AzTrials
AzTrials

Breast CancerPhase 3monarchENCT03155997

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

A Phase 3 study testing Abemaciclib and Standard Adjuvant Endocrine Therapy in people with Breast Cancer, run by Eli Lilly and Company at 619 sites in 38 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Breast Cancer
What is being tested?
Abemaciclib and Standard Adjuvant Endocrine Therapy
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
5,637 participants
Where
619 sitesin 38 countries
Study dates
12 Jul 2017to May 2029
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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).
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  • 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.

Trial locations and contacts

619 sites in 38 countries.

619 sites in 38 countries

United States162 sites

  • Abington Medical Specialists

    Abington, Pennsylvania, 19001

  • Providence Alaska Medical Center

    Anchorage, Alaska, 99508

  • University Cancer & Blood Center, LLC

    Athens, Georgia, 30607

  • Northside Hospital

    Atlanta, Georgia, 30342

  • MultiCare Regional Cancer Center - Auburn

    Auburn, Washington, 98001

  • Texas Oncology Cancer Care and Research Center

    Austin, Texas, 78731

  • Memorial Sloan Kettering - Basking Ridge

    Basking Ridge, New Jersey, 07920

  • Mary Bird Perkins Cancer Center - Baton Rouge

    Baton Rouge, Louisiana, 70817

  • St. Luke's Hospital & Health Network

    Bethlehem, Pennsylvania, 18015

  • Beverly Hills Cancer Center

    Beverly Hills, California, 90211

  • Broome Oncology

    Binghamton, New York, 13905

  • University of Alabama Birmingham

    Birmingham, Alabama, 32594

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • USO-Rocky Mountain Cancer Center

    Boulder, Colorado, 80303

  • Cancer Care of Maine

    Brewer, Maine, 04412

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

    Burbank, California, 91505

  • The University of Vermont Medical Center Inc.

    Burlington, Vermont, 05401

  • Aultman Hospital

    Canton, Ohio, 44710

  • WakeMed Cancer Care - Waverly Hematology & Medical Oncology

    Cary, North Carolina, 27518

  • Erlanger Health System

    Chattanooga, Tennessee, 37403

  • Chattanooga Research and Medicine

    Chattanooga, Tennessee, 37404

  • John H. Stroger Hospital of Cook County

    Chicago, Illinois, 60612

  • Rush University Medical Center

    Chicago, Illinois, 60612

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • Cleveland Clinic Foundation

    Cleveland, Ohio, 44195

  • Columbus Community Clinical Oncology Program

    Columbus, Ohio, 43215

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center at Dallas

    Dallas, Texas, 75390

  • City of Hope National Medical Center

    Duarte, California, 91010-0269

  • McLeod Regional Medical Center

    Florence, South Carolina, 29502

  • Summit Medical Group Cancer Center

    Florham Park, New Jersey, 07932

  • Florida Cancer Specialists - South

    Fort Myers, Florida, 37203

  • Texas Oncology Fort Worth

    Fort Worth, Texas, 76104

  • Hematology Oncology Associates of Fredericksburg Inc.

    Fredericksburg, Virginia, 22408

  • California Cancer Associates Research and Excellence

    Fresno, California, 93720

  • University of Florida College of Medicine

    Gainesville, Florida, 32610

  • The West Clinic, PLLC dba West Cancer Center

    Germantown, Tennessee, 38138

  • Banner MD Anderson Cancer Center

    Gilbert, Arizona, 85234

  • Arizona Oncology Associates, P.C. - HOPE

    Goodyear, Arizona, 85395

  • St Francis Cancer Center

    Greenville, South Carolina, 29607

  • Meritus John Marsh Cancer Center

    Hagerstown, Maryland, 21742

  • Kaiser Permanente

    Harbor City, California, 92505

  • Margaret R. Pardee Memorial Hospital

    Hendersonville, North Carolina, 28739

  • Millennium Oncology - Hollywood

    Hollywood, Florida, 33024

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813

  • Terrebonne General Medical Center

    Houma, Louisiana, 70360

  • Oncology Consultants, P.A.

    Houston, Texas, 77030

  • Franciscan St. Francis Health

    Indianapolis, Indiana, 46237

  • Jackson Oncology Associates PLLC

    Jackson, Mississippi, 39202

  • Mayo Clinic in Florida

    Jacksonville, Florida, 32224

  • Cancer Specialists of North Florida

    Jacksonville, Florida, 32256

  • St. Bernards Medical Center

    Jonesboro, Arkansas, 72401

  • HCA Midwest Kansas City, MidAmerica Division, Inc.

    Kansas City, Missouri, 37203

  • New England Cancer Specialists - Kennebunk

    Kennebunk, Maine, 04043

  • Urology Associates of Kingsport

    Kingsport, Tennessee, 37660

  • Tennessee Cancer Specialists

    Knoxville, Tennessee, 37909

  • University of Tennessee Medical Center

    Knoxville, Tennessee, 37920

  • Community Howard Oncology Center

    Kokomo, Indiana, 46902

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Florida Cancer Specialists - North

    Lecanto, Florida, 34461

  • Central Maine Medical Center

    Lewiston, Maine, 04240

  • Texas Oncology P.A.

    Lewisville, Texas, 75056

  • Loma Linda University School of Medicine

    Loma Linda, California, 92354

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Univ of Louisville School of Medicine

    Louisville, Kentucky, 40202

  • Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital

    Marietta, Georgia, 30060

  • Asante Rogue Regional Medical Center

    Medford, Oregon, 97504

  • Baptist Cancer Center

    Memphis, Tennessee, 38120

  • Pacific Cancer Care

    Monterey, California, 93940

  • Edward Cancer Center

    Naperville, Illinois, 60540

  • Florida Cancer Specialists

    Nashville, Tennessee, 37203

  • Sarah Cannon Cancer Center

    Nashville, Tennessee, 37203

  • Tennessee Oncology Nashville

    Nashville, Tennessee, 37203

  • Yale-New Haven Hospital

    New Haven, Connecticut, 06510

  • Weill Cornell Medical College

    New York, New York, 10065

  • Newark Beth Israel Medical Center

    Newark, New Jersey, 07112

  • Ocala Oncology, P.A.

    Ocala, Florida, 34474

  • Cancer Alliance of Nebraska

    Omaha, Nebraska, 68106

  • Nebraska Methodist Hospital

    Omaha, Nebraska, 68114

  • Tennessee Cancer Specialists

    Omaha, Nebraska, 68130

  • St. Joseph Hospital

    Orange, California, 92868

  • The Valley Hospital, Inc.

