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

May 14, 2026 updated by: Celcuity Inc

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

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.

Study Overview

Status

Recruiting

Conditions

Breast Cancer

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Estimated)

1180

Phase

Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Name: Nadene Zack, MS
Phone Number: 844-310-3900
Email: viktoria-2_trial@celcuity.com

Study Locations

Argentina
- - Buenos Aires, Argentina, C1426ABP
    - Not yet recruiting
    - Fundacion Respirar
  - Buenos Aires, Argentina
    - Not yet recruiting
    - Center for Medical Education and Clinical Research (CEMIC)
  - Buenos Aires, Argentina, B1884BBF
    - Not yet recruiting
    - Centro de Oncología e Investigación Buenos Aires COIBA
  - Buenos Aires, Argentina, B2700CPM
    - Not yet recruiting
    - Pergamino Clinic
  - Buenos Aires, Argentina, C1025ABI
    - Not yet recruiting
    - CENIT Foundation
  - Buenos Aires, Argentina, C1414
    - Not yet recruiting
    - Fleischer Medical Center (Centro Medico Fleischer)
  - Buenos Aires, Argentina, C1426AGE
    - Not yet recruiting
    - Centro Oncologico Korben
  - Buenos Aires, Argentina, C1426ANZ
    - Not yet recruiting
    - Alexander Fleming Institute
  - Córdoba, Argentina, X5006HBF
    - Not yet recruiting
    - Cordoba Oncology Institute (IONC)
  - La Plata, Argentina
    - Not yet recruiting
    - Centro Oncológico de Excelencia
  - La Rioja, Argentina
    - Not yet recruiting
    - Fundación CORI
  - Paraná, Argentina, E3100HYB
    - Not yet recruiting
    - Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
  - Rosario, Argentina
    - Not yet recruiting
    - Rosario's Oncology Institute and Medical Specialities (IOR)
Australia
- - Adelaide, Australia, 5000
    - Recruiting
    - GenesisCare - St Andrews
  - Nedlands, Australia, 6009
    - Recruiting
    - Breast Cancer Research Centre
  - Southport, Australia, 4215
    - Recruiting
    - ICON Cancer Centre Southport
  - Wahroonga, Australia, 2076
    - Recruiting
    - Sydney Adventist Hospital
  - Westmead, Australia, 2145
    - Recruiting
    - Westmead Hospital
  - Woodville, Australia, 5011
    - Recruiting
    - The Queen Elizabeth Hospital
Belgium
- - Brussels, Belgium, 1200
    - Not yet recruiting
    - Cliniques Universitaires Saint-luc
  - Charleroi, Belgium, 6060
    - Not yet recruiting
    - Grand Hôpital de Charleroi
  - Ghent, Belgium, 9000
    - Not yet recruiting
    - Universitair Ziekenhuis Gent - Medische Oncologie
  - Hasselt, Belgium, 3500
    - Not yet recruiting
    - Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
  - Leuven, Belgium, 3000
    - Not yet recruiting
    - Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Brazil
- - Belo Horizonte, Brazil, 30360-680
    - Not yet recruiting
    - Oncocentro Belo Horizonte
  - Belém, Brazil, 66073-005
    - Not yet recruiting
    - CTO Centro de Tratamento Oncológico
  - Fortaleza, Brazil, 60336-232
    - Not yet recruiting
    - Centro Regional Integrado de Oncologia - CRIO
  - Fortaleza, Brazil, 60810-180
    - Not yet recruiting
    - Pronutrir Oncologia e Nutrição
  - Ijuí, Brazil, 98700-000
    - Not yet recruiting
    - Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda
  - Itajaí, Brazil, 88301-220
    - Not yet recruiting
    - Catarina Pesquisa Clinica
  - Porto Alegre, Brazil, 90610-000
    - Not yet recruiting
    - Hospital Sao Lucas Da Pucrs
  - Ribeirão Preto, Brazil, 14051-140
    - Not yet recruiting
    - Hospital das Clínicas da Faculdade de Medicina de Ribeirão Preto - USP
