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

NCT ID: NCT06757634

Last Updated: 2026-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

674 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-07-24

Study Completion Date

2028-12-30

Brief Summary

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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.

Detailed Description

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This is a Phase 3, open-label, randomized clinical trial evaluating the efficacy and safety of gedatolisib plus fulvestrant combined with a CDK4/6 inhibitor (Investigator's choice of palbociclib or 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 whose disease has progressed during or within 12 months of adjuvant treatment with endocrine therapy (either an AI or tamoxifen), and who have not received prior systemic therapy for ABC. Gedatolisib is an intravenously administered pan-PI3K/mTOR inhibitor. Palbociclib is a CDK4/6 inhibitor. Fulvestrant is a selective estrogen receptor degrader (SERD). Following completion of the safety run-in phase to determine the gedatolisib dose with ribociclib, subjects will be assigned to 1 of 2 cohorts based on their PIK3CA status and then randomized to either the investigational treatment arm (gedatolisib with fulvestrant and ribociclib or palbociclib) or standard-of-care control arm (fulvestrant and ribociclib or palbociclib).

Conditions

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Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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

Group Type EXPERIMENTAL

Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant

Intervention Type DRUG

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

Intervention Type DRUG

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

Arm B: Palbociclib or Ribociclib + Fulvestrant

Drug: Palbociclib Participants will receive oral palbociclib on Days 1-21 of each 28-day cycle

Group Type ACTIVE_COMPARATOR

Arm A: Gedatolisib + Palbociclib or Ribociclib + Fulvestrant

Intervention Type DRUG

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

Intervention Type DRUG

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

Interventions

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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

Intervention Type DRUG

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

Intervention Type DRUG

Other Intervention Names

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PF-05212384, IBRANCE, KISQALI®, Faslodex IBRANCE, KISQALI®, Faslodex

Eligibility Criteria

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Inclusion Criteria

1. Histologically or cytologically confirmed diagnosis of metastatic or locally advanced HR+/HER2- breast cancer
2. 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.
3. 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.
4. Progression of disease during or within 12 months of completing (neo)adjuvant ET.
5. Adequate archival, fresh tumor tissue, or liquid biopsy for the analysis of PIK3CA mutational status.
6. Permitted prior therapies:

1. (neo)adjuvant fulvestrant or any selective ER degrader 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
7. 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.
8. Eastern Cooperative Oncology Group (ECOG) performance status of 0-2.
9. Life expectancy of at least \>6 months.
10. Adequate bone marrow, hepatic, renal and coagulation function.

Exclusion Criteria

1. 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.
2. Prior treatment with a phosphoinositide 3-kinase (PI3K) inhibitor, a protein kinase B (Akt) inhibitor, or a mechanistic target of rapamycin (mTOR) inhibitor
3. Prior treatment with systemic anticancer therapy for ABC
4. Subjects with type 1 diabetes
5. Known and untreated, or active, brain or leptomeningeal metastases
6. History of clinically significant cardiovascular abnormalities
7. History of drug-induced symptomatic interstitial lung disease (pneumonitis) or hepatitis
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Celcuity Inc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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City of Hope Medical Center

Duarte, California, United States

Site Status NOT_YET_RECRUITING

Providence Medical Foundation

Fullerton, California, United States

Site Status RECRUITING

UCLA Hematology Oncology Santa Monica

Los Angeles, California, United States

Site Status RECRUITING

BRCR Medical Center, Inc- Internal Medicine

Plantation, Florida, United States

Site Status RECRUITING

BRCR Medical Center, INC

Tamarac, Florida, United States

Site Status RECRUITING

The University of Kansas Cancer Center

Westwood, Kansas, United States

Site Status RECRUITING

Mercy Health-Paducah Cancer Center

Paducah, Kentucky, United States

Site Status RECRUITING

American Oncology Partners, P.A.

Bethesda, Maryland, United States

Site Status RECRUITING

Massachusetts General Hospital Cancer Center

Boston, Massachusetts, United States

Site Status NOT_YET_RECRUITING

Henry Ford Health System

Detroit, Michigan, United States

Site Status RECRUITING

Saint Luke's Cancer Institute

Kansas City, Missouri, United States

Site Status RECRUITING

Washington University School of Medicine in Saint Louis

St Louis, Missouri, United States

Site Status RECRUITING

SCL Health - Cancer Centers of Montana

Billings, Montana, United States

Site Status RECRUITING

Weill Cornell Medical College - NewYork-Presbyterian Hospital

New York, New York, United States

Site Status NOT_YET_RECRUITING

Clinical Research Alliance, Inc.

