Endocrine Therapy With or Without Abemaciclib (LY2835219) Following Surgery in Participants With Breast Cancer

NCT ID: NCT03155997

Last Updated: 2025-04-20

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE3

Total Enrollment

5637 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-12

Study Completion Date

2029-05-31

Brief Summary

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The purpose of this study is to evaluate the safety and efficacy of the study drug abemaciclib in participants with high risk, node positive, early stage, hormone receptor positive (HR+), human epidermal receptor 2 negative (HER2-), breast cancer.

Detailed Description

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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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150 mg Abemaciclib + Endocrine Therapy

Participants received Abemaciclib orally at 150 milligrams (mg) twice daily with at least 6 hours between doses for up to 2 years or until evidence of disease recurrence or other discontinuation criteria were met, whichever occurs first. Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.

Group Type EXPERIMENTAL

Abemaciclib

Intervention Type DRUG

Administered orally.

Standard Adjuvant Endocrine Therapy

Intervention Type DRUG

Administered according to label instructions.

Endocrine Therapy

Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.

Group Type OTHER

Standard Adjuvant Endocrine Therapy

Intervention Type DRUG

Administered according to label instructions.

Interventions

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Abemaciclib

Administered orally.

Intervention Type DRUG

Standard Adjuvant Endocrine Therapy

Administered according to label instructions.

Intervention Type DRUG

Other Intervention Names

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LY2835219

Eligibility Criteria

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Inclusion Criteria

* Women (regardless of menopausal status) or men ≥18 years of age (or per local regulations).
* The participant has confirmed HR+, HER2-, early stage resected invasive breast cancer without evidence of distant metastases.
* The participant must have undergone definitive surgery of the primary breast tumor.
* The participant must have tumor tissue from breast (preferred) or lymph node for exploratory biomarker analysis available prior to randomization.
* Pathologic lymph node involvement and at least one of the following indicating a higher risk of recurrence:

* 4 or more positive axillary lymph nodes
* Tumor size of at least 5 centimeters
* Grade 3 defined as at least 8 points on the Bloom Richardson grading system
* Ki-67 index by central analysis of ≥20% on untreated breast tissue
* The participant must be randomized within 16 months from the time of definitive breast cancer surgery.
* The participant may receive up to 12 weeks of endocrine therapy until randomization following the last non-endocrine therapy (surgery, chemotherapy, or radiation) whichever is last.
* Participants must have recovered (grade ≤1) from the acute effects of chemotherapy and radiotherapy and from surgical side effects following definitive breast surgery.
* Women of reproductive potential must have a negative blood pregnancy test and agree to use highly effective contraceptive methods.
* The participant has a Eastern Cooperative Oncology Group (ECOG) performance status ≤1.
* The participant has adequate organ function.
* The participant is able to swallow oral medications.

Exclusion Criteria

* Metastatic disease (including contralateral axillary lymph nodes) or node-negative disease.
* Participants with inflammatory breast cancer.
* Participants with a history of previous breast cancer, with the exception of ipsilateral ductal carcinoma in situ (DCIS) treated by locoregional therapy alone ≥5 years ago. Participants with a history of contralateral DCIS treated by local regional therapy at any time may be eligible. Participants with a history of any other cancer (except non-melanoma skin cancer or carcinoma in situ of the cervix), unless in complete remission with no therapy for a minimum of 5 years from the date of randomization are excluded.
* Females who are pregnant or lactating.
* The participant has previously received treatment with any CDK4 and CDK6 inhibitor.
* The participant is receiving concurrent exogenous reproductive hormone therapy (for example, birth control pills, hormone replacement therapy, or megestrol acetate).
* The participant has previously received endocrine therapy for breast cancer prevention (tamoxifen or aromatase inhibitors) or raloxifene.
* The participant has serious preexisting medical condition(s) that, in the judgment of the investigator, would preclude participation in this study.
* The participant has a personal history of any of the following conditions: syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin or sudden cardiac arrest. Any participant with a history of venous thromboembolism (VTE).
* The participant has active systemic infections or viral load.
* The participant has received an experimental treatment in a clinical trial within the last 30 days or 5 half-lives, whichever is longer.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NSABP Foundation Inc

NETWORK

Sponsor Role collaborator

Eli Lilly and Company

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)

Role: STUDY_DIRECTOR

Eli Lilly and Company

Locations

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University of Alabama Birmingham

Birmingham, Alabama, United States

Site Status

Providence Alaska Medical Center

Anchorage, Alaska, United States

Site Status

Banner MD Anderson Cancer Center

Gilbert, Arizona, United States

Site Status

Arizona Oncology Associates, P.C. - HOPE

Goodyear, Arizona, United States

Site Status

St. Joseph's Hospital and Medical Center

Phoenix, Arizona, United States

Site Status

Mayo Clinic Hospital

Phoenix, Arizona, United States

Site Status

The University of Arizona Cancer Center

Tucson, Arizona, United States

Site Status

Yuma Regional Cancer Center

Yuma, Arizona, United States

Site Status

St. Bernards Medical Center

Jonesboro, Arkansas, United States

Site Status

Highlands Oncology Group

Springdale, Arkansas, United States

Site Status

Beverly Hills Cancer Center

Beverly Hills, California, United States

Site Status

Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center

Burbank, California, United States

Site Status

City of Hope National Medical Center

Duarte, California, United States

Site Status

California Cancer Associates Research and Excellence

Fresno, California, United States

Site Status

Kaiser Permanente

Harbor City, California, United States

Site Status

Loma Linda University School of Medicine

Loma Linda, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Pacific Cancer Care

Monterey, California, United States

Site Status

St. Joseph Hospital

Orange, California, United States

Site Status

University of California Davis (UC Davis) Comprehensive Cancer Center

Sacramento, California, United States

Site Status

UCSF Medical Center at Mission Bay

San Francisco, California, United States

Site Status

California Cancer Associates in Research and Excellence

San Marcos, California, United States

Site Status

Dignity Health Dominican Oncology and Hematology

Santa Cruz, California, United States

Site Status

Kaiser Permanente

Vallejo, California, United States

Site Status

USO-Rocky Mountain Cancer Center

Boulder, Colorado, United States

Site Status

USO-Rocky Mountain Cancer Center

Thornton, Colorado, United States

Site Status

Yale-New Haven Hospital

New Haven, Connecticut, United States

Site Status

Florida Cancer Specialists - South

Fort Myers, Florida, United States

Site Status

University of Florida College of Medicine

Gainesville, Florida, United States

Site Status

Millennium Oncology - Hollywood

Hollywood, Florida, United States

Site Status

Mayo Clinic in Florida

Jacksonville, Florida, United States

Site Status

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Site Status

Florida Cancer Specialists - North

Lecanto, Florida, United States

Site Status

Ocala Oncology, P.A.

Ocala, Florida, United States

Site Status

Tallahassee Memorial Cancer Center

Tallahassee, Florida, United States

Site Status

Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center

Tampa, Florida, United States

Site Status

University Cancer & Blood Center, LLC

Athens, Georgia, United States

Site Status

Northside Hospital

Atlanta, Georgia, United States

Site Status

Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

Marietta, Georgia, United States

Site Status

Summit Cancer Care DBA Candler Medical Oncology Practice

Savannah, Georgia, United States

Site Status

University of Hawaii Cancer Center

Honolulu, Hawaii, United States

Site Status

John H. Stroger Hospital of Cook County

Chicago, Illinois, United States

Site Status

Rush University Medical Center

Chicago, Illinois, United States

Site Status

Edward Cancer Center

Naperville, Illinois, United States

Site Status

Quincy Medical Group

Quincy, Illinois, United States

Site Status

Franciscan St. Francis Health

Indianapolis, Indiana, United States

Site Status

Community Howard Oncology Center

Kokomo, Indiana, United States

Site Status

Cancer Center of Kansas

Wichita, Kansas, United States

Site Status

Univ of Louisville School of Medicine

Louisville, Kentucky, United States

Site Status

Mary Bird Perkins Cancer Center - Baton Rouge

Baton Rouge, Louisiana, United States

Site Status

Terrebonne General Medical Center

Houma, Louisiana, United States

Site Status

Cancer Care of Maine

Brewer, Maine, United States

Site Status

New England Cancer Specialists - Kennebunk

Kennebunk, Maine, United States

Site Status

Central Maine Medical Center

Lewiston, Maine, United States

Site Status

Meritus John Marsh Cancer Center

Hagerstown, Maryland, United States

Site Status

Dana-Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Reliant Medical Group, Inc.

