Recruiting
The Catholic University of Korea, Seoul St. Mary's Hospital - Hematology and Oncology
Seoul, 6591
Not yet recruiting
Ajou University Hospital - Hematology/Oncology
Suwon, 16499
Recruiting
Ulsan University Hospital
Ulsan, 44033
Recruiting

Other trials in South Korea

Spain13 sites, 13 recruiting

Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
Not yet recruiting
Hospital Universitario de Badajoz
Badajoz, 06006
Not yet recruiting
Hospital Del Mar
Barcelona, 08003
Not yet recruiting
Hospital Clinic De Barcelona
Barcelona, 08036
Not yet recruiting
Caceres Hospital Complex - San Pedro de Alcantara General Hospital
Cáceres, 10002
Not yet recruiting
Hospital Clínico Universitario Virgen De La Arrixaca
El Palmar, 30120
Not yet recruiting
Institut Catala D'oncologia
L'Hospitalet de Llobregat, 08908
Not yet recruiting
H.U Arnau De Vilanova Lleida
Lleida, 25198
Not yet recruiting
Hospital Beata Maria Ana de Jesus
Madrid, 28007
Not yet recruiting
Hospital Universitario Ramon y Cajal - Oncología Médica
Madrid, 28034
Not yet recruiting
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Not yet recruiting
Complejo Hospitalario Universitario De Santiago
Santiago de Compostela, 15706
Not yet recruiting
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009
Not yet recruiting

Other trials in Spain

Taiwan12 sites, 12 recruiting

Changhua Christian Medical Foundation - Changhua Christian Hospital - Neurology
Changhua, 500209
Recruiting
National Taiwan University Hospital - Yunlin Branch - Oncology
Douliu, 640203
Not yet recruiting
Kaohsiung Medical University - Chung-Ho Memorial Hospital - Breast Surgery
Kaohsiung City, 807377
Recruiting
China Medical University Hospital - Breast Surgery
Taichung, 404327
Recruiting
Taichung Veterans General Hospital - General Surgery
Taichung, 407219
Not yet recruiting
National Cheng Kung University Hospital - Gynecology/Obstetrics
Tainan, 704302
Recruiting
Chi Mei Medical Center - YongKang - Oncology and Hematology
Tainan, 71004
Not yet recruiting
Chi Mei Medical Center - Liouying - Oncology
Tainan, 736402
Not yet recruiting
National Taiwan University Hospital - Oncology
Taipei, 100225
Recruiting
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare - Nephrology
Taipei, 112201
Recruiting
Taipei Veterans General Hospital - Hematology
Taipei, 112201
Recruiting
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology
Taipei, 116079
Not yet recruiting

Other trials in Taiwan

Poland9 sites, 9 recruiting

Centrum Onkologii im. prof. F. Lukaszczyka - Ambulatorium Chemioterapii
Bydgoszcz, 85796
Not yet recruiting
Przychodnia Lekarska KOMED
Konin, 62500
Not yet recruiting
Pratia MCM Kraków
Krakow, 30727
Not yet recruiting
Instytut Medyczny Santa Familia
Lodz, 90302
Not yet recruiting
SP ZOZ Opolskie Centrum Onkologii - Oddzial Onkologii Klinicznej z Odcinkiem Dziennym
Opole, 45060
Not yet recruiting
Mazowiecki Szpital Wojewodzki im. sw. Jana Pawla II w Siedlcach Sp. z o.o. - Oddział Onkologii Klinicznej i Radioterapii
Siedlce, Masovian Voivodeship, 08-110
Not yet recruiting
Zachodniopomorskie Centrum Onkologii - Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
Szczecin, 71730
Not yet recruiting
LUX MED Onkologia Sp. z o.o., Szpital Szamocka - Oddzial Onkologii Klinicznej/Chemioterapii
Warsaw, 01748
Not yet recruiting
Narodowy Instytut Onkologii im. Marii SkÅ'odowskiej-Curie â€" PaÅ"stwowy Instytut Badawczy - Klinika Nowotworow Piersi i Chirurg
Warsaw, 02781
Not yet recruiting