Westbury, New York, United States

Site Status RECRUITING

Stefanie Spielman Comprehensive Breast Center at Olentangy River Road

Columbus, Ohio, United States

Site Status RECRUITING

Rittenhouse Hematology/Oncology

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Sanford Health

Sioux Falls, South Dakota, United States

Site Status NOT_YET_RECRUITING

University of Texas MD Anderson Cancer Center

Houston, Texas, United States

Site Status RECRUITING

Mays Cancer Center

San Antonio, Texas, United States

Site Status RECRUITING

Bon Secours St. Francis Medical Oncology Center

Midlothian, Virginia, United States

Site Status RECRUITING

Fred Hutchinson Cancer Center

Seattle, Washington, United States

Site Status RECRUITING

Centro de Oncologia e Investigacion Buenos Aires COIBA

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Pergamino Clinic

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

CENIT Foundation

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Fleischer Medical Center (Centro Medico Fleischer)

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Fundacion Respirar

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Centro Oncológico Korben

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Alexander Fleming Institute

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Center for Medical Education and Clinical Research (CEMIC)

Buenos Aires, , Argentina

Site Status NOT_YET_RECRUITING

Cordoba Oncology Institute (IONC)

Córdoba, , Argentina

Site Status NOT_YET_RECRUITING

Centro Oncologico de Excelencia

La Plata, , Argentina

Site Status NOT_YET_RECRUITING

Fundación CORI

La Rioja, , Argentina

Site Status NOT_YET_RECRUITING

Center of Nuclear and Molecular Medicine of Entre Rios (CEMENER)

Paraná, , Argentina

Site Status NOT_YET_RECRUITING

Rosario's Oncology Institute and Medical Specialities (IOR)

Rosario, , Argentina

Site Status NOT_YET_RECRUITING

GenesisCare - St Andrews

Adelaide, , Australia

Site Status RECRUITING

Breast Cancer Research Centre

Nedlands, , Australia

Site Status RECRUITING

Icon Cancer Centre Southport

Southport, , Australia

Site Status RECRUITING

Sydney Adventist Hospital

Wahroonga, , Australia

Site Status RECRUITING

Westmead Hospital

Westmead, , Australia

Site Status RECRUITING

The Queen Elizabeth Hospital

Woodville, , Australia

Site Status RECRUITING

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

Site Status NOT_YET_RECRUITING

Grand Hopital De Charleroi

Charleroi, , Belgium

Site Status NOT_YET_RECRUITING

Universitair Ziekenhuis Gent - Medische Oncologie

Ghent, , Belgium

Site Status NOT_YET_RECRUITING

Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie

Hasselt, , Belgium

Site Status NOT_YET_RECRUITING

Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg

Leuven, , Belgium

Site Status NOT_YET_RECRUITING

CTO Centro de Tratamento Oncológico

Belém, , Brazil

Site Status NOT_YET_RECRUITING

Oncocentro Belo Horizonte

Belo Horizonte, , Brazil

Site Status NOT_YET_RECRUITING

Centro Regional Integrado de Oncologia - CRIO

Fortaleza, , Brazil

Site Status NOT_YET_RECRUITING

Pronutrir Oncologia e Nutrição

Fortaleza, , Brazil

Site Status NOT_YET_RECRUITING

ONCOSITE - Centro de Pesquisa Clinica em Oncologia LTDA

Ijuí, , Brazil

Site Status NOT_YET_RECRUITING

Catarina Pesquisa Clinica

Itajaí, , Brazil

Site Status NOT_YET_RECRUITING

Hospital Sao Lucas da PUCRS

Porto Alegre, , Brazil

Site Status NOT_YET_RECRUITING

Hospital Das Clinicas da Faculdade de Medicina de Ribeirão Preto - USP

Ribeirão Preto, , Brazil

Site Status NOT_YET_RECRUITING

Bahia Oncology Center

Salvador, , Brazil

Site Status NOT_YET_RECRUITING

Hospital A.C.Camargo

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Instituto D'or de Pesquisa e Ensino - ONCO STAR

São Paulo, , Brazil

Site Status NOT_YET_RECRUITING

Complex Oncology Center - Burgas

Burgas, , Bulgaria

Site Status NOT_YET_RECRUITING

Multi-profile Hospital For Active Treatment-Uni Hospital Ltd.

