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

April 7, 2026 updated by: Eli Lilly and Company

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.

Study Overview

Status

Active, not recruiting

Conditions

Breast Cancer

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5637

Phase

Phase 3

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Argentina
- - Buenos Aires, Argentina, 1426
    - Instituto Alexander Fleming
  - Buenos Aires, Argentina, C1012AAR
    - IDIM - Instituto de Diagnostico e Investigaciones Metabolicas
  - Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
    - Clinica Adventista de Belgrano
  - La Rioja, Argentina, F5300COE
    - Fundación CORI para la investigación y Prevención del Cancer
  - Salta, Argentina, 4400
    - Consultorio Dr. Miguel Ángel Escudero
  - San Juan, Argentina, 5400
    - Cer San Juan
  - San Miguel de Tucumán, Argentina, 4000
    - Centro Médico San Roque
- Buenos Aires
  - Berazategui, Buenos Aires, Argentina, B1884BBF
    - Centro de Oncologia e Investigacion Buenos Aires
  - Mar del Plata, Buenos Aires, Argentina, 7600
    - Instituto de Investigaciones Clinicas Mar del Plata
  - Pilar, Buenos Aires, Argentina, 1629
    - Hospital Universitario Austral
- Buenos Aires F.D.
  - Buenos Aires, Buenos Aires F.D., Argentina, C1118AAT
    - Hospital Alemán
- Ciudad Autonoma Buenos Aires
  - CABA, Ciudad Autonoma Buenos Aires, Argentina, 1125
    - Fundación Cenit para la Investigación en Neurociencias
- Río Negro Province
  - Viedma, Río Negro Province, Argentina, R8500ACE
    - Clínica Viedma
- Santa Fe Province
  - Rosario, Santa Fe Province, Argentina, S2000KZE
    - Instituto de Oncologia de Rosario
- Tucumán Province
  - San Miguel de Tucumán, Tucumán Province, Argentina, 4000
    - Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
Australia
- New South Wales
  - Camperdown, New South Wales, Australia, 2050
    - Chris O'Brien Lifehouse
  - Darlinghurst, New South Wales, Australia, 2010
    - St Vincent's Hospital
  - Lismore, New South Wales, Australia, 2480
    - Lismore Base Hospital
  - Liverpool, New South Wales, Australia, 2170
    - Liverpool Hospital
  - Sydney, New South Wales, Australia, 2060
    - Mater Hospital Sydney
  - Waratah, New South Wales, Australia, 2298
    - Calvary Mater Newcastle
  - Westmead, New South Wales, Australia, 2145
    - Westmead Hospital
  - Wollongong, New South Wales, Australia, 2500
    - Southern Medical Day Care Centre
- Queensland
  - Brisbane, Queensland, Australia, 4101
    - Mater Misericordiae Limited
  - Southport, Queensland, Australia, 4215
    - Gold Coast University Hospital
  - Townsville, Queensland, Australia, 4814
    - The Townsville Hospital
- South Australia
  - Elizabeth Vale, South Australia, Australia, 5112
    - Lyell McEwin Hospital
  - Kurralta Park, South Australia, Australia, 5037
    - Ashford Cancer Centre Research
- Tasmania
  - Launceston, Tasmania, Australia, 7250
    - Launceston General Hospital
- Victoria
  - Box Hill, Victoria, Australia, 3128
    - Box Hill Hospital
  - East Melbourne, Victoria, Australia, 3121
    - Epworth Hospital
  - Melbourne, Victoria, Australia, 3135
    - Maroondah Hospital
  - Melbourne, Victoria, Australia, 3050
    - Peter MacCallum Cancer Centre
- Western Australia
  - Nedlands, Western Australia, Australia, 6009
    - Breast Cancer Research Centre WA
  - Subiaco, Western Australia, Australia, 6008
    - St John of God Subiaco Hospital
Austria
- - Salzburg, Austria, 5020
    - Universitätsklinikum Salzburg
- State of Vienna
  - Vienna, State of Vienna, Austria, 1090
    - Medizinische Universität Wien
  - Vienna, State of Vienna, Austria, 1090
    - Universitaetsklinikum Allgemeines Krankenhaus Wien
  - Vienna, State of Vienna, Austria, 1130
    - Klinik Hietzing
- Styria
  - Graz, Styria, Austria, 8036
    - Medizinische Universität Graz
- Tyrol
  - Innsbruck, Tyrol, Austria, 6020
    - Medizinische Universitaet Innsbruck
  - Schwaz, Tyrol, Austria, 6130
    - Private Practice - Dr. Hubalek
Belgium
- - Namur, Belgium, 5000
    - CHU UCL Namur/Site Sainte Elisabeth
- Antwerpen
  - Brasschaat, Antwerpen, Belgium, 2930
    - Algemeen Ziekenhuis klina
  - Edegem, Antwerpen, Belgium, 2650
    - Antwerp University Hospital
- Bruxelles-Capitale, Région de
  - Brussels, Bruxelles-Capitale, Région de, Belgium, 1200
    - Cliniques Universitaires Saint-Luc
- Hainaut
  - Lodelinsart, Hainaut, Belgium, 6042
    - CHU de Charleroi - Hopital Civil Marie Curie
- Limburg
  - Hasselt, Limburg, Belgium, 3500
    - Jessa Ziekenhuis
- Liège
  - Liège, Liège, Belgium, 4000
    - Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
- Luxembourg
  - Libramont, Luxembourg, Belgium, 6800
    - Centre Hospitalier D'Ardenne - Forget
- Namur
  - Yvoir, Namur, Belgium, 5000
    - Université Catholique de Louvain-Namur - Centre Hospitalier Universitaire Dinant-Godinne - Site Godinne
- Oost-Vlaanderen
  - Sint-Niklaas, Oost-Vlaanderen, Belgium, B-9100
    - AZ Nikolaas
- Vlaams-Brabant
  - Leuven, Vlaams-Brabant, Belgium, 3000
    - UZ Leuven
- Wallonne, Région
  - La Louvière, Wallonne, Région, Belgium, 7100
    - Groupe Jolimont
  - Liège, Wallonne, Région, Belgium, 4000
    - Clinical Chc Montlégia
  - Ottignies, Wallonne, Région, Belgium, 1340
    - Clinique Saint Pierre
- West-Vlaanderen
  - Bruges, West-Vlaanderen, Belgium, 8000
    - AZ Sint-Jan Brugge-Oostende AV
  - Ieper, West-Vlaanderen, Belgium, 8900
    - Jan Yperman Ziekenhuis
  - Kortrijk, West-Vlaanderen, Belgium, 8500
    - AZ Groeninge Campus Kennedylaan
Brazil
- - Rio de Janeiro, Brazil, 20560121
    - INCA - Instituto Nacional Do Cancer
  - São Paulo, Brazil, 01308-060
    - Hospital Sirio Libanes
  - São Paulo, Brazil, 04543-000
    - Instituto D'Or de Pesquisa e Ensino (IDOR)
  - São Paulo, Brazil, 01317-000
    - Pérola Centro de Pesquisa em Oncologia
  - São Paulo, Brazil, 04014-002
    - IBCC - Núcleo de Pesquisa e Ensino
  - São Paulo, Brazil, 04038-034
    - Instituto de Assistência Médica ao Servidor Público Estadual - IAMSPE/HSPE-FMO Conhecer Centro de Oncolog -T
- Ceará
  - Fortaleza, Ceará, Brazil, 60430-230
    - Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
- Federal District
  - Brasília, Federal District, Brazil, 70200-730
    - Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
- Goiás
  - Goiânia, Goiás, Brazil, 74605-070
    - Hospital Araujo Jorge
- Paraná
  - Curitiba, Paraná, Brazil, 80810-050
    - CIONC - Centro Integrado de Oncologia de Curitiba
  - Londrina, Paraná, Brazil, 86015-520
    - Hospital de Cancer de Londrina
- Rio Grande do Sul
  - Ijuí, Rio Grande do Sul, Brazil, 98700 000
    - ONCOSITE - Centro de Pesquisa Clinica em Oncologia
  - Lajeado, Rio Grande do Sul, Brazil, 95900-000
    - Hospital Bruno Born
  - Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
    - Hospital Sao Lucas da PUCRS
- Rio de Janeiro
  - Rio de Janeiro, Rio de Janeiro, Brazil, 22775-002
    - Instituto de Educação, Pesquisa e Gestão em Saúde
- São Paulo
  - Barretos, São Paulo, Brazil, 14784-400
    - Fundação Pio XII - Hospital de Câncer de Barretos
  - Ribeirão Preto, São Paulo, Brazil, 14051-140
    - Hospital de Clínicas de Ribeirão Preto
  - Santo André, São Paulo, Brazil, 09060-650
    - Faculdade de Medicina do ABC
  - Sao Jose Rio Preto, São Paulo, Brazil, 15091-000
    - Hospital de Base de Sao Jose do Rio Preto
  - São Paulo, São Paulo, Brazil, 01246-000
    - Instituto do Cancer do Estado de Sao Paulo - ICESP
Canada
- Ontario
  - Ottawa, Ontario, Canada, K1H 8L6
    - The Ottawa Hospital - General Campus
  - Toronto, Ontario, Canada, M3M 0B2
    - Humber River Hospital
  - Toronto, Ontario, Canada, M2K 1E1
    - North York General Hospital
  - Toronto, Ontario, Canada, M5B 1W8
    - Unity Health Toronto, St. Michael's Hospital
- Quebec
  - Montreal, Quebec, Canada, H3T 1E2
    - Jewish General Hospital
  - Montreal, Quebec, Canada, H4J 1C5
    - Hopital Du Sacre-Coeur de Montreal
  - Montreal, Quebec, Canada, H2X 3E4
    - Centre Hospitalier de l'Université de Montréal