Other trials in Poland

Australia8 sites, 8 recruiting

GenesisCare - St Andrews
Adelaide, 5000
Recruiting
Sunshine Coast University Private Hospital-Coastal Cancer Care
Birtinya, Queensland, 4575
Not yet recruiting
Austin Health
Heidelberg, Victoria, 3084
Not yet recruiting
Breast Cancer Research Centre
Nedlands, 6009
Recruiting
Icon Cancer Centre Southport
Southport, 4215
Recruiting
Sydney Adventist Hospital
Wahroonga, 2076
Recruiting
Westmead Hospital
Westmead, 2145
Recruiting
The Queen Elizabeth Hospital
Woodville, 5011
Recruiting

Other trials in Australia

France8 sites, 8 recruiting

Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Oncologie Medicale - Cancerolo
Amiens, 80054
Not yet recruiting
Centre Georges François Baclesse
Caen, 14076 Cedex 05
Not yet recruiting
Centre Georges Francois Leclerc - service d'oncologie médicale
Dijon, 21079
Not yet recruiting
Clinique Victor Hugo / Centre Jean Bernard
Le Mans, 72015
Not yet recruiting
CHU La Timone
Marseille, 13005
Not yet recruiting
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495
Not yet recruiting
Centre Hospitalier Universitaire de Poitiers - Médico-Chirurgical De Cardiol
Poitiers, 86000
Not yet recruiting
Institut Gustave Roussy
Villejuif, 94800
Not yet recruiting

Other trials in France

Romania8 sites, 8 recruiting

Centrul de Oncologie Sf Nectarie - Medical Oncology
Baia Mare, 200746
Not yet recruiting
Oncopremium Team - Medical Oncology
Baia Mare, 430295
Not yet recruiting
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Bucharest, 400015
Not yet recruiting
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
Cluj-Napoca, 022328
Not yet recruiting
Onco Clinic Consult
Craiova, 200094
Not yet recruiting
Radiotherapy Center Cluj
Floreşti, 407280
Not yet recruiting
Victoria Hospital - Oncology
Iași, 700106
Not yet recruiting
Institutul Regional de Oncologie Iasi - Medical Oncology
Iași, 700483
Not yet recruiting

Other trials in Romania

United Kingdom8 sites, 8 recruiting

NHS Lothian - Western General Hospital
Bathgate, Edinburgh, EH4 2XU
Not yet recruiting
Cambridge University Hospitals NHS Foundation Trust - Addenbrooke's Hospital
Cambridge, Cambridgeshire, CB2 0QQ
Not yet recruiting
Hull University Teaching Hospitals NHS Trust - Castle Hill Hospital- Queen's Centre for Oncology & Haematology
Cottingham, HU16 5JQ
Not yet recruiting
NHS Greater Glasgow and Clyde - The Beatson West of Scotland Cancer Centre
Glasgow, G12 0YN
Not yet recruiting
Leeds Teaching Hospitals NHS Trust - St James' University Hospital
Leeds, LS9 7TF
Not yet recruiting
Maidstone and Tunbridge Wells NHS Trust - Kent Oncology Centre
Maidstone, Kent, ME16 9QQ
Not yet recruiting
East and North Hertfordshire NHS Trust - Mount Vernon Cancer Centre
Rickmansworth, Hertfordshire, HA6 2RN
Not yet recruiting
Somerset NHS Foundation Trust - Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
Not yet recruiting

Other trials in United Kingdom

Czechia7 sites, 7 recruiting

Masarykuv onkologicky ustav - Oddeleni klinickych hodnoceni
Brno, 656 53
Not yet recruiting
Multiscan s.r.o. - Ambulance klinicke onkologie se stacionarem
Hořovice, 268 31
Not yet recruiting
FN Hradec Kralove - Klinika onkologie a radioterap
Hradec Králové, 500 05
Not yet recruiting
Fakultni nemocnice Olomouc - Onkologicka klinika
Olomouc, 779 00
Not yet recruiting
FN Kralovske Vinohrady - Radioterapeuticka a onkologicka klinika
Prague, 100 34
Not yet recruiting
Fakultni Thomayerova Nemocnice - Onkologicka klinika
Prague, 140 59
Not yet recruiting
Fakultni Nemocnice v Motole
Prague, 150 06
Not yet recruiting