    Paramus, New Jersey, 07652

  • Albert Einstein Healthcare Network

    Philadelphia, Pennsylvania, 19141

  • St. Joseph's Hospital and Medical Center

    Phoenix, Arizona, 85013

  • Mayo Clinic Hospital

    Phoenix, Arizona, 85054

  • AHN Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • NSABP Foundation

    Pittsburgh, Pennsylvania, 15213

  • PinnacleHealth Cancer Institute

    Pittsburgh, Pennsylvania, 15213

  • Univ of Pittsburgh Cancer Inst. (UPCI)

    Pittsburgh, Pennsylvania, 15213

  • Oregon Health and Science University

    Portland, Oregon, 97239

  • Vassar Brothers Medical Center

    Poughkeepsie, New York, 12601

  • Quincy Medical Group

    Quincy, Illinois, 62301

  • Renown Regional Medical Center

    Reno, Nevada, 89502

  • Virginia Commonwealth University (VCU) Medical Center

    Richmond, Virginia, 23219

  • Mayo Clinic in Rochester, Minnesota

    Rochester, Minnesota, 55905

  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California, 95817

  • Utah Cancer Specialists

    Salt Lake City, Utah, 84106

  • University of Texas Health Science Center - San Antonio

    San Antonio, Texas, 78229

  • UCSF Medical Center at Mission Bay

    San Francisco, California, 94158

  • California Cancer Associates in Research and Excellence

    San Marcos, California, 92069

  • Dignity Health Dominican Oncology and Hematology

    Santa Cruz, California, 95065

  • Summit Cancer Care DBA Candler Medical Oncology Practice

    Savannah, Georgia, 31405

  • Swedish Medical Center

    Seattle, Washington, 98104

  • Sanford USD Medical Center

    Sioux Falls, South Dakota, 57105

  • Spartanburg Regional Medical Center

    Spartanburg, South Carolina, 29303

  • Highlands Oncology Group

    Springdale, Arkansas, 72762

  • SUNY At Stony Brook

    Stony Brook, New York, 11794

  • Tallahassee Memorial Cancer Center

    Tallahassee, Florida, 32308

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

    Tampa, Florida, 33612

  • Arizona Oncology Associates, P.C. - HOPE

    The Woodlands, Texas, 77380

  • Comprehensive Cancer Centers of Nevada

    The Woodlands, Texas, 77380

  • Illinois Cancer Specialists

    The Woodlands, Texas, 77380

  • Miami Cancer Institute at Baptist Health, Inc.

    The Woodlands, Texas, 77380

  • Minnesota Oncology/Hematology PA

    The Woodlands, Texas, 77380

  • Northwest Cancer Specialists PC

    The Woodlands, Texas, 77380

  • Oncology and Hematology Associates of Southwest Virginia Inc

    The Woodlands, Texas, 77380

  • Oncology Hematology Care Inc

    The Woodlands, Texas, 77380

  • Oncology Hematology West

    The Woodlands, Texas, 77380

  • Sansum Clinic

    The Woodlands, Texas, 77380

  • Shenandoah Oncology, P.C.

    The Woodlands, Texas, 77380

  • Texas Oncology - Dallas Presbyterian Hospital

    The Woodlands, Texas, 77380

  • Texas Oncology - Denison

    The Woodlands, Texas, 77380

  • Texas Oncology - McAllen

    The Woodlands, Texas, 77380

  • Texas Oncology - McKinney

    The Woodlands, Texas, 77380

  • Texas Oncology - Medical City Dallas

    The Woodlands, Texas, 77380

  • Texas Oncology - Methodist Dallas Cancer Center

    The Woodlands, Texas, 77380

  • Texas Oncology - Paris

    The Woodlands, Texas, 77380

  • Texas Oncology - San Antonio Medical Center

    The Woodlands, Texas, 77380

  • Texas Oncology - The Woodlands

    The Woodlands, Texas, 77380

  • Texas Oncology - Tyler

    The Woodlands, Texas, 77380

  • Texas Oncology - West Texas

    The Woodlands, Texas, 77380

  • Texas Oncology Cancer Care and Research Center

    The Woodlands, Texas, 77380

  • Texas Oncology Denton

    The Woodlands, Texas, 77380

  • Texas Oncology Fort Worth

    The Woodlands, Texas, 77380

  • Texas Oncology P.A.

    The Woodlands, Texas, 77380

  • Texas Oncology- Mesquite

    The Woodlands, Texas, 77380

  • Texas Oncology-Arlington South

    The Woodlands, Texas, 77380

  • Texas Oncology-Baylor Charles A. Sammons Cancer Center

    The Woodlands, Texas, 77380

  • Texas Oncology-Deke Slayton Cancer Center

    The Woodlands, Texas, 77380

  • Texas Oncology-Plano East

    The Woodlands, Texas, 77380

  • Texas Oncology-Plano West

    The Woodlands, Texas, 77380

  • US Oncology

    The Woodlands, Texas, 77380

  • USO - Texas Oncology, P. A.

    The Woodlands, Texas, 77380

  • USO-Maryland Oncology Hematology, P.A.

    The Woodlands, Texas, 77380

  • USO-New York Oncology Hematology, P.C

    The Woodlands, Texas, 77380

  • USO-Rocky Mountain Cancer Center

    The Woodlands, Texas, 77380

  • USO-Southern Cancer Center, P.C.

    The Woodlands, Texas, 77380

  • USO-Virginia Oncology Associates

    The Woodlands, Texas, 77380

  • Virginia Cancer Specialists

    The Woodlands, Texas, 77380

  • Willamette Valley Cancer Institute & Research Ctr.

    The Woodlands, Texas, 77380

  • USO-Rocky Mountain Cancer Center

    Thornton, Colorado, 80260

  • Community Medical Center

    Toms River, New Jersey, 08755

  • The University of Arizona Cancer Center

    Tucson, Arizona, 85719

  • Texas Oncology - Paris

    Tyler, Texas, 75702

  • Texas Oncology - Tyler

    Tyler, Texas, 75702

  • Kaiser Permanente

    Vallejo, California, 94589

  • White Plains Hospital

    White Plains, New York, 10601

  • Cancer Center of Kansas

    Wichita, Kansas, 67214

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Reliant Medical Group, Inc.