  - Salvador, Brazil, 40170-110
    - Not yet recruiting
    - Bahia Oncology Center
  - São Paulo, Brazil, 01509-010
    - Not yet recruiting
    - Hospital A.C.Camargo
  - São Paulo, Brazil, 04543-000
    - Not yet recruiting
    - Instituto D'or de Pesquisa e Ensino - ONCO STAR
Bulgaria
- - Burgas, Bulgaria, 8000
    - Not yet recruiting
    - Complex Oncology Center - Burgas
  - Panagyurishte, Bulgaria, 4500
    - Not yet recruiting
    - Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
  - Rousse, Bulgaria, 7002
    - Not yet recruiting
    - Complex Oncological Centre Ruse
  - Sofia, Bulgaria, 1330
    - Not yet recruiting
    - MHAT Nadezhda - Medical Oncology Clinic
  - Sofia, Bulgaria, 1632
    - Not yet recruiting
    - MHAT "Serdika" EOOD, Base 2 - Second Department of Medical Oncology
  - Sofia, Bulgaria, 1756
    - Not yet recruiting
    - USHAT of Oncology
Czechia
- - Brno, Czechia, 656 53
    - Not yet recruiting
    - Masarykuv onkologicky ustav - Oddeleni klinickych hodnoceni
  - Hořovice, Czechia, 268 31
    - Not yet recruiting
    - Multiscan s.r.o. - Ambulance klinicke onkologie se stacionarem
  - Hradec Králové, Czechia, 500 05
    - Not yet recruiting
    - FN Hradec Kralove - Klinika onkologie a radioterap
  - Olomouc, Czechia, 779 00
    - Not yet recruiting
    - Fakultní nemocnice Olomouc - Onkologická klinika
  - Prague, Czechia, 150 06
    - Not yet recruiting
    - Fakultni nemocnice v Motole
  - Prague, Czechia, 100 34
    - Not yet recruiting
    - FN Kralovske Vinohrady - Radioterapeuticka a onkologicka klinika
  - Prague, Czechia, 140 59
    - Not yet recruiting
    - Fakultni Thomayerova nemocnice - Onkologicka klinika
France
- - Amiens, France, 80054
    - Not yet recruiting
    - Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Oncologie Medicale - Cancerolo
  - Caen, France, 14076 Cedex 05
    - Not yet recruiting
    - Centre Georges François Baclesse
  - Dijon, France, 21079
    - Not yet recruiting
    - Centre Georges Francois Leclerc - service d'oncologie médicale
  - Le Mans, France, 72015
    - Not yet recruiting
    - Clinique Victor Hugo / Centre Jean Bernard
  - Marseille, France, 13005
    - Not yet recruiting
    - CHU La Timone
  - Pierre-Bénite, France, 69495
    - Not yet recruiting
    - Centre Hospitalier Lyon Sud
  - Poitiers, France, 86000
    - Not yet recruiting
    - Centre Hospitalier Universitaire de Poitiers - Médico-Chirurgical De Cardiol
  - Saint-Herblain, France, 44805
    - Not yet recruiting
    - Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau - Oncology
  - Villejuif, France, 94800
    - Not yet recruiting
    - Institut Gustave Roussy
Germany
- - Düsseldorf, Germany, 40225
    - Not yet recruiting
    - Universitätsklinikum Düsseldorf - Gynecology
  - Mainz, Germany, 55131
    - Not yet recruiting
    - Universitätsmedizin Johannes Gutenberg
  - Saarbrücken, Germany, 66113
    - Not yet recruiting
    - Caritasklinikum Saarbrücken St. Theresia
  - Wuppertal, Germany, 42283
    - Not yet recruiting
    - Helios Klinikum Wuppertal
Greece
- - Athens, Greece, 11528
    - Not yet recruiting
    - Areteio Hospital
  - Heraklion, Greece, 71110
    - Not yet recruiting
    - University General Hospital of Heraklion
  - Larissa, Greece, 41000
    - Not yet recruiting
    - Iaso Thessalia General Clinic Private Obstetrics S.A.
  - Larissa, Greece, 41110
    - Not yet recruiting
    - General University Hospital Of Larissa
  - Piraeus, Greece, 18547
    - Not yet recruiting
    - Metropolitan Hospital
  - Thessaloniki, Greece, 54639
    - Not yet recruiting
    - Athens Medical Center S.A.
  - Thessaloniki, Greece, 54639