Worcester, Massachusetts, United States

Site Status

Mayo Clinic in Rochester, Minnesota

Rochester, Minnesota, United States

Site Status

Jackson Oncology Associates PLLC

Jackson, Mississippi, United States

Site Status

HCA Midwest Kansas City, MidAmerica Division, Inc.

Kansas City, Missouri, United States

Site Status

Cancer Alliance of Nebraska

Omaha, Nebraska, United States

Site Status

Nebraska Methodist Hospital

Omaha, Nebraska, United States

Site Status

Tennessee Cancer Specialists

Omaha, Nebraska, United States

Site Status

Renown Regional Medical Center

Reno, Nevada, United States

Site Status

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, United States

Site Status

Memorial Sloan Kettering - Basking Ridge

Basking Ridge, New Jersey, United States

Site Status

Summit Medical Group Cancer Center

Florham Park, New Jersey, United States

Site Status

Newark Beth Israel Medical Center

Newark, New Jersey, United States

Site Status

The Valley Hospital, Inc.

Paramus, New Jersey, United States

Site Status

Community Medical Center

Toms River, New Jersey, United States

Site Status

Broome Oncology

Binghamton, New York, United States

Site Status

Weill Cornell Medical College

New York, New York, United States

Site Status

Vassar Brothers Medical Center

Poughkeepsie, New York, United States

Site Status

SUNY At Stony Brook

Stony Brook, New York, United States

Site Status

White Plains Hospital

White Plains, New York, United States

Site Status

WakeMed Cancer Care - Waverly Hematology & Medical Oncology

Cary, North Carolina, United States

Site Status

Margaret R. Pardee Memorial Hospital

Hendersonville, North Carolina, United States

Site Status

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Site Status

Aultman Hospital

Canton, Ohio, United States

Site Status

University Hospitals Cleveland Medical Center

Cleveland, Ohio, United States

Site Status

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Site Status

Columbus Community Clinical Oncology Program

Columbus, Ohio, United States

Site Status

Asante Rogue Regional Medical Center

Medford, Oregon, United States

Site Status

Oregon Health and Science University

Portland, Oregon, United States

Site Status

Abington Medical Specialists

Abington, Pennsylvania, United States

Site Status

St. Luke's Hospital & Health Network

Bethlehem, Pennsylvania, United States

Site Status

Albert Einstein Healthcare Network

Philadelphia, Pennsylvania, United States

Site Status

AHN Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

NSABP Foundation

Pittsburgh, Pennsylvania, United States

Site Status

PinnacleHealth Cancer Institute

Pittsburgh, Pennsylvania, United States

Site Status

Univ of Pittsburgh Cancer Inst. (UPCI)

Pittsburgh, Pennsylvania, United States

Site Status

WellSpan Health/York Cancer Center Oncology Research

York, Pennsylvania, United States

Site Status

McLeod Regional Medical Center

Florence, South Carolina, United States

Site Status

St Francis Cancer Center

Greenville, South Carolina, United States

Site Status

Spartanburg Regional Medical Center

Spartanburg, South Carolina, United States

Site Status

Sanford USD Medical Center

Sioux Falls, South Dakota, United States

Site Status

Erlanger Health System

Chattanooga, Tennessee, United States

Site Status

Chattanooga Research and Medicine

Chattanooga, Tennessee, United States

Site Status

The West Clinic, PLLC dba West Cancer Center

Germantown, Tennessee, United States

Site Status

Urology Associates of Kingsport

Kingsport, Tennessee, United States

Site Status

Tennessee Cancer Specialists

Knoxville, Tennessee, United States

Site Status

University of Tennessee Medical Center

Knoxville, Tennessee, United States

Site Status

Baptist Cancer Center

Memphis, Tennessee, United States

Site Status

Florida Cancer Specialists

Nashville, Tennessee, United States

Site Status

Sarah Cannon Cancer Center

Nashville, Tennessee, United States

Site Status

Tennessee Oncology Nashville

Nashville, Tennessee, United States

Site Status

Texas Oncology Cancer Care and Research Center

Austin, Texas, United States

Site Status

Texas Oncology-Baylor Charles A. Sammons Cancer Center

Dallas, Texas, United States

Site Status

University of Texas Southwestern Medical Center at Dallas

Dallas, Texas, United States

Site Status

Texas Oncology Fort Worth

Fort Worth, Texas, United States

Site Status

Oncology Consultants, P.A.

Houston, Texas, United States

Site Status

Texas Oncology P.A.

Lewisville, Texas, United States

Site Status

University of Texas Health Science Center - San Antonio

San Antonio, Texas, United States

Site Status

Arizona Oncology Associates, P.C. - HOPE

The Woodlands, Texas, United States

Site Status

Comprehensive Cancer Centers of Nevada

The Woodlands, Texas, United States

Site Status

Illinois Cancer Specialists

The Woodlands, Texas, United States

Site Status

Miami Cancer Institute at Baptist Health, Inc.

The Woodlands, Texas, United States

Site Status

Minnesota Oncology/Hematology PA

The Woodlands, Texas, United States

Site Status

Northwest Cancer Specialists PC

The Woodlands, Texas, United States

Site Status

Oncology and Hematology Associates of Southwest Virginia Inc

The Woodlands, Texas, United States

Site Status

Oncology Hematology Care Inc

The Woodlands, Texas, United States

Site Status

Oncology Hematology West

The Woodlands, Texas, United States

Site Status

Sansum Clinic

The Woodlands, Texas, United States

Site Status

Shenandoah Oncology, P.C.

The Woodlands, Texas, United States

Site Status

Texas Oncology - Dallas Presbyterian Hospital

The Woodlands, Texas, United States

Site Status

Texas Oncology - Denison

The Woodlands, Texas, United States

Site Status

Texas Oncology - McAllen

The Woodlands, Texas, United States

Site Status

Texas Oncology - McKinney

The Woodlands, Texas, United States

Site Status

Texas Oncology - Medical City Dallas

The Woodlands, Texas, United States

Site Status

Texas Oncology - Methodist Dallas Cancer Center

The Woodlands, Texas, United States

Site Status

Texas Oncology - Paris

The Woodlands, Texas, United States

Site Status

Texas Oncology - San Antonio Medical Center

The Woodlands, Texas, United States

Site Status

Texas Oncology - The Woodlands

The Woodlands, Texas, United States

Site Status

Texas Oncology - Tyler

The Woodlands, Texas, United States

Site Status

Texas Oncology - West Texas

The Woodlands, Texas, United States

Site Status

Texas Oncology Cancer Care and Research Center

The Woodlands, Texas, United States

Site Status

Texas Oncology Denton

The Woodlands, Texas, United States

Site Status

Texas Oncology Fort Worth

The Woodlands, Texas, United States

Site Status

Texas Oncology P.A.

The Woodlands, Texas, United States

Site Status

Texas Oncology- Mesquite

The Woodlands, Texas, United States

Site Status

Texas Oncology-Arlington South

The Woodlands, Texas, United States

Site Status

Texas Oncology-Baylor Charles A. Sammons Cancer Center

The Woodlands, Texas, United States

Site Status

Texas Oncology-Deke Slayton Cancer Center

The Woodlands, Texas, United States

Site Status

Texas Oncology-Plano East

The Woodlands, Texas, United States

Site Status

Texas Oncology-Plano West

The Woodlands, Texas, United States

Site Status

US Oncology

The Woodlands, Texas, United States

Site Status

USO - Texas Oncology, P. A.