    Worcester, Massachusetts, 01606

  • WellSpan Health/York Cancer Center Oncology Research

    York, Pennsylvania, 17403

  • Yuma Regional Cancer Center

    Yuma, Arizona, 85364

Other trials in United States

Japan35 sites

  • KKR Tohoku Kosai Hospital

    Aoba-ku, Sendai-shi, Miyagi, 980-0803

  • Juntendo University Hospital

    Bunkyō-Ku, Tokyo, 113-8431

  • Chiba Cancer Center

    Chiba, Chiba, 260-8717

  • National Cancer Center Hospital

    Chuo Ku, Tokyo, 104-0045

  • St. Lukes International Hospital

    Chuo-Ku, Tokyo, 104 8560

  • National Hospital Organization Kyushu Cancer Center

    Fukuoka, 811-1395

  • Saitama Medical University International Medical Center

    Hidaka, Saitama, 350-1298

  • Hiroshima University Hospital

    Hiroshima, Hiroshima, 734-8551

  • Saitama Prefectural Cancer Center

    Ina-machi, Saitama, 362-0806

  • Tokai University Hospital- Isehara Campus

    Isehara, Kanagawa, 259-1143

  • Sagara Hospital

    Kagoshima, 892-0833

  • National Cancer Center Hospital East

    Kashiwa, Chiba, 277 8577

  • St Marianna University School of Medicine Hospital

    Kawasaki, Kanagawa, 216-8511

  • Japanese Foundation for Cancer Research

    Koto, Tokyo, 135-8550

  • Kumamoto University Hospital

    Kumamoto, 860-8556

  • Kumamoto Shinto General hospital

    Kumamoto, 862-8655

  • Kurume General Hospital

    Kurume, Fukuoka, 830-0013

  • Kyoto University Hospital

    Kyoto, 606-8507

  • National Hospital Organization Shikoku Cancer Center

    Matsuyama, Ehime, 791-0280

  • Aichi Cancer Center Hospital

    Nagoya, Aichi-ken, 464-8681

  • Shizuoka Cancer Center

    Nakatogari, Shizuoka, 411-8777

  • Niigata Cancer Center Hospital

    Niigata, Niigata, 951-8566

  • Hyogo College of Medecine

    Nishinomiya, Hyōgo, 663-8501

  • National Hospital Organization Osaka Medical Center

    Osaka, 540-0006

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • Kindai University Hospital- Osakasayama Campus

    Osaka Sayama-shi, Osaka, 589 8511

  • Gunma Prefectural Cancer Center

    Ōta, Gunma, 373-0828

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, Hokkaido, 003-0804

  • Jichi Medical University Hospital

    Shimotsuke, Tochigi, 329-0498

  • Showa University Hospital

    Shinagawa-ku, Tokyo, 142-8555

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo, 160-0023

  • National Center for Global Health and Medicine

    Shinjuku-ku, Tokyo, 162-8655

  • University of tsukuba hospital

    Tsukuba, Ibaragi, 305-8576

  • Tochigi Cancer Center

    Utsunomiya, Tochigi, 320-0834

  • Kanagawa Cancer Center

    Yokohama, Kanagawa, 241 8515

Other trials in Japan

Germany33 sites

  • Klinikum St. Marien Amberg

    Amberg, Bavaria, 92224

  • Gemeinschaftspraxis hop-augsburg

    Augsburg, Bavaria, 86150

  • Helios Klinikum Berlin-Buch

    Berlin, 13125

  • Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim

    Berlin, 14195

  • Universitätsklinikum Bonn

    Bonn, North Rhine-Westphalia, 53127

  • Universitätsklinikum Carl Gustav Carus

    Dresden, Saxony, 1307

  • Universitätsklinikum Düsseldorf

    Düsseldorf, North Rhine-Westphalia, 40225

  • Universitätsklinikum Erlangen

    Erlangen, Bavaria, 91054

  • Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung

    Essen, North Rhine-Westphalia, 45136

  • Agaplesion Markus Krankenhaus

    Frankfurt am Main, Hesse, 60431

  • Praxis für interdisziplinäre Onkologie & Hämatologie

    Freiburg im Breisgau, Baden-Wurttemberg, 69126

  • Universitätsklinikum Freiburg

    Freiburg im Breisgau, Baden-Wurttemberg, 79106

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

    Friedrichshafen, Baden-Wurttemberg, 88045

  • Franziskus-Hospital Harderberg

    Georgsmarienhütte, Lower Saxony, 49124

  • SRH Wald-Klinikum Gera gGmbH

    Gera, Thuringia, 07548

  • Mammazentrum HH - Krankenhaus Jerusalem

    Hamburg, 20246

  • Kath. Marienkrankenhaus gGmbH

    Hamburg, 22087

  • Asklepios Kliniken Hamburg

    Hamburg, 22307

  • Gynäkologisch-Onkologische Praxis am Pelikanplatz

    Hanover, Lower Saxony, 30177

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, Schleswig-Holstein, 24105

  • Zentrum fuer ambulante gynaekologische Onkologie (ZAGO)

    Krefeld, North Rhine-Westphalia, 47805

  • Private Practice - Dres. Andreas Köhler und Roswitha Fuchs

    Langen, Hesse, 63225

  • Klinikum Ludwigsburg

    Ludwigsburg, Baden-Wurttemberg, 71640

  • Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH

    Mönchengladbach, North Rhine-Westphalia, 41061

  • Klinikum der Ludwig-Maximilians-Universitaet Muenchen

    München, Bavaria, 80336

  • Klinikum Rechts Der Isar Der Technischen Universität München

    München, Bavaria, 81675

  • Rotkreuzklinikum München gemeinnützige GmbH

    München, Bavaria, 81675

  • Universitätsklinikum Münster - Albert Schweitzer Campus

    Münster, North Rhine-Westphalia, 52074

  • Sana Klinikum Offenbach

    Offenbach, Hesse, 63069

  • Universitätsklinikum Tübingen

    Tübingen, Baden-Wurttemberg, 72076

  • Universitätsklinikum Ulm

    Ulm, Baden-Wurttemberg, 89075

  • Marien Hospital Witten

    Witten, North Rhine-Westphalia, 58452

Other trials in Germany

Spain28 sites

  • Hospital Universitario Fundacion ALcorcon

    Alcorcón, Madrid, Comunidad de, 28922

  • Hospital Quiron Barcelona

    Barcelona, Barcelona [Barcelona], 8023

  • Hospital Clínic de Barcelona

    Barcelona, Catalunya [Cataluña], 08908

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, Catalunya [Cataluña], 8041

  • Parc de Salut Mar - Hospital del Mar

    Barcelona, 8003

  • Hospital Universitari Vall d'Hebron

    Barcelona, 8035

  • Hospital Universitario Reina Sofia

    Córdoba, Andalusia, 14004

  • Hospital Universitario San Cecilio

    Granada, 18016

  • Complejo Hospitalario de Jaén

    Jaén, 23007

  • Hospital Universitario Arnau de Vilanova de Lleida

    Lleida, Lleida [Lérida], 25198

  • Hospital Universitario Ramón y Cajal

    Madrid, Madrid, Comunidad de, 28034

  • Hospital Universitario 12 de Octubre

    Madrid, Madrid, Comunidad de, 28041

  • Hospital La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28009

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario HM Sanchinarro

    Madrid, 28050

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223

  • Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca

    Salamanca, 37007

  • Hospital Universitario de Canarias

    San Cristóbal de La Laguna, Santa Cruz De Tenerife, 38320

  • CHUS - Hospital Clinico Universitario

    Santiago de Compostela, La Coruna, 15706

  • Hospital Universitario Virgen Macarena

    Seville, 41009

  • Hospital Universitario Virgen del Rocio

    Seville, 41013

  • Hospital Universitario Virgen de Valme

    Seville, 41014

  • Hospital Clínico de Valencia

    Valencia, Valenciana, Comunitat, 46010

  • Hospital Quirón Salud Valencia

    Valencia, 46010

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

Australia20 sites

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • Mater Misericordiae Limited