Panagyurishte, , Bulgaria

Site Status NOT_YET_RECRUITING

Complex Oncological Centre Ruse

Rousse, , Bulgaria

Site Status NOT_YET_RECRUITING

MHAT Nadezhda - Medical Oncology Clinic

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

MHAT "Serdika" EOOD, Base 2 - Second Department of Medical Oncology

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

USHAT of Oncology

Sofia, , Bulgaria

Site Status NOT_YET_RECRUITING

Masarykuv onkologicky ustav - Oddeleni klinickych hodnoceni

Brno, , Czechia

Site Status NOT_YET_RECRUITING

Multiscan s.r.o. - Ambulance klinicke onkologie se stacionarem

Hořovice, , Czechia

Site Status NOT_YET_RECRUITING

FN Hradec Kralove - Klinika onkologie a radioterap

Hradec Králové, , Czechia

Site Status NOT_YET_RECRUITING

Fakultni nemocnice Olomouc - Onkologicka klinika

Olomouc, , Czechia

Site Status NOT_YET_RECRUITING

FN Kralovske Vinohrady - Radioterapeuticka a onkologicka klinika

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Fakultni Thomayerova Nemocnice - Onkologicka klinika

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Fakultni Nemocnice v Motole

Prague, , Czechia

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire D'Amiens (Hopital Sud) - Oncologie Medicale - Cancerolo

Amiens, , France

Site Status NOT_YET_RECRUITING

Centre Georges François Baclesse

Caen, , France

Site Status NOT_YET_RECRUITING

Centre Georges Francois Leclerc - service d'oncologie médicale

Dijon, , France

Site Status NOT_YET_RECRUITING

Clinique Victor Hugo / Centre Jean Bernard

Le Mans, , France

Site Status NOT_YET_RECRUITING

CHU La Timone

Marseille, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status NOT_YET_RECRUITING

Centre Hospitalier Universitaire de Poitiers - Médico-Chirurgical De Cardiol

Poitiers, , France

Site Status NOT_YET_RECRUITING

Centre de Lutte Contre le Cancer (CLCC) - Institut de Cancerologie de l'Ouest (ICO) - Rene Gauducheau - Oncology

Saint-Herblain, , France

Site Status NOT_YET_RECRUITING

Institut Gustave Roussy

Villejuif, , France

Site Status NOT_YET_RECRUITING

Universitätsklinikum Düsseldorf - Gynecology

Düsseldorf, , Germany

Site Status NOT_YET_RECRUITING

Universitätsmedizin Johannes Gutenberg

Mainz, , Germany

Site Status NOT_YET_RECRUITING

CaritasKlinikum Saarbrücken St. Theresia

Saarbrücken, , Germany

Site Status NOT_YET_RECRUITING

Helios Klinikum Wuppertal

Wuppertal, , Germany

Site Status NOT_YET_RECRUITING

Areteio Hospital

Athens, , Greece

Site Status NOT_YET_RECRUITING

University General Hospital of Heraklion

Heraklion, , Greece

Site Status NOT_YET_RECRUITING

Iaso Thessalia General Clinic Private Obstetrics S.A.

Larissa, , Greece

Site Status NOT_YET_RECRUITING

General University Hospital Of Larissa

Larissa, , Greece

Site Status NOT_YET_RECRUITING

Metropolitan Hospital

Piraeus, , Greece

Site Status NOT_YET_RECRUITING

Athens Medical Center S.A.