The Woodlands, Texas, United States

Site Status

USO-Maryland Oncology Hematology, P.A.

The Woodlands, Texas, United States

Site Status

USO-New York Oncology Hematology, P.C

The Woodlands, Texas, United States

Site Status

USO-Rocky Mountain Cancer Center

The Woodlands, Texas, United States

Site Status

USO-Southern Cancer Center, P.C.

The Woodlands, Texas, United States

Site Status

USO-Virginia Oncology Associates

The Woodlands, Texas, United States

Site Status

Virginia Cancer Specialists

The Woodlands, Texas, United States

Site Status

Willamette Valley Cancer Institute & Research Ctr.

The Woodlands, Texas, United States

Site Status

Texas Oncology - Paris

Tyler, Texas, United States

Site Status

Texas Oncology - Tyler

Tyler, Texas, United States

Site Status

Utah Cancer Specialists

Salt Lake City, Utah, United States

Site Status

The University of Vermont Medical Center Inc.

Burlington, Vermont, United States

Site Status

Hematology Oncology Associates of Fredericksburg Inc.

Fredericksburg, Virginia, United States

Site Status

Virginia Commonwealth University (VCU) Medical Center

Richmond, Virginia, United States

Site Status

MultiCare Regional Cancer Center - Auburn

Auburn, Washington, United States

Site Status

Swedish Medical Center

Seattle, Washington, United States

Site Status

Centro de Oncologia e Investigacion Buenos Aires

Berazategui, Buenos Aires, Argentina

Site Status

Instituto de Investigaciones Clinicas Mar del Plata

Mar del Plata, Buenos Aires, Argentina

Site Status

Hospital Universitario Austral

Pilar, Buenos Aires, Argentina

Site Status

Hospital Aleman

Buenos Aires, Buenos Aires F.D., Argentina

Site Status

Fundacion CENIT para la Investigacion en Neurociencias

CABA, Ciudad Autonoma Buenos Aires, Argentina

Site Status

Clinica Viedma

Viedma, Río Negro Province, Argentina

Site Status

Instituto de Oncologia de Rosario

Rosario, Santa Fe Province, Argentina

Site Status

Centro Para la Atención Integral del Paciente Oncologico (CAIPO)

San Miguel de Tucumán, Tucumán Province, Argentina

Site Status

Instituto Alexander Fleming

Buenos Aires, , Argentina

Site Status

IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas

Buenos Aires, , Argentina

Site Status

Clinica Adventista de Belgrano

Ciudad Autonoma Buenos Aires, , Argentina

Site Status

Fundación CORI para la Investigación y Prevención del Cáncer

La Rioja, , Argentina

Site Status

Consultorio Dr. Miguel Ángel Escudero

Salta, , Argentina

Site Status

CER San Juan

San Juan, , Argentina

Site Status

Centro Medico San Roque

San Miguel de Tucumán, , Argentina

Site Status

Chris O'Brien Lifehouse

Camperdown, New South Wales, Australia

Site Status

St Vincent's Hospital

Darlinghurst, New South Wales, Australia

Site Status

Lismore Base Hospital

Lismore, New South Wales, Australia

Site Status

Liverpool Hospital

Liverpool, New South Wales, Australia

Site Status

Mater Hospital Sydney

Sydney, New South Wales, Australia

Site Status

Calvary Mater Newcastle

Waratah, New South Wales, Australia

Site Status

Westmead Hospital

Westmead, New South Wales, Australia

Site Status

Southern Medical Day Care Centre

Wollongong, New South Wales, Australia

Site Status

Mater Misericordiae Limited

Brisbane, Queensland, Australia

Site Status

Gold Coast University Hospital

Southport, Queensland, Australia

Site Status

The Townsville Hospital

Townsville, Queensland, Australia

Site Status

Lyell McEwin Hospital

Elizabeth Vale, South Australia, Australia

Site Status

Ashford Cancer Centre Research

Kurralta Park, South Australia, Australia

Site Status

Launceston General Hospital

Launceston, Tasmania, Australia

Site Status

Box Hill Hospital

Box Hill, Victoria, Australia

Site Status

Epworth Hospital

East Melbourne, Victoria, Australia

Site Status

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Site Status

Maroondah Hospital

Melbourne, Victoria, Australia

Site Status

Breast Cancer Research Centre WA

Nedlands, Western Australia, Australia

Site Status

St John of God Subiaco Hospital

Subiaco, Western Australia, Australia

Site Status

Medizinische Universität Graz

Graz, Styria, Austria

Site Status

Medizinische Universitaet Innsbruck

Innsbruck, Tyrol, Austria

Site Status

Private Practice - Dr. Hubalek

Schwaz, Tyrol, Austria

Site Status

Medizinische Universität Wien

Vienna, Vienna, Austria

Site Status

Universitaetsklinikum Allgemeines Krankenhaus Wien

Vienna, Vienna, Austria

Site Status

Klinik Hietzing

Vienna, Vienna, Austria

Site Status

Universitätsklinikum Salzburg

Salzburg, , Austria

Site Status

Algemeen Ziekenhuis klina

Brasschaat, Antwerpen, Belgium

Site Status

Antwerp University Hospital

Edegem, Antwerpen, Belgium

Site Status

Cliniques Universitaires Saint-Luc

Brussels, Bruxelles-Capitale, Région de, Belgium

Site Status

CHU de Charleroi - Hopital Civil Marie Curie

Lodelinsart, Hainaut, Belgium

Site Status

Jessa Ziekenhuis

Hasselt, Limburg, Belgium

Site Status

Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

Liège, Liège, Belgium

Site Status

Centre Hospitalier D'Ardenne - Forget

Libramont, Luxembourg, Belgium

Site Status

Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne

Yvoir, Namur, Belgium

Site Status

AZ Nikolaas

Sint-Niklaas, Oost-Vlaanderen, Belgium

Site Status

UZ Leuven

Leuven, Vlaams-Brabant, Belgium

Site Status

Groupe Jolimont

La Louvière, Wallonne, Région, Belgium

Site Status

Clinical Chc Montlégia

Liège, Wallonne, Région, Belgium

Site Status

Clinique Saint Pierre

Ottignies, Wallonne, Région, Belgium

Site Status

AZ Sint-Jan Brugge-Oostende AV

Bruges, West-Vlaanderen, Belgium

Site Status

Jan Yperman ziekenhuis

Ieper, West-Vlaanderen, Belgium

Site Status

AZ Groeninge Campus Kennedylaan

Kortrijk, West-Vlaanderen, Belgium

Site Status

CHU UCL Namur/Site Sainte Elisabeth

Namur, , Belgium

Site Status

Centro de Pesquisa Clínica do Instituto do Câncer do Ceará

Fortaleza, Ceará, Brazil

Site Status

Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul

Brasília, Federal District, Brazil

Site Status

Hospital Araújo Jorge

Goiânia, Goiás, Brazil

Site Status

CIONC - Centro Integrado de Oncologia de Curitiba

Curitiba, Paraná, Brazil

Site Status

Hospital de Cancer de Londrina

Londrina, Paraná, Brazil

Site Status

Instituto de Educação, Pesquisa e Gestão em Saúde

Rio de Janeiro, Rio de Janeiro, Brazil

Site Status

ONCOSITE - Centro de Pesquisa Clinica em Oncologia

Ijuí, Rio Grande do Sul, Brazil

Site Status

Hospital Bruno Born

Lajeado, Rio Grande do Sul, Brazil

Site Status

Hospital São Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status

Fundação Pio XII - Hospital de Câncer de Barretos

Barretos, São Paulo, Brazil

Site Status

Hospital de Clínicas de Ribeirão Preto

Ribeirão Preto, São Paulo, Brazil

Site Status

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

Site Status

Hospital de Base de São José do Rio Preto

Sao Jose Rio Preto, São Paulo, Brazil

Site Status

Instituto do Cancer do Estado de Sao Paulo - ICESP

São Paulo, São Paulo, Brazil

Site Status

INCA - Instituto Nacional Do Cancer

Rio de Janeiro, , Brazil

Site Status

Hospital Sírio Libanês

São Paulo, , Brazil

Site Status

Pérola Centro de Pesquisa em Oncologia

São Paulo, , Brazil

Site Status

IBCC - Núcleo de Pesquisa e Ensino

São Paulo, , Brazil

Site Status

Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T

São Paulo, , Brazil

Site Status

Instituto D'Or de Pesquisa e Ensino (IDOR)