Other trials in Czechia

Greece7 sites, 7 recruiting

Evgenidion Clinic Agia Trias S.A.
Attiki, Athens, 11528
Not yet recruiting
University General Hospital of Heraklion
Heraklion, 71110
Not yet recruiting
Iaso Thessalia General Clinic Private Obstetrics S.A.
Larissa, 41000
Not yet recruiting
General University Hospital Of Larissa
Larissa, 41110
Not yet recruiting
Metropolitan Hospital
Piraeus, 18547
Not yet recruiting
Athens Medical Center S.A.
Thessaloniki, 54639
Not yet recruiting
Theageneio Cancer Hospital
Thessaloniki, 54639
Not yet recruiting

Other trials in Greece

Malaysia7 sites, 7 recruiting

Penang Adventist Hospital
George Town, 10350
Not yet recruiting
Hospital Universiti Sains Malaysia
Kota Bharu, 16150
Recruiting
Hospital Kuala Lumpur - Surgery
Kuala Lumpur, 50603
Recruiting
Pantai Hospital Kuala Lumpur
Kuala Lumpur, 50603
Recruiting
Hospital Umum Sarawak
Kuching, 93586
Recruiting
Beacon Hospital
Petaling Jaya, 46050
Not yet recruiting
National Cancer Institute - Radiotherapy and Oncology
Putrajaya, 62250
Recruiting

Other trials in Malaysia

Mexico7 sites, 7 recruiting

San Peregrino Unidad de Investigacion
Aguascalientes, 20230
Not yet recruiting
Office of Emanuel de la Mora Jimenez, MD/equiv
Guadalajara, 44680
Not yet recruiting
Clinical Research Center Chapultepec Mexico City
Mexico City, 04100
Not yet recruiting
Centro de Atencion Oncologica Viva
Mexico City, 06760
Not yet recruiting
Avix Clinical Research
Monterrey, 64623
Not yet recruiting
Filios High Medicine
Monterrey, 64710
Not yet recruiting
Administrative Society of Health Services, SC
Morelia, 58260
Not yet recruiting

Other trials in Mexico

Bulgaria6 sites, 6 recruiting

Complex Oncology Center - Burgas
Burgas, 8000
Not yet recruiting
Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, 4500
Not yet recruiting
Complex Oncological Centre Ruse
Rousse, 7002
Not yet recruiting
MHAT Nadezhda - Medical Oncology Clinic
Sofia, 1330
Not yet recruiting
MHAT "Serdika" EOOD, Base 2 - Second Department of Medical Oncology
Sofia, 1632
Not yet recruiting
USHAT of Oncology
Sofia, 1756
Not yet recruiting

Other trials in Bulgaria

Hungary6 sites, 6 recruiting

Debreceni Egyetem Klinikai Központ Nagyerdei Campus - Onkológiai Klinika
Debrecen, 4032
Not yet recruiting
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, 9024
Not yet recruiting
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház - Oncology
Gyula, 5700
Not yet recruiting
Bacs-Kiskun Varmegyei Oktatakorhaz
Kecskemét, 6000
Not yet recruiting
University of Pecs- Oncology Dept.
Pécs, 7624
Not yet recruiting
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100
Not yet recruiting

Other trials in Hungary

Portugal6 sites, 6 recruiting

Centro Hospitalar e Universitário de Coimbra
Coimbra, 3000-993
Not yet recruiting
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
Lisbon, 1099-023
Not yet recruiting
Hospital da Luz de Lisboa - Learning Health
Lisbon, 1500-650
Not yet recruiting
H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia
Lisbon, 1649-035
Not yet recruiting
Hospital CUF Descobertas
Lisbon, 1998018
Not yet recruiting
Centro Hospitalar Universitario do Porto - H. Santo Antonio
Porto, 4099-001
Not yet recruiting

Other trials in Portugal

Belgium5 sites, 5 recruiting

Cliniques Universitaires Saint-Luc
Brussels, 1200
Not yet recruiting
Grand Hopital De Charleroi
Charleroi, 6060
Not yet recruiting
Universitair Ziekenhuis Gent - Medische Oncologie
Ghent, 9000
Not yet recruiting
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
Hasselt, 3500
Not yet recruiting
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000
Not yet recruiting

Other trials in Belgium

Thailand5 sites, 5 recruiting

King Chulalongkorn Memorial Hospital [Medical Oncology]
Bangkok, 10330
Recruiting
Rajavithi Hospital
Bangkok, 10400
Recruiting
Siriraj Hospital - Medical Oncology
Bangkok, 10700
Recruiting
Prince of Songkla University - Internal Medicine
Hat Yai, 90110
Recruiting
Banphaeo General Hospital
Samut Sakhon, 74120
Recruiting

Other trials in Thailand

Denmark4 sites, 4 recruiting

Aalborg Universitetshospital - Oncology
Aalborg, North Denmark, 9100 North Jutland Region
Not yet recruiting
Rigshospitalet
Copenhagen, Capital Region of Denmark, 2100
Not yet recruiting
Region Hovedstaden
Hillerød, Capital Region of Denmark, 3400
Not yet recruiting
Odense Universitetshospital - Oncology
Odense, Region of South Denmark, 5000
Not yet recruiting

Other trials in Denmark

Finland4 sites, 4 recruiting

Comprehensive Cancer Center, Helsinki University Hospital
Helsinki, Uusimaa, 00029
Not yet recruiting
Tampere University Hospital Department of Oncology
Tampere, Uusimaa, 33520
Not yet recruiting
Turku University Hospital - Oncology And Radiotherapy
Turku, Länsi-Suomen Lääni, 20520
Not yet recruiting
Vaasa Central Hospital
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Germany4 sites, 4 recruiting

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Düsseldorf, 40225
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Universitätsmedizin Johannes Gutenberg
Mainz, 55131
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CaritasKlinikum Saarbrücken St. Theresia
Saarbrücken, 66113
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Helios Klinikum Wuppertal
Wuppertal, 42283
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About this study

Official title: VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer

Read the detailed description

This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus endocrine therapy and palbociclib versus endocrine therapy and ribociclib 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 completion of the screening procedures to determine eligibility, patients will be assigned manually according to their endocrine sensitivity status to either Study 1 (endocrine-resistant) or Study 2 (endocrine-sensitive) and subsequently be randomized 1:1 to either investigational treatment or standard-of-care control.

Study 1 is expected to enroll approximately 440 subjects with treatment-naïve endocrine-resistant ABC whose cancer progressed while receiving or within 12 months of completing adjuvant endocrine therapy. The trial will evaluate the efficacy and safety of the investigational arm (gedatolisib combined with palbociclib and fulvestrant - Arm A) compared to the control arm (ribociclib combined with fulvestrant - Arm B).

Study 2 is expected to enroll approximately 740 subjects with treatment-naïve endocrine-sensitive ABC whose cancer relapsed or progressed 12 months or more after completion of adjuvant endocrine therapy, or those with de novo metastatic disease without prior endocrine therapy exposure. The trial will evaluate the efficacy and safety of the investigational arm (gedatolisib combined with palbociclib and letrozole - Arm C) compared to the control arm (ribociclib combined with letrozole - Arm D).

Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib and ribociclib are CDK4/6 inhibitors. Fulvestrant is a selective estrogen receptor degrader (SERD). Letrozole is an aromatase inhibitor (AI).

Conditions: Breast Cancer
Being tested: Arm A: Gedatolisib + Palbociclib + Fulvestrant, Arm B: Ribociclib + Fulvestrant, Arm C: Gedatolisib + Palbociclib + Letrozole, Arm D: Ribociclib + Letrozole
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.