    Brisbane, Queensland, 4101

  • Chris O'Brien Lifehouse

    Camperdown, New South Wales, 2050

  • St Vincent's Hospital

    Darlinghurst, New South Wales, 2010

  • Epworth Hospital

    East Melbourne, Victoria, 3121

  • Lyell McEwin Hospital

    Elizabeth Vale, South Australia, 5112

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Launceston General Hospital

    Launceston, Tasmania, 7250

  • Lismore Base Hospital

    Lismore, New South Wales, 2480

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Peter MacCallum Cancer Centre

    Melbourne, Victoria, 3050

  • Maroondah Hospital

    Melbourne, Victoria, 3135

  • Breast Cancer Research Centre WA

    Nedlands, Western Australia, 6009

  • Gold Coast University Hospital

    Southport, Queensland, 4215

  • St John of God Subiaco Hospital

    Subiaco, Western Australia, 6008

  • Mater Hospital Sydney

    Sydney, New South Wales, 2060

  • The Townsville Hospital

    Townsville, Queensland, 4814

  • Calvary Mater Newcastle

    Waratah, New South Wales, 2298

  • Westmead Hospital

    Westmead, New South Wales, 2145

  • Southern Medical Day Care Centre

    Wollongong, New South Wales, 2500

Other trials in Australia

Brazil20 sites

  • Fundação Pio XII - Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul

    Brasília, Federal District, 70200-730

  • CIONC - Centro Integrado de Oncologia de Curitiba

    Curitiba, Paraná, 80810-050

  • Centro de Pesquisa Clínica do Instituto do Câncer do Ceará

    Fortaleza, Ceará, 60430-230

  • Hospital Araújo Jorge

    Goiânia, Goiás, 74605-070

  • ONCOSITE - Centro de Pesquisa Clinica em Oncologia

    Ijuí, Rio Grande do Sul, 98700 000

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-000

  • Hospital de Cancer de Londrina

    Londrina, Paraná, 86015-520

  • Hospital São Lucas da PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital de Clínicas de Ribeirão Preto

    Ribeirão Preto, São Paulo, 14051-140

  • Instituto de Educação, Pesquisa e Gestão em Saúde

    Rio de Janeiro, Rio de Janeiro, 22775-002

  • INCA - Instituto Nacional Do Cancer

    Rio de Janeiro, 20560121

  • Faculdade de Medicina do ABC

    Santo André, São Paulo, 09060-650

  • Hospital de Base de São José do Rio Preto

    Sao Jose Rio Preto, São Paulo, 15091-000

  • Instituto do Cancer do Estado de Sao Paulo - ICESP

    São Paulo, São Paulo, 01246-000

  • Hospital Sírio Libanês

    São Paulo, 01308-060

  • Pérola Centro de Pesquisa em Oncologia

    São Paulo, 01317-000

  • IBCC - Núcleo de Pesquisa e Ensino

    São Paulo, 04014-002

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

    São Paulo, 04038-034

  • Instituto D'Or de Pesquisa e Ensino (IDOR)