  - Québec, Quebec, Canada, G1S 4L8
    - CHU de Quebec-Hopital de Saint-Sacrement
  - Sherbrooke, Quebec, Canada, J1J 3H5
    - Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitair -T
China
- Beijing Municipality
  - Beijing, Beijing Municipality, China, 100142
    - Beijing Cancer Hospital
  - Beijing, Beijing Municipality, China, 100039
    - The Fifth Medical Center of PLA General Hospital
- Fujian
  - Fuzhou, Fujian, China, 350001
    - Fujian Medical University Union Hospital-1 Bingfanglou
- Guangdong
  - Guangzhou, Guangdong, China, 510080
    - Guangdong Provincial People's Hospital
  - Guangzhou, Guangdong, China, 510080
    - The First Affiliated Hospital, Sun-Yat Sen University
  - Guangzhou, Guangdong, China, 510120
    - Sun Yat-Sen University
- Heilongjiang
  - Harbin, Heilongjiang, China, 150081
    - Harbin Medical University Cancer Hospital
- Henan
  - Zhengzhou, Henan, China, 450008
    - Henan Cancer Hospital
- Hunan
  - Changsha, Hunan, China, 410013
    - Hunan Cancer Hospital
- Jiangsu
  - Nanjing, Jiangsu, China, 210009
    - Jiangsu Cancer Hospital
- Nanjing
  - Nanjing, Nanjing, China, 210029
    - Jiangsu Province Hospital
- Shandong
  - Jinan, Shandong, China, 250117
    - Shandong Cancer Hospital
- Shanghai Municipality
  - Shanghai, Shanghai Municipality, China, 200032
    - Fudan University Shanghai Cancer Center
  - Shanghai, Shanghai Municipality, China, 200025
    - Shanghai Jiaotong University School of Medicine Ruijin Hospital
- Zhejiang
  - Hangzhou, Zhejiang, China, 310022
    - Zhejiang Cancer Hospital
  - Hangzhou, Zhejiang, China, 310052
    - The Second Affiliated Hospital of Zhejiang University School of Medicine
Czechia
- - Pilsen, Czechia, 30460
    - FN Plzen Lochotin
- Beroun
  - Hořovice, Beroun, Czechia, 268 31
    - Nemocnice Horovice
- Brno-město
  - Brno, Brno-město, Czechia, 656 53
    - Masarykuv Onkologicky Ustav
- Moravian-Silesian Region
  - Ostrava, Moravian-Silesian Region, Czechia, 708 52
    - Fakultni nemocnice Ostrava
- Pardubice Region
  - Pardubice, Pardubice Region, Czechia, 532 03
    - Multiscan
- Praha 4
  - Prague, Praha 4, Czechia, 14059
    - Fakultni Thomayerova nemocnice
Denmark
- Capital Region
  - Copenhagen, Capital Region, Denmark, 2730
    - Herlev and Gentofte Hospital
  - København Ø, Capital Region, Denmark, 2100
    - Rigshospitalet
- Central Jutland
  - Aarhus, Central Jutland, Denmark, 8200
    - Aarhus Universitetshospital, Skejby
  - Herning, Central Jutland, Denmark, 7400
    - Regionshospitalet Herning
- North Denmark
  - Aalborg, North Denmark, Denmark, 9000
    - Aalborg Universitetshospital, Syd
- Region Sjælland
  - Næstved, Region Sjælland, Denmark, 4700
    - Næstved Sygehus
- Region Syddanmark
  - Esbjerg, Region Syddanmark, Denmark, 6700
    - Sydvestjysk Sygehus Esbjerg
  - Odense, Region Syddanmark, Denmark, 5000
    - Odense Universitetshospital
  - Sønderborg, Region Syddanmark, Denmark, 6400
    - Sygehus Soenderjylland
  - Vejle, Region Syddanmark, Denmark, 7100
    - Vejle Sygehus
Finland
- - Lahti, Finland, 15850
    - Päijät-Häme Central Hospital
- Central Finland
  - Jyväskylä, Central Finland, Finland, 40620
    - Keski-Suomen Keskussairaala
- North Ostrobothnia
  - Oulu, North Ostrobothnia, Finland, 90220
    - Oulun yliopistollinen sairaala
- Northern Savonia
  - Kuopio, Northern Savonia, Finland, 70210
    - Kuopion Yliopistollinen Sairaala
- Pirkanmaa
  - Tampere, Pirkanmaa, Finland, 33520
    - Tampereen yliopistollinen sairaala
- Pohjanmaa
  - Vaasa, Pohjanmaa, Finland
    - Vaasan Keskussairaala
- Satakunta
  - Pori, Satakunta, Finland, 28500
    - Satakunnan Keskussairaala
- Southwest Finland
  - Turku, Southwest Finland, Finland, 20520
    - Turku University Central Hospital
- Uusimaa
  - Helsinki, Uusimaa, Finland, 00029
    - Docrates Syöpäsairaala
France
- - Paris, France, 75248
    - Institut Curie
- Auvergne-Rhône-Alpes
  - Lyon, Auvergne-Rhône-Alpes, France, 69008
    - Centre Leon Berard
- Brittany Region
  - Brest, Brittany Region, France, 29200
    - Centre Hospitalier Regional Universitaire de Brest - Hopital Morvan
- Centre-Val de Loire
  - La Chaussée-Saint-Victor, Centre-Val de Loire, France, 41260
    - Polyclinique de Blois
- Côte-d'Or
  - Dijon, Côte-d'Or, France, 21079
    - Centre Georges Francois Leclerc
- Côtes-d'Armor
  - Plérin, Côtes-d'Armor, France, 22190
    - Hôpital Privé des Côtes d'Armor- HPCA
- Doubs
  - Besançon, Doubs, France, 25000
    - CHU de Besancon Hopital Jean Minjoz
- Ille-et-Vilaine
  - Rennes, Ille-et-Vilaine, France, 35042
    - Centre Eugène Marquis Rennes - Centre de Lutte Contre le Cancer
- Languedoc-Roussillon
  - Montpellier, Languedoc-Roussillon, France, 34070
    - Centre de Cancerologie du Grand Montpellier
- Loire-Atlantique
  - Saint-Herblain, Loire-Atlantique, France, 44805
    - Institut de Cancerologie de L'Ouest
- Meurthe-et-Moselle
  - Nancy, Meurthe-et-Moselle, France, 54519
    - Polyclinique de Gentilly
- Pays de la Loire Region
  - Le Mans, Pays de la Loire Region, France, 72000
    - Clinique Victor Hugo Le Mans
- Puy-de-Dôme
  - Clermont-Ferrand, Puy-de-Dôme, France, 63011
    - Centre Jean Perrin - Centre Régional de Lutte contre le Cancer d'Auvergne
- Seine-Maritime
  - Rouen, Seine-Maritime, France, 76038
    - Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
- Seine-et-Marne
  - Créteil, Seine-et-Marne, France, 94000
    - Henri Mondor Hospital
- Vaucluse
  - Avignon, Vaucluse, France, 84918
    - Sainte Catherine Institut du Cancer Avignon Provence
- Vendée
  - La Roche-sur-Yon, Vendée, France, 85000
    - Centre Hospitalier de Vendee Les Oudairies
Germany
- - Berlin, Germany, 13125
    - HELIOS Klinikum Berlin-Buch
  - Berlin, Germany, 14195
    - Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim
  - Hamburg, Germany, 22087
    - Kath. Marienkrankenhaus gGmbH
  - Hamburg, Germany, 22307
    - Asklepios Kliniken Hamburg
  - Hamburg, Germany, 20246
    - Mammazentrum HH - Krankenhaus Jerusalem
- Baden-Wurttemberg
  - Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
    - Universitätsklinikum Freiburg
  - Freiburg im Breisgau, Baden-Wurttemberg, Germany, 69126
    - Praxis für interdisziplinäre Onkologie & Hämatologie
  - Friedrichshafen, Baden-Wurttemberg, Germany, 88045
    - Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer
  - Ludwigsburg, Baden-Wurttemberg, Germany, 71640
    - Klinikum Ludwigsburg
  - Tübingen, Baden-Wurttemberg, Germany, 72076
    - Universitätsklinikum Tübingen
  - Ulm, Baden-Wurttemberg, Germany, 89075
    - Universitätsklinikum Ulm
- Bavaria
  - Amberg, Bavaria, Germany, 92224
    - Klinikum St. Marien Amberg
  - Augsburg, Bavaria, Germany, 86150
    - Gemeinschaftspraxis hop-augsburg
  - Erlangen, Bavaria, Germany, 91054
    - Universitätsklinikum Erlangen
  - München, Bavaria, Germany, 80336
    - Klinikum der Ludwig-Maximilians-Universitaet Muenchen
  - München, Bavaria, Germany, 81675
    - Klinikum rechts der Isar der Technischen Universität München
  - München, Bavaria, Germany, 81675
    - Rotkreuzklinikum München gemeinnützige GmbH
- Hesse
  - Frankfurt am Main, Hesse, Germany, 60431
    - Agaplesion Markus Krankenhaus
  - Langen, Hesse, Germany, 63225
    - Private Practice - Dres. Andreas Köhler und Roswitha Fuchs
  - Offenbach, Hesse, Germany, 63069
    - Sana Klinikum Offenbach
- Lower Saxony
  - Georgsmarienhütte, Lower Saxony, Germany, 49124
    - Franziskus-Hospital Harderberg
  - Hanover, Lower Saxony, Germany, 30625
    - Medizinische Hochschule Hannover
  - Hanover, Lower Saxony, Germany, 30177
    - Gynäkologisch-Onkologische Praxis am Pelikanplatz
- North Rhine-Westphalia
  - Bonn, North Rhine-Westphalia, Germany, 53127
    - Universitätsklinikum Bonn
  - Düsseldorf, North Rhine-Westphalia, Germany, 40225
    - Universitätsklinikum Düsseldorf
  - Essen, North Rhine-Westphalia, Germany, 45136
    - Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung
  - Krefeld, North Rhine-Westphalia, Germany, 47805
    - Zentrum fuer ambulante gynaekologische Onkologie (ZAGO)