São Paulo, , Brazil

Site Status

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

Site Status

North York General Hospital

Toronto, Ontario, Canada

Site Status

Humber River Hospital

Toronto, Ontario, Canada

Site Status

Unity Health Toronto, St. Michael's Hospital

Toronto, Ontario, Canada

Site Status

Centre Hospitalier de l'Universite de Montreal

Montreal, Quebec, Canada

Site Status

Jewish General Hospital

Montreal, Quebec, Canada

Site Status

Hopital du Sacre-Coeur de Montreal

Montreal, Quebec, Canada

Site Status

CHU de Quebec-Hopital de Saint-Sacrement

Québec, Quebec, Canada

Site Status

Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitair -T

Sherbrooke, Quebec, Canada

Site Status

The Fifth Medical Center of PLA General Hospital

Beijing, Beijing Municipality, China

Site Status

Beijing Cancer Hospital

Beijing, Beijing Municipality, China

Site Status

Fujian Medical University Union Hospital-1 Bingfanglou

Fuzhou, Fujian, China

Site Status

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Site Status

The First Affiliated Hospital, Sun-Yat Sen University

Guangzhou, Guangdong, China

Site Status

Sun Yat-Sen University

Guangzhou, Guangdong, China

Site Status

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status

Henan Cancer Hospital

Zhengzhou, Henan, China

Site Status

Hunan Cancer Hospital

Changsha, Hunan, China

Site Status

Jiangsu Cancer Hospital

Nanjing, Jiangsu, China

Site Status

Jiangsu Province Hospital

Nanjing, Nanjing, China

Site Status

Shandong Cancer Hospital

Jinan, Shandong, China

Site Status

Shanghai Jiaotong University School of Medicine Ruijin Hospital

Shanghai, Shanghai Municipality, China

Site Status

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Site Status

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

Site Status

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status

Nemocnice Horovice

Hořovice, Beroun, Czechia

Site Status

Masarykuv onkologicky ustav

Brno, Brno-město, Czechia

Site Status

Fakultni Nemocnice Ostrava

Ostrava, Moravskoslezský kraj, Czechia

Site Status

Multiscan

Pardubice, Pardubický kraj, Czechia

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Fakultni Thomayerova nemocnice

Prague, Praha 4, Czechia

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FN Plzen Lochotin

Pilsen, , Czechia

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Herlev and Gentofte Hospital

Copenhagen, Capital Region, Denmark

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Rigshospitalet

København Ø, Capital Region, Denmark

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Aarhus Universitetshospital, Skejby

Aarhus, Central Jutland, Denmark

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Regionshospitalet Herning

Herning, Central Jutland, Denmark

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Aalborg Universitetshospital, Syd

Aalborg, North Denmark, Denmark

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Næstved Sygehus

Næstved, Region Sjælland, Denmark

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Sydvestjysk Sygehus Esbjerg

Esbjerg, Region Syddanmark, Denmark

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Odense Universitetshospital

Odense, Region Syddanmark, Denmark

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Sygehus Soenderjylland

Sønderborg, Region Syddanmark, Denmark

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Vejle Sygehus

Vejle, Region Syddanmark, Denmark

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Keski-Suomen Keskussairaala

Jyväskylä, Central Finland, Finland

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Oulun yliopistollinen sairaala

Oulu, North Ostrobothnia, Finland

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Kuopion Yliopistollinen Sairaala

Kuopio, Northern Savonia, Finland

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Tampereen yliopistollinen sairaala

Tampere, Pirkanmaa, Finland

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Vaasan Keskussairaala

Vaasa, Pohjanmaa, Finland

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Satakunnan Keskussairaala

Pori, Satakunta, Finland

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Turku University Central Hospital

Turku, Southwest Finland, Finland

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Docrates Syöpäsairaala

Helsinki, Uusimaa, Finland

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Päijät-Häme Central hospital

Lahti, , Finland

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Centre Leon Berard

Lyon, Auvergne-Rhône-Alpes, France

Site Status

Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

Brest, Brittany Region, France

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Polyclinique De Blois

La Chaussée-Saint-Victor, Centre-Val de Loire, France

Site Status

Centre Georges Francois Leclerc

Dijon, Côte-d'Or, France

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Hôpital Privé des Côtes d'Armor- HPCA

Plérin, Côtes-d'Armor, France

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CHU de Besancon Hopital Jean Minjoz

Besançon, Doubs, France

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Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer

Rennes, Ille-et-Vilaine, France

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Centre de Cancérologie du Grand Montpellier

Montpellier, Languedoc-Roussillon, France

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Institut de Cancérologie de l'Ouest

Saint-Herblain, Loire-Atlantique, France

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Polyclinique de Gentilly

Nancy, Meurthe-et-Moselle, France

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Clinique Victor Hugo Le Mans

Le Mans, Pays de la Loire Region, France

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Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne

Clermont-Ferrand, Puy-de-Dôme, France

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Henri Mondor Hospital

Créteil, Seine-et-Marne, France

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Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen

Rouen, Seine-Maritime, France

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Sainte Catherine Institut du Cancer Avignon Provence

Avignon, Vaucluse, France

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Centre Hospitalier de Vendee Les Oudairies

La Roche-sur-Yon, Vendée, France

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Institut Curie

Paris, , France

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Praxis für interdisziplinäre Onkologie & Hämatologie

Freiburg im Breisgau, Baden-Wurttemberg, Germany

Site Status

Universitätsklinikum Freiburg

Freiburg im Breisgau, Baden-Wurttemberg, Germany

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Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer

Friedrichshafen, Baden-Wurttemberg, Germany

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Klinikum Ludwigsburg

Ludwigsburg, Baden-Wurttemberg, Germany

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Universitätsklinikum Tübingen

Tübingen, Baden-Wurttemberg, Germany

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Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

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Klinikum St. Marien Amberg

Amberg, Bavaria, Germany

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Gemeinschaftspraxis hop-augsburg

Augsburg, Bavaria, Germany

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Universitätsklinikum Erlangen

Erlangen, Bavaria, Germany

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Klinikum der Ludwig-Maximilians-Universitaet Muenchen

München, Bavaria, Germany

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Klinikum Rechts Der Isar Der Technischen Universität München

München, Bavaria, Germany

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Rotkreuzklinikum München gemeinnützige GmbH

München, Bavaria, Germany

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Agaplesion Markus Krankenhaus

Frankfurt am Main, Hesse, Germany

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Private Practice - Dres. Andreas Köhler und Roswitha Fuchs

Langen, Hesse, Germany

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Sana Klinikum Offenbach

Offenbach, Hesse, Germany

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Franziskus-Hospital Harderberg

Georgsmarienhütte, Lower Saxony, Germany

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Gynäkologisch-Onkologische Praxis am Pelikanplatz

Hanover, Lower Saxony, Germany

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Medizinische Hochschule Hannover

Hanover, Lower Saxony, Germany

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Universitätsklinikum Bonn

Bonn, North Rhine-Westphalia, Germany

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Universitätsklinikum Düsseldorf

Düsseldorf, North Rhine-Westphalia, Germany

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Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

Essen, North Rhine-Westphalia, Germany

Site Status

Zentrum fuer ambulante gynaekologische Onkologie (ZAGO)

Krefeld, North Rhine-Westphalia, Germany

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Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH

Mönchengladbach, North Rhine-Westphalia, Germany

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Universitätsklinikum Münster - Albert Schweitzer Campus

Münster, North Rhine-Westphalia, Germany

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Marien Hospital Witten

Witten, North Rhine-Westphalia, Germany

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Universitätsklinikum Carl Gustav Carus

Dresden, Saxony, Germany

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Universitaetsklinikum Schleswig-Holstein Campus Kiel

Kiel, Schleswig-Holstein, Germany

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SRH Wald-Klinikum Gera gGmbH

Gera, Thuringia, Germany

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Helios Klinikum Berlin-Buch

Berlin, , Germany

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Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim

Berlin, , Germany

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Mammazentrum HH - Krankenhaus Jerusalem

Hamburg, , Germany

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Kath. Marienkrankenhaus gGmbH

Hamburg, , Germany

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Asklepios Kliniken Hamburg

Hamburg, , Germany

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University Hospital of Patras

Pátrai, Achaia, Greece

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Errikos Dunant Hospital Center

Athens, Attikí (Region), Greece

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Alexandra Hospital

Athens, Attikí, Greece

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Agios Savvas Regional Cancer Hospital

Athens, Attikí, Greece

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Metropolitan Hospital

Athens, Attikí, Greece

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Attikon General University Hospital

Chaïdári, Attikí, Greece

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General Oncology Hospital of Kifissia "Agioi Anargiroi"

Nea Kifissia, Attikí, Greece

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Bioclinic of Thessaloniki

Thessaloniki, Kentrikí Makedonía, Greece

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University General Hospital of Heraklion

Heraklion, Krítí, Greece

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European Interbalkan Medical Center

Thessaloniki, Thessaloníki, Greece

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Euromedica - General Clinic of Thessaloniki

Thessaloniki, , Greece

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Papageorgiou General Hospital of Thessaloniki

Thessaloniki, , Greece

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University Hospital of Ioannina

Ioannina, Ípeiros, Greece

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Pamela Youde Nethersole Eastern Hospital

Chai Wan, , Hong Kong

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Queen Mary Hospital

Hksar, , Hong Kong

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Tuen Mun Hospital

Tuenmen, , Hong Kong

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Queen Elizabeth Hospital

Yau Ma Tei, , Hong Kong

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Bacs-Kiskun Varmegyei Oktatokorhaz

Kecskemét, Bács-Kiskun county, Hungary

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Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

Szolnok, Jász-Nagykun-Szolnok, Hungary

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Szent Margit Kórház

Budapest, , Hungary

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Magyar Honvedseg Egeszsegugyi Kozpont

Budapest, , Hungary

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Semmelweis University

Budapest, , Hungary

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Szent Imre Egyetemi Oktatokorhaz

Budapest, , Hungary

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Uzsoki Utcai Kórház

Budapest, , Hungary

Site Status

MNJ Institute of Oncology

Hyderabad, Andhra Pradesh, India

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HCG Cancer Centre

Ahmedabad, Gujarat, India

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HCG Cancer Centre

Vadodara, Gujarat, India

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Artemis Hospital

Gurgaon, Haryana, India

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Manipal Hospital

Bangalore, Karmnataka, India

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Regional Cancer Centre

Trivandrum, Kerala, India

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Tata Memorial Hospital

Mumbai, Maharashtra, India

Site Status

HCG Manavata Cancer Centre

Nashik, Maharashtra, India

Site Status

Grant Medical Foundation - Ruby Hall Clinic

Pune, Maharashtra, India

Site Status

Deenanth Mangeshkar Hospital and Research Centre

Pune, Maharashtra, India

Site Status

Dr. B. L. Kapur Memorial Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status

Apollo Speciality Hospital - Teynampet

Chennai, Tamil Nadu, India

Site Status

Apollo Gleneagles Hospitals

Kolkata, West Bengal, India

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Medica Superspecialty Hospital

Kolkata, West Bengal, India

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Post Graduate Institute of Medical Education & Research

Chandigarh, , India

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Meir Medical Center

Kfar Saba, Central District, Israel

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Rabin Medical Center

Petah Tikva, Central District, Israel

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Sheba Medical Center

Ramat Gan, Central District, Israel

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Kaplan Medical Center

Rehovot, Central District, Israel

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Yitzhak Shamir Medical Center

Ẕerifin, Central District, Israel

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Shaare Zedek Medical Center

Jerusalem, Jerusalem, Israel

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Hadassah Medical Center

Jerusalem, Jerusalem, Israel

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Soroka Medical Center

Beersheba, Southern District, Israel

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Rambam Health Care Campus

Haifa, Ḥeifā, Israel

Site Status

University of Naples Federico II

Napoli, Campania, Italy

Site Status

Azienda Ospedaliero Universitaria S.Anna

Cona, Emilia-Romagna, Italy

Site Status

Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

Meldola, Emilia-Romagna, Italy

Site Status

Fondazione IRCCS San Gerardo dei Tintori

Monza, Lombardy, Italy

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Ospedale Fatebenefratelli-Oftalmico

Milan, Milano, Italy

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Humanitas

Rozzano, Milano, Italy

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Istituto Nazionale Tumori Regina Elena

Rome, Roma, Italy

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Azienda Ospedaliera Sant'Andrea

Rome, Roma, Italy

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Azienda Ospedaliera Santa Maria

Terni, TR, Italy

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Ospedale Bellaria - Azienda USL di Bologna

Bologna, , Italy

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Ospedale Antonio Perrino

Brindisi, , Italy

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Ospedale San Martino

Genova, , Italy

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Azienda Ospedaliero Universitaria

Modena, , Italy

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Istituto Nazionale Tumori IRCCS Fondazione Pascale

Napoli, , Italy

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Istituto Oncologico Veneto IRCCS

Padua, , Italy

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Azienda Ospedaliera Di Parma

Parma, , Italy

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Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino

Torino, , Italy

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APSS - Presidio Ospedaliero Santa Chiara

Trento, , Italy

Site Status

Aichi Cancer Center Hospital

Nagoya, Aichi-ken, Japan

Site Status

Chiba Cancer Center

Chiba, Chiba, Japan

Site Status

National Cancer Center Hospital East

Kashiwa, Chiba, Japan

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National Hospital Organization Shikoku Cancer Center

Matsuyama, Ehime, Japan

Site Status

Kurume General Hospital

Kurume, Fukuoka, Japan

Site Status

Gunma Prefectural Cancer Center

Ōta, Gunma, Japan

Site Status

Hiroshima University Hospital

Hiroshima, Hiroshima, Japan

Site Status

National Hospital Organization Hokkaido Cancer Center

Sapporo, Hokkaido, Japan

Site Status

Hyogo College of Medecine

Nishinomiya, Hyōgo, Japan

Site Status

University of tsukuba hospital

Tsukuba, Ibaragi, Japan

Site Status

Tokai University Hospital- Isehara Campus

Isehara, Kanagawa, Japan

Site Status

St Marianna University School of Medicine Hospital

Kawasaki, Kanagawa, Japan

Site Status

Kanagawa Cancer Center

Yokohama, Kanagawa, Japan

Site Status

KKR Tohoku Kosai Hospital

Aoba-ku, Sendai-shi, Miyagi, Japan

Site Status

Niigata Cancer Center Hospital

Niigata, Niigata, Japan

Site Status

Kindai University Hospital- Osakasayama Campus

Osaka Sayama-shi, Osaka, Japan

Site Status

Saitama Medical University International Medical Center

Hidaka, Saitama, Japan

Site Status

Saitama Prefectural Cancer Center

Ina-machi, Saitama, Japan

Site Status

Shizuoka Cancer Center

Nakatogari, Shizuoka, Japan

Site Status

Jichi Medical University Hospital

Shimotsuke, Tochigi, Japan

Site Status

Tochigi Cancer Center

Utsunomiya, Tochigi, Japan

Site Status

Juntendo University Hospital

Bunkyō-Ku, Tokyo, Japan

Site Status

National Cancer Center Hospital

Chuo Ku, Tokyo, Japan

Site Status

St. Lukes International Hospital

Chuo-Ku, Tokyo, Japan

Site Status

Japanese Foundation for Cancer Research

Koto, Tokyo, Japan

Site Status

Showa University Hospital

Shinagawa-ku, Tokyo, Japan

Site Status

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

Site Status

National Center for Global Health and Medicine

Shinjuku-ku, Tokyo, Japan

Site Status

National Hospital Organization Kyushu Cancer Center

Fukuoka, , Japan

Site Status

Sagara Hospital

Kagoshima, , Japan

Site Status

Kumamoto University Hospital

Kumamoto, , Japan

Site Status

Kumamoto Shinto General hospital

Kumamoto, , Japan

Site Status

Kyoto University Hospital

Kyoto, , Japan

Site Status

National Hospital Organization Osaka Medical Center

Osaka, , Japan

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Osaka International Cancer Institute

Osaka, , Japan

Site Status

CIMAB S.A. de C.V.