    - Not yet recruiting
    - Theageneio Cancer Hospital
Hungary
- - Debrecen, Hungary, 4032
    - Not yet recruiting
    - Debreceni Egyetem Klinikai Központ Nagyerdei Campus - Onkológiai Klinika
  - Gyula, Hungary, 5700
    - Not yet recruiting
    - Békés Megyei Központi Kórház Pándy Kálmán Tagkórház - Oncology
  - Győr, Hungary, 9024
    - Not yet recruiting
    - Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
  - Kecskemét, Hungary, 6000
    - Not yet recruiting
    - Bacs-Kiskun Varmegyei Oktatakorhaz
  - Pécs, Hungary, 7624
    - Not yet recruiting
    - University of Pecs- Oncology Dept.
  - Szekszárd, Hungary, 7100
    - Not yet recruiting
    - Tolna Varmegyei Balassa Janos Korhaz
Italy
- - Fano, Italy, 61032
    - Not yet recruiting
    - Presidio Ospedaliero S. Croce - Oncologia
  - Genova, Italy, 16132
    - Not yet recruiting
    - IRCCS Ospedale Policlinico San Martino - Clinica di Oncologia Medica
  - Meldola, Italy, 47014
    - Not yet recruiting
    - IRST IRCCS - Oncologia Medica
  - Milan, Italy
    - Not yet recruiting
    - Istituto Clinico Humanitas
  - Milan, Italy, 20141
    - Not yet recruiting
    - IEO - Istituto Europeo di Oncologia, IRCCS
  - Modena, Italy, 41124
    - Not yet recruiting
    - AOU di Modena, Policlinico di Modena - Attività Integrata di Oncologia ed Ematologia
  - Naples, Italy, 80131
    - Not yet recruiting
    - Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
  - Parma, Italy, 43126
    - Not yet recruiting
    - Ospedale Maggiore, AOU Parma
  - Pavia, Italy, 27100
    - Not yet recruiting
    - IRCCS Policlinico San Matteo, Università degli studi di Pavia
  - Ravenna, Italy, 48121
    - Not yet recruiting
    - Ospedale "Santa Maria delle Croci" di Ravenna - Oncologia
  - Roma, Italy, 00128
    - Not yet recruiting
    - Fondazione Policlinico Universitario Campus Bio-medico
  - Roma, Italy, 00161
    - Not yet recruiting
    - Umberto I Policlinico di Roma, Università La Sapienza
  - Rozzano, Italy, 20089
    - Not yet recruiting
    - Istituto Clinico Humanitas
  - Terni, Italy, 05100
    - Not yet recruiting
    - Azienda Ospedaliera Santa Maria di Terni
  - Verona, Italy, 37126
    - Not yet recruiting
    - Borgo Trento, Ospedale Civile Maggiore, AOU Integrata Verona
Malaysia
- - George Town, Malaysia, 10350
    - Not yet recruiting
    - Penang Adventist Hospital
  - Kota Bharu, Malaysia, 16150
    - Recruiting
    - Hospital Universiti Sains Malaysia
  - Kuala Lumpur, Malaysia, 50603
    - Recruiting
    - Hospital Kuala Lumpur - Surgery
  - Kuala Lumpur, Malaysia, 50603
    - Recruiting
    - Pantai Hospital Kuala Lumpur
  - Kuching, Malaysia, 93586
    - Recruiting
    - Hospital Umum Sarawak
  - Petaling Jaya, Malaysia, 46050
    - Not yet recruiting
    - Beacon Hospital
  - Putrajaya, Malaysia, 62250
    - Recruiting
    - National Cancer Institute - Radiotherapy and Oncology
Mexico
- - Aguascalientes, Mexico, 20230
    - Not yet recruiting
    - San Peregrino Unidad de Investigación
  - Guadalajara, Mexico, 44680
    - Not yet recruiting
    - Office of Emanuel de la Mora Jimenez, MD/equiv
  - Mexico City, Mexico, 04100
    - Not yet recruiting
    - Clinical Research Center Chapultepec Mexico City
  - Mexico City, Mexico, 06760
    - Not yet recruiting
    - Centro de Atencion Oncologica Viva
  - Monterrey, Mexico, 64623
    - Not yet recruiting
    - Avix Clinical Research
  - Monterrey, Mexico, 64710
    - Not yet recruiting
    - Filios High Medicine
  - Morelia, Mexico, 58260
    - Not yet recruiting
    - Administrative Society of Health Services, SC
Poland
- - Bydgoszcz, Poland, 85796
    - Not yet recruiting