  - Mönchengladbach, North Rhine-Westphalia, Germany, 41061
    - Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH
  - Münster, North Rhine-Westphalia, Germany, 52074
    - Universitätsklinikum Münster - Albert Schweitzer Campus
  - Witten, North Rhine-Westphalia, Germany, 58452
    - Marien Hospital Witten
- Saxony
  - Dresden, Saxony, Germany, 1307
    - Universitatsklinikum Carl Gustav Carus
- Schleswig-Holstein
  - Kiel, Schleswig-Holstein, Germany, 24105
    - Universitaetsklinikum Schleswig-Holstein Campus Kiel
- Thuringia
  - Gera, Thuringia, Germany, 07548
    - SRH Wald-Klinikum Gera gGmbH
Greece
- - Thessaloniki, Greece, 54645
    - Euromedica - General Clinic of Thessaloniki
  - Thessaloniki, Greece, 564 29
    - Papageorgiou General Hospital of Thessaloniki
- Achaia
  - Pátrai, Achaia, Greece, 26504
    - University Hospital of Patras
- Attikí
  - Athens, Attikí, Greece, 115 28
    - Alexandra Hospital
  - Athens, Attikí, Greece, 11522
    - Agios Savvas Regional Cancer Hospital
  - Athens, Attikí, Greece, 18547
    - Metropolitan Hospital
  - Chaïdári, Attikí, Greece, 12462
    - Attikon General University Hospital
  - Nea Kifissia, Attikí, Greece, 14564
    - General Oncology Hospital of Kifissia "Agioi Anargiroi"
- Attikí (Region)
  - Athens, Attikí (Region), Greece, 11526
    - Errikos Dunant Hospital Center
- Kentrikí Makedonía
  - Thessaloniki, Kentrikí Makedonía, Greece, 54622
    - Bioclinic of Thessaloniki
- Krítí
  - Heraklion, Krítí, Greece, 71110
    - University General Hospital of Heraklion
- Thessaloníki
  - Thessaloniki, Thessaloníki, Greece, 570 01
    - European Interbalkan Medical Center
- Ípeiros
  - Ioannina, Ípeiros, Greece, 45500
    - University Hospital of Ioannina
Hong Kong
- - Chai Wan, Hong Kong, 999077
    - Pamela Youde Nethersole Eastern Hospital
  - Hksar, Hong Kong
    - Queen Mary Hospital
  - Tuenmen, Hong Kong, 999077
    - Tuen Mun Hospital
  - Yau Ma Tei, Hong Kong, 999077
    - Queen Elizabeth Hospital
Hungary
- - Budapest, Hungary, 1062
    - Magyar Honvédség Egészségügyi Központ
  - Budapest, Hungary, 1145
    - Uzsoki Utcai Kórház
  - Budapest, Hungary, 1032
    - Szent Margit Kórház
  - Budapest, Hungary, 1088
    - Semmelweis University
  - Budapest, Hungary, 1115
    - Szent Imre Egyetemi Oktatokorhaz
- Bács-Kiskun county
  - Kecskemét, Bács-Kiskun county, Hungary, 6000
    - Bács-Kiskun Vármegyei Oktatókórház
- Jász-Nagykun-Szolnok
  - Szolnok, Jász-Nagykun-Szolnok, Hungary, 5004
    - Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
India
- - Chandigarh, India, 160012
    - Post Graduate Institute of Medical Education & Research
- Andhra Pradesh
  - Hyderabad, Andhra Pradesh, India, 500004
    - MNJ Institute of Oncology
- Gujarat
  - Ahmedabad, Gujarat, India, 380060
    - HCG Cancer Centre
  - Vadodara, Gujarat, India, 390012
    - HCG Cancer Centre
- Haryana
  - Gurgaon, Haryana, India, 122003
    - Artemis Hospital
- Karmnataka
  - Bangalore, Karmnataka, India, 560017
    - Manipal Hospital
- Kerala
  - Trivandrum, Kerala, India, 695 011
    - Regional Cancer Centre
- Maharashtra
  - Mumbai, Maharashtra, India, 400012
    - Tata Memorial Hospital
  - Nashik, Maharashtra, India, 422001
    - HCG Manavata Cancer Centre
  - Pune, Maharashtra, India, 411004
    - Deenanth Mangeshkar Hospital and Research Centre
  - Pune, Maharashtra, India, 411001
    - Grant Medical Foundation - Ruby Hall Clinic
- National Capital Territory of Delhi
  - New Delhi, National Capital Territory of Delhi, India, 110005
    - Dr. B. L. Kapur Memorial Hospital
- Tamil Nadu
  - Chennai, Tamil Nadu, India, 600035
    - Apollo Speciality Hospital - Teynampet
- West Bengal
  - Kolkata, West Bengal, India, 700054
    - Apollo Gleneagles Hospitals
  - Kolkata, West Bengal, India, 700099
    - Medica Superspecialty Hospital
Israel
- Central District
  - Kfar Saba, Central District, Israel, 4428164
    - Meir Medical Center
  - Petah Tikva, Central District, Israel, 49100
    - Rabin Medical Center
  - Ramat Gan, Central District, Israel, 5265601
    - Sheba Medical Center
  - Rehovot, Central District, Israel, 7610001
    - Kaplan Medical Center
  - Ẕerifin, Central District, Israel, 6093000
    - Yitzhak Shamir Medical Center
- Jerusalem
  - Jerusalem, Jerusalem, Israel, 9112001
    - Hadassah Medical Center
  - Jerusalem, Jerusalem, Israel, 9013102
    - Shaare Zedek Medical Center
- Southern District
  - Beersheba, Southern District, Israel, 8400000
    - Soroka Medical Center
- Ḥeifā
  - Haifa, Ḥeifā, Israel, 3109601
    - Rambam Health Care Campus
Italy
- - Bologna, Italy, 40139
    - Ospedale Bellaria - Azienda USL di Bologna
  - Brindisi, Italy, 72100
    - Ospedale Antonio Perrino
  - Genova, Italy, 16132
    - Ospedale San Martino
  - Modena, Italy, 41125
    - Azienda Ospedaliero Universitaria
  - Naples, Italy, 80131
    - Istituto Nazionale Tumori Irccs Fondazione Pascale
  - Padova, Italy, 35128
    - Istituto Oncologico Veneto IRCCS
  - Parma, Italy, 43126
    - Azienda Ospedaliera Di Parma
  - Torino, Italy, 10126
    - Azienda Ospedaliero-Universitaria Città della Salute e della Scienza di Torino
  - Trento, Italy, 38122
    - APSS - Presidio Ospedaliero Santa Chiara
- Campania
  - Naples, Campania, Italy, 80131
    - University of Naples Federico II
- Emilia-Romagna
  - Cona, Emilia-Romagna, Italy, 44124
    - Azienda Ospedaliero Universitaria S.Anna
  - Meldola, Emilia-Romagna, Italy, 47014
    - Istituto Scientifico Romagnolo Per Lo Studio e La Cura Dei Tumori
- Lombardy
  - Monza, Lombardy, Italy, 20900
    - Fondazione IRCCS San Gerardo dei Tintori
- Milano
  - Milan, Milano, Italy, 20121
    - Ospedale Fatebenefratelli-Oftalmico
  - Rozzano, Milano, Italy, 20141
    - Humanitas
- Roma
  - Rome, Roma, Italy, 00144
    - Istituto Nazionale Tumori Regina Elena
  - Rome, Roma, Italy, 00157
    - Azienda Ospedaliera Sant'Andrea
- TR
  - Terni, TR, Italy, 05100
    - Azienda Ospedaliera Santa Maria
Japan
- - Fukuoka, Japan, 811-1395
    - National Hospital Organization Kyushu Cancer Center
  - Kagoshima, Japan, 892-0833
    - Sagara Hospital
  - Kumamoto, Japan, 860-8556
    - Kumamoto University Hospital
  - Kumamoto, Japan, 862-8655
    - Kumamoto Shinto General Hospital
  - Kyoto, Japan, 606-8507
    - Kyoto University Hospital
  - Osaka, Japan, 541-8567
    - Osaka International Cancer Institute
  - Osaka, Japan, 540-0006
    - National Hospital Organization Osaka Medical Center
- Aichi-ken
  - Nagoya, Aichi-ken, Japan, 464-8681
    - Aichi Cancer Center Hospital
- Chiba
  - Chiba, Chiba, Japan, 260-8717
    - Chiba Cancer Center
  - Kashiwa, Chiba, Japan, 277 8577
    - National Cancer Center Hospital East
- Ehime
  - Matsuyama, Ehime, Japan, 791-0280
    - National Hospital Organization Shikoku Cancer Center
- Fukuoka
  - Kurume, Fukuoka, Japan, 830-0013
    - Kurume General Hospital
- Gunma
  - Ōta, Gunma, Japan, 373-0828
    - Gunma Prefectural Cancer Center
- Hiroshima
  - Hiroshima, Hiroshima, Japan, 734-8551
    - Hiroshima University Hospital
- Hokkaido
  - Sapporo, Hokkaido, Japan, 003-0804
    - National Hospital Organization Hokkaido Cancer Center
- Hyōgo
  - Nishinomiya, Hyōgo, Japan, 663-8501
    - Hyogo College of Medecine
- Ibaragi
  - Tsukuba, Ibaragi, Japan, 305-8576
    - University of Tsukuba Hospital
- Kanagawa
  - Isehara, Kanagawa, Japan, 259-1143
    - Tokai University Hospital- Isehara Campus
  - Kawasaki, Kanagawa, Japan, 216-8511
    - St Marianna University School of Medicine Hospital
  - Yokohama, Kanagawa, Japan, 241 8515
    - Kanagawa Cancer Center
- Miyagi
  - Aoba-ku, Sendai-shi, Miyagi, Japan, 980-0803
    - KKR Tohoku Kosai Hospital
- Niigata
  - Niigata, Niigata, Japan, 951-8566
    - Niigata Cancer Center Hospital
- Osaka
  - Osaka Sayama-shi, Osaka, Japan, 589 8511
    - Kindai University Hospital- Osakasayama Campus
- Saitama
  - Hidaka, Saitama, Japan, 350-1298
    - Saitama Medical University International Medical Center
  - Ina-machi, Saitama, Japan, 362-0806
    - Saitama Prefectural Cancer Center
- Shizuoka
