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

March 16, 2024 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

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

5637

Phase

  • Phase 3

Expanded Access

Available outside the clinical trial. 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, C1012AAR
        • Instituto de Investigaciones Metabólicas
      • Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
        • Clinica Adventista de Belgrano
      • Ciudad Autónoma de Buenos Aires, Argentina, 1426
        • Alexander Fleming
      • La Rioja, Argentina, F5300COE
        • Fundacion CORI para la Investigacion y Prevencion del Cancer
      • Salta, Argentina, 4400
        • Consultorio Dr. Miguel Angel Escudero
      • San Juan, Argentina, 5400
        • CER San Juan
      • Tucuman, Argentina, 4000
        • Centro Medico 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
    • Ciudad Autonoma Buenos Aires
      • Caba, Ciudad Autonoma Buenos Aires, Argentina, 1125
        • Fundación Cenit Para La Investigación En Neurociencias
    • Ciudad Autónoma De Buenos Aires
      • Buenos Aires, Ciudad Autónoma De Buenos Aires, Argentina, C1118AAT
        • Hospital Aleman
    • Rio Negro
      • Viedma, Rio Negro, Argentina, R8500ACE
        • Clinica Viedma
    • Santa Fe
      • Rosario, Santa Fe, Argentina, S2000KZE
        • Instituto de Oncología de Rosario
    • Tucumán
      • San Miguel de Tucuman, Tucumán, Argentina, 4000
        • Centro Para la Atención Integral del Paciente Oncologico (CAIPO)
  • Australia
      • Nedlands, Australia, 6009
        • Breast Cancer Research Centre WA
    • 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
      • Newcastle, New South Wales, Australia, 2298
        • Calvary Mater Newcastle
      • Sydney, New South Wales, Australia, 2060
        • Mater Hospital Sydney
      • 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 Research Institute
      • Melbourne, Victoria, Australia, 3135
        • Maroondah Hospital
      • Melbourne, Victoria, Australia, 3050
        • Peter Maccallum Cancer Centre
    • Western Australia
      • Subiaco, Western Australia, Australia, 6008
        • St John of God Hospital - Subiaco
  • Austria
      • Salzburg, Austria, 5020
        • Universitätsklinikum Salzburg
    • Steiermark
      • Graz, Steiermark, Austria, 8036
        • Medizinische Universität Graz
    • Tirol
      • Innsbruck, Tirol, Austria, 6020
        • Medizinische Universitaet Innsbruck
      • Schwaz, Tirol, Austria, 6130
        • Private Practice - Dr. Hubalek
    • Wien
      • Vienna, Wien, Austria, 1090
        • Medizinische Universität Wien
      • Vienna, Wien, Austria, 1130
        • Klinik Hietzing
  • Belgium
      • Liege, Belgium, 4000
        • Clinique St Joseph
      • Namur, Belgium, 5000
        • CHU UCL Namur/Site Sainte Elisabeth
      • Yvoir, Belgium, 5000
        • CHU Dinant Godinne - UCL Namur
    • 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
      • Liege, Liège, Belgium, 4000
        • Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman
    • Luxembourg
      • Libramont, Luxembourg, Belgium, 6800
        • Centre Hospitalier D'Ardenne - Forget
    • Oost-Vlaanderen
      • Sint-Niklaas, Oost-Vlaanderen, Belgium, B-9100
        • AZ Nikolaas, Campus Moerland
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgium, 3000
        • UZ Leuven
    • Wallonne, Région
      • La Louvière, Wallonne, Région, Belgium, 7100
        • Groupe Jolimont
      • Ottignies, Wallonne, Région, Belgium, 1340
        • Clinique Saint Pierre Ottignies
    • West-Vlaanderen
      • Brugge, 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
      • Sao Paulo, Brazil, 04543-000
        • Icesp - Instituto Do Câncer Do Estado de São Paulo
      • São Paulo, Brazil, 01308-050
        • Hospital Sírio Libanês
      • São Paulo, Brazil, 04014-002
        • Núcleo de Pesquisa Clínica da Rede São Camilo
      • São Paulo, Brazil, 01317-000
        • Hospital Perola Byington
      • São Paulo, Brazil, 04038-034
        • Instituto de Assistência Médica ao Servidor Público Estadual
    • Ceara
      • Fortaleza, Ceara, Brazil, 60430-230
        • Centro de Pesquisa Clínica do Instituto do Câncer do Ceará
    • District Federal
      • Brasilia, District Federal, Brazil, 70200-730
        • Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
    • Goias
      • Goiania, Goias, Brazil, 74605-070
        • Hospital Araujo Jorge
    • Parana
      • Londrina, Parana, Brazil, 86015-520
        • Hospital de Cancer de Londrina
    • Paraná
      • Curitiba, Paraná, Brazil, 80810-050
        • CIONC - Centro Integrado de Oncologia de Curitiba
    • RJ
      • Rio de Janeiro, RJ, Brazil, 22775-002
        • Grupo COI - Clínicas Oncológicas Integradas
    • RS
      • Lajeado, RS, Brazil, 95900
        • Hospital Bruno Born de Lajeado
    • Rio Grande Do Sul
      • Ijui, Rio Grande Do Sul, Brazil, 98700 000
        • ONCOSITE - Centro de Pesquisa Clinica em Oncologia
      • Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
        • Hospital São Lucas - PUCRS - ONCOLOGY
    • SP
      • São Paulo, SP, Brazil, 01246-000
        • Instituto do Cancer do Estado de Sao Paulo - ICESP
    • Sao Paulo
      • Barretos, Sao Paulo, Brazil, 14784-400
        • Fundação Pio XII
      • Sao Jose Rio Preto, Sao Paulo, Brazil, 15091-000
        • Hospital de Base Fac de Medicina de Sao Jose do Rio Preto
    • São Paulo
      • Ribeirao Preto, São Paulo, Brazil, 14051-140
        • Hospital de Clínicas de Ribeirão Preto
      • Santo André, São Paulo, Brazil, 09060-650
        • Faculdade de Medicina do ABC
  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H 8L6
        • The Ottawa Hospital
      • Toronto, Ontario, Canada, M2K 1E1
        • North York General Hospital
      • Toronto, Ontario, Canada, M3M 0B2
        • Humber River Regional 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, H2X 3E4
        • Centre Hospitalier de l'Universite de Montreal
      • Montreal, Quebec, Canada, H4J 1C5
        • Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - H -T
      • Quebec City, 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, China, 100142
        • Beijing Cancer Hospital
      • Shanghai, China, 200025
        • Ruijin Hospital affiliated to Shanghai Jiao Tong University
      • Shanghai, China, 200030
        • Fudan University Shanghai Cancer Center
    • Beijing
      • Beijing, Beijing, 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, 510120
        • Sun Yat-sen Memorial Hospital, Sun Yat-Sen University
      • Guangzhou, Guangdong, China, 510080
        • Guangdong Provincial People's Hospital
      • Guangzhou, Guangdong, China, 510080
        • The First Affiliated Hospital, 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
        • Shandong Cancer Hospital
    • Zhejiang
      • Hang Zhou, Zhejiang, China, 310022
        • Zhejiang Cancer Hospital
      • Hangzhou, Zhejiang, China, 310052
        • The second affiliated hospital of zhejiang university school of medicine
  • Czechia
      • Horovice, Czechia, 268 31
        • Nemocnice Horovice
      • Ostrava, Czechia, 708 52
        • Fakultni nemocnice Ostrava
      • Plzen, Czechia, 30460