Thessaloniki, , Greece

Site Status NOT_YET_RECRUITING

Theageneio Cancer Hospital

Thessaloniki, , Greece

Site Status NOT_YET_RECRUITING

Debreceni Egyetem Klinikai Központ Nagyerdei Campus - Onkológiai Klinika

Debrecen, , Hungary

Site Status NOT_YET_RECRUITING

Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktatokorhaz

Győr, , Hungary

Site Status NOT_YET_RECRUITING

Békés Megyei Központi Kórház Pándy Kálmán Tagkórház - Oncology

Gyula, , Hungary

Site Status NOT_YET_RECRUITING

Bacs-Kiskun Varmegyei Oktatakorhaz

Kecskemét, , Hungary

Site Status NOT_YET_RECRUITING

University of Pecs- Oncology Dept.

Pécs, , Hungary

Site Status NOT_YET_RECRUITING

Tolna Varmegyei Balassa Janos Korhaz

Szekszárd, , Hungary

Site Status NOT_YET_RECRUITING

Presidio Ospedaliero S. Croce - Oncologia

Fano, , Italy

Site Status NOT_YET_RECRUITING

IRCCS Ospedale Policlinico San Martino - Clinica di Oncologia Medica

Genova, , Italy

Site Status NOT_YET_RECRUITING

IRST IRCCS - Oncologia Medica

Meldola, , Italy

Site Status NOT_YET_RECRUITING

IEO - Istituto Europeo di Oncologia, IRCCS

Milan, , Italy

Site Status NOT_YET_RECRUITING

Istituto Clinico Humanitas

Milan, , Italy

Site Status NOT_YET_RECRUITING

AOU di Modena, Policlinico di Modena - Attività Integrata di Oncologia ed Ematologia

Modena, , Italy

Site Status NOT_YET_RECRUITING

Istituto Nazionale dei Tumori - Fondazione Pascale, IRCCS

Napoli, , Italy

Site Status NOT_YET_RECRUITING

Ospedale Maggiore, AOU Parma

Parma, , Italy

Site Status NOT_YET_RECRUITING

IRCCS Policlinico San Matteo, Università degli studi di Pavia

Pavia, , Italy

Site Status NOT_YET_RECRUITING

Ospedale "Santa Maria delle Croci" di Ravenna - Oncologia

Ravenna, , Italy

Site Status NOT_YET_RECRUITING

Fondazione Policlinico Universitario Campus Bio-Medico

Roma, , Italy

Site Status NOT_YET_RECRUITING

Umberto I Policlinico di Roma, Università La Sapienza

Roma, , Italy

Site Status NOT_YET_RECRUITING

Istituto Clinico Humanitas

Rozzano, , Italy

Site Status NOT_YET_RECRUITING

Azienda Ospedaliera Santa Maria di Terni

Terni, , Italy

Site Status NOT_YET_RECRUITING

Borgo Trento, Ospedale Civile Maggiore, AOU Integrata Verona

Verona, , Italy

Site Status NOT_YET_RECRUITING

Penang Adventist Hospital

George Town, , Malaysia

Site Status NOT_YET_RECRUITING

Hospital Universiti Sains Malaysia

Kota Bharu, , Malaysia

Site Status RECRUITING

Hospital Kuala Lumpur - Surgery

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Pantai Hospital Kuala Lumpur

Kuala Lumpur, , Malaysia

Site Status RECRUITING

Hospital Umum Sarawak

Kuching, , Malaysia

Site Status RECRUITING

Beacon Hospital

Petaling Jaya, , Malaysia

Site Status NOT_YET_RECRUITING

National Cancer Institute - Radiotherapy and Oncology

Putrajaya, , Malaysia

Site Status RECRUITING

San Peregrino Unidad de Investigacion

Aguascalientes, , Mexico

Site Status NOT_YET_RECRUITING

Office of Emanuel de la Mora Jimenez, MD/equiv

Guadalajara, , Mexico

Site Status NOT_YET_RECRUITING

Clinical Research Center Chapultepec Mexico City

Mexico City, , Mexico

Site Status NOT_YET_RECRUITING

Centro de Atencion Oncologica Viva

Mexico City, , Mexico

Site Status NOT_YET_RECRUITING

Avix Clinical Research

Monterrey, , Mexico

Site Status NOT_YET_RECRUITING

Filios High Medicine

Monterrey, , Mexico

Site Status NOT_YET_RECRUITING

Administrative Society of Health Services, SC

Morelia, , Mexico

Site Status NOT_YET_RECRUITING

Centrum Onkologii im. prof. F. Lukaszczyka - Ambulatorium Chemioterapii

Bydgoszcz, , Poland

Site Status NOT_YET_RECRUITING

Przychodnia Lekarska KOMED

Konin, , Poland

Site Status NOT_YET_RECRUITING

Pratia MCM Kraków

Krakow, , Poland

Site Status NOT_YET_RECRUITING

Instytut Medyczny Santa Familia

Lodz, , Poland

Site Status NOT_YET_RECRUITING

SP ZOZ Opolskie Centrum Onkologii - Oddzial Onkologii Klinicznej z Odcinkiem Dziennym