  - Nakatogari, Shizuoka, Japan, 411-8777
    - Shizuoka Cancer Center
- Tochigi
  - Shimotsuke, Tochigi, Japan, 329-0498
    - Jichi Medical University Hospital
  - Utsunomiya, Tochigi, Japan, 320-0834
    - Tochigi Cancer Center
- Tokyo
  - Bunkyō-Ku, Tokyo, Japan, 113-8431
    - Juntendo University Hospital
  - Chuo Ku, Tokyo, Japan, 104-0045
    - National Cancer Center Hospital
  - Chuo-Ku, Tokyo, Japan, 104 8560
    - St. Lukes International Hospital
  - Koto, Tokyo, Japan, 135-8550
    - Japanese Foundation for Cancer Research
  - Shinagawa-ku, Tokyo, Japan, 142-8555
    - Showa University Hospital
  - Shinjuku-ku, Tokyo, Japan, 162-8655
    - National Center for Global Health and Medicine
  - Shinjuku-ku, Tokyo, Japan, 160-0023
    - Tokyo Medical University Hospital
Mexico
- - Chihuahua City, Mexico, 31203
    - Unidad de Investigacion en Salud
  - Oaxaca City, Mexico, 68000
    - Oaxaca Site Management Organization SC
  - Puebla City, Mexico, 72424
    - Unidad Médica Onco-hematológica
  - San Luis Potosí City, Mexico, 78209
    - Oncológico Potosino
- Coahuila
  - Torreón, Coahuila, Mexico, 27000
    - CIMAB S.A. de C.V.
- Federal District
  - Mexico City, Federal District, Mexico, 3100
    - Health Pharma Professional Research, S.A. de C.V.
- Jalisco
  - Guadalajara, Jalisco, Mexico, 44280
    - Hospital Civil Fray Antonio Alcalde
  - Guadalajara, Jalisco, Mexico, 45647
    - Centro Oncológico Internacional (COI)
- Mexico City
  - Mexico City, Mexico City, Mexico, 3310
    - Grupo Medico Camino S.C.
- Nuevo León
  - Monterrey, Nuevo León, Mexico, 64060
    - Centro Regiomontano de Investigacion
  - Monterrey, Nuevo León, Mexico, 64320
    - Private Practice - Dr. Joaquin Reinoso
  - Monterrey, Nuevo León, Mexico, 64460
    - Filios Alta Medicina
- Oaxaca
  - Juchitán de Zaragoza, Oaxaca, Mexico, 70020
    - Centro de Estudios y Prevencion del Cancer
- Sinaloa
  - Culiacán, Sinaloa, Mexico, 80020
    - Neurociencias Estudios Clinicos S.C.
- Toluca
  - Toluca, Toluca, Mexico, 50120
    - Centro Hemato Oncologico Privado
- Yucatán
  - Mérida, Yucatán, Mexico, 97070
    - Medical Care and Research, S.A. de C.V.
  - Mérida, Yucatán, Mexico, 97134
    - Centro de Atención e Investigación Clínica en Oncología
Netherlands
- Limburg
  - Maastricht, Limburg, Netherlands, 6229 HX
    - Maastricht Umc+
- North Holland
  - Amsterdam, North Holland, Netherlands, 1091AC
    - Onze Lieve Vrouwe Gasthuis (OLVG)
- South Holland
  - Dordrecht, South Holland, Netherlands, 3318 AT
    - Albert Schweitzer Ziekenhuis, Locatie Dordwijk
  - The Hague, South Holland, Netherlands, 2545 AA
    - Haga Ziekenhuis locatie Leyweg
New Zealand
- - Auckland, New Zealand, 1023
    - Auckland City Hospital
- Waikato Region
  - Hamilton, Waikato Region, New Zealand, 3240
    - Waikato Hospital
- Wanganui
  - Palmerston North, Wanganui, New Zealand, 4414
    - Palmerston North Hospital
Poland
- Greater Poland Voivodeship
  - Konin, Greater Poland Voivodeship, Poland, 62-500
    - Przychodnia Lekarska "Komed"
  - Poznan, Greater Poland Voivodeship, Poland, 61-866
    - Wielkopolskie Centrum Onkologii
- Lower Silesian Voivodeship
  - Wroclaw, Lower Silesian Voivodeship, Poland, 53-413
    - Dolnośląskie Centrum Onkologii we Wrocławiu
- Lublin Voivodeship
  - Lublin, Lublin Voivodeship, Poland, 20-081
    - Centrum Onkologii Ziemii Lubelskiej
- Masovian Voivodeship
  - Warsaw, Masovian Voivodeship, Poland, 02-781
    - Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy w Warszawie
  - Warsaw, Masovian Voivodeship, Poland, 07-100
    - Luxmed Onkologia sp. z o. o.
- Opole Voivodeship
  - Opole, Opole Voivodeship, Poland, 45-061
    - Opolskie Centrum Onkologii w Opolu im. prof. Tadeusza Koszarowskiego
- Pomeranian Voivodeship
  - Gdansk, Pomeranian Voivodeship, Poland, 80-214
    - Uniwersyteckie Centrum Kliniczne
  - Gdynia, Pomeranian Voivodeship, Poland, 81-519
    - Szpitale Pomorskie Sp. z o. o.
- Warmian-Masurian Voivodeship
  - Olsztyn, Warmian-Masurian Voivodeship, Poland, 82-300
    - Olsztyński Ośrodek Onkologiczny Kopernik
- Łódź Voivodeship
  - Lodz, Łódź Voivodeship, Poland, 90338
    - Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
Portugal
- - Coimbra, Portugal, 3000-075
    - Instituto Portugês de Oncologia de Coimbra Francisco Gentil
  - Lisbon, Portugal, 1400-038
    - Champalimaud Foundation
  - Lisbon, Portugal, 1649-028
    - Centro Hospitalar Lisboa Norte, E.P.E. - Hospital de Santa Maria
  - Porto, Portugal, 4099-001
    - Centro Hospitalar do Porto - Hospital de Santo António
  - Porto, Portugal, 4200-072
    - IPOFG - Porto
Puerto Rico
- PR
  - Bayamón, PR, Puerto Rico, 00961
    - Puerto Rico Hematology/Oncology Group
  - San Juan, PR, Puerto Rico, 00935
    - UPR Comprehensive Cancer Center
Romania
- - Bucharest, Romania, 11171
    - Spitalul Clinic Filantropia
- Bucharest
  - Bucharest, Bucharest, Romania, 22328
    - Institutul Oncologic
- Cluj
  - Cluj-Napoca, Cluj, Romania, 400015
    - Institutul Oncologic
- Constanța County
  - Ovidiu, Constanța County, Romania, 905900
    - Ovidius Clinical Hospital OCH
- Dolj
  - Craiova, Dolj, Romania, 200542
    - Centrul de Oncologie "Sfântul Nectarie"
- Ilfov
  - Otopeni, Ilfov, Romania, 75100
    - Radiology Therapeutic Center
- Maramureş
  - Baia Mare, Maramureş, Romania, 430291
    - Oncopremium Team
Russia
- - Moscow, Russia, 115478
    - Blokhin Cancer Research Center
- Chelyabinsk Oblast
  - Chelyabinsk, Chelyabinsk Oblast, Russia, 454087
    - Chelyabinsk Regional Oncology Dispensary
- Kalužskaja Oblast'
  - Kaluga, Kalužskaja Oblast', Russia, 248007
    - Kaluga Regional Clinical Oncology Center
- Kursk Oblast
  - Kursk, Kursk Oblast, Russia, 305524
    - Kursk Regional Oncology Dispensary
- Moscow
  - Moscow, Moscow, Russia, 115478
    - Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
  - Moscow, Moscow, Russia, 117198
    - Burdenko Main Military Hospital
- Orenburg Oblast
  - Orenburg, Orenburg Oblast, Russia, 460021
    - Orenburg Regional Clinical Oncology Dispensary
- Samara Oblast
  - Samara, Samara Oblast, Russia, 443031
    - Samara Regional Clinical Oncology Center
- Sankt-Peterburg
  - Saint Petersburg, Sankt-Peterburg, Russia, 197758
    - Saint-Petersburg Scientific-Practical Center of Specialized Kinds of Medical Care (oncological) named afte -T
  - Saint Petersburg, Sankt-Peterburg, Russia, 197758
    - N.N.Petrov Research Institute of Oncology
  - Saint Petersburg, Sankt-Peterburg, Russia, 188663
    - Leningrad Regional Oncology Dispensary
  - Saint Petersburg, Sankt-Peterburg, Russia, 191015
    - North-Western State Medical University named after I.I.Mechnikov
  - Saint Petersburg, Sankt-Peterburg, Russia, 197022
    - St. Petersburg City Oncological Dispensary - Berezovaya Avenue
- Tatarstan Republic
  - Kazan', Tatarstan Republic, Russia, 420029
    - Republican Clinical Oncology Dispensary
- Volgograd Oblast
  - Volzhsky, Volgograd Oblast, Russia, 404130
    - Volgograd Regional Oncological Dispensary No. 3
- Yaroslavl Oblast
  - Yaroslavl, Yaroslavl Oblast, Russia, 150054
    - Yaroslavl Regional Cancer Hospital
Saudi Arabia
- - Riyadh, Saudi Arabia, 11211
    - King Faisal Specialist Hospital & Research Center
- Eastern Province
  - Dammam, Eastern Province, Saudi Arabia, 31444
    - King Fahad Specialist Hospital-Dammam
- Riyadh Region
  - Riyadh, Riyadh Region, Saudi Arabia, 11426
    - King Abdulaziz Medical City - National Guard Hospital
  - Riyadh, Riyadh Region, Saudi Arabia, 11525
    - King Fahad Medical City
Singapore
- - Singapore, Singapore, 119074
    - National University Hospital
- Central Singapore
  - Singapore, Central Singapore, Singapore, 168583
    - National Cancer Center
South Africa
- Eastern Cape
  - Port Elizabeth, Eastern Cape, South Africa, 6055
    - Cancercare Langenhoven Drive Oncology Centre
- Gauteng
  - Pretoria, Gauteng, South Africa, 181
    - Life Groenkloof
  - Pretoria, Gauteng, South Africa, 81
    - Eastleigh Breast Care Center
  - Sandton, Gauteng, South Africa, 2196
    - Sandton Oncology Medical Group (Pty) Ltd