Torreón, Coahuila, Mexico

Site Status

Health Pharma Professional Research, S.A. de C.V.

Mexico City, Federal District, Mexico

Site Status

Hospital Civil Fray Antonio Alcalde

Guadalajara, Jalisco, Mexico

Site Status

Centro Oncológico Internacional (COI)

Guadalajara, Jalisco, Mexico

Site Status

Grupo Medico Camino S.C.

Mexico City, Mexico City, Mexico

Site Status

Centro Regiomontano de Investigacion

Monterrey, Nuevo León, Mexico

Site Status

Private Practice - Dr. Joaquin Reinoso

Monterrey, Nuevo León, Mexico

Site Status

Filios Alta Medicina

Monterrey, Nuevo León, Mexico

Site Status

Centro de Estudios y Prevencion del Cancer

Juchitán de Zaragoza, Oaxaca, Mexico

Site Status

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, Mexico

Site Status

Centro Hemato Oncologico Privado

Toluca, Toluca, Mexico

Site Status

Medical Care and Research, S.A. de C.V.

Mérida, Yucatán, Mexico

Site Status

Centro de Atención e Investigación Clínica en Oncología

Mérida, Yucatán, Mexico

Site Status

Unidad de Investigacion en Salud

Chihuahua City, , Mexico

Site Status

Oaxaca Site Management Organization SC

Oaxaca City, , Mexico

Site Status

Unidad Médica Onco-hematológica

Puebla City, , Mexico

Site Status

Oncológico Potosino

San Luis Potosí City, , Mexico

Site Status

Maastricht UMC+

Maastricht, Limburg, Netherlands

Site Status

Onze Lieve Vrouwe Gasthuis (OLVG)

Amsterdam, North Holland, Netherlands

Site Status

Albert Schweitzer Ziekenhuis, locatie Dordwijk

Dordrecht, South Holland, Netherlands

Site Status

Haga Ziekenhuis locatie Leyweg

The Hague, South Holland, Netherlands

Site Status

Waikato Hospital

Hamilton, Waikato Region, New Zealand

Site Status

Palmerston North Hospital

Palmerston North, Wanganui, New Zealand

Site Status

Auckland City Hospital

Auckland, , New Zealand

Site Status

Przychodnia Lekarska "Komed"

Konin, Greater Poland Voivodeship, Poland

Site Status

Wielkopolskie Centrum Onkologii

Poznan, Greater Poland Voivodeship, Poland

Site Status

Dolnośląskie Centrum Onkologii we Wrocławiu

Wroclaw, Lower Silesian Voivodeship, Poland

Site Status

Centrum Onkologii Ziemii Lubelskiej

Lublin, Lublin Voivodeship, Poland

Site Status

Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie

Warsaw, Masovian Voivodeship, Poland

Site Status

Luxmed Onkologia sp. z o. o.

Warsaw, Masovian Voivodeship, Poland

Site Status

Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

Opole, Opole Voivodeship, Poland

Site Status

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Site Status

Szpitale Pomorskie Sp. z o. o.

Gdynia, Pomeranian Voivodeship, Poland

Site Status

Olsztyński Ośrodek Onkologiczny Kopernik

Olsztyn, Warmian-Masurian Voivodeship, Poland

Site Status

Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna

Lodz, Łódź Voivodeship, Poland

Site Status

Instituto Portugês de Oncologia de Coimbra Francisco Gentil

Coimbra, , Portugal

Site Status

Champalimaud Foundation

Lisbon, , Portugal

Site Status

Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria

Lisbon, , Portugal

Site Status

Centro Hospitalar do Porto - Hospital de Santo António

Porto, , Portugal

Site Status

IPOFG - Porto

Porto, , Portugal

Site Status

Puerto Rico Hematology/Oncology Group

Bayamón, PR, Puerto Rico

Site Status

UPR Comprehensive Cancer Center

San Juan, PR, Puerto Rico

Site Status

Institutul Oncologic

Bucharest, București, Romania

Site Status

Institutul Oncologic

Cluj-Napoca, Cluj, Romania

Site Status

Ovidius Clinical Hospital OCH

Ovidiu, Constanța County, Romania

Site Status

Centrul de Oncologie "Sfântul Nectarie"

Craiova, Dolj, Romania

Site Status

Radiology Therapeutic Center

Otopeni, Ilfov, Romania

Site Status

Oncopremium Team

Baia Mare, Maramureş, Romania

Site Status

Spitalul Clinic Filantropia

Bucharest, , Romania

Site Status

Chelyabinsk Regional Oncology Dispensary

Chelyabinsk, Chelyabinsk Oblast, Russia

Site Status

Kaluga Regional Clinical Oncology Center

Kaluga, Kalužskaja Oblast', Russia

Site Status

Kursk Regional Oncology Dispensary

Kursk, Kursk Oblast, Russia

Site Status

Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF

Moscow, Moscow, Russia

Site Status

Burdenko Main Military Hospital

Moscow, Moscow, Russia

Site Status

Orenburg Regional Clinical Oncology Dispensary

Orenburg, Orenburg Oblast, Russia

Site Status

Samara Regional Clinical Oncology Center

Samara, Samara Oblast, Russia

Site Status

Leningrad Regional Oncology Dispensary

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

North-Western State Medical University named after I.I.Mechnikov

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

St. Petersburg City Oncological Dispensary - Berezovaya Avenue

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

N.N.Petrov Research Institute of Oncology

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (oncological) named afte -T

Saint Petersburg, Sankt-Peterburg, Russia

Site Status

Republican Clinical Oncology Dispensary

Kazan', Tatarstan Republic, Russia

Site Status

Volgograd Regional Oncological Dispensary No. 3

Volzhsky, Volgograd Oblast, Russia

Site Status

Yaroslavl Regional Cancer Hospital

Yaroslavl, Yaroslavl Oblast, Russia

Site Status

Blokhin Cancer Research Center

Moscow, , Russia

Site Status

King Fahad Specialist Hospital-Dammam

Dammam, Eastern Province, Saudi Arabia

Site Status

King Abdulaziz Medical City - National Guard Hospital

Riyadh, Riyadh Region, Saudi Arabia

Site Status

King Fahad Medical City

Riyadh, Riyadh Region, Saudi Arabia

Site Status

King Faisal Specialist Hospital & Research Center

Riyadh, , Saudi Arabia

Site Status

National Cancer Center

Singapore, Central Singapore, Singapore

Site Status

National University Hospital

Singapore, , Singapore

Site Status

Cancercare Langenhoven Drive Oncology Centre

Port Elizabeth, Eastern Cape, South Africa

Site Status

Life Groenkloof

Pretoria, Gauteng, South Africa

Site Status

Eastleigh Breast Care Center

Pretoria, Gauteng, South Africa

Site Status

Sandton Oncology Medical Group (Pty) Ltd

Sandton, Gauteng, South Africa

Site Status

Cancercare Rondebosch Oncology

Cape Town, Western Cape, South Africa

Site Status

GVI Oncology

George, Western Cape, South Africa

Site Status

Chungbuk National University Hospital

Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea

Site Status

Soon chun hyang University Cheonan Hospital

Cheonan-si, Chungcheongnam-do [Chungnam], South Korea

Site Status

Inha University Hospital

Incheon, Incheon-gwangyeoksi [Incheon], South Korea

Site Status

Gachon University Gil Medical Center

Namdong-gu, Incheon-gwangyeoksi [Incheon], South Korea

Site Status

National Cancer Center

Goyang-si, Kyǒnggi-do, South Korea

Site Status

Seoul National University Bundang Hospital

Seongnam, Kyǒnggi-do, South Korea

Site Status

Dongnam Institute of Radiological and Medical Sciences

Busan, Pusan-Kwangyǒkshi, South Korea

Site Status

Inje University Haeundae Paik Hospital

Haeundae-gu, Pusan-Kwangyǒkshi, South Korea

Site Status

Korea University Anam Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Seoul National University Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Severance Hospital Yonsei University Health System