        • FN Plzen Lochotin
    • Brno-město
      • Brno, Brno-město, Czechia, 656 53
        • Masarykuv onkologicky ustav
    • Pardubický Kraj
      • Pardubice, Pardubický Kraj, Czechia, 532 03
        • Multiscan
    • Praha 4
      • Prague, Praha 4, Czechia, 140 59
        • Fakultni Thomayerova nemocnice
  • Denmark
    • Hovedstaden
      • Copenhagen, Hovedstaden, Denmark, 2730
        • Herlev and Gentofte Hospital
      • København Ø, Hovedstaden, Denmark, 2100
        • Rigshospitalet
    • Midtjylland
      • Aarhus C, Midtjylland, Denmark, 8200
        • Aarhus Universitetshospital, Aarhus Sygehus
      • Herning, Midtjylland, Denmark, 7400
        • Regionshospitalet Herning
    • Nordjylland
      • Aalborg, Nordjylland, Denmark, 9000
        • Aalborg Universitets hospital
    • Sjælland
      • Næstved, Sjælland, Denmark, 4700
        • Næstved Sygehus
    • Syddanmark
      • Esbjerg, Syddanmark, Denmark, 6700
        • Sydvestjysk Sygehus Esbjerg
      • Odense, Syddanmark, Denmark, 5000
        • Odense Universitetshospital
      • Soenderborg, Syddanmark, Denmark, 6400
        • Sygehus Soenderjylland
      • Vejle, Syddanmark, Denmark, 7100
        • Vejle Sygehus
  • Finland
      • Lahti, Finland, 15850
        • Päijät-Häme Central Hospital
      • Uusimaa, Finland, 00029
        • Docrates Syopasairaala
    • Mellersta Finland
      • Jyväskylä, Mellersta Finland, Finland, 40620
        • Keski-Suomen Keskussairaala
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampereen yliopistollinen sairaala
    • Pohjanmaa
      • Vaasa, Pohjanmaa, Finland
        • Vaasan keskussairaala
    • Pohjois-Pohjanmaa
      • Oulu, Pohjois-Pohjanmaa, Finland, 90220
        • Oulun Yliopistollinen Sairaala
    • Pohjois-Savo
      • Kuopio, Pohjois-Savo, Finland, 70210
        • Kuopion Yliopistollinen Sairaala
    • Satakunta
      • Pori, Satakunta, Finland, 28500
        • Satakunnan Keskussairaala
    • Varsinais-Suomi
      • Turku, Varsinais-Suomi, Finland, 20520
        • Turku University Central Hospital
  • France
      • Paris CEDEX 05, France, 75248
        • Institut Curie
    • Bretagne
      • Brest, Bretagne, France, 29200
        • CHRU de Brest - Hopital Morvan
    • Centre
      • La Chaussee Saint Victor, Centre, France, 41260
        • Polyclinique De Blois
    • Côte-d'Or
      • Dijon Cedex, Côte-d'Or, France, 21079
        • Centre Georges François Leclerc
    • Côtes-d'Armor
      • Plérin, Côtes-d'Armor, France, 22190
        • Hôpital Privé des Côtes d'Armor- HPCA
    • Doubs
      • Besancon, Doubs, France, 25000
        • CHU de Besancon Hopital Jean Minjoz
    • Ille-et-Vilaine
      • Rennes Cedex, Ille-et-Vilaine, France, 35042
        • Centre Eugène Marquis
    • Languedoc-Roussillon
      • Montpellier, Languedoc-Roussillon, France, 34070
        • Centre de Cancérologie du Grand Montpellier
    • Loire-Atlantique
      • Saint Herblain Cedex, Loire-Atlantique, France, 44805
        • Institut de Cancérologie de l'Ouest Centre René Gauducheau
    • Meurthe-et-Moselle
      • Nancy, Meurthe-et-Moselle, France, 54519
        • Polyclinique de Gentilly
    • Pays-de-la-Loire
      • Le Mans, Pays-de-la-Loire, France, 72000
        • Clinique Victor Hugo Le Mans
    • Puy-de-Dôme
      • Clermont-Ferrand, Puy-de-Dôme, France, 63011
        • Centre Jean Perrin
    • Rhône-Alpes
      • Lyon, Rhône-Alpes, France, 69008
        • Centre Leon Bérard
    • Seine-Maritime
      • Rouen Cedex, Seine-Maritime, France, 76038
        • Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen
    • Seine-et-Marne
      • Creteil Cedex, Seine-et-Marne, France, 94000