- Western Cape
  - Cape Town, Western Cape, South Africa, 7700
    - Cancercare Rondebosch Oncology
  - George, Western Cape, South Africa, 7764
    - GVI Oncology
South Korea
- Chungcheongbuk-do [Chungbuk]
  - Cheongju-si, Chungcheongbuk-do [Chungbuk], South Korea, 28644
    - Chungbuk National University Hospital
- Chungcheongnam-do [Chungnam]
  - Cheonan-si, Chungcheongnam-do [Chungnam], South Korea, 31151
    - Soon Chun Hyang University Cheonan Hospital
- Incheon-gwangyeoksi [Incheon]
  - Incheon, Incheon-gwangyeoksi [Incheon], South Korea, 22332
    - Inha University Hospital
  - Namdong-gu, Incheon-gwangyeoksi [Incheon], South Korea, 21565
    - Gachon University Gil Medical Center
- Kyǒnggi-do
  - Goyang-si, Kyǒnggi-do, South Korea, 10408
    - National Cancer Center
  - Seongnam, Kyǒnggi-do, South Korea, 13620
    - Seoul National University Bundang Hospital
- Pusan-Kwangyǒkshi
  - Busan, Pusan-Kwangyǒkshi, South Korea, 46033
    - Dongnam Institute of Radiological and Medical Sciences
  - Haeundae-gu, Pusan-Kwangyǒkshi, South Korea, 48108
    - Inje University Haeundae Paik Hospital
- Seoul-teukbyeolsi [Seoul]
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3080
    - Seoul National University Hospital
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 5505
    - Asan Medical Center
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 6351
    - Samsung Medical Center
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 8308
    - Korea University Guro Hospital
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 2841
    - Korea University Anam Hospital
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea, 3722
    - Severance Hospital Yonsei University Health System
  - Seoul, Seoul-teukbyeolsi [Seoul], South Korea
    - Ewha Womans University Mokdong Hospital
- Taegu-Kwangyǒkshi
  - Daegu, Taegu-Kwangyǒkshi, South Korea, 41404
    - Kyungpook National University Chilgok Hospital
Spain
- - Barcelona, Spain, 8035
    - Hospital Universitari Vall d'Hebron
  - Barcelona, Spain, 8003
    - Parc de Salut Mar - Hospital del Mar
  - Granada, Spain, 18016
    - Hospital Universitario San Cecilio
  - Jaén, Spain, 23007
    - Complejo Hospitalario de Jaén
  - Madrid, Spain, 28040
    - Hospital Clinico San Carlos
  - Madrid, Spain, 28006
    - Hospital La Princesa
  - Madrid, Spain, 28009
    - Hospital General Universitario Gregorio Marañon
  - Madrid, Spain, 28050
    - Hospital Universitario Hm Sanchinarro
  - Salamanca, Spain, 37007
    - Hospital Universitario de Salamanca - Complejo Asistencial Universitario de Salamanca
  - Seville, Spain, 41013
    - Hospital Universitario Virgen del Rocio
  - Seville, Spain, 41009
    - Hospital Universitario Virgen Macarena
  - Seville, Spain, 41014
    - Hospital Universitario Virgen de Valme
  - Valencia, Spain, 46010
    - Hospital Quirón Salud Valencia
  - Zaragoza, Spain, 50009
    - Hospital Universitario Miguel Servet
- Andalusia
  - Córdoba, Andalusia, Spain, 14004
    - Hospital Universitario Reina Sofía
- Barcelona [Barcelona]
  - Barcelona, Barcelona [Barcelona], Spain, 8023
    - Hospital Quiron Barcelona
- Catalunya [Cataluña]
  - Barcelona, Catalunya [Cataluña], Spain, 08908
    - Hospital Clinic de Barcelona
  - Barcelona, Catalunya [Cataluña], Spain, 8041
    - Hospital de La Santa Creu I Sant Pau
- La Coruna
  - Santiago de Compostela, La Coruna, Spain, 15706
    - CHUS - Hospital Clinico Universitario
- Lleida [Lérida]
  - Lleida, Lleida [Lérida], Spain, 25198
    - Hospital Universitario Arnau de Vilanova de Lleida
- Madrid
  - Pozuelo de Alarcón, Madrid, Spain, 28223
    - Hospital Universitario Quironsalud Madrid
- Madrid, Comunidad de
  - Alcorcón, Madrid, Comunidad de, Spain, 28922
    - Hospital Universitario Fundacion Alcorcon
  - Madrid, Madrid, Comunidad de, Spain, 28034
    - Hospital Universitario Ramon Y Cajal
  - Madrid, Madrid, Comunidad de, Spain, 28041
    - Hospital Universitario 12 de Octubre
- Málaga
  - Málaga, Málaga, Spain, 29010
    - Hospital Universitario Virgen de la Victoria
- Principality of Asturias
  - Oviedo, Principality of Asturias, Spain, 33011
    - Hospital Universitario Central de Asturias
- Santa Cruz De Tenerife
  - San Cristóbal de La Laguna, Santa Cruz De Tenerife, Spain, 38320
    - Hospital Universitario de Canarias
- Valenciana, Comunitat
  - Valencia, Valenciana, Comunitat, Spain, 46010
    - Hospital Clinico de Valencia
Sweden
- - Vaxjo, Sweden, 35234
    - Växjö Centrallasarettet
- Skåne Län [se-12]
  - Malmo, Skåne Län [se-12], Sweden, 205 02
    - Skanes Universitetssjukhus Lund
- Västerbottens Län [se-24]
  - Umeå, Västerbottens Län [se-24], Sweden, 90185
    - Norrlands universitetssjukhus
- Västernorrlands Län [se-22]
  - Sundsvall, Västernorrlands Län [se-22], Sweden, 856 43
    - Sundsvalls sjukhus
- Västmanlands Län [se-19]
  - Västerås, Västmanlands Län [se-19], Sweden, 721 89
    - Västmanlands sjukhus Västerås
Taiwan
- - Changhua, Taiwan, 50006
    - Changhua Christian Hospital
  - Kaohsiung City, Taiwan, 80756
    - Kaohsiung Medical University Chung-Ho Memorial Hospital
  - New Taipei City, Taiwan, 235
    - Taipei Medical University Hospital
  - Taichung, Taiwan, 40447
    - China Medical University Hospital
  - Taipei, Taiwan, 10002
    - National Taiwan University Hospital
  - Taipei, Taiwan, 11217
    - Taipei Veterans General Hospital
  - Taipei, Taiwan, 10449
    - Mackay Memorial Hospital
  - Taipei, Taiwan, 112
    - Koo Foundation Sun Yat-Sen Cancer Center
  - Taoyuan, Taiwan, 333
    - Chang Gung Medical Foundation-Linkou Branch
- Kaohsiung
  - Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
    - Chang Gung Memorial Hospital - Kaohsiung
- Taipei
  - Taipei City, Taipei, Taiwan, 114
    - Tri-Service General Hospital
Turkey (Türkiye)
- - Adana, Turkey (Türkiye), 01250
    - Baskent University Dr. Turgut Noyan Research and Training Center
  - Ankara, Turkey (Türkiye), 6230
    - Hacettepe Universitesi
  - Ankara, Turkey (Türkiye), 06100
    - Ankara Universitesi Tip Fakultesi Hastanesi
  - Antalya, Turkey (Türkiye), 7070
    - Akdeniz Universitesi Hastanesi
  - Edirne, Turkey (Türkiye), 22030
    - Trakya University Faculty of Medicine
  - Istanbul, Turkey (Türkiye), 34090
    - TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
  - Kocaeli, Turkey (Türkiye), 41380
    - Kocaeli Üniversitesi
  - Malatya, Turkey (Türkiye), 44280
    - İnönü Üniversitesi Turgut Özal Tıp Merkezi
- Istanbul
  - Istanbul- Fatih, Istanbul, Turkey (Türkiye), 34098
    - Istanbul Universitesi Cerrahpasa
  - Üsküdar/stanbul, Istanbul, Turkey (Türkiye), 34662
    - Acibadem Altunizade Hospital
- Kecioren
  - Ankara, Kecioren, Turkey (Türkiye), 6010
    - Ankara Gülhane Eitim ve Aratrma Hastanesi
- Turkey
  - Ankara, Turkey, Turkey (Türkiye), 6200
    - Abdurrahman Yurtaslan Ankara Oncology, education and Research Hospital
- İzmir
  - Bornova, İzmir, Turkey (Türkiye), 35100
    - Ege University Medicine of Faculty
  - Izmir, Karsiyaka, İzmir, Turkey (Türkiye), 9035575
    - Izmir Medical Park Hospital
Ukraine
- Dnipropetrovsk Oblast
  - Dnipro, Dnipropetrovsk Oblast, Ukraine, 49102
    - Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
  - Kryvyi Rih, Dnipropetrovsk Oblast, Ukraine, 50048
    - Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council
- Odesa Oblast
  - Odesa, Odesa Oblast, Ukraine, 65025
    - Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
- Poltava Oblast
  - Poltava, Poltava Oblast, Ukraine, 36011
    - Poltava Regional Clinical Oncology Center
- Vinnytsia Oblast
  - Vinnytsia, Vinnytsia Oblast, Ukraine, 21029
    - Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
- Volyn Oblast
  - Lutsk, Volyn Oblast, Ukraine, 43018
    - Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
- Zakarpattia Oblast
  - Uzhhorod, Zakarpattia Oblast, Ukraine, 88000
    - Uzhgorod Central City Clinical Hospital
United Kingdom
- - Bradford, United Kingdom, BD20 6TD
    - Airedale General Hospital
  - Manchester, United Kingdom, M20 4BX
    - The Christie
- England
