Phase 3 Study of Gedatolisib as First-Line Treatment for Patients With HR-Positive, HER2-Negative Advanced Breast Cancer (VIKTORIA-2)
VIKTORIA-2: A Randomized, Open-Label, Phase 3 Study of Fulvestrant and CDK4/6 Inhibitors With or Without Gedatolisib as First-Line Treatment in Patients With HR-Positive and HER2-Negative Advanced Breast Cancer
1 other identifier
interventional
674
22 countries
203
Brief Summary
This is a Phase 3, open-label, randomized, clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant and CDK4/6 Inhibitors for the treatment of patients with locally advanced or metastatic HR+/HER2- advanced breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 breast-cancer
Started Jul 2025
Shorter than P25 for phase_3 breast-cancer
203 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 24, 2024
CompletedFirst Posted
Study publicly available on registry
January 3, 2025
CompletedStudy Start
First participant enrolled
July 24, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 30, 2028
February 5, 2026
February 1, 2026
2.4 years
December 24, 2024
February 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Progression Free Survival (PFS)
Progression Free Survival (PFS) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer 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 Outcomes (8)
Overall Survival (OS) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer
From date of randomization to the date of death due to any cause, up to approximately 48 months
Overall Response Rate (ORR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer
Up to approximately 48 months
Overall Response Rate (ORR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer
Up to approximately 48 months
Duration of Response (DOR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer
Up to approximately 48 months
Time to Response (TTR) in Patients with PIK3CA ND and PIK3CA MT Breast Cancer
Time from randomization to the first assessment of PR or better as assessed by BICR
- +3 more secondary outcomes
Study Arms (2)
Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant
EXPERIMENTALDrug: Gedatolisib Participants will receive intravenous (IV) gedatolisib once weekly for 3 weeks (Days 1, 8, 15) followed by 1 week off
Arm B: Palbociclib or Ribociclib + Fulvestrant
ACTIVE COMPARATORDrug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle
Interventions
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
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
Eligibility Criteria
You may qualify if:
- Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer
- Adult females, pre- and/or post-menopausal, and adult males. Pre-menopausal (and peri-menopausal) women can be enrolled if amenable to treatment with an LHRH agonist. Patients are to have commenced concomitant treatment with LHRH agonist prior to or on Cycle 1, Day 1 and must be willing to continue for the duration of the study.
- Negative pregnancy test for females of childbearing potential. Female subjects who are not surgically sterile must use a medically effective contraceptive method from screening until 2 years after the last dose of study treatment.
- Progression of disease during or within 12 months of completing (neo)adjuvant ET.
- Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.
- Permitted prior therapies:
- (neo)adjuvant fulvestrant or any selective ER degrader only if the treatment duration \< 6 months
- (neo)adjuvant chemotherapy
- (neo)adjuvant CDK4/6 inhibitor, unless PD was on or within 6 months of discontinuation of CDK4/6i
- Subject has radiologically measurable disease according to RECIST v1.1, per local assessment. Patients with evaluable bone-only disease are not eligible. Patients with bone-only disease that has lytic or mixed lytic/blastic lesions and at least one measurable soft tissue component per RECIST v1.1 may be eligible.
- Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
- Life expectancy of at least \>6 months.
- Adequate bone marrow, hepatic, renal and coagulation function.
You may not qualify if:
- 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
- Prior treatment with systemic anticancer therapy for ABC
- Subjects with type 1 diabetes
- Known and untreated, or active, brain or leptomeningeal metastases
- History of clinically significant cardiovascular abnormalities
- History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Celcuity Inclead
Study Sites (203)
City of Hope Medical Center
Duarte, California, 91010, United States
Providence Medical Foundation
Fullerton, California, 92835, United States
UCLA Hematology Oncology Santa Monica
Los Angeles, California, 90404, United States
BRCR Medical Center, Inc- Internal Medicine
Plantation, Florida, 33322, United States
BRCR Medical Center, INC
Tamarac, Florida, 33321, United States
The University of Kansas Cancer Center
Westwood, Kansas, 66205, United States
Mercy Health-Paducah Cancer Center
Paducah, Kentucky, 42003, United States
American Oncology Partners, P.A.
Bethesda, Maryland, 20817, United States
Massachusetts General Hospital Cancer Center
Boston, Massachusetts, 02114, United States
Henry Ford Health System
Detroit, Michigan, 48202, United States
Saint Luke's Cancer Institute
Kansas City, Missouri, 64111-5965, United States
Washington University School of Medicine in Saint Louis
St Louis, Missouri, 63110, United States
SCL Health - Cancer Centers of Montana
Billings, Montana, 59102, United States
Weill Cornell Medical College - NewYork-Presbyterian Hospital
New York, New York, 10065, United States
Clinical Research Alliance, Inc.
Westbury, New York, 11590, United States
Stefanie Spielman Comprehensive Breast Center at Olentangy River Road
Columbus, Ohio, 43210, United States
Rittenhouse Hematology/Oncology
Philadelphia, Pennsylvania, 19004, United States
Sanford Health
Sioux Falls, South Dakota, 57106, United States
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4000, United States
Mays Cancer Center
San Antonio, Texas, 78229, United States
Bon Secours St. Francis Medical Oncology Center
Midlothian, Virginia, 23114-3203, United States
Fred Hutchinson Cancer Center
Seattle, Washington, 98109, United States
Centro de Oncologia e Investigacion Buenos Aires COIBA
Buenos Aires, B1884BBF, Argentina
Pergamino Clinic
Buenos Aires, B2700CPM, Argentina
CENIT Foundation
Buenos Aires, C1025ABI, Argentina
Fleischer Medical Center (Centro Medico Fleischer)
Buenos Aires, C1414, Argentina
Fundacion Respirar
Buenos Aires, C1426ABP, Argentina
Centro Oncológico Korben
Buenos Aires, C1426AGE, Argentina
Alexander Fleming Institute
Buenos Aires, C1426ANZ, Argentina
Center for Medical Education and Clinical Research (CEMIC)
Buenos Aires, Argentina
Cordoba Oncology Institute (IONC)
Córdoba, X5006HBF, Argentina
Centro Oncologico de Excelencia
La Plata, Argentina
Fundación CORI
La Rioja, Argentina
Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)
Paraná, E3100HYB, Argentina
Rosario's Oncology Institute and Medical Specialities (IOR)
Rosario, Argentina
GenesisCare - St Andrews
Adelaide, 5000, Australia
Breast Cancer Research Centre
Nedlands, 6009, Australia
Icon Cancer Centre Southport
Southport, 4215, Australia
Sydney Adventist Hospital
Wahroonga, 2076, Australia
Westmead Hospital
Westmead, 2145, Australia
The Queen Elizabeth Hospital
Woodville, 5011, Australia
Cliniques Universitaires Saint-Luc
Brussels, 1200, Belgium
Grand Hopital De Charleroi
Charleroi, 6060, Belgium
Universitair Ziekenhuis Gent - Medische Oncologie
Ghent, 9000, Belgium
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
Hasselt, 3500, Belgium
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, 3000, Belgium
CTO Centro de Tratamento Oncológico
Belém, 66073-005, Brazil
Oncocentro Belo Horizonte
Belo Horizonte, 30360-680, Brazil
Centro Regional Integrado de Oncologia - CRIO
Fortaleza, 60336-232, Brazil
Pronutrir Oncologia e Nutrição
Fortaleza, 60810-180, Brazil
ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA
Ijuí, 98700-000, Brazil
Catarina Pesquisa Clinica
Itajaí, 88301-220, Brazil
Hospital Sao Lucas da PUCRS
Porto Alegre, 90610-000, Brazil
Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP
Ribeirão Preto, 14051-140, Brazil
Bahia Oncology Center
Salvador, 40170-110, Brazil
Hospital A.C.Camargo
São Paulo, 01509-010, Brazil
Instituto D'or de Pesquisa e Ensino - ONCO STAR
São Paulo, 04543-000, Brazil
Complex Oncology Center - Burgas
Burgas, 8000, Bulgaria
Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.