    São Paulo, 04543-000

Other trials in Brazil

United Kingdom19 sites

  • Victoria Hospital

    Blackpool, Lancashire, FY3 8NR

  • Boston Pilgrim Hospital

    Boston, Lincolnshire, PE21 9QS

  • Airedale General Hospital

    Bradford, BD20 6TD

  • James Cook University Hospital

    Central Middlesbrough, Middlesbrough, TS4 3BW

  • Mid Essex Hospital Services NHS Trust

    Chelmsford, Essex, CM1 7ET

  • Western General Hospital

    Edinburgh, Midlothian, EH4 2XU

  • Royal Surrey County Hospital

    Guildford, Surrey, GU2 7XX

  • North Middlesex Hospital

    London, Greater London, N18 1QX

  • Charing Cross Hospital

    London, Hammersmith and Fulham, W6 8RF

  • Sarah Canon Research Institute UK

    London, London, City of, NW1 2PG

  • Guy's & St Thomas' NHS Foundation Trust

    London, London, City of, SE1 9RT

  • Royal Marsden Hospital

    London, Sutton, SM2 5PT

  • The Christie

    Manchester, M20 4BX

  • Mount Vernon Hospital

    Northwood, Hertfordshire, HA6 2RN

  • Nottingham City Hospital

    Nottingham, Nottinghamshire, NG5 1PB

  • The Churchill Hospital

    Oxford, Oxfordshire, OX3 7LE

  • Royal Preston Hospital

    Preston, Lancashire, PR2 9HT

  • Musgrove Park Hospital

    Taunton, Somerset, TA1 5DA

  • The Royal Cornwall Hospital

    Truro, England, TR1 3LJ

Other trials in United Kingdom

Italy18 sites

  • Ospedale Bellaria - Azienda USL di Bologna

    Bologna, 40139

  • Ospedale Antonio Perrino

    Brindisi, 72100

  • Azienda Ospedaliero Universitaria S.Anna

    Cona, Emilia-Romagna, 44124

  • Ospedale San Martino

    Genova, 16132

  • Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori

    Meldola, Emilia-Romagna, 47014

  • Ospedale Fatebenefratelli-Oftalmico

    Milan, Milano, 20121

  • Azienda Ospedaliero Universitaria

    Modena, 41125

  • Fondazione IRCCS San Gerardo dei Tintori

    Monza, Lombardy, 20900

  • University of Naples Federico II

    Naples, Campania, 80131

  • Istituto Nazionale Tumori IRCCS Fondazione Pascale

    Naples, 80131

  • Istituto Oncologico Veneto IRCCS

    Padova, 35128

  • Azienda Ospedaliera Di Parma

    Parma, 43126

  • Istituto Nazionale Tumori Regina Elena

    Rome, Roma, 00144

  • Azienda Ospedaliera Sant'Andrea

    Rome, Roma, 00157

  • Humanitas

    Rozzano, Milano, 20141

  • Azienda Ospedaliera Santa Maria

    Terni, TR, 05100

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

    Torino, 10126

  • APSS - Presidio Ospedaliero Santa Chiara

    Trento, 38122

Other trials in Italy

Belgium17 sites

  • Algemeen Ziekenhuis klina

    Brasschaat, Antwerpen, 2930

  • AZ Sint-Jan Brugge-Oostende AV

    Bruges, West-Vlaanderen, 8000

  • Cliniques Universitaires Saint-Luc

    Brussels, Bruxelles-Capitale, Région de, 1200

  • Antwerp University Hospital

    Edegem, Antwerpen, 2650

  • Jessa Ziekenhuis

    Hasselt, Limburg, 3500

  • Jan Yperman ziekenhuis

    Ieper, West-Vlaanderen, 8900

  • AZ Groeninge Campus Kennedylaan

    Kortrijk, West-Vlaanderen, 8500

  • Groupe Jolimont

    La Louvière, Wallonne, Région, 7100

  • UZ Leuven

    Leuven, Vlaams-Brabant, 3000

  • Centre Hospitalier D'Ardenne - Forget

    Libramont, Luxembourg, 6800

  • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman

    Liège, Liège, 4000

  • Clinical Chc Montlégia

    Liège, Wallonne, Région, 4000

  • CHU de Charleroi - Hopital Civil Marie Curie

    Lodelinsart, Hainaut, 6042

  • CHU UCL Namur/Site Sainte Elisabeth

    Namur, 5000

  • Clinique Saint Pierre

    Ottignies, Wallonne, Région, 1340

  • AZ Nikolaas

    Sint-Niklaas, Oost-Vlaanderen, B-9100

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

    Yvoir, Namur, 5000

Other trials in Belgium

France17 sites

  • Sainte Catherine Institut du Cancer Avignon Provence

    Avignon, Vaucluse, 84918

  • CHU de Besancon Hopital Jean Minjoz

    Besançon, Doubs, 25000

  • Centre Hospitalier Régional Universitaire de Brest - Hôpital Morvan

    Brest, Brittany Region, 29200

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

    Clermont-Ferrand, Puy-de-Dôme, 63011

  • Henri Mondor Hospital

    Créteil, Seine-et-Marne, 94000

  • Centre Georges Francois Leclerc

    Dijon, Côte-d'Or, 21079

  • Polyclinique De Blois

    La Chaussée-Saint-Victor, Centre-Val de Loire, 41260

  • Centre Hospitalier de Vendee Les Oudairies

    La Roche-sur-Yon, Vendée, 85000

  • Clinique Victor Hugo Le Mans

    Le Mans, Pays de la Loire Region, 72000

  • Centre Leon Berard

    Lyon, Auvergne-Rhône-Alpes, 69008

  • Centre de Cancérologie du Grand Montpellier

    Montpellier, Languedoc-Roussillon, 34070

  • Polyclinique de Gentilly

    Nancy, Meurthe-et-Moselle, 54519

  • Institut Curie

    Paris, 75248

  • Hôpital Privé des Côtes d'Armor- HPCA

    Plérin, Côtes-d'Armor, 22190

  • Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer

    Rennes, Ille-et-Vilaine, 35042

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

    Rouen, Seine-Maritime, 76038

  • Institut de Cancérologie de l'Ouest

    Saint-Herblain, Loire-Atlantique, 44805

Other trials in France

Mexico17 sites

  • Unidad de Investigacion en Salud

    Chihuahua City, 31203

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80020

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

  • Centro Oncológico Internacional (COI)

    Guadalajara, Jalisco, 45647

  • Centro de Estudios y Prevencion del Cancer

    Juchitán de Zaragoza, Oaxaca, 70020

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

    Mérida, Yucatán, 97070

  • Centro de Atención e Investigación Clínica en Oncología

    Mérida, Yucatán, 97134

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

    Mexico City, Federal District, 3100

  • Grupo Medico Camino S.C.

    Mexico City, Mexico City, 3310

  • Centro Regiomontano de Investigacion

    Monterrey, Nuevo León, 64060

  • Private Practice - Dr. Joaquin Reinoso

    Monterrey, Nuevo León, 64320

  • Filios Alta Medicina

    Monterrey, Nuevo León, 64460

  • Oaxaca Site Management Organization SC

    Oaxaca City, 68000

  • Unidad Médica Onco-hematológica

    Puebla City, 72424

  • Oncológico Potosino

    San Luis Potosí City, 78209

  • Centro Hemato Oncologico Privado

    Toluca, Toluca, 50120

  • CIMAB S.A. de C.V.

    Torreón, Coahuila, 27000

Other trials in Mexico

China16 sites

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100039

  • Beijing Cancer Hospital

    Beijing, Beijing Municipality, 100142

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • Fujian Medical University Union Hospital-1 Bingfanglou

    Fuzhou, Fujian, 350001

  • Guangdong Provincial People's Hospital

    Guangzhou, Guangdong, 510080

  • The First Affiliated Hospital, Sun-Yat Sen University

    Guangzhou, Guangdong, 510080

  • Sun Yat-Sen University

    Guangzhou, Guangdong, 510120

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang, 310052

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150081

  • Shandong Cancer Hospital

    Jinan, Shandong, 250117

  • Jiangsu Cancer Hospital

    Nanjing, Jiangsu, 210009

  • Jiangsu Province Hospital

    Nanjing, Nanjing, 210029

  • Shanghai Jiaotong University School of Medicine Ruijin Hospital

    Shanghai, Shanghai Municipality, 200025

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Russia16 sites

  • Chelyabinsk Regional Oncology Dispensary

    Chelyabinsk, Chelyabinsk Oblast, 454087

  • Kaluga Regional Clinical Oncology Center

    Kaluga, Kalužskaja Oblast', 248007

  • Republican Clinical Oncology Dispensary

    Kazan', Tatarstan Republic, 420029

  • Kursk Regional Oncology Dispensary

    Kursk, Kursk Oblast, 305524

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

    Moscow, Moscow, 115478

  • Burdenko Main Military Hospital

    Moscow, Moscow, 117198

  • Blokhin Cancer Research Center

    Moscow, 115478

  • Orenburg Regional Clinical Oncology Dispensary

    Orenburg, Orenburg Oblast, 460021

  • Leningrad Regional Oncology Dispensary

    Saint Petersburg, Sankt-Peterburg, 188663

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

    Saint Petersburg, Sankt-Peterburg, 191015

  • St. Petersburg City Oncological Dispensary - Berezovaya Avenue

    Saint Petersburg, Sankt-Peterburg, 197022

  • N.N.Petrov Research Institute of Oncology

    Saint Petersburg, Sankt-Peterburg, 197758

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

    Saint Petersburg, Sankt-Peterburg, 197758

  • Samara Regional Clinical Oncology Center

    Samara, Samara Oblast, 443031

  • Volgograd Regional Oncological Dispensary No. 3

    Volzhsky, Volgograd Oblast, 404130

  • Yaroslavl Regional Cancer Hospital

    Yaroslavl, Yaroslavl Oblast, 150054

Other trials in Russia

South Korea16 sites

  • Dongnam Institute of Radiological and Medical Sciences

    Busan, Pusan-Kwangyǒkshi, 46033

  • Soon chun hyang University Cheonan Hospital

    Cheonan-si, Chungcheongnam-do [Chungnam], 31151

  • Chungbuk National University Hospital

    Cheongju-si, Chungcheongbuk-do [Chungbuk], 28644

  • Kyungpook National University Chilgok Hospital

    Daegu, Taegu-Kwangyǒkshi, 41404

  • National Cancer Center

    Goyang-si, Kyǒnggi-do, 10408

  • Inje University Haeundae Paik Hospital

    Haeundae-gu, Pusan-Kwangyǒkshi, 48108

  • Inha University Hospital

    Incheon, Incheon-gwangyeoksi [Incheon], 22332

  • Gachon University Gil Medical Center

    Namdong-gu, Incheon-gwangyeoksi [Incheon], 21565

  • Seoul National University Bundang Hospital

    Seongnam, Kyǒnggi-do, 13620

  • Korea University Anam Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 2841