  - Truro, England, United Kingdom, TR1 3LJ
    - The Royal Cornwall Hospital
- Essex
  - Chelmsford, Essex, United Kingdom, CM1 7ET
    - Mid Essex Hospital Services NHS Trust
- Greater London
  - London, Greater London, United Kingdom, N18 1QX
    - North Middlesex Hospital
- Hammersmith and Fulham
  - London, Hammersmith and Fulham, United Kingdom, W6 8RF
    - Charing Cross Hospital
- Hertfordshire
  - Northwood, Hertfordshire, United Kingdom, HA6 2RN
    - Mount Vernon Hospital
- Lancashire
  - Blackpool, Lancashire, United Kingdom, FY3 8NR
    - Victoria Hospital
  - Preston, Lancashire, United Kingdom, PR2 9HT
    - Royal Preston Hospital
- Lincolnshire
  - Boston, Lincolnshire, United Kingdom, PE21 9QS
    - Boston Pilgrim Hospital
- London, City of
  - London, London, City of, United Kingdom, NW1 2PG
    - Sarah Canon Research Institute UK
  - London, London, City of, United Kingdom, SE1 9RT
    - Guy's & St Thomas' NHS Foundation Trust
- Middlesbrough
  - Central Middlesbrough, Middlesbrough, United Kingdom, TS4 3BW
    - James Cook University Hospital
- Midlothian
  - Edinburgh, Midlothian, United Kingdom, EH4 2XU
    - Western General Hospital
- Nottinghamshire
  - Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
    - Nottingham City Hospital
- Oxfordshire
  - Oxford, Oxfordshire, United Kingdom, OX3 7LE
    - The Churchill Hospital
- Somerset
  - Taunton, Somerset, United Kingdom, TA1 5DA
    - Musgrove Park Hospital
- Surrey
  - Guildford, Surrey, United Kingdom, GU2 7XX
    - Royal Surrey County Hospital
- Sutton
  - London, Sutton, United Kingdom, SM2 5PT
    - Royal Marsden Hospital
United States
- Alabama
  - Birmingham, Alabama, United States, 32594
    - University of Alabama Birmingham
- Alaska
  - Anchorage, Alaska, United States, 99508
    - Providence Alaska Medical Center
- Arizona
  - Gilbert, Arizona, United States, 85234
    - Banner MD Anderson Cancer Center
  - Goodyear, Arizona, United States, 85395
    - Arizona Oncology Associates, P.C. - HOPE
  - Phoenix, Arizona, United States, 85054
    - Mayo Clinic Hospital
  - Phoenix, Arizona, United States, 85013
    - St. Joseph's Hospital and Medical Center
  - Tucson, Arizona, United States, 85719
    - The University of Arizona Cancer Center
  - Yuma, Arizona, United States, 85364
    - Yuma Regional Cancer Center
- Arkansas
  - Jonesboro, Arkansas, United States, 72401
    - St. Bernards Medical Center
  - Springdale, Arkansas, United States, 72762
    - Highlands Oncology Group
- California
  - Beverly Hills, California, United States, 90211
    - Beverly Hills Cancer Center
  - Burbank, California, United States, 91505
    - Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center
  - Duarte, California, United States, 91010-0269
    - City of Hope National Medical Center
  - Fresno, California, United States, 93720
    - California Cancer Associates Research and Excellence
  - Harbor City, California, United States, 92505
    - Kaiser Permanente
  - Loma Linda, California, United States, 92354
    - Loma Linda University School of Medicine
  - Los Angeles, California, United States, 90048
    - Cedars-Sinai Medical Center
  - Monterey, California, United States, 93940
    - Pacific Cancer Care
  - Orange, California, United States, 92868
    - St. Joseph Hospital
  - Sacramento, California, United States, 95817
    - University of California Davis (UC Davis) Comprehensive Cancer Center
  - San Francisco, California, United States, 94158
    - UCSF Medical Center at Mission Bay
  - San Marcos, California, United States, 92069
    - California Cancer Associates in Research and Excellence
  - Santa Cruz, California, United States, 95065
    - Dignity Health Dominican Oncology and Hematology
  - Vallejo, California, United States, 94589
    - Kaiser Permanente
- Colorado
  - Boulder, Colorado, United States, 80303
    - USO-Rocky Mountain Cancer Center
  - Thornton, Colorado, United States, 80260
    - USO-Rocky Mountain Cancer Center
- Connecticut
  - New Haven, Connecticut, United States, 06510
    - Yale-New Haven Hospital
- Florida
  - Fort Myers, Florida, United States, 37203
    - Florida Cancer Specialists - South
  - Gainesville, Florida, United States, 32610
    - University of Florida College of Medicine
  - Hollywood, Florida, United States, 33024
    - Millennium Oncology - Hollywood
  - Jacksonville, Florida, United States, 32256
    - Cancer Specialists of North Florida
  - Jacksonville, Florida, United States, 32224
    - Mayo Clinic in Florida
  - Lecanto, Florida, United States, 34461
    - Florida Cancer Specialists - North
  - Ocala, Florida, United States, 34474
    - Ocala Oncology, P.A.
  - Tallahassee, Florida, United States, 32308
    - Tallahassee Memorial Cancer Center
  - Tampa, Florida, United States, 33612
    - Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center
- Georgia
  - Athens, Georgia, United States, 30607
    - University Cancer & Blood Center, LLC
  - Atlanta, Georgia, United States, 30342
    - Northside Hospital
  - Marietta, Georgia, United States, 30060
    - Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital
  - Savannah, Georgia, United States, 31405
    - Summit Cancer Care DBA Candler Medical Oncology Practice
- Hawaii
  - Honolulu, Hawaii, United States, 96813
    - University of Hawaii Cancer Center
- Illinois
  - Chicago, Illinois, United States, 60612
    - Rush University Medical Center
  - Chicago, Illinois, United States, 60612
    - John H. Stroger Hospital of Cook County
  - Naperville, Illinois, United States, 60540
    - Edward Cancer Center
  - Quincy, Illinois, United States, 62301
    - Quincy Medical Group
- Indiana
  - Indianapolis, Indiana, United States, 46237
    - Franciscan St. Francis Health
  - Kokomo, Indiana, United States, 46902
    - Community Howard Oncology Center
- Kansas
  - Wichita, Kansas, United States, 67214
    - Cancer Center of Kansas
- Kentucky
  - Louisville, Kentucky, United States, 40202
    - Univ of Louisville School of Medicine
- Louisiana
  - Baton Rouge, Louisiana, United States, 70817
    - Mary Bird Perkins Cancer Center - Baton Rouge
  - Houma, Louisiana, United States, 70360
    - Terrebonne General Medical Center
- Maine
  - Brewer, Maine, United States, 04412
    - Cancer Care of Maine
  - Kennebunk, Maine, United States, 04043
    - New England Cancer Specialists - Kennebunk
  - Lewiston, Maine, United States, 04240
    - Central Maine Medical Center
- Maryland
  - Hagerstown, Maryland, United States, 21742
    - Meritus John Marsh Cancer Center
- Massachusetts
  - Boston, Massachusetts, United States, 02215
    - Dana-Farber Cancer Institute
  - Worcester, Massachusetts, United States, 01606
    - Reliant Medical Group, Inc.
- Minnesota
  - Rochester, Minnesota, United States, 55905
    - Mayo Clinic in Rochester, Minnesota
- Mississippi
  - Jackson, Mississippi, United States, 39202
    - Jackson Oncology Associates PLLC
- Missouri
  - Kansas City, Missouri, United States, 37203
    - HCA Midwest Kansas City, MidAmerica Division, Inc.
- Nebraska
  - Omaha, Nebraska, United States, 68114
    - Nebraska Methodist Hospital
  - Omaha, Nebraska, United States, 68106
    - Cancer Alliance of Nebraska
  - Omaha, Nebraska, United States, 68130
    - Tennessee Cancer Specialists
- Nevada
  - Reno, Nevada, United States, 89502
    - Renown Regional Medical Center
- New Hampshire
  - Lebanon, New Hampshire, United States, 03756
    - Dartmouth Hitchcock Medical Center
- New Jersey
  - Basking Ridge, New Jersey, United States, 07920
    - Memorial Sloan Kettering - Basking Ridge
  - Florham Park, New Jersey, United States, 07932
    - Summit Medical Group Cancer Center
  - Newark, New Jersey, United States, 07112
    - Newark Beth Israel Medical Center
  - Paramus, New Jersey, United States, 07652
    - The Valley Hospital, Inc.
  - Toms River, New Jersey, United States, 08755
    - Community Medical Center
- New York
  - Binghamton, New York, United States, 13905
    - Broome Oncology
  - New York, New York, United States, 10065