Opole, , Poland

Site Status NOT_YET_RECRUITING

Zachodniopomorskie Centrum Onkologii - Osrodek Innowacyjnosci, Rozwoju i Badan Klinicznych

Szczecin, , Poland

Site Status NOT_YET_RECRUITING

LUX MED Onkologia Sp. z o.o., Szpital Szamocka - Oddzial Onkologii Klinicznej/Chemioterapii

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

Narodowy Instytut Onkologii im. Marii SkÅ'odowskiej-Curie â€" PaÅ"stwowy Instytut Badawczy - Klinika Nowotworow Piersi i Chirurg

Warsaw, , Poland

Site Status NOT_YET_RECRUITING

Centro Hospitalar e Universitário de Coimbra

Coimbra, , Portugal

Site Status NOT_YET_RECRUITING

Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

Hospital da Luz de Lisboa - Learning Health

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

H. de Santa Maria. Centro Hospitalar Lisboa Norte - Oncologia

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

Hospital CUF Descobertas

Lisbon, , Portugal

Site Status NOT_YET_RECRUITING

Centro Hospitalar Universitario do Porto - H. Santo Antonio

Porto, , Portugal

Site Status NOT_YET_RECRUITING

Centrul de Oncologie Sf Nectarie - Medical Oncology

Baia Mare, , Romania

Site Status NOT_YET_RECRUITING

Oncopremium Team - Medical Oncology

Baia Mare, , Romania

Site Status NOT_YET_RECRUITING

Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca

Bucharest, , Romania

Site Status NOT_YET_RECRUITING

Institutul Oncologic Prof Dr Alexandru Trestioreanu Bucuresti

Cluj-Napoca, , Romania

Site Status NOT_YET_RECRUITING

Onco Clinic Consult

Craiova, , Romania

Site Status NOT_YET_RECRUITING

Radiotherapy Center Cluj

Floreşti, , Romania

Site Status NOT_YET_RECRUITING

Centrul de Oncologie Euroclinic

Iași, , Romania

Site Status NOT_YET_RECRUITING

Institutul Regional de Oncologie Iasi - Medical Oncology

Iași, , Romania

Site Status NOT_YET_RECRUITING

National Cancer Center - Breast Cancer

Goyang, , South Korea

Site Status NOT_YET_RECRUITING

Gachon University Gil Medical Center - Oncology

Incheon, , South Korea

Site Status NOT_YET_RECRUITING

CHA Bundang Medical Center - Oncology

Seongnam-si, , South Korea

Site Status NOT_YET_RECRUITING

Korea University Anam Hospital - Gastroenterological Surgery

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Yonsei University Health System, Severance hospital

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center - Oncology

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center - Hematology & Oncology

Seoul, , South Korea

Site Status RECRUITING

Korea University Guro Hospital

Seoul, , South Korea

Site Status RECRUITING

The Catholic University of Korea, Seoul St. Mary's Hospital - Hematology and Oncology

Seoul, , South Korea

Site Status NOT_YET_RECRUITING

Ajou University Hospital - Hematology/Oncology

Suwon, , South Korea

Site Status RECRUITING

Ulsan University Hospital

Ulsan, , South Korea

Site Status RECRUITING

Complexo Hospitalario Universitario A Coruña

A Coruña, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario de Badajoz

Badajoz, , Spain

Site Status NOT_YET_RECRUITING

Hospital Del Mar

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Clinic De Barcelona

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Caceres Hospital Complex - San Pedro de Alcantara General Hospital

Cáceres, , Spain

Site Status NOT_YET_RECRUITING

Hospital Clínico Universitario Virgen De La Arrixaca

El Palmar, , Spain

Site Status NOT_YET_RECRUITING

Institut Catala D'oncologia

L'Hospitalet de Llobregat, , Spain

Site Status NOT_YET_RECRUITING

H.U Arnau De Vilanova Lleida

Lleida, , Spain

Site Status NOT_YET_RECRUITING

Hospital Beata Maria Ana de Jesus

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Ramon y Cajal - Oncología Médica

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Fundacion Jimenez Diaz

Madrid, , Spain

Site Status NOT_YET_RECRUITING

Complejo Hospitalario Universitario De Santiago

Santiago de Compostela, , Spain

Site Status NOT_YET_RECRUITING

Fundacion Instituto Valenciano de Oncologia

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Changhua Christian Medical Foundation - Changhua Christian Hospital - Neurology

Changhua, , Taiwan

Site Status RECRUITING

National Taiwan University Hospital - Yunlin Branch - Oncology

Douliu, , Taiwan

Site Status NOT_YET_RECRUITING

Kaohsiung Medical University - Chung-Ho Memorial Hospital - Breast Surgery

Kaohsiung City, , Taiwan

Site Status RECRUITING

China Medical University Hospital - Breast Surgery

Taichung, , Taiwan

Site Status RECRUITING

Taichung Veterans General Hospital - General Surgery

Taichung, , Taiwan

Site Status NOT_YET_RECRUITING

National Cheng Kung University Hospital - Gynecology/Obstetrics

Tainan, , Taiwan

Site Status RECRUITING

Chi Mei Medical Center - YongKang - Oncology and Hematology

Tainan, , Taiwan

Site Status NOT_YET_RECRUITING

National Taiwan University Hospital - Oncology

Taipei, , Taiwan

Site Status RECRUITING

Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare - Nephrology

Taipei, , Taiwan

Site Status RECRUITING

Taipei Veterans General Hospital - Hematology

Taipei, , Taiwan

Site Status RECRUITING

Taipei Municipal Wanfang Hospital - Managed by Taipei Medical University - Hematology and Oncology

Taipei, , Taiwan

Site Status NOT_YET_RECRUITING

King Chulalongkorn Memorial Hospital [Medical Oncology]

Bangkok, , Thailand

Site Status RECRUITING

Rajavithi Hospital

Bangkok, , Thailand

Site Status RECRUITING

Siriraj Hospital - Medical Oncology

Bangkok, , Thailand

Site Status RECRUITING

Prince of Songkla University - Internal Medicine

Hat Yai, , Thailand

Site Status RECRUITING

Banphaeo General Hospital

Samut Sakhon, , Thailand

Site Status RECRUITING

Adana Baskent Practice and Research Hospital - Oncology

Adana, , Turkey (Türkiye)

Site Status RECRUITING

Gulhane Training and Research Hospital - Medical Oncology

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Hacettepe University Medical Faculty - Hematology

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Dr Abdurrahman Yurtaslan Training and Research Hospital - Medical Oncology

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Memorial Ankara Hastanesi

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Ankara University Medical Faculty - Oncology

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Dicle University Medical Faculty Hospital Medical Oncology

Diyarbakır, , Turkey (Türkiye)

Site Status RECRUITING

Trakya University Medical Faculty - Oncology

Edirne, , Turkey (Türkiye)

Site Status RECRUITING

Medical Park Hastaneler Grubu - I.A.U. VM Medical Park Florya

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Medipol Mega Hospital - Medical Oncology

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Istanbul Goztepe Prof. Dr. Suleyman Yalcin City Hospital - Medical Oncology

Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Kocaeli Uni Egt ve Uyg Hast

İzmit, , Turkey (Türkiye)

Site Status RECRUITING

Necmettin Erbakan University Meram Medical Faculty - Oncology

Konya, , Turkey (Türkiye)

Site Status RECRUITING

VM Medical Park Mersin Hastanesi

Mezitli, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Belgium Brazil Bulgaria Czechia France Germany Greece Hungary Italy Malaysia Mexico Poland Portugal Romania South Korea Spain Taiwan Thailand Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Nadene Zack, MS

Role: CONTACT

844-310-3900

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

CELC-G-302

Identifier Type: -

Identifier Source: org_study_id

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