Panagyurishte, 4500, Bulgaria
Complex Oncological Centre Ruse
Rousse, 7002, Bulgaria
MHAT Nadezhda - Medical Oncology Clinic
Sofia, 1330, Bulgaria
MHAT "Serdika" EOOD, Base 2 - Second Department of Medical Oncology
Sofia, 1632, Bulgaria
USHAT of Oncology
Sofia, 1756, Bulgaria
Masarykuv onkologicky ustav - Oddeleni klinickych hodnoceni
Brno, 656 53, Czechia
Multiscan s.r.o. - Ambulance klinicke onkologie se stacionarem
Hořovice, 268 31, Czechia
FN Hradec Kralove - Klinika onkologie a radioterap
Hradec Králové, 500 05, Czechia
Fakultni nemocnice Olomouc - Onkologicka klinika
Olomouc, 779 00, Czechia
FN Kralovske Vinohrady - Radioterapeuticka a onkologicka klinika
Prague, 100 34, Czechia
Fakultni Thomayerova Nemocnice - Onkologicka klinika
Prague, 140 59, Czechia
Fakultni Nemocnice v Motole
Prague, 150 06, Czechia
Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Oncologie Medicale - Cancerolo
Amiens, 80054, France
Centre Georges François Baclesse
Caen, 14076 Cedex 05, France
Centre Georges Francois Leclerc - service d'oncologie médicale
Dijon, 21079, France
Clinique Victor Hugo / Centre Jean Bernard
Le Mans, 72015, France
CHU La Timone
Marseille, 13005, France
Centre Hospitalier Lyon Sud
Pierre-Bénite, 69495, France
Centre Hospitalier Universitaire de Poitiers - Médico-Chirurgical De Cardiol
Poitiers, 86000, France
Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau - Oncology
Saint-Herblain, 44805, France
Institut Gustave Roussy
Villejuif, 94800, France
Universitätsklinikum Düsseldorf - Gynecology
Düsseldorf, 40225, Germany
Universitätsmedizin Johannes Gutenberg
Mainz, 55131, Germany
CaritasKlinikum Saarbrücken St. Theresia
Saarbrücken, 66113, Germany
Helios Klinikum Wuppertal
Wuppertal, 42283, Germany
Areteio Hospital
Athens, 11528, Greece
University General Hospital of Heraklion
Heraklion, 71110, Greece
Iaso Thessalia General Clinic Private Obstetrics S.A.
Larissa, 41000, Greece
General University Hospital Of Larissa
Larissa, 41110, Greece
Metropolitan Hospital
Piraeus, 18547, Greece
Athens Medical Center S.A.
Thessaloniki, 54639, Greece
Theageneio Cancer Hospital
Thessaloniki, 54639, Greece
Debreceni Egyetem Klinikai Központ Nagyerdei Campus - Onkológiai Klinika
Debrecen, 4032, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz
Győr, 9024, Hungary
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház - Oncology
Gyula, 5700, Hungary
Bacs-Kiskun Varmegyei Oktatakorhaz
Kecskemét, 6000, Hungary
University of Pecs- Oncology Dept.
Pécs, 7624, Hungary
Tolna Varmegyei Balassa Janos Korhaz
Szekszárd, 7100, Hungary
Presidio Ospedaliero S. Croce - Oncologia
Fano, 61032, Italy
IRCCS Ospedale Policlinico San Martino - Clinica di Oncologia Medica
Genova, 16132, Italy
IRST IRCCS - Oncologia Medica
Meldola, 47014, Italy
IEO - Istituto Europeo di Oncologia, IRCCS
Milan, 20141, Italy
Istituto Clinico Humanitas
Milan, Italy
AOU di Modena, Policlinico di Modena - Attività Integrata di Oncologia ed Ematologia
Modena, 41124, Italy
Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS
Naples, 80131, Italy
Ospedale Maggiore, AOU Parma
Parma, 43126, Italy
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Pavia, 27100, Italy
Ospedale "Santa Maria delle Croci" di Ravenna - Oncologia
Ravenna, 48121, Italy
Fondazione Policlinico Universitario Campus Bio-Medico
Roma, 00128, Italy
Umberto I Policlinico di Roma, Università La Sapienza
Roma, 00161, Italy
Istituto Clinico Humanitas
Rozzano, 20089, Italy
Azienda Ospedaliera Santa Maria di Terni
Terni, 05100, Italy