    - Weill Cornell Medical College
  - Poughkeepsie, New York, United States, 12601
    - Vassar Brothers Medical Center
  - Stony Brook, New York, United States, 11794
    - SUNY at Stony Brook
  - White Plains, New York, United States, 10601
    - White Plains Hospital
- North Carolina
  - Cary, North Carolina, United States, 27518
    - WakeMed Cancer Care - Waverly Hematology & Medical Oncology
  - Hendersonville, North Carolina, United States, 28739
    - Margaret R. Pardee Memorial Hospital
  - Winston-Salem, North Carolina, United States, 27157
    - Wake Forest University Health Sciences
- Ohio
  - Canton, Ohio, United States, 44710
    - Aultman Hospital
  - Cleveland, Ohio, United States, 44195
    - Cleveland Clinic Foundation
  - Cleveland, Ohio, United States, 44106
    - University Hospitals Cleveland Medical Center
  - Columbus, Ohio, United States, 43215
    - Columbus Community Clinical Oncology Program
- Oregon
  - Medford, Oregon, United States, 97504
    - Asante Rogue Regional Medical Center
  - Portland, Oregon, United States, 97239
    - Oregon Health and Science University
- Pennsylvania
  - Abington, Pennsylvania, United States, 19001
    - Abington Medical Specialists
  - Bethlehem, Pennsylvania, United States, 18015
    - St. Luke's Hospital & Health Network
  - Philadelphia, Pennsylvania, United States, 19141
    - Albert Einstein Healthcare Network
  - Pittsburgh, Pennsylvania, United States, 15212
    - AHN Allegheny General Hospital
  - Pittsburgh, Pennsylvania, United States, 15213
    - Univ of Pittsburgh Cancer Inst. (UPCI)
  - Pittsburgh, Pennsylvania, United States, 15213
    - NSABP Foundation
  - Pittsburgh, Pennsylvania, United States, 15213
    - PinnacleHealth Cancer Institute
  - York, Pennsylvania, United States, 17403
    - WellSpan Health/York Cancer Center Oncology Research
- South Carolina
  - Florence, South Carolina, United States, 29502
    - McLeod Regional Medical Center
  - Greenville, South Carolina, United States, 29607
    - St Francis Cancer Center
  - Spartanburg, South Carolina, United States, 29303
    - Spartanburg Regional Medical Center
- South Dakota
  - Sioux Falls, South Dakota, United States, 57105
    - Sanford USD Medical Center
- Tennessee
  - Chattanooga, Tennessee, United States, 37403
    - Erlanger Health System
  - Chattanooga, Tennessee, United States, 37404
    - Chattanooga Research and Medicine
  - Germantown, Tennessee, United States, 38138
    - The West Clinic, PLLC dba West Cancer Center
  - Kingsport, Tennessee, United States, 37660
    - Urology Associates of Kingsport
  - Knoxville, Tennessee, United States, 37920
    - University of Tennessee Medical Center
  - Knoxville, Tennessee, United States, 37909
    - Tennessee Cancer Specialists
  - Memphis, Tennessee, United States, 38120
    - Baptist Cancer Center
  - Nashville, Tennessee, United States, 37203
    - Sarah Cannon Cancer Center
  - Nashville, Tennessee, United States, 37203
    - Tennessee Oncology Nashville
  - Nashville, Tennessee, United States, 37203
    - Florida Cancer Specialists
- Texas
  - Austin, Texas, United States, 78731
    - Texas Oncology Cancer Care and Research Center
  - Dallas, Texas, United States, 75246
    - Texas Oncology-Baylor Charles A. Sammons Cancer Center
  - Dallas, Texas, United States, 75390
    - University Of Texas Southwestern Medical Center At Dallas
  - Fort Worth, Texas, United States, 76104
    - Texas Oncology Fort Worth
  - Houston, Texas, United States, 77030
    - Oncology Consultants, P.A.
  - Lewisville, Texas, United States, 75056
    - Texas Oncology P.A.
  - San Antonio, Texas, United States, 78229
    - University of Texas Health Science Center - San Antonio
  - The Woodlands, Texas, United States, 77380
    - US Oncology
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - The Woodlands
  - The Woodlands, Texas, United States, 77380
    - Northwest Cancer Specialists PC
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology Cancer Care and Research Center
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology Fort Worth
  - The Woodlands, Texas, United States, 77380
    - Arizona Oncology Associates, P.C. - HOPE
  - The Woodlands, Texas, United States, 77380
    - Comprehensive Cancer Centers of Nevada
  - The Woodlands, Texas, United States, 77380
    - Illinois Cancer Specialists
  - The Woodlands, Texas, United States, 77380
    - Miami Cancer Institute at Baptist Health, Inc.
  - The Woodlands, Texas, United States, 77380
    - Minnesota Oncology/Hematology PA
  - The Woodlands, Texas, United States, 77380
    - Oncology and Hematology Associates of Southwest Virginia Inc
  - The Woodlands, Texas, United States, 77380
    - Oncology Hematology Care Inc
  - The Woodlands, Texas, United States, 77380
    - Oncology Hematology West
  - The Woodlands, Texas, United States, 77380
    - Sansum Clinic
  - The Woodlands, Texas, United States, 77380
    - Shenandoah Oncology, P.C.
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - Dallas Presbyterian Hospital
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - Denison
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - McAllen
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - McKinney
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - Medical City Dallas
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - Methodist Dallas Cancer Center
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - Paris
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - San Antonio Medical Center
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - Tyler
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology - West Texas
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology Denton
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology P.A.
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology- Mesquite
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology-Arlington South
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology-Baylor Charles A. Sammons Cancer Center
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology-Deke Slayton Cancer Center
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology-Plano East
  - The Woodlands, Texas, United States, 77380
    - Texas Oncology-Plano West
  - The Woodlands, Texas, United States, 77380
    - USO - Texas Oncology, P. A.
  - The Woodlands, Texas, United States, 77380
    - USO-Maryland Oncology Hematology, P.A.
  - The Woodlands, Texas, United States, 77380
    - USO-New York Oncology Hematology, P.C
  - The Woodlands, Texas, United States, 77380
    - USO-Rocky Mountain Cancer Center
  - The Woodlands, Texas, United States, 77380
    - USO-Southern Cancer Center, P.C.
  - The Woodlands, Texas, United States, 77380
    - USO-Virginia Oncology Associates
  - The Woodlands, Texas, United States, 77380
    - Virginia Cancer Specialists
  - The Woodlands, Texas, United States, 77380
    - Willamette Valley Cancer Institute & Research Ctr.
  - Tyler, Texas, United States, 75702
    - Texas Oncology - Tyler
  - Tyler, Texas, United States, 75702
    - Texas Oncology - Paris
- Utah
  - Salt Lake City, Utah, United States, 84106
    - Utah Cancer Specialists
- Vermont
  - Burlington, Vermont, United States, 05401
    - The University of Vermont Medical Center Inc.
- Virginia
  - Fredericksburg, Virginia, United States, 22408
    - Hematology Oncology Associates of Fredericksburg Inc.
  - Richmond, Virginia, United States, 23219
    - Virginia Commonwealth University (VCU) Medical Center
- Washington
  - Auburn, Washington, United States, 98001
    - MultiCare Regional Cancer Center - Auburn
  - Seattle, Washington, United States, 98104
    - Swedish Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Abemaciclib Administered orally. Other Names: LY2835219 Drug: Standard Adjuvant Endocrine Therapy Administered according to label instructions.
Other: Endocrine Therapy Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.	Drug: Standard Adjuvant Endocrine Therapy Administered according to label instructions.