    - Centrum Onkologii im. prof. F. Lukaszczyka - Ambulatorium Chemioterapii
  - Konin, Poland, 62500
    - Not yet recruiting
    - Przychodnia Lekarska KOMED
  - Krakow, Poland, 30727
    - Not yet recruiting
    - PRATIA MCM Kraków
  - Lodz, Poland, 90302
    - Not yet recruiting
    - Instytut Medyczny Santa Familia
  - Opole, Poland, 45060
    - Not yet recruiting
    - SP ZOZ Opolskie Centrum Onkologii - Oddzial Onkologii Klinicznej z Odcinkiem Dziennym
  - Szczecin, Poland, 71730
    - Not yet recruiting
    - Zachodniopomorskie Centrum Onkologii - Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
  - Warsaw, Poland, 01748
    - Not yet recruiting
    - LUX MED Onkologia Sp. z o.o., Szpital Szamocka - Oddzial Onkologii Klinicznej/Chemioterapii
  - Warsaw, Poland, 02781
    - Not yet recruiting
    - Narodowy Instytut Onkologii im. Marii SkÅ'odowskiej-Curie â€" PaÅ"stwowy Instytut Badawczy - Klinika Nowotworow Piersi i Chirurg
Portugal
- - Coimbra, Portugal, 3000-993
    - Not yet recruiting
    - Centro Hospitalar E Universitário De Coimbra
  - Lisbon, Portugal, 1099-023
    - Not yet recruiting
    - Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
  - Lisbon, Portugal, 1500-650
    - Not yet recruiting
    - Hospital da Luz de Lisboa - Learning Health
  - Lisbon, Portugal, 1649-035
    - Not yet recruiting
    - H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia
  - Lisbon, Portugal, 1998018
    - Not yet recruiting
    - Hospital CUF Descobertas
  - Porto, Portugal, 4099-001
    - Not yet recruiting
    - Centro Hospitalar Universitario do Porto - H. Santo Antonio
Romania
- - Baia Mare, Romania, 430295
    - Not yet recruiting
    - Oncopremium Team - Medical Oncology
  - Baia Mare, Romania, 200746
    - Not yet recruiting
    - Centrul de Oncologie Sf Nectarie - Medical Oncology
  - Bucharest, Romania, 400015
    - Not yet recruiting
    - Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
  - Cluj-Napoca, Romania, 022328
    - Not yet recruiting
    - Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
  - Craiova, Romania, 200094
    - Not yet recruiting
    - Onco Clinic Consult
  - Floreşti, Romania, 407280
    - Not yet recruiting
    - Radiotherapy Center Cluj
  - Iași, Romania, 700106
    - Not yet recruiting
    - Centrul de Oncologie Euroclinic
  - Iași, Romania, 700483
    - Not yet recruiting
    - Institutul Regional de Oncologie Iasi - Medical Oncology
South Korea
- - Goyang, South Korea, 10408
    - Not yet recruiting
    - National Cancer Center - Breast Cancer
  - Incheon, South Korea, 21565
    - Not yet recruiting
    - Gachon University Gil Medical Center - Oncology
  - Seongnam-si, South Korea, 13496
    - Not yet recruiting
    - CHA Bundang Medical Center - Oncology
  - Seoul, South Korea, 03080
    - Recruiting
    - Seoul National University Hospital
  - Seoul, South Korea, 08308
    - Recruiting
    - Korea University Guro Hospital
  - Seoul, South Korea, 06273
    - Recruiting
    - Gangnam Severance Hospital
  - Seoul, South Korea, 03722
    - Recruiting
    - Yonsei University Health System, Severance Hospital
  - Seoul, South Korea, 05505
    - Recruiting
    - Asan Medical Center - Oncology
  - Seoul, South Korea, 02841
    - Recruiting
    - Korea University Anam Hospital - Gastroenterological Surgery
  - Seoul, South Korea, 06351
    - Recruiting
    - Samsung Medical Center - Hematology & Oncology
  - Seoul, South Korea, 6591
    - Not yet recruiting
    - The Catholic University of Korea, Seoul St. Mary's Hospital - Hematology and Oncology
  - Suwon, South Korea, 16499
    - Recruiting
    - Ajou University Hospital - Hematology/Oncology
  - Ulsan, South Korea, 44033
    - Recruiting
    - Ulsan University Hospital
Spain
- - A Coruña, Spain, 15006
    - Not yet recruiting
    - Complexo Hospitalario Universitario A Coruña
  - Badajoz, Spain, 06006
    - Not yet recruiting
    - Hospital Universitario de Badajoz
  - Barcelona, Spain, 08036
    - Not yet recruiting
    - Hospital Clinic De Barcelona
  - Barcelona, Spain, 08003
    - Not yet recruiting
    - Hospital del Mar
  - Cáceres, Spain, 10002
    - Not yet recruiting
    - Caceres Hospital Complex - San Pedro de Alcantara General Hospital
  - El Palmar, Spain, 30120
    - Not yet recruiting
    - Hospital Clínico Universitario Virgen de la Arrixaca
  - L'Hospitalet de Llobregat, Spain, 08908
    - Not yet recruiting
    - Institut Catala d'Oncologia
  - Lleida, Spain, 25198
    - Not yet recruiting
    - H.U Arnau De Vilanova Lleida
  - Madrid, Spain, 28040
    - Not yet recruiting
    - Hospital Universitario Fundacion Jimenez Diaz
  - Madrid, Spain, 28007
    - Not yet recruiting
    - Hospital Beata Maria Ana de Jesus
  - Madrid, Spain, 28034
    - Not yet recruiting
    - Hospital Universitario Ramon y Cajal - Oncología Médica
  - Santiago de Compostela, Spain, 15706
    - Not yet recruiting
    - Complejo Hospitalario Universitario de Santiago
  - Valencia, Spain, 46009
    - Not yet recruiting
    - Fundación Instituto Valenciano de Oncología
Taiwan
- - Changhua, Taiwan, 500209
    - Recruiting
    - Changhua Christian Medical Foundation - Changhua Christian Hospital - Neurology
  - Douliu, Taiwan, 640203
    - Not yet recruiting
    - National Taiwan University Hospital - Yunlin Branch - Oncology
  - Kaohsiung City, Taiwan, 807377
    - Recruiting
    - Kaohsiung Medical University - Chung-Ho Memorial Hospital - Breast Surgery
  - Taichung, Taiwan, 404327
    - Recruiting
    - China Medical University Hospital - Breast Surgery
  - Taichung, Taiwan, 407219
    - Not yet recruiting
    - Taichung Veterans General Hospital - General Surgery
  - Tainan, Taiwan, 704302
    - Recruiting
    - National Cheng Kung University Hospital - Gynecology/Obstetrics
  - Tainan, Taiwan, 71004
    - Not yet recruiting
    - Chi Mei Medical Center - YongKang - Oncology and Hematology
  - Taipei, Taiwan, 100225
    - Recruiting
    - National Taiwan University Hospital - Oncology
  - Taipei, Taiwan, 112201
    - Recruiting
    - Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare - Nephrology
  - Taipei, Taiwan, 112201
    - Recruiting
    - Taipei Veterans General Hospital - Hematology
  - Taipei, Taiwan, 116079
    - Not yet recruiting
    - Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology
Thailand
- - Bangkok, Thailand, 10400
    - Recruiting
    - Rajavithi Hospital
  - Bangkok, Thailand, 10330
    - Recruiting
    - King Chulalongkorn Memorial Hospital [Medical Oncology]
  - Bangkok, Thailand, 10700
    - Recruiting
    - Siriraj Hospital - Medical Oncology
  - Hat Yai, Thailand, 90110
    - Recruiting
    - Prince of Songkla University - Internal Medicine
  - Samut Sakhon, Thailand, 74120
    - Recruiting
    - Banphaeo General Hospital
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 1120
    - Recruiting
    - Adana Baskent Practice and Research Hospital - Oncology
  - Ankara, Turkey (Türkiye), 06520
    - Recruiting
    - Memorial Ankara Hastanesi
  - Ankara, Turkey (Türkiye), 06200
    - Recruiting
    - Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology
  - Ankara, Turkey (Türkiye), 06010
    - Recruiting
    - Gulhane Training and Research Hospital - Medical Oncology
  - Ankara, Turkey (Türkiye), 06100
    - Recruiting
    - Hacettepe University Medical Faculty - Hematology
  - Ankara, Turkey (Türkiye), 06590
    - Recruiting
    - Ankara University Medical Faculty - Oncology
  - Diyarbakır, Turkey (Türkiye), 21280
    - Recruiting
    - Dicle University Medical Faculty Hospital Medical Oncology
  - Edirne, Turkey (Türkiye), 22030
    - Recruiting
    - Trakya University Medical Faculty - Oncology
  - Istanbul, Turkey (Türkiye), 34153
    - Recruiting
    - Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya
  - Istanbul, Turkey (Türkiye), 34214
    - Recruiting
    - Medipol Mega Hospital - Medical Oncology
  - Istanbul, Turkey (Türkiye), 34722
    - Recruiting
    - Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
  - Konya, Turkey (Türkiye), 42080
    - Recruiting
    - Necmettin Erbakan University Meram Medical Faculty - Oncology
  - Mezitli, Turkey (Türkiye), 33200
    - Recruiting
    - VM Medical Park Mersin Hastanesi
  - İzmit, Turkey (Türkiye), 41001
    - Recruiting
    - Kocaeli Uni Egt ve Uyg Hast
United States
- California
  - Duarte, California, United States, 91010
    - Not yet recruiting
    - City of Hope Medical Center
  - Fullerton, California, United States, 92835
    - Recruiting
    - Providence Medical Foundation
  - Los Angeles, California, United States, 90404
    - Recruiting
    - UCLA Hematology Oncology Santa Monica
- Florida
  - Plantation, Florida, United States, 33322
    - Recruiting
    - BRCR Medical Center, Inc- Internal Medicine
  - Tamarac, Florida, United States, 33321
    - Recruiting
    - BRCR Medical Center, Inc
- Kansas
  - Westwood, Kansas, United States, 66205
    - Recruiting
    - The University of Kansas Cancer Center
- Kentucky
  - Paducah, Kentucky, United States, 42003
    - Recruiting
    - Mercy Health-Paducah Cancer Center
- Maryland
  - Bethesda, Maryland, United States, 20817
    - Recruiting
    - American Oncology Partners, P.A.
- Massachusetts
  - Boston, Massachusetts, United States, 02114
    - Not yet recruiting
    - Massachusetts General Hospital Cancer Center
- Michigan
  - Detroit, Michigan, United States, 48202
    - Recruiting
    - Henry Ford Health System
- Missouri
  - Kansas City, Missouri, United States, 64111-5965
    - Recruiting
    - Saint Luke's Cancer Institute
  - St Louis, Missouri, United States, 63110
    - Recruiting
    - Washington University School of Medicine in Saint Louis
- Montana
  - Billings, Montana, United States, 59102
    - Recruiting
    - SCL Health - Cancer Centers of Montana
- New York
  - New York, New York, United States, 10065
    - Not yet recruiting
    - Weill Cornell Medical College - NewYork-Presbyterian Hospital
  - Westbury, New York, United States, 11590
    - Recruiting
    - Clinical Research Alliance, Inc.
- Ohio
  - Columbus, Ohio, United States, 43210
    - Recruiting
    - Stefanie Spielman Comprehensive Breast Center at Olentangy River Road
- Pennsylvania
  - Philadelphia, Pennsylvania, United States, 19004
    - Recruiting
    - Rittenhouse Hematology/Oncology
- South Dakota
  - Sioux Falls, South Dakota, United States, 57106
    - Not yet recruiting
    - Sanford Health
- Texas
  - Houston, Texas, United States, 77030-4000
    - Recruiting
    - University of Texas MD Anderson Cancer Center
  - San Antonio, Texas, United States, 78229
    - Recruiting
    - Mays Cancer Center
- Virginia
  - Midlothian, Virginia, United States, 23114-3203
    - Recruiting
    - Bon Secours St. Francis Medical Oncology Center
- Washington
  - Seattle, Washington, United States, 98109
    - Recruiting
    - Fred Hutchinson Cancer Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Adult
Older Adult

Accepts Healthy Volunteers

Description

Inclusion Criteria:

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:
1. (neo)adjuvant fulvestrant only if the treatment duration < 6 months
2. (neo)adjuvant chemotherapy
3. (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i
i. Study 1: if disease progression was on or within event occurred >6 months of discontinuation after completion of CDK4/6 inhibitor portion of treatment.
ii. 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.

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm A: Gedatolisib + Palbociclib + Fulvestrant Subjects with treatment-naïve endocrine-resistant ABC.	Drug: Arm A: Gedatolisib + Palbociclib + Fulvestrant 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 Other Names: PF-05212384, IBRANCE, Faslodex
Active Comparator: Arm B: Ribociclib + Fulvestrant Subjects with treatment-naïve endocrine-resistant ABC.	Drug: Arm B: Ribociclib + Fulvestrant 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 Other Names: KISQALI®, Faslodex
Experimental: Arm C: Gedatolisib + Palbociclib + Letrozole Subjects with treatment-naïve endocrine-sensitive ABC.	Drug: Arm C: Gedatolisib + Palbociclib + Letrozole 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. Other Names: PF-05212384, IBRANCE, FEMARA
Active Comparator: Arm D: Ribociclib + Letrozole Subjects with treatment-naïve endocrine-sensitive ABC.	Drug: Arm D: Ribociclib + Letrozole Drug: Ribociclib Participants will receive oral ribociclib on Days 1-21 of each 28-day cycle Drug: Letrozole Participants will receive oral letrozole daily. Other Names: KISQALI®, FEMARA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From date of randomization to the date of death due to any cause, up to approximately 48 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Overall Survival (OS) Time Frame: From date of randomization to the date of death due to any cause, up to approximately 48 months	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)	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	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)	Up to approximately 48 months
Duration of Response (DOR) Time Frame: Up to approximately 48 months	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	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	Time to Response (TTR)	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	Percentage of subjects with CR or PR; or with stable disease (SD) lasting >24 weeks as assessed by BICR	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		From baseline to 30 Day Safety Follow-up
Adverse Events Time Frame: Up to approximately 48 months	Type, incidence, severity (as graded by the NCI CTCAE v5.0), seriousness, and relationship to study medications of Adverse Events and any laboratory abnormalities	Up to approximately 48 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Celcuity Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 24, 2025

Primary Completion (Estimated)

March 31, 2029

Study Completion (Estimated)

July 30, 2033

Study Registration Dates

First Submitted

December 24, 2024

First Submitted That Met QC Criteria

January 2, 2025

First Posted (Actual)

January 3, 2025

Study Record Updates

Last Update Posted (Actual)

May 18, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

CELC-G-302

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Study Overview

Status

Conditions

Intervention / Treatment

Detailed Description

Study Type

Enrollment (Estimated)

Phase

Contacts and Locations

Study Contact

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Estimated)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Breast Cancer

Clinical Trials on Arm A: Gedatolisib + Palbociclib + Fulvestrant

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