Arm A: Gedatolisib + Palbociclib + FulvestrantDrug
Also called PF-05212384, IBRANCE, Faslodex
Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Other Names:
- PF-05212384
Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle.
Other Names:
- IBRANCE
Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks
Other Names:
- Faslodex
Arm B: Ribociclib + FulvestrantDrug
Also called KISQALI®, Faslodex
Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle
Other Names:
- KISQALI®
Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant approximately every 2 weeks during Cycle 1 then approximately every 4 weeks
Other Names:
- Faslodex
Arm C: Gedatolisib + Palbociclib + LetrozoleDrug
Also called PF-05212384, IBRANCE, FEMARA
Drug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle.
Drug: Letrozole Participants will receive oral letrozole daily.
Arm D: Ribociclib + LetrozoleDrug
Also called KISQALI®, FEMARA
Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle
Drug: Letrozole Participants will receive oral letrozole daily.

Study groups in NCT06757634
Study group	Role	What they receive
Arm A: Gedatolisib + Palbociclib + Fulvestrant	Experimental	Subjects with treatment-naïve endocrine-resistant ABC. Receives: Drug: Arm A: Gedatolisib + Palbociclib + Fulvestrant
Arm B: Ribociclib + Fulvestrant	Active comparator	Subjects with treatment-naïve endocrine-resistant ABC. Receives: Drug: Arm B: Ribociclib + Fulvestrant
Arm C: Gedatolisib + Palbociclib + Letrozole	Experimental	Subjects with treatment-naïve endocrine-sensitive ABC. Receives: Drug: Arm C: Gedatolisib + Palbociclib + Letrozole
Arm D: Ribociclib + Letrozole	Active comparator	Subjects with treatment-naïve endocrine-sensitive ABC. Receives: Drug: Arm D: Ribociclib + Letrozole

What is being measured

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

Progression Free Survival (PFS)
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

Secondary outcomes (7)

Overall Survival (OS)
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
Overall Response Rate (ORR)
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
Duration of Response (DOR)
Time from the assessment of initial response (PR or better) to death or first documented radiologically confirmed disease progression as assessed by BICR, whichever occurs first
Measured: Up to approximately 48 months
Time to Response (TTR)
Time to Response (TTR)
Measured: Time from randomization to the first assessment of PR or better as assessed by BICR
Clinical Benefit Rate (CBR)
Percentage of subjects with CR or PR; or with stable disease (SD) lasting >24 weeks as assessed by BICR
Measured: Up to approximately 48 months
Quality of Life (QOL) Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI)
Measured: From baseline to 30 Day Safety Follow-up
Adverse Events
Type, incidence, severity (as graded by the NCI CTCAE v5.0), seriousness, and relationship to study medications of Adverse Events 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.

24 Jul 202530 Jul 2033

First posted3 Jan 2025
Study start24 Jul 2025
Primary completion31 Mar 2029 (estimated)
Study completion30 Jul 2033 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 1,180 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT06757634
Sponsor's protocol ID: CELC-G-302
Status last verified: May 2026
First submitted: 24 Dec 2024
Last updated: 9 Oct 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided

Interested in taking part?

Nadene Zack, MS

844-310-3900

viktoria-2_trial@celcuity.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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Study at a glance

From the registry record, last updated by the sponsor on 9 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study Evaluating Efficacy and Safety of Gedatolisib With Endocrine Therapy and Palbociclib vs Endocrine Therapy and Ribociclib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer
ClinicalTrials.gov ID: NCT06757634
Acronym / sponsor ID: CELC-G-302
Conditions: Breast Cancer
Keywords: Breast Cancer, Advanced or Metastatic, Gedatolisib, HR Positive, ER Positive, HER2 Negative, PIK3CA MT, PI3K
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 1,180 participants (estimated)
Lead sponsor: Celcuity IncIndustry (pharma, biotech, devices)
Study start: 24 Jul 2025 (actual)
Primary completion: 31 Mar 2029 (estimated)
Study completion: 30 Jul 2033 (estimated)
First posted: 3 Jan 2025 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Arm A: Gedatolisib + Palbociclib + Fulvestrant	Experimental	Drug: Arm A: Gedatolisib + Palbociclib + FulvestrantSubjects with treatment-naïve endocrine-resistant ABC.
Arm B: Ribociclib + Fulvestrant	Active comparator	Drug: Arm B: Ribociclib + FulvestrantSubjects with treatment-naïve endocrine-resistant ABC.
Arm C: Gedatolisib + Palbociclib + Letrozole	Experimental	Drug: Arm C: Gedatolisib + Palbociclib + LetrozoleSubjects with treatment-naïve endocrine-sensitive ABC.
Arm D: Ribociclib + Letrozole	Active comparator	Drug: Arm D: Ribociclib + LetrozoleSubjects with treatment-naïve endocrine-sensitive ABC.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (15 listed)