  • Seoul National University Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 3080

  • Severance Hospital Yonsei University Health System

    Seoul, Seoul-teukbyeolsi [Seoul], 3722

  • Asan Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 5505

  • Samsung Medical Center

    Seoul, Seoul-teukbyeolsi [Seoul], 6351

  • Korea University Guro Hospital

    Seoul, Seoul-teukbyeolsi [Seoul], 8308

  • Ewha Womans University Mokdong Hospital

    Seoul, Seoul-teukbyeolsi [Seoul]

Other trials in South Korea

Argentina15 sites

  • Centro de Oncologia e Investigacion Buenos Aires

    Berazategui, Buenos Aires, B1884BBF

  • Hospital Aleman

    Buenos Aires, Buenos Aires F.D., C1118AAT

  • Instituto Alexander Fleming

    Buenos Aires, 1426

  • IDIM - Instituto de Diagnóstico e Investigaciones Metabólicas

    Buenos Aires, C1012AAR

  • Fundacion CENIT para la Investigacion en Neurociencias

    CABA, Ciudad Autonoma Buenos Aires, 1125

  • Clinica Adventista de Belgrano

    Ciudad Autonoma Buenos Aires, C1430EGF

  • Fundación CORI para la Investigación y Prevención del Cáncer

    La Rioja, F5300COE

  • Instituto de Investigaciones Clinicas Mar del Plata

    Mar del Plata, Buenos Aires, 7600

  • Hospital Universitario Austral

    Pilar, Buenos Aires, 1629

  • Instituto de Oncologia de Rosario

    Rosario, Santa Fe Province, S2000KZE

  • Consultorio Dr. Miguel Ángel Escudero

    Salta, 4400

  • CER San Juan

    San Juan, 5400

  • Centro Para la Atención Integral del Paciente Oncologico (CAIPO)

    San Miguel de Tucumán, Tucumán Province, 4000

  • Centro Medico San Roque

    San Miguel de Tucumán, 4000

  • Clinica Viedma

    Viedma, Río Negro Province, R8500ACE

Other trials in Argentina

India15 sites

  • HCG Cancer Centre

    Ahmedabad, Gujarat, 380060

  • Manipal Hospital

    Bangalore, Karmnataka, 560017

  • Post Graduate Institute of Medical Education & Research

    Chandigarh, 160012

  • Apollo Speciality Hospital - Teynampet

    Chennai, Tamil Nadu, 600035

  • Artemis Hospital

    Gurgaon, Haryana, 122003

  • MNJ Institute of Oncology

    Hyderabad, Andhra Pradesh, 500004

  • Apollo Gleneagles Hospitals

    Kolkata, West Bengal, 700054

  • Medica Superspecialty Hospital

    Kolkata, West Bengal, 700099

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400012

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422001

  • Dr. B. L. Kapur Memorial Hospital

    New Delhi, National Capital Territory of Delhi, 110005

  • Grant Medical Foundation - Ruby Hall Clinic

    Pune, Maharashtra, 411001

  • Deenanth Mangeshkar Hospital and Research Centre

    Pune, Maharashtra, 411004

  • Regional Cancer Centre

    Trivandrum, Kerala, 695 011

  • HCG Cancer Centre

    Vadodara, Gujarat, 390012

Other trials in India

Turkey (Türkiye)14 sites

  • Baskent University Dr. Turgut Noyan Research and Training Center

    Adana, 01250

  • Ankara Gülhane Eitim ve Aratrma Hastanesi

    Ankara, Kecioren, 6010

  • Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital

    Ankara, Turkey, 6200

  • Ankara Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100

  • Hacettepe Universitesi

    Ankara, 6230

  • Akdeniz Universitesi Hastanesi

    Antalya, 7070

  • Ege University Medicine of Faculty

    Bornova, İzmir, 35100

  • Trakya University Faculty of Medicine

    Edirne, 22030

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

    Istanbul, 34090

  • Istanbul Universitesi Cerrahpasa

    Istanbul- Fatih, Istanbul, 34098

  • Izmir Medical Park Hospital

    Izmir, Karsiyaka, İzmir, 9035575

  • Kocaeli Üniversitesi

    Kocaeli, 41380

  • İnönü Üniversitesi Turgut Özal Tıp Merkezi

    Malatya, 44280

  • Acibadem Altunizade Hospital

    Üsküdar/stanbul, Istanbul, 34662

Other trials in Turkey (Türkiye)

Greece13 sites

  • Errikos Dunant Hospital Center

    Athens, Attikí (Region), 11526

  • Alexandra Hospital

    Athens, Attikí, 115 28

  • Agios Savvas Regional Cancer Hospital

    Athens, Attikí, 11522

  • Metropolitan Hospital

    Athens, Attikí, 18547

  • Attikon General University Hospital

    Chaïdári, Attikí, 12462

  • University General Hospital of Heraklion

    Heraklion, Krítí, 71110

  • University Hospital of Ioannina

    Ioannina, Ípeiros, 45500

  • General Oncology Hospital of Kifissia "Agioi Anargiroi"

    Nea Kifissia, Attikí, 14564

  • University Hospital of Patras

    Pátrai, Achaia, 26504

  • Bioclinic of Thessaloniki

    Thessaloniki, Kentrikí Makedonía, 54622

  • European Interbalkan Medical Center

    Thessaloniki, Thessaloníki, 570 01

  • Euromedica - General Clinic of Thessaloniki

    Thessaloniki, 54645

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 564 29

Other trials in Greece

Poland11 sites

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, 80-214

  • Szpitale Pomorskie Sp. z o. o.

    Gdynia, Pomeranian Voivodeship, 81-519

  • Przychodnia Lekarska "Komed"

    Konin, Greater Poland Voivodeship, 62-500

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

    Lodz, Łódź Voivodeship, 90338

  • Centrum Onkologii Ziemii Lubelskiej

    Lublin, Lublin Voivodeship, 20-081

  • Olsztyński Ośrodek Onkologiczny Kopernik

    Olsztyn, Warmian-Masurian Voivodeship, 82-300

  • Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego

    Opole, Opole Voivodeship, 45-061

  • Wielkopolskie Centrum Onkologii

    Poznan, Greater Poland Voivodeship, 61-866

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

    Warsaw, Masovian Voivodeship, 02-781

  • Luxmed Onkologia sp. z o. o.

    Warsaw, Masovian Voivodeship, 07-100

  • Dolnośląskie Centrum Onkologii we Wrocławiu

    Wroclaw, Lower Silesian Voivodeship, 53-413

Other trials in Poland

Taiwan11 sites

  • Changhua Christian Hospital

    Changhua, 50006

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 80756

  • Chang Gung Memorial Hospital - Kaohsiung

    Kaohsiung Niao Sung Dist, Kaohsiung, 83301

  • Taipei Medical University Hospital

    New Taipei City, 235

  • China Medical University Hospital

    Taichung, 40447

  • National Taiwan University Hospital

    Taipei, 10002

  • MacKay Memorial Hospital

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Tri-Service General Hospital

    Taipei City, Taipei, 114

  • Chang Gung Medical Foundation-Linkou Branch

    Taoyuan City, 333

Other trials in Taiwan

Denmark10 sites

  • Aalborg Universitetshospital, Syd

    Aalborg, North Denmark, 9000

  • Aarhus Universitetshospital, Skejby

    Aarhus, Central Jutland, 8200

  • Herlev and Gentofte Hospital

    Copenhagen, Capital Region, 2730

  • Sydvestjysk Sygehus Esbjerg

    Esbjerg, Region Syddanmark, 6700

  • Regionshospitalet Herning

    Herning, Central Jutland, 7400

  • Rigshospitalet

    København Ø, Capital Region, 2100

  • Næstved Sygehus

    Næstved, Region Sjælland, 4700

  • Odense Universitetshospital

    Odense, Region Syddanmark, 5000

  • Sygehus Soenderjylland

    Sønderborg, Region Syddanmark, 6400

  • Vejle Sygehus

    Vejle, Region Syddanmark, 7100

Other trials in Denmark

Canada9 sites

  • Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2X 3E4

  • Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • Hopital du Sacre-Coeur de Montreal

    Montreal, Quebec, H4J 1C5

  • The Ottawa Hospital - General Campus

    Ottawa, Ontario, K1H 8L6

  • CHU de Quebec-Hopital de Saint-Sacrement

    Québec, Quebec, G1S 4L8

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

    Sherbrooke, Quebec, J1J 3H5

  • North York General Hospital

    Toronto, Ontario, M2K 1E1

  • Humber River Hospital

    Toronto, Ontario, M3M 0B2

  • Unity Health Toronto, St. Michael's Hospital

    Toronto, Ontario, M5B 1W8

Other trials in Canada

Finland9 sites

  • Docrates Syöpäsairaala

    Helsinki, Uusimaa, 00029

  • Keski-Suomen Keskussairaala

    Jyväskylä, Central Finland, 40620

  • Kuopion Yliopistollinen Sairaala

    Kuopio, Northern Savonia, 70210

  • Päijät-Häme Central hospital

    Lahti, 15850

  • Oulun yliopistollinen sairaala

    Oulu, North Ostrobothnia, 90220

  • Satakunnan Keskussairaala

    Pori, Satakunta, 28500

  • Tampereen yliopistollinen sairaala

    Tampere, Pirkanmaa, 33520

  • Turku University Central Hospital

    Turku, Southwest Finland, 20520

  • Vaasan Keskussairaala

    Vaasa, Pohjanmaa

Other trials in Finland

Israel9 sites

  • Soroka Medical Center

    Beersheba, Southern District, 8400000

  • Rambam Health Care Campus

    Haifa, Ḥeifā, 3109601

  • Shaare Zedek Medical Center

    Jerusalem, Jerusalem, 9013102

  • Hadassah Medical Center

    Jerusalem, Jerusalem, 9112001

  • Meir Medical Center

    Kfar Saba, Central District, 4428164

  • Rabin Medical Center

    Petah Tikva, Central District, 49100

  • Sheba Medical Center

    Ramat Gan, Central District, 5265601

  • Kaplan Medical Center

    Rehovot, Central District, 7610001

  • Yitzhak Shamir Medical Center

    Ẕerifin, Central District, 6093000

Other trials in Israel

Austria7 sites

  • Medizinische Universität Graz

    Graz, Styria, 8036

  • Medizinische Universitaet Innsbruck

    Innsbruck, Tyrol, 6020

  • Universitätsklinikum Salzburg

    Salzburg, 5020

  • Private Practice - Dr. Hubalek

    Schwaz, Tyrol, 6130

  • Medizinische Universität Wien

    Vienna, State of Vienna, 1090

  • Universitaetsklinikum Allgemeines Krankenhaus Wien

    Vienna, State of Vienna, 1090

  • Klinik Hietzing

    Vienna, State of Vienna, 1130

Other trials in Austria

Hungary7 sites

  • Szent Margit Kórház

    Budapest, 1032

  • Magyar Honvedseg Egeszsegugyi Kozpont

    Budapest, 1062

  • Semmelweis University

    Budapest, 1088

  • Szent Imre Egyetemi Oktatokorhaz

    Budapest, 1115

  • Uzsoki Utcai Kórház

    Budapest, 1145

  • Bacs-Kiskun Varmegyei Oktatokorhaz

    Kecskemét, Bács-Kiskun county, 6000

  • Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz

    Szolnok, Jász-Nagykun-Szolnok, 5004

Other trials in Hungary

Romania7 sites

  • Oncopremium Team

    Baia Mare, Maramureş, 430291

  • Institutul Oncologic

    Bucharest, Bucharest, 22328

  • Spitalul Clinic Filantropia

    Bucharest, 11171

  • Institutul Oncologic

    Cluj-Napoca, Cluj, 400015

  • Centrul de Oncologie "Sfântul Nectarie"