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

Drug: Abemaciclib

Administered orally.

Other Names:

LY2835219

Drug: Standard Adjuvant Endocrine Therapy

Administered according to label instructions.

Other: Endocrine Therapy

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

Drug: Standard Adjuvant Endocrine Therapy

Administered according to label instructions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Invasive Disease Free Survival (IDFS) Time Frame: Baseline to Recurrence or Death from Any Cause (Up to 32 Months)	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.	Baseline to Recurrence or Death from Any Cause (Up to 32 Months)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
IDFS for Participants With Ki-67 Index ≥20% Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)	Outcome data will be provided after the study is completed.	Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)
Distant Relapse-Free Survival (DRFS) Time Frame: Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)	Distant relapse-free survival is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.	Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)
Overall Survival (OS) Time Frame: Baseline to Death from Any Cause (Approximately 10 Years)	Outcome data will be provided after the study is completed.	Baseline to Death from Any Cause (Approximately 10 Years)
Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib Time Frame: Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose	Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib	Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose
Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B) Time Frame: Baseline, Follow Up (Approximately 3 Years)	Outcome data will be provided after the study is completed.	Baseline, Follow Up (Approximately 3 Years)
Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) Time Frame: Baseline, Follow Up (Approximately 3 Years)]	Outcome data will be provided after the study is completed.	Baseline, Follow Up (Approximately 3 Years)]
Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Time Frame: Baseline, Follow Up (Approximately 3 Years)]	Outcome data will be provided after the study is completed.	Baseline, Follow Up (Approximately 3 Years)]
Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) Time Frame: Baseline, Follow Up (Approximately 3 Years)]	Outcome data will be provided after the study is completed.	Baseline, Follow Up (Approximately 3 Years)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Eli Lilly and Company

Collaborators

NSABP Foundation Inc

Investigators

Study Director: 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), Eli Lilly and Company

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

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)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 12, 2017

Primary Completion (Actual)

March 16, 2020

Study Completion (Estimated)

May 1, 2029

Study Registration Dates

First Submitted

May 15, 2017

First Submitted That Met QC Criteria

May 15, 2017

First Posted (Actual)

May 16, 2017

Study Record Updates

Last Update Posted (Actual)

April 24, 2026

Last Update Submitted That Met QC Criteria

April 7, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

16338
I3Y-MC-JPCF (Other Identifier: Eli Lilly and Company)
2016-004362-26 (EudraCT Number)
NSABP B-58 (Other Identifier: NSABP)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing Time Frame

Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.

IPD Sharing Access Criteria

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

IPD Sharing Supporting Information Type

STUDY_PROTOCOL
SAP
CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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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

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Expanded Access

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Secondary Outcome Measures

Outcome Measure

Measure Description

Time Frame

Collaborators and Investigators

Sponsor

Collaborators

Investigators

Publications and helpful links

General Publications

Helpful Links

Study record dates

Study Major Dates

Study Start (Actual)

Primary Completion (Actual)

Study Completion (Estimated)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Actual)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

IPD Plan Description

IPD Sharing Time Frame

IPD Sharing Access Criteria

IPD Sharing Supporting Information Type

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Studies a U.S. FDA-regulated device product

Clinical Trials on Breast Cancer

Clinical Trials on Abemaciclib

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Japan

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators