674
Participants
Start Date
June 30, 2025
Primary Completion Date
December 31, 2027
Study Completion Date
December 30, 2028
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~Other Names:~• PF-05212384 Drug: Palbociclib Participants will receive oral palbociclib on days 1-21 of each 28-day cycle.~Other Names:~• IBRANCE 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 every 2 weeks during Cycle 1 and then every 4 weeks~Other Names:~• Faslodex"
Arm B: Palbociclib or Ribociclib + Fulvestrant
"Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle~Other Names:~• IBRANCE 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~Other Names:~• Faslodex"
NOT_YET_RECRUITING
Cliniques Universitaires Saint-Luc, Brussels
NOT_YET_RECRUITING
MHAT Nadezhda - Medical Oncology Clinic, Sofia
NOT_YET_RECRUITING
"MHAT Serdika EOOD, Base 2 - Second Department of Medical Oncology", Sofia
NOT_YET_RECRUITING
USHAT of Oncology, Sofia
NOT_YET_RECRUITING
Sydney Adventist Hospital, Wahroonga
NOT_YET_RECRUITING
Westmead Hospital, Westmead
NOT_YET_RECRUITING
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg, Leuven
NOT_YET_RECRUITING
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie, Hasselt
NOT_YET_RECRUITING
Debreceni Egyetem Klinikai Központ Nagyerdei Campus - Onkológiai Klinika, Debrecen
NOT_YET_RECRUITING
Icon Cancer Centre Southport, Southport
NOT_YET_RECRUITING
Multi-profile Hospital For Active Treatment-Uni Hospital Ltd., Panagyurishte
NOT_YET_RECRUITING
GenesisCare - St Andrews, Adelaide
NOT_YET_RECRUITING
Bekes Varmegyei Kozponti Korhaz Pandy Kalman Tagkorhaza, Gyula
NOT_YET_RECRUITING
Bacs-Kiskun Varmegyei Oktatakorhaz, Kecskemét
NOT_YET_RECRUITING
Breast Cancer Research Centre, Nedlands
NOT_YET_RECRUITING
Grand Hopital De Charleroi, Charleroi
NOT_YET_RECRUITING
Complex Oncological Centre Ruse, Rousse
NOT_YET_RECRUITING
Tolna Varmegyei Balassa Janos Korhaz, Szekszárd
NOT_YET_RECRUITING
Pecsi Tudomanyegyetem Klinikai Kozpont, Pécs
NOT_YET_RECRUITING
Complex Oncology Center - Burgas, Burgas
NOT_YET_RECRUITING
Universitair Ziekenhuis Gent - Medische Oncologie, Ghent
NOT_YET_RECRUITING
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz, Győr
NOT_YET_RECRUITING
Hospital San Pedro de Alcántara, Cáceres
NOT_YET_RECRUITING
Weill Cornell Medical College - NewYork-Presbyterian Hospital, New York
NOT_YET_RECRUITING
King Chulalongkorn Memorial Hospital [Medical Oncology], Bangkok
NOT_YET_RECRUITING
Rajavithi Hospital, Bangkok
NOT_YET_RECRUITING
Siriraj Hospital - Medical Oncology, Bangkok
NOT_YET_RECRUITING
Areteio Hospital, Athens
RECRUITING
Clinical Research Alliance, Inc., Westbury
NOT_YET_RECRUITING
APHM Hopital Timone, Marseille
NOT_YET_RECRUITING
University of Rochester Medical Center (URMC) - James P. Wilmot Cancer Center - Pluta Cancer Center (PCC), Rochester
NOT_YET_RECRUITING
Complexo Hospitalario Universitario A Coruña, A Coruña
NOT_YET_RECRUITING
Complejo Hospitalario Universitario De Santiago, Santiago de Compostela
NOT_YET_RECRUITING
Ospedale San Martino IRCSS - Oncologia Medica 1, Genova
NOT_YET_RECRUITING
Hospital Universiti Sains Malaysia, Kota Bharu
NOT_YET_RECRUITING
Ajou University Hospital - Hematology/Oncology, Suwon
NOT_YET_RECRUITING
Metropolitan Hospital, Piraeus
NOT_YET_RECRUITING
Rittenhouse Hematology/Oncology, Philadelphia
NOT_YET_RECRUITING
Istituto Clinico Humanitas, Rozzano
NOT_YET_RECRUITING
IEO - Istituto Europeo di Oncologia, IRCCS, Milan
NOT_YET_RECRUITING
San Peregrino Unidad de Investigacion, Aguascalientes
RECRUITING
American Oncology Partners, P.A., Bethesda
NOT_YET_RECRUITING
Centre Georges Francois Leclerc - service d'oncologie médicale, Dijon
NOT_YET_RECRUITING
Dicle Universitesi Hastanesi, Diyarbakır
NOT_YET_RECRUITING
Trakya Univ Hastanesi Ic Hastal, Edirne
NOT_YET_RECRUITING
H.U Arnau De Vilanova Lleida, Lleida
NOT_YET_RECRUITING
IRCCS Policlinico San Matteo, Università degli studi di Pavia, Pavia
NOT_YET_RECRUITING
Hospital Beata Maria Ana, Madrid
NOT_YET_RECRUITING
Hospital Universitario Ramon y Cajal - Oncología Médica, Madrid
NOT_YET_RECRUITING
Hospital Universitario Fundacion Jimenez Diaz, Madrid
NOT_YET_RECRUITING
Hospital Clínico Universitario Virgen De La Arrixaca, El Palmar
NOT_YET_RECRUITING
Pratia MCM Kraków, Krakow
NOT_YET_RECRUITING
VM Medical Park Mersin Hastanesi, Mersin
NOT_YET_RECRUITING
Medipol Mega Hospital - Medical Oncology, Istanbul
NOT_YET_RECRUITING
Medical Park Florya Hastanesi, Istanbul
NOT_YET_RECRUITING
Goztepe SuleymanYalcin Sehir Hast, Istanbul
NOT_YET_RECRUITING
Izmir Medical Park Hospital - Medical Oncology, Izmir
NOT_YET_RECRUITING
Borgo Trento, Ospedale Civile Maggiore, AOU Integrata Verona, Verona
NOT_YET_RECRUITING
Universitätsklinikum Düsseldorf - Gynecology, Düsseldorf
NOT_YET_RECRUITING
Iaso Thessalia General Clinic Private Obstetrics S.A., Larissa
NOT_YET_RECRUITING
Kocaeli Uni Uyg ve Ars Hst, İzmit
NOT_YET_RECRUITING
General University Hospital Of Larissa, Larissa
NOT_YET_RECRUITING
AOU di Modena, Policlinico di Modena - Attività Integrata di Oncologia ed Ematologia, Modena
RECRUITING
Mercy Health-Paducah Cancer Center, Paducah
NOT_YET_RECRUITING
Necmettin Erbakan University Meram Medical Faculty - Oncology, Konya
NOT_YET_RECRUITING
Helios Klinikum Wuppertal, Wuppertal
NOT_YET_RECRUITING
Ospedale Maggiore, AOU Parma, Parma
NOT_YET_RECRUITING
Stefanie Spielman Comprehensive Breast Center at Olentangy River Road, Columbus
RECRUITING
Ulsan University Hospital, Ulsan
NOT_YET_RECRUITING
Office of Emanuel de la Mora Jimenez, MD/equiv, Guadalajara
NOT_YET_RECRUITING
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau - Oncology, Saint-Herblain
NOT_YET_RECRUITING
SP ZOZ Opolskie Centrum Onkologii - Oddzial Onkologii Klinicznej z Odcinkiem Dziennym, Opole
NOT_YET_RECRUITING
Fundacion Instituto Valenciano de Oncologia, Valencia
NOT_YET_RECRUITING
Istituto Romagnolo Per Lo Studio Dei Tumori Dino Amadori IRST S.R.L, Meldola
NOT_YET_RECRUITING
Henry Ford Health System, Detroit
NOT_YET_RECRUITING
Hospital Kuala Lumpur - Surgery, Kuala Lumpur
NOT_YET_RECRUITING
Pantai Hospital Kuala Lumpur, Kuala Lumpur
NOT_YET_RECRUITING
Athens Medical Center S.A., Thessaloniki
NOT_YET_RECRUITING
Theageneio Cancer Hospital, Thessaloniki
NOT_YET_RECRUITING
Universitätsmedizin Johannes Gutenberg, Mainz
NOT_YET_RECRUITING
Sanford Health, Sioux Falls
NOT_YET_RECRUITING
Administrative Society of Health Services, SC, Morelia
NOT_YET_RECRUITING
SCL Health - Cancer Centers of Montana, Billings
NOT_YET_RECRUITING
Institut Kanser Negara, Putrajaya
NOT_YET_RECRUITING
Przychodnia Lekarska KOMED, Konin
NOT_YET_RECRUITING
Washington University School of Medicine in Saint Louis, St Louis
NOT_YET_RECRUITING
Mays Cancer Center, San Antonio
NOT_YET_RECRUITING
Avix Clinical Research, Monterrey
NOT_YET_RECRUITING
Filios High Medicine, Monterrey
NOT_YET_RECRUITING
CaritasKlinikum Saarbrücken St. Theresia, Saarbrücken
NOT_YET_RECRUITING
The University of Kansas Cancer Center, Westwood
NOT_YET_RECRUITING
Centre Hospitalier Lyon Sud, Pierre-Bénite
NOT_YET_RECRUITING
University General Hospital of Heraklion, Heraklion
NOT_YET_RECRUITING
Zachodniopomorskie Centrum Onkologii - Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych, Szczecin
NOT_YET_RECRUITING
Clinique Victor Hugo / Centre Jean Bernard, Le Mans
NOT_YET_RECRUITING
Banphaeo General Hospital, Samut Sakhon
NOT_YET_RECRUITING
Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Oncologie Medicale - Cancerolo, Amiens
NOT_YET_RECRUITING
Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS, Napoli
NOT_YET_RECRUITING
Centrum Onkologii im. prof. F. Lukaszczyka - Ambulatorium Chemioterapii, Bydgoszcz
NOT_YET_RECRUITING
Centre Hospitalier Universitaire de Poitiers - Médico-Chirurgical De Cardiol, Poitiers
NOT_YET_RECRUITING
Prince of Songkla University - Internal Medicine, Hat Yai
NOT_YET_RECRUITING
Instytut Medyczny Santa Familia, Lodz
NOT_YET_RECRUITING
Providence Medical Foundation, Fullerton
NOT_YET_RECRUITING
UCLA Hematology Oncology Ventura, Los Angeles
NOT_YET_RECRUITING
Hospital Umum Sarawak, Kuching
NOT_YET_RECRUITING
Institut Gustave Roussy, Villejuif
NOT_YET_RECRUITING
National Taiwan University Hospital - Oncology, Taipei
NOT_YET_RECRUITING
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare - Nephrology, Taipei
NOT_YET_RECRUITING
Taipei Veterans General Hospital - Hematology, Taipei
NOT_YET_RECRUITING
Onco Clinic Consult, Craiova
NOT_YET_RECRUITING
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti, Cluj-Napoca
NOT_YET_RECRUITING
China Medical University Hospital - Breast Surgery, Taichung
NOT_YET_RECRUITING
Radiotherapy Center Cluj, Floreşti
NOT_YET_RECRUITING
Centrul de Oncologie Sf Nectarie - Medical Oncology, Baia Mare
NOT_YET_RECRUITING
Oncopremium Team - Medical Oncology, Baia Mare
NOT_YET_RECRUITING
Changhua Christian Medical Foundation - Changhua Christian Hospital - Neurology, Changhua
NOT_YET_RECRUITING
Centrul de Oncologie Euroclinic, Iași
NOT_YET_RECRUITING
Institutul Regional de Oncologie Iasi - Medical Oncology, Iași
NOT_YET_RECRUITING
National Cheng Kung University Hospital - Gynecology/Obstetrics, Tainan City
NOT_YET_RECRUITING
Kaohsiung Medical University - Chung-Ho Memorial Hospital - Breast Surgery, Kaohsiung City
NOT_YET_RECRUITING
Hospital CUF Descobertas, Lisbon
NOT_YET_RECRUITING
Saint Luke's Cancer Institute, Kansas City
NOT_YET_RECRUITING
University of Texas MD Anderson Cancer Center, Houston
NOT_YET_RECRUITING
Bon Secours St. Francis Medical Oncology Center, Midlothian
NOT_YET_RECRUITING
Centro de Oncologia e Investigacion Buenos Aires COIBA, Buenos Aires
NOT_YET_RECRUITING
Pergamino Clinic, Buenos Aires
NOT_YET_RECRUITING
CENIT Foundation, Buenos Aires
NOT_YET_RECRUITING
Fleischer Medical Center (Centro Medico Fleischer), Buenos Aires
NOT_YET_RECRUITING
Fundacion Respirar, Buenos Aires
NOT_YET_RECRUITING
Centro Oncológico Korben, Buenos Aires
NOT_YET_RECRUITING
Alexander Fleming Institute, Buenos Aires
NOT_YET_RECRUITING
Center for Medical Education and Clinical Research (CEMIC), Buenos Aires
NOT_YET_RECRUITING
Centro Oncologico de Excelencia, La Plata
NOT_YET_RECRUITING
Fundación CORI, La Rioja
NOT_YET_RECRUITING
Rosario's Oncology Institute and Medical Specialities (IOR), Rosario
NOT_YET_RECRUITING
Istituto Clinico Humanitas, Milan
NOT_YET_RECRUITING
Cordoba Oncology Institute (IONC), Córdoba
NOT_YET_RECRUITING
Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER), Paraná
NOT_YET_RECRUITING
CTO Centro de Tratamento Oncológico, Belém
NOT_YET_RECRUITING
Oncocentro Belo Horizonte, Belo Horizonte
NOT_YET_RECRUITING
Centro Regional Integrado de Oncologia - CRIO, Fortaleza
NOT_YET_RECRUITING
Pronutrir Oncologia e Nutrição, Fortaleza
NOT_YET_RECRUITING
ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA, Ijuí
NOT_YET_RECRUITING
Catarina Pesquisa Clinica, Itajaí
NOT_YET_RECRUITING
Hospital Sao Lucas da PUCRS, Porto Alegre
NOT_YET_RECRUITING
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP, Ribeirão Preto
NOT_YET_RECRUITING
Bahia Oncology Center, Salvador
NOT_YET_RECRUITING
Hospital A.C.Camargo, São Paulo
NOT_YET_RECRUITING
Instituto D'or de Pesquisa e Ensino - ONCO STAR, São Paulo
NOT_YET_RECRUITING
Masarykuv onkologicky ustav - Oddeleni klinickych hodnoceni, Brno
NOT_YET_RECRUITING
Multiscan s.r.o. - Ambulance klinicke onkologie se stacionarem, Hořovice
NOT_YET_RECRUITING
FN Hradec Kralove - Klinika onkologie a radioterap, Hradec Králové
NOT_YET_RECRUITING
Fakultni nemocnice Olomouc - Onkologicka klinika, Olomouc
NOT_YET_RECRUITING
FN Kralovske Vinohrady - Radioterapeuticka a onkologicka klinika, Prague
NOT_YET_RECRUITING
Fakultni Thomayerova Nemocnice - Onkologicka klinika, Prague
NOT_YET_RECRUITING
Fakultni Nemocnice v Motole, Prague
NOT_YET_RECRUITING
Centre Georges François Baclesse, Caen
NOT_YET_RECRUITING
Fondazione PU Campus Biomedico, Roma
NOT_YET_RECRUITING
Umberto I Policlinico di Roma, Università La Sapienza, Roma
NOT_YET_RECRUITING
Azienda Ospedaliera Santa Maria di Terni, Terni
NOT_YET_RECRUITING
"Ospedale Santa Maria delle Croci di Ravenna - Oncologia", Terni
NOT_YET_RECRUITING
Clinical Research Center Chapultepec Mexico City, Mexico City
NOT_YET_RECRUITING
Centro de Atencion Oncologica Viva, Mexico City
NOT_YET_RECRUITING
LUX MED Onkologia Sp. z o.o., Szpital Szamocka - Oddzial Onkologii Klinicznej/Chemioterapii, Warsaw
NOT_YET_RECRUITING
"Narodowy Instytut Onkologii im. Marii SkÅ'odowskiej-Curie †PaÅstwowy Instytut Badawczy - Klinika Nowotworow Piersi i Chirurg", Warsaw
NOT_YET_RECRUITING
Centro Hospitalar e Universitário de Coimbra, Coimbra
NOT_YET_RECRUITING
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica, Lisbon
NOT_YET_RECRUITING
Hospital da Luz de Lisboa - Learning Health, Lisbon
NOT_YET_RECRUITING
H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia, Lisbon
NOT_YET_RECRUITING
ULS de Santo Antonio E.P.E., Porto
NOT_YET_RECRUITING
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca, Bucharest
NOT_YET_RECRUITING
Korea University Anam Hospital - Gastroenterological Surgery, Seoul
NOT_YET_RECRUITING
Seoul National University Hospital, Seoul
NOT_YET_RECRUITING
Yonsei University Health System, Severance hospital, Seoul
RECRUITING
Asan Medical Center - Oncology, Seoul
NOT_YET_RECRUITING
Gangnam Severance Hospital, Seoul
NOT_YET_RECRUITING
Samsung Medical Center - Hematology & Oncology, Seoul
NOT_YET_RECRUITING
Korea University Guro Hospital, Seoul
NOT_YET_RECRUITING
Hospital Universitario de Badajoz, Badajoz
NOT_YET_RECRUITING
Hospital Del Mar, Barcelona
NOT_YET_RECRUITING
Hospital Clinic De Barcelona, Barcelona
NOT_YET_RECRUITING
Institut Catala D'oncologia, L'Hospitalet de Llobregat
NOT_YET_RECRUITING
Medical Park Seyhan Hastanesi, Adana
NOT_YET_RECRUITING
Gulhane Egitim Arastirma Hastanesi, Ankara
NOT_YET_RECRUITING
Hacettepe University Medical Faculty - Hematology, Ankara
NOT_YET_RECRUITING
Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi, Ankara
NOT_YET_RECRUITING
Memorial Ankara Hastanesi, Ankara
NOT_YET_RECRUITING
Ankara University Medical Faculty - Oncology, Ankara
Lead Sponsor
Celcuity Inc
INDUSTRY