        • CHU Henri Mondor
    • Vaucluse
      • Avignon Cedex 9, 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, 20246
        • Mammazentrum Hamburg Brustklinik am Krankenhaus Jerusalem
      • Hamburg, Germany, 22307
        • Asklepios Kliniken Hamburg
    • Baden-Württemberg
      • Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
        • Universitätsklinikum Freiburg
      • Freiburg im Breisgau, Baden-Württemberg, Germany, 69126
        • Praxis für interdisziplinäre Onkologie & Hämatologie
      • Friedrichshafen, Baden-Württemberg, Germany, 88045
        • Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer
      • Ludwigsburg, Baden-Württemberg, Germany, 71640
        • Klinikum Ludwigsburg
      • Tübingen, Baden-Württemberg, Germany, 72076
        • Universitätsklinikum Tübingen
      • Ulm, Baden-Württemberg, Germany, 89075
        • Universitätsklinikum Ulm
    • Bayern
      • Amberg, Bayern, Germany, 92224
        • Klinikum St. Marien Amberg
      • Augsburg, Bayern, Germany, 86150
        • Gemeinschaftspraxis hop-augsburg
      • Erlangen, Bayern, Germany, 91054
        • Universitätsklinikum Erlangen
      • München, Bayern, Germany, 81675
        • Klinikum rechts der Isar der TU München
      • München, Bayern, Germany, 81675
        • Klinikum der Universität München
      • München, Bayern, Germany, 81675
        • Rotkreuzklinikum München gemeinnützige GmbH
    • Hesse
      • Langen, Hesse, Germany, 63225
        • Private Practice - Dres. Andreas Köhler und Roswitha Fuchs
    • Hessen
      • Frankfurt am Main, Hessen, Germany, 60431
        • Agaplesion Markus Krankenhaus
      • Offenbach, Hessen, Germany, 63069
        • Sana Klinikum Offenbach
    • Niedersachsen
      • Georgsmarienhütte, Niedersachsen, Germany, 49124
        • Franziskus-Hospital Harderberg
      • Hannover, Niedersachsen, Germany, 30625
        • Medizinische Hochschule Hannover
      • Hannover, Niedersachsen, Germany, 30177
        • Gynäkologisch-Onkologische Praxis am Pelikanplatz
    • Nordrhein-Westfalen
      • Bonn, Nordrhein-Westfalen, Germany, 53127
        • Universitätsklinikum Bonn
      • Düsseldorf, Nordrhein-Westfalen, Germany, 40225
        • Universitatsklinikum Dusseldorf
      • Essen, Nordrhein-Westfalen, Germany, 45136
        • Kliniken Essen-Mitte Ev. Huyssens-Stiftung
      • Krefeld, Nordrhein-Westfalen, Germany, 47805
        • Zentrum fuer ambulante gynaekologische Onkologie (ZAGO)
      • Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
        • Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH
      • Münster, Nordrhein-Westfalen, Germany, 52074
        • Universitätsklinikum Münster - Albert Schweitzer Campus
      • Witten, Nordrhein-Westfalen, Germany, 58452
        • St. Elisabeth Gruppe - Marien Hospital Witten
    • Sachsen
      • Dresden, Sachsen, Germany, 1307
        • Universitätsklinikum Carl Gustav Carus
    • Schleswig-Holstein
      • Kiel, Schleswig-Holstein, Germany, 24105
        • Universitaetsklinikum Schleswig-Holstein Campus Kiel
    • Thüringen
      • Gera, Thüringen, Germany, 07548
        • SRH Wald-Klinikum Gera gGmbH
  • Greece
      • Pylaia/Thessaloniki, Greece, 57001
        • European Interbalkan Medical Center
      • Thessaloniki, Greece, 54645
        • Euromedica - General Clinic of Thessaloniki
      • Thessaloniki, Greece, 564 29
        • Papageorgiou General Hospital of Thessaloniki
    • Achaia
      • Patras, Achaia, Greece, 26504
        • University General Hospital of Patras
    • Attikí
      • Athens, Attikí, Greece, 11522
        • Agios Savvas Regional Cancer Hospital