Borgo Trento, Ospedale Civile Maggiore, AOU Integrata Verona
Verona, 37126, Italy
Penang Adventist Hospital
George Town, 10350, Malaysia
Hospital Universiti Sains Malaysia
Kota Bharu, 16150, Malaysia
Hospital Kuala Lumpur - Surgery
Kuala Lumpur, 50603, Malaysia
Pantai Hospital Kuala Lumpur
Kuala Lumpur, 50603, Malaysia
Hospital Umum Sarawak
Kuching, 93586, Malaysia
Beacon Hospital
Petaling Jaya, 46050, Malaysia
National Cancer Institute - Radiotherapy and Oncology
Putrajaya, 62250, Malaysia
San Peregrino Unidad de Investigacion
Aguascalientes, 20230, Mexico
Office of Emanuel de la Mora Jimenez, MD/equiv
Guadalajara, 44680, Mexico
Clinical Research Center Chapultepec Mexico City
Mexico City, 04100, Mexico
Centro de Atencion Oncologica Viva
Mexico City, 06760, Mexico
Avix Clinical Research
Monterrey, 64623, Mexico
Filios High Medicine
Monterrey, 64710, Mexico
Administrative Society of Health Services, SC
Morelia, 58260, Mexico
Centrum Onkologii im. prof. F. Lukaszczyka - Ambulatorium Chemioterapii
Bydgoszcz, 85796, Poland
Przychodnia Lekarska KOMED
Konin, 62500, Poland
Pratia MCM Kraków
Krakow, 30727, Poland
Instytut Medyczny Santa Familia
Lodz, 90302, Poland
SP ZOZ Opolskie Centrum Onkologii - Oddzial Onkologii Klinicznej z Odcinkiem Dziennym
Opole, 45060, Poland
Zachodniopomorskie Centrum Onkologii - Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych
Szczecin, 71730, Poland
LUX MED Onkologia Sp. z o.o., Szpital Szamocka - Oddzial Onkologii Klinicznej/Chemioterapii
Warsaw, 01748, Poland
Narodowy Instytut Onkologii im. Marii SkÅ'odowskiej-Curie â€" PaÅ"stwowy Instytut Badawczy - Klinika Nowotworow Piersi i Chirurg
Warsaw, 02781, Poland
Centro Hospitalar e Universitário de Coimbra
Coimbra, 3000-993, Portugal
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
Lisbon, 1099-023, Portugal
Hospital da Luz de Lisboa - Learning Health
Lisbon, 1500-650, Portugal
H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia
Lisbon, 1649-035, Portugal
Hospital CUF Descobertas
Lisbon, 1998018, Portugal
Centro Hospitalar Universitario do Porto - H. Santo Antonio
Porto, 4099-001, Portugal
Centrul de Oncologie Sf Nectarie - Medical Oncology
Baia Mare, 200746, Romania
Oncopremium Team - Medical Oncology
Baia Mare, 430295, Romania
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Bucharest, 400015, Romania
Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti
Cluj-Napoca, 022328, Romania
Onco Clinic Consult
Craiova, 200094, Romania
Radiotherapy Center Cluj
Floreşti, 407280, Romania
Centrul de Oncologie Euroclinic
Iași, 700106, Romania
Institutul Regional de Oncologie Iasi - Medical Oncology
Iași, 700483, Romania
National Cancer Center - Breast Cancer
Goyang, 10408, South Korea
Gachon University Gil Medical Center - Oncology
Incheon, 21565, South Korea
CHA Bundang Medical Center - Oncology
Seongnam-si, 13496, South Korea
Korea University Anam Hospital - Gastroenterological Surgery
Seoul, 02841, South Korea
Seoul National University Hospital
Seoul, 03080, South Korea
Yonsei University Health System, Severance hospital
Seoul, 03722, South Korea
Asan Medical Center - Oncology
Seoul, 05505, South Korea
Gangnam Severance Hospital
Seoul, 06273, South Korea
Samsung Medical Center - Hematology & Oncology
Seoul, 06351, South Korea
Korea University Guro Hospital
Seoul, 08308, South Korea
The Catholic University of Korea, Seoul St. Mary's Hospital - Hematology and Oncology
Seoul, 6591, South Korea
Ajou University Hospital - Hematology/Oncology
Suwon, 16499, South Korea
Ulsan University Hospital
Ulsan, 44033, South Korea
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006, Spain
Hospital Universitario de Badajoz
Badajoz, 06006, Spain
Hospital Del Mar
Barcelona, 08003, Spain
Hospital Clinic De Barcelona
Barcelona, 08036, Spain
Caceres Hospital Complex - San Pedro de Alcantara General Hospital
Cáceres, 10002, Spain
Hospital Clínico Universitario Virgen De La Arrixaca
El Palmar, 30120, Spain
Institut Catala D'oncologia
L'Hospitalet de Llobregat, 08908, Spain
H.U Arnau De Vilanova Lleida
Lleida, 25198, Spain
Hospital Beata Maria Ana de Jesus
Madrid, 28007, Spain
Hospital Universitario Ramon y Cajal - Oncología Médica
Madrid, 28034, Spain
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040, Spain
Complejo Hospitalario Universitario De Santiago
Santiago de Compostela, 15706, Spain
Fundacion Instituto Valenciano de Oncologia
Valencia, 46009, Spain
Changhua Christian Medical Foundation - Changhua Christian Hospital - Neurology
Changhua, 500209, Taiwan
National Taiwan University Hospital - Yunlin Branch - Oncology
Douliu, 640203, Taiwan
Kaohsiung Medical University - Chung-Ho Memorial Hospital - Breast Surgery
Kaohsiung City, 807377, Taiwan
China Medical University Hospital - Breast Surgery
Taichung, 404327, Taiwan
Taichung Veterans General Hospital - General Surgery
Taichung, 407219, Taiwan
National Cheng Kung University Hospital - Gynecology/Obstetrics
Tainan, 704302, Taiwan
Chi Mei Medical Center - YongKang - Oncology and Hematology
Tainan, 71004, Taiwan
National Taiwan University Hospital - Oncology
Taipei, 100225, Taiwan
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare - Nephrology
Taipei, 112201, Taiwan
Taipei Veterans General Hospital - Hematology
Taipei, 112201, Taiwan
Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology
Taipei, 116079, Taiwan
King Chulalongkorn Memorial Hospital [Medical Oncology]
Bangkok, 10330, Thailand
Rajavithi Hospital
Bangkok, 10400, Thailand
Siriraj Hospital - Medical Oncology
Bangkok, 10700, Thailand
Prince of Songkla University - Internal Medicine
Hat Yai, 90110, Thailand
Banphaeo General Hospital
Samut Sakhon, 74120, Thailand
Adana Baskent Practice and Research Hospital - Oncology
Adana, 1120, Turkey (Türkiye)
Gulhane Training and Research Hospital - Medical Oncology
Ankara, 06010, Turkey (Türkiye)
Hacettepe University Medical Faculty - Hematology
Ankara, 06100, Turkey (Türkiye)
Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology
Ankara, 06200, Turkey (Türkiye)
Memorial Ankara Hastanesi
Ankara, 06520, Turkey (Türkiye)
Ankara University Medical Faculty - Oncology
Ankara, 06590, Turkey (Türkiye)
Dicle University Medical Faculty Hospital Medical Oncology
Diyarbakır, 21280, Turkey (Türkiye)
Trakya University Medical Faculty - Oncology
Edirne, 22030, Turkey (Türkiye)
Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya
Istanbul, 34153, Turkey (Türkiye)
Medipol Mega Hospital - Medical Oncology
Istanbul, 34214, Turkey (Türkiye)
Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology
Istanbul, 34722, Turkey (Türkiye)
Kocaeli Uni Egt ve Uyg Hast
İzmit, 41001, Turkey (Türkiye)
Necmettin Erbakan University Meram Medical Faculty - Oncology
Konya, 42080, Turkey (Türkiye)
VM Medical Park Mersin Hastanesi
Mezitli, 33200, Turkey (Türkiye)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 24, 2024
First Posted
January 3, 2025
Study Start
July 24, 2025
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 30, 2028
Last Updated
February 5, 2026
Record last verified: 2026-02