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Samsung Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Korea University Guro Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Ewha Womans University Mokdong Hospital

Seoul, Seoul-teukbyeolsi [Seoul], South Korea

Site Status

Kyungpook National University Chilgok Hospital

Daegu, Taegu-Kwangyǒkshi, South Korea

Site Status

Hospital Universitario Reina Sofia

Córdoba, Andalusia, Spain

Site Status

Hospital Quiron Barcelona

Barcelona, Barcelona [Barcelona], Spain

Site Status

Hospital Clínic de Barcelona

Barcelona, Catalunya [Cataluña], Spain

Site Status

Hospital de la Santa Creu i Sant Pau

Barcelona, Catalunya [Cataluña], Spain

Site Status

CHUS - Hospital Clinico Universitario

Santiago de Compostela, La Coruna, Spain

Site Status

Hospital Universitario Arnau de Vilanova de Lleida

Lleida, Lleida [Lérida], Spain

Site Status

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, Spain

Site Status

Hospital Universitario Fundacion ALcorcon

Alcorcón, Madrid, Comunidad de, Spain

Site Status

Hospital Universitario Ramón y Cajal

Madrid, Madrid, Comunidad de, Spain

Site Status

Hospital Universitario 12 de Octubre

Madrid, Madrid, Comunidad de, Spain

Site Status

Hospital Universitario Virgen de la Victoria

Málaga, Málaga, Spain

Site Status

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, Spain

Site Status

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain

Site Status

Hospital Clínico de Valencia

Valencia, Valenciana, Comunitat, Spain

Site Status

Parc de Salut Mar - Hospital del Mar

Barcelona, , Spain

Site Status

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status

Hospital Universitario San Cecilio

Granada, , Spain

Site Status

Complejo Hospitalario de Jaén

Jaén, , Spain

Site Status

Hospital La Princesa

Madrid, , Spain

Site Status

Hospital General Universitario Gregorio Marañon

Madrid, , Spain

Site Status

Hospital Clinico San Carlos

Madrid, , Spain

Site Status

Hospital Universitario HM Sanchinarro

Madrid, , Spain

Site Status

Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

Salamanca, , Spain

Site Status

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status

Hospital Universitario Virgen de Valme

Seville, , Spain

Site Status

Hospital Quirón Salud Valencia

Valencia, , Spain

Site Status

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Site Status

Skånes universitetssjukhus Lund

Malmo, Skåne Län [se-12], Sweden

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Norrlands universitetssjukhus

Umeå, Västerbottens Län [se-24], Sweden

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Sundsvalls Sjukhus

Sundsvall, Västernorrlands Län [se-22], Sweden

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Västmanlands sjukhus Västerås

Västerås, Västmanlands Län [se-19], Sweden

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Växjö Centrallasarettet

Vaxjo, , Sweden

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Chang Gung Memorial Hospital - Kaohsiung

Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan

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Tri-Service General Hospital

Taipei City, Taipei, Taiwan

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Changhua Christian Hospital

Changhua, , Taiwan

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Kaohsiung Medical University Chung-Ho Memorial Hospital

Kaohsiung City, , Taiwan

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Taipei Medical University Hospital

New Taipei City, , Taiwan

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China Medical University Hospital

Taichung, , Taiwan

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National Taiwan University Hospital

Taipei, , Taiwan

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MacKay Memorial Hospital

Taipei, , Taiwan

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Taipei Veterans General Hospital

Taipei, , Taiwan

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Koo Foundation Sun Yat-Sen Cancer Center

Taipei, , Taiwan

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Chang Gung Medical Foundation-Linkou Branch

Taoyuan, , Taiwan

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Istanbul Universitesi Cerrahpasa

Istanbul- Fatih, Istanbul, Turkey (Türkiye)

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Acibadem Altunizade Hospital

Üsküdar/stanbul, Istanbul, Turkey (Türkiye)

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Ege University Medicine of Faculty

Bornova, İzmir, Turkey (Türkiye)

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Izmir Medical Park Hospital

Izmir, Karsiyaka, İzmir, Turkey (Türkiye)

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Ankara Gülhane Eitim ve Aratrma Hastanesi

Ankara, Kecioren, Turkey (Türkiye)

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Baskent University Dr. Turgut Noyan Research and Training Center

Adana, , Turkey (Türkiye)

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Ankara Universitesi Tip Fakultesi Hastanesi

Ankara, , Turkey (Türkiye)

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Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

Ankara, , Turkey (Türkiye)

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Hacettepe Universitesi

Ankara, , Turkey (Türkiye)

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Akdeniz Universitesi Hastanesi

Antalya, , Turkey (Türkiye)

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Trakya University Faculty of Medicine

Edirne, , Turkey (Türkiye)

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TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi

Istanbul, , Turkey (Türkiye)

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Kocaeli Üniversitesi

Kocaeli, , Turkey (Türkiye)

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İnönü Üniversitesi Turgut Özal Tıp Merkezi

Malatya, , Turkey (Türkiye)

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Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council

Dnipro, Dnipropetrovsk Oblast, Ukraine

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Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council

Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine

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Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council

Odesa, Odesa Oblast, Ukraine

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Poltava Regional Clinical Oncology Center

Poltava, Poltava Oblast, Ukraine

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Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"

Vinnytsia, Vinnytsia Oblast, Ukraine

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Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council

Lutsk, Volyn Oblast, Ukraine

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Uzhgorod Central City Clinical Hospital

Uzhhorod, Zakarpattia Oblast, Ukraine

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The Royal Cornwall Hospital

Truro, England, United Kingdom

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Mid Essex Hospital Services NHS Trust

Chelmsford, Essex, United Kingdom

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North Middlesex Hospital

London, Greater London, United Kingdom

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Charing Cross Hospital

London, Hammersmith and Fulham, United Kingdom

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Mount Vernon Hospital

Northwood, Hertfordshire, United Kingdom

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Victoria Hospital

Blackpool, Lancashire, United Kingdom

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Royal Preston Hospital

Preston, Lancashire, United Kingdom

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Boston Pilgrim Hospital

Boston, Lincolnshire, United Kingdom

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Sarah Canon Research Institute UK

London, London, City of, United Kingdom

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Guy's & St Thomas' NHS Foundation Trust

London, London, City of, United Kingdom

Site Status

James Cook University Hospital

Central Middlesbrough, Middlesbrough, United Kingdom

Site Status

Western General Hospital

Edinburgh, Midlothian, United Kingdom

Site Status

Nottingham City Hospital

Nottingham, Nottinghamshire, United Kingdom

Site Status

The Churchill Hospital

Oxford, Oxfordshire, United Kingdom

Site Status

Musgrove Park Hospital

Taunton, Somerset, United Kingdom

Site Status

Royal Surrey County Hospital

Guildford, Surrey, United Kingdom

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Royal Marsden Hospital

London, Sutton, United Kingdom

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Airedale General Hospital

Bradford, , United Kingdom

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The Christie

Manchester, , United Kingdom

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Countries

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United States Argentina Australia Austria Belgium Brazil Canada China Czechia Denmark Finland France Germany Greece Hong Kong Hungary India Israel Italy Japan Mexico Netherlands New Zealand Poland Portugal Puerto Rico Romania Russia Saudi Arabia Singapore South Africa South Korea Spain Sweden Taiwan Turkey (Türkiye) Ukraine United Kingdom

References

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Zhang Q, Shen K, Song CG, Ouyang Q, Liu Z, Liu Q, Feng J, Chiu JWY, Tang J, Jiang Z, Tseng LM, Wang X, Yang L, Qian C, Shao Z. Abemaciclib combined with endocrine therapy as adjuvant treatment for hormone-receptor-positive, HER2-, high-risk early breast cancer: 5-year Chinese population analysis of the phase III randomized monarchE study. Ther Adv Med Oncol. 2024 Oct 23;16:17588359241286775. doi: 10.1177/17588359241286775. eCollection 2024.