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 endocrine therapy (ET) or progression of disease after 12 months of completing (neo)adjuvant ET.
Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.

Key exclusion criteria (8 listed)

Concurrent malignancies other than adequately treated non-melanoma skin cancer. Previous malignancies in remission but curatively treated with no evidence of disease progression and judged by local Investigator to be at low risk of impacting health or survival while on study.
Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor or any other selective estrogen receptor degrader (SERD), except fulvestrant, used in (neo)adjuvant setting.
Prior treatment with systemic anticancer therapy for ABC
Subjects with type 1 diabetes, or uncontrolled type 2 diabetes requiring daily insulin therapy.
Known and untreated, or active, brain or leptomeningeal metastases

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Arm A: Gedatolisib + Palbociclib + FulvestrantAlso: PF-05212384, IBRANCE, FaslodexDrug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Other Names: • PF-05212384 Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Other Names: • IBRANCE Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant every 2 weeks during Cycle 1 and then every 4 weeks Other Names: • Faslodex	Drug	Arm A: Gedatolisib + Palbociclib + Fulvestrant
Arm B: Ribociclib + FulvestrantAlso: KISQALI®, FaslodexDrug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Other Names: • KISQALI® Drug: Fulvestrant Participants will receive intramuscular (IM) fulvestrant approximately every 2 weeks during Cycle 1 then approximately every 4 weeks Other Names: • Faslodex	Drug	Arm B: Ribociclib + Fulvestrant
Arm C: Gedatolisib + Palbociclib + LetrozoleAlso: PF-05212384, IBRANCE, FEMARADrug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle. Drug: Letrozole Participants will receive oral letrozole daily.	Drug	Arm C: Gedatolisib + Palbociclib + Letrozole
Arm D: Ribociclib + LetrozoleAlso: KISQALI®, FEMARADrug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Drug: Letrozole Participants will receive oral letrozole daily.	Drug	Arm D: Ribociclib + Letrozole

Primary outcome

Progression Free Survival (PFS)
Time frame: From date of randomization to the date of death due to any cause, up to approximately 48 months
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)

7 secondary outcomes

Overall Survival (OS)
Time frame: From date of randomization to the date of death due to any cause, up to approximately 48 months
Overall Response Rate (ORR)
Time frame: Up to approximately 48 months
Duration of Response (DOR)
Time frame: Up to approximately 48 months
Time to Response (TTR)
Time frame: Time from randomization to the first assessment of PR or better as assessed by BICR
Clinical Benefit Rate (CBR)
Time frame: Up to approximately 48 months
Quality of Life (QOL) Functional Assessment of Cancer Therapy - Breast Trial Outcome Index (FACT-B TOI)
Time frame: From baseline to 30 Day Safety Follow-up
Adverse Events
Time frame: Up to approximately 48 months

Results and safety

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

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 9 Oct 2026.
Individual participant dataSharing planned: Undecided

Related trials for Breast Cancer

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Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Nadene Zack, MS contact

844-310-3900

viktoria-2_trial@celcuity.com

239 sites in 25 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 15 inclusion and 8 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: looking for participants now, as of the sponsor's last update on 9 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 239 sites in United States, China, Italy, Turkey (Türkiye), Argentina and 20 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?

Contact Nadene Zack, MS (844-310-3900, viktoria-2_trial@celcuity.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression Free Survival (PFS) (time frame: From date of randomization to the date of death due to any cause, up to 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 NCT06757634.

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 9 Oct 2026.