    Craiova, Dolj, 200542

  • Radiology Therapeutic Center

    Otopeni, Ilfov, 75100

  • Ovidius Clinical Hospital OCH

    Ovidiu, Constanța County, 905900

Other trials in Romania

Ukraine7 sites

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

    Dnipro, Dnipropetrovsk Oblast, 49102

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

    Kryvyi Rih, Dnipropetrovsk Oblast, 50048

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

    Lutsk, Volyn Oblast, 43018

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

    Odesa, Odesa Oblast, 65025

  • Poltava Regional Clinical Oncology Center

    Poltava, Poltava Oblast, 36011

  • Uzhgorod Central City Clinical Hospital

    Uzhhorod, Zakarpattia Oblast, 88000

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

    Vinnytsia, Vinnytsia Oblast, 21029

Other trials in Ukraine

Czechia6 sites

  • Masarykuv onkologicky ustav

    Brno, Brno-město, 656 53

  • Nemocnice Horovice

    Hořovice, Beroun, 268 31

  • Fakultni Nemocnice Ostrava

    Ostrava, Moravian-Silesian Region, 708 52

  • Multiscan

    Pardubice, Pardubice Region, 532 03

  • FN Plzen Lochotin

    Pilsen, 30460

  • Fakultni Thomayerova nemocnice

    Prague, Praha 4, 14059

Other trials in Czechia

South Africa6 sites

  • Cancercare Rondebosch Oncology

    Cape Town, Western Cape, 7700

  • GVI Oncology

    George, Western Cape, 7764

  • Cancercare Langenhoven Drive Oncology Centre

    Port Elizabeth, Eastern Cape, 6055

  • Life Groenkloof

    Pretoria, Gauteng, 181

  • Eastleigh Breast Care Center

    Pretoria, Gauteng, 81

  • Sandton Oncology Medical Group (Pty) Ltd

    Sandton, Gauteng, 2196

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Portugal5 sites

  • Instituto Portugês de Oncologia de Coimbra Francisco Gentil

    Coimbra, 3000-075

  • Champalimaud Foundation

    Lisbon, 1400-038

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

    Lisbon, 1649-028

  • Centro Hospitalar do Porto - Hospital de Santo António

    Porto, 4099-001

  • IPOFG - Porto

    Porto, 4200-072

Other trials in Portugal

Sweden5 sites

  • Skånes universitetssjukhus Lund

    Malmö, Skåne Län [se-12], 205 02

  • Sundsvalls Sjukhus

    Sundsvall, Västernorrlands Län [se-22], 856 43

  • Norrlands universitetssjukhus

    Umeå, Västerbottens Län [se-24], 90185

  • Västmanlands sjukhus Västerås

    Västerås, Västmanlands Län [se-19], 721 89

  • Växjö Centrallasarettet

    Vaxjo, 35234

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Hong Kong4 sites

  • Pamela Youde Nethersole Eastern Hospital

    Chai Wan, 999077

  • Queen Mary Hospital

    Hksar

  • Tuen Mun Hospital

    Tuenmen, 999077

  • Queen Elizabeth Hospital

    Yau Ma Tei, 999077

Other trials in Hong Kong

Netherlands4 sites

  • Onze Lieve Vrouwe Gasthuis (OLVG)

    Amsterdam, North Holland, 1091AC

  • Albert Schweitzer Ziekenhuis, locatie Dordwijk

    Dordrecht, South Holland, 3318 AT

  • Maastricht UMC+

    Maastricht, Limburg, 6229 HX

  • Haga Ziekenhuis locatie Leyweg

    The Hague, South Holland, 2545 AA

Other trials in Netherlands

Saudi Arabia4 sites

  • King Fahad Specialist Hospital-Dammam

    Dammam, Eastern Province, 31444

  • King Abdulaziz Medical City - National Guard Hospital

    Riyadh, Riyadh Region, 11426

  • King Fahad Medical City

    Riyadh, Riyadh Region, 11525

  • King Faisal Specialist Hospital & Research Center

    Riyadh, 11211

Other trials in Saudi Arabia

New Zealand3 sites

  • Auckland City Hospital

    Auckland, 1023

  • Waikato Hospital

    Hamilton, Waikato Region, 3240

  • Palmerston North Hospital

    Palmerston North, Wanganui, 4414

Other trials in New Zealand

Puerto Rico2 sites

  • Puerto Rico Hematology/Oncology Group

    Bayamón, PR, 00961

  • UPR Comprehensive Cancer Center

    San Juan, PR, 00935

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Singapore2 sites

  • National Cancer Center

    Singapore, Central Singapore, 168583

  • National University Hospital

    Singapore, 119074

Other trials in Singapore

About this study

Official title: A Randomized, Open-Label, Phase 3 Study of Abemaciclib Combined With Standard Adjuvant Endocrine Therapy Versus Standard Adjuvant Endocrine Therapy Alone in Patients With High Risk, Node Positive, Early Stage, Hormone Receptor Positive, Human Epidermal Receptor 2 Negative, Breast Cancer

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.

Conditions
Breast Cancer
Being tested
Abemaciclib, Standard Adjuvant Endocrine Therapy
Keywords
early stage breast cancer, cyclin-dependent kinase (CDK)
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • AbemaciclibDrug

    Also called LY2835219

    Administered orally.

  • Standard Adjuvant Endocrine TherapyDrug

    Administered according to label instructions.

Study groups in NCT03155997
Study groupRoleWhat they receive
150 mg Abemaciclib + Endocrine TherapyExperimentalParticipants 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.
Receives: Drug: Abemaciclib; Drug: Standard Adjuvant Endocrine Therapy
Endocrine TherapyOtherEndocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.
Receives: Drug: Standard Adjuvant Endocrine Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive Disease Free Survival (IDFS)

    IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.

    Measured: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)

Secondary outcomes (8)

  1. IDFS for Participants With Ki-67 Index ≥20%

    Outcome data will be provided after the study is completed.

    Measured: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)

  2. Distant Relapse-Free Survival (DRFS)

    Distant relapse-free survival is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.

    Measured: Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)

  3. Overall Survival (OS)

    Outcome data will be provided after the study is completed.

    Measured: Baseline to Death from Any Cause (Approximately 10 Years)

  4. Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib

    Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib

    Measured: Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose

  5. Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)

    Outcome data will be provided after the study is completed.

    Measured: Baseline, Follow Up (Approximately 3 Years)

  6. Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)

    Outcome data will be provided after the study is completed.

    Measured: Baseline, Follow Up (Approximately 3 Years)]

  7. Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

    Outcome data will be provided after the study is completed.

    Measured: Baseline, Follow Up (Approximately 3 Years)]

  8. Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)

    Outcome data will be provided after the study is completed.

    Measured: Baseline, Follow Up (Approximately 3 Years)]

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 May 2017
  2. Study start12 Jul 2017
  3. Primary completion16 Mar 2020
  4. Study completionMay 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
5,637 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03155997
Sponsor's protocol ID
16338
Other IDs
I3Y-MC-JPCF, 2016-004362-26, NSABP B-58, 2016
Acronym
monarchE
Status last verified
Apr 2026
First submitted
15 May 2017
Last updated
24 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
Expanded access
Available

Publications

  • Johnston S, Martin M, O'Shaughnessy J, Hegg R, Tolaney SM, Guarneri V, Del Mastro L, Campone M, Sohn J, Boyle F, Cortes J, Rugo HS, Goetz MP, Hamilton EP, Huang CS, Senkus E, Cicin I, Testa L, Neven P, Huober J, Shao Z, Wei R, Munoz M, San Antonio B, Shahir A, Rastogi P, Harbeck N. Overall survival with abemaciclib in early breast cancer. Ann Oncol. 2026 Feb;37(2):155-165. doi: 10.1016/j.annonc.2025.10.005. Epub 2025 Oct 17.

    PubMed 41110697

  • 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.

    PubMed 39463748

  • 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.

    PubMed 39023253

  • 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.

    PubMed 38194616

  • Ganfornina Andrades A, Fenix Caballero S, Salguero Olid A, Alegre Del-Rey Emilio J. Abemaciclib as adjuvant treatment for high-risk early breast cancer. Farm Hosp. 2024 Mar-Apr;48(2):75-78. doi: 10.1016/j.farma.2023.08.006. Epub 2023 Sep 19. English, Spanish.

    PubMed 37735004

  • 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.

    PubMed 36493792

  • 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.

    PubMed 36342342

  • 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.

    PubMed 35653145

  • 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.

    PubMed 35594464

  • 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.

    PubMed 35384873

  • 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.

    PubMed 35337972

  • 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.

    PubMed 35084948

  • 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.

    PubMed 32954927

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Abemaciclib and Standard Adjuvant Endocrine Therapy in people with Breast Cancer, run by Eli Lilly and Company at 619 sites in 38 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 16 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 619 sites in United States, Japan, Germany, Spain, Australia and 33 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Apr 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Invasive Disease Free Survival (IDFS) (time frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03155997, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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