Reference Type DERIVED
PMID: 39463748 (View on PubMed)

Johnston SRD, Rugo HS, Tolaney SM, Munoz Fernandez M, Wei R, Martin M. Abemaciclib plus endocrine therapy for HR+, HER2-, node-positive, high-risk early breast cancer: a plain language summary of the monarchE study. Future Oncol. 2024;20(28):2037-2048. doi: 10.1080/14796694.2024.2362095. Epub 2024 Jul 18.

Reference Type DERIVED
PMID: 39023253 (View on PubMed)

Rastogi P, O'Shaughnessy J, Martin M, Boyle F, Cortes J, Rugo HS, Goetz MP, Hamilton EP, Huang CS, Senkus E, Tryakin A, Cicin I, Testa L, Neven P, Huober J, Shao Z, Wei R, Andre V, Munoz M, San Antonio B, Shahir A, Harbeck N, Johnston S. Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes. J Clin Oncol. 2024 Mar 20;42(9):987-993. doi: 10.1200/JCO.23.01994. Epub 2024 Jan 9.

Reference Type DERIVED
PMID: 38194616 (View on PubMed)

Johnston SRD, Toi M, O'Shaughnessy J, Rastogi P, Campone M, Neven P, Huang CS, Huober J, Jaliffe GG, Cicin I, Tolaney SM, Goetz MP, Rugo HS, Senkus E, Testa L, Del Mastro L, Shimizu C, Wei R, Shahir A, Munoz M, San Antonio B, Andre V, Harbeck N, Martin M; monarchE Committee Members. Abemaciclib plus endocrine therapy for hormone receptor-positive, HER2-negative, node-positive, high-risk early breast cancer (monarchE): results from a preplanned interim analysis of a randomised, open-label, phase 3 trial. Lancet Oncol. 2023 Jan;24(1):77-90. doi: 10.1016/S1470-2045(22)00694-5. Epub 2022 Dec 6.

Reference Type DERIVED
PMID: 36493792 (View on PubMed)

Toi M, Boyle F, Im YH, Reinisch M, Molthrop D, Jiang Z, Wei R, Sapunar F, Grimes BR, Nabinger SC, Johnston SRD. Adjuvant Abemaciclib Combined with Endocrine Therapy: Efficacy Results in monarchE Cohort 1. Oncologist. 2023 Jan 18;28(1):e77-e81. doi: 10.1093/oncolo/oyac234.

Reference Type DERIVED
PMID: 36342342 (View on PubMed)

Martin M, Hegg R, Kim SB, Schenker M, Grecea D, Garcia-Saenz JA, Papazisis K, Ouyang Q, Lacko A, Oksuzoglu B, Reeves J, Okera M, Testa L, Shimizu C, Denduluri N, Adamchuk H, Dakhil S, Wei R, Forrester T, Fernandez MM, Zimmermann A, Headley D, Johnston SRD. Treatment With Adjuvant Abemaciclib Plus Endocrine Therapy in Patients With High-risk Early Breast Cancer Who Received Neoadjuvant Chemotherapy: A Prespecified Analysis of the monarchE Randomized Clinical Trial. JAMA Oncol. 2022 Aug 1;8(8):1190-1194. doi: 10.1001/jamaoncol.2022.1488.

Reference Type DERIVED
PMID: 35653145 (View on PubMed)

Perachino M, Poggio F, Arecco L, Blondeaux E, Spinaci S, Marrocco C, Levaggi A, Lambertini M. Update on Pregnancy Following Breast Cancer Diagnosis and Treatment. Cancer J. 2022 May-Jun 01;28(3):176-182. doi: 10.1097/PPO.0000000000000599.

Reference Type DERIVED
PMID: 35594464 (View on PubMed)

Polewski MD, Nielsen GB, Gu Y, Weaver AT, Gegg G, Tabuena-Frolli S, Cajaiba M, Hanks D, Method M, Press MF, Gottstein C, Gruver AM. A Standardized Investigational Ki-67 Immunohistochemistry Assay Used to Assess High-Risk Early Breast Cancer Patients in the monarchE Phase 3 Clinical Study Identifies a Population With Greater Risk of Disease Recurrence When Treated With Endocrine Therapy Alone. Appl Immunohistochem Mol Morphol. 2022 Apr 1;30(4):237-245. doi: 10.1097/PAI.0000000000001009.

Reference Type DERIVED
PMID: 35384873 (View on PubMed)

Rugo HS, O'Shaughnessy J, Boyle F, Toi M, Broom R, Blancas I, Gumus M, Yamashita T, Im YH, Rastogi P, Zagouri F, Song C, Campone M, San Antonio B, Shahir A, Hulstijn M, Brown J, Zimmermann A, Wei R, Johnston SRD, Reinisch M, Tolaney SM; monarchE Committee Members. Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: safety and patient-reported outcomes from the monarchE study. Ann Oncol. 2022 Jun;33(6):616-627. doi: 10.1016/j.annonc.2022.03.006. Epub 2022 Mar 23.

Reference Type DERIVED
PMID: 35337972 (View on PubMed)

Royce M, Osgood C, Mulkey F, Bloomquist E, Pierce WF, Roy A, Kalavar S, Ghosh S, Philip R, Rizvi F, Mixter BD, Tang S, Pazdur R, Beaver JA, Amiri-Kordestani L. FDA Approval Summary: Abemaciclib With Endocrine Therapy for High-Risk Early Breast Cancer. J Clin Oncol. 2022 Apr 10;40(11):1155-1162. doi: 10.1200/JCO.21.02742. Epub 2022 Jan 27.

Reference Type DERIVED
PMID: 35084948 (View on PubMed)

Johnston SRD, Harbeck N, Hegg R, Toi M, Martin M, Shao ZM, Zhang QY, Martinez Rodriguez JL, Campone M, Hamilton E, Sohn J, Guarneri V, Okada M, Boyle F, Neven P, Cortes J, Huober J, Wardley A, Tolaney SM, Cicin I, Smith IC, Frenzel M, Headley D, Wei R, San Antonio B, Hulstijn M, Cox J, O'Shaughnessy J, Rastogi P; monarchE Committee Members and Investigators. Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE). J Clin Oncol. 2020 Dec 1;38(34):3987-3998. doi: 10.1200/JCO.20.02514. Epub 2020 Sep 20.

Reference Type DERIVED
PMID: 32954927 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

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Document Type: Statistical Analysis Plan

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Related Links

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https://trials.lillytrialguide.com/en-US/trial/3qEzEekhpuCEESS2KeSM8m

A Study to Compare Treatment After Surgery of Abemaciclib (LY2835219) Combined With Standard Endocrine Therapy Versus Endocrine Therapy Alone in Participants With Breast Cancer (monarchE)

Other Identifiers

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I3Y-MC-JPCF

Identifier Type: OTHER

Identifier Source: secondary_id

2016-004362-26

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

NSABP B-58

Identifier Type: OTHER

Identifier Source: secondary_id

16338

Identifier Type: -

Identifier Source: org_study_id

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