      • Athens, Attikí, Greece, 18547
        • Metropolitan Hospital
      • Athina, Attikí, Greece, 115 28
        • General Hospital of Athens 'Alexandra'
      • Chaidari, Attikí, Greece, 12462
        • Attikon' University Hospital
      • N. Kifissia, Attikí, Greece, 14564
        • Gen Onc Hosp Ag. Anargyroi
    • 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
    • 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
      • Tuen Mun, Hong Kong, 999077
        • Tuen Mun Hospital
      • Yau Ma Tei, Hong Kong, 999077
        • Queen Elizabeth Hospital
  • Hungary
      • Budapest, Hungary, 1062
        • Magyar Honvedseg Egeszsegugyi Kozpont
      • Budapest, Hungary, 1145
        • Uzsoki Utcai Kórház
      • Budapest, Hungary, 1032
        • Szent Margit Kórház
      • Budapest, Hungary, 1088
        • Semmelweis University
      • Budapest, Hungary, 1115
        • Szent Imre Egyetemi Oktatokorhaz
    • Bacs-Kiskun
      • Kecskemet, Bacs-Kiskun, Hungary, 6000
        • Bacs-Kiskun Varmegyei Oktatokorhaz
    • 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
    • Delhi
      • New Delhi, Delhi, India, 110005
        • Dr. B. L. Kapur Memorial Hospital
    • 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
      • Nasik, Maharashtra, India, 422001
        • HCG Manavata Cancer Centre
      • Pune, Maharashtra, India, 411001
        • Ruby Hall Clinic and Grant Medical Foundation
      • Pune, Maharashtra, India, 411004
        • Deenanth Mangeshkar Hospital and Research Centre
    • 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
    • HaDarom
      • Beer Sheva, HaDarom, Israel, 8400000
        • Soroka Medical Center
    • HaMerkaz
      • Kfar Saba, HaMerkaz, Israel, 4428164
        • Meir Medical Center
      • Petach Tikva, HaMerkaz, Israel, 49100
        • Rabin Medical Center
      • Ramat Gan, HaMerkaz, Israel, 5265601
        • Sheba Medical Center
      • Rehovot, HaMerkaz, Israel, 7610001
        • Kaplan Medical Center
      • Zerifin, HaMerkaz, Israel, 6093000
        • Yitzhak Shamir Medical Center
    • Yerushalayim
      • Jerusalem, Yerushalayim, Israel, 9112001
        • Hadassah Medical Center
      • Jerusalem, Yerushalayim, Israel, 9103102
        • Shaare Zedek Medical Center
    • Ḥeifā
      • Haifa, Ḥeifā, Israel, 3109601
        • Rambam Medical Center
  • Italy
      • Bologna, Italy, 40139
        • Ospedale Bellaria - Azienda USL di Bologna
      • Genova, Italy, 16132
        • Ospedale San Martino
      • Modena, Italy, 41125
        • Azienda Ospedaliera Universitaria Policlinico de Modena
      • Napoli, Italy, 80131
        • Istituto Nazionale Tumori IRCCS Fondazione Pascale
      • Padova, Italy, 35128
        • Istituto Oncologico Veneto
      • Parma, Italy, 43126
        • Azienda Ospedaliera Di Parma
      • Torino, Italy, 10126
        • Azienda Ospedaliero-Universitaria S.Giovanni Battista
      • Trento, Italy, 38122
        • Presidio Ospedaliero Santa Chiara
    • BR
      • Brindisi, BR, Italy, 72100
        • Ospedale Perrino
    • Campania
      • Napoli, 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
    • Milano
      • Milan, Milano, Italy, 20121
        • Ospedale Fatebenefratelli-Oftalmico
      • Rozzano, Milano, Italy, 20141
        • Humanitas
    • Monza E Brianza
      • Monza, Monza E Brianza, Italy, 20900
        • Ospedale San Gerardo-ASST Monza
    • Roma
      • Rome, Roma, Italy, 00144
        • I.F.O. 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, 540-0006
        • National Hospital Organization Osaka National Hospital
      • Osaka, Japan, 541-8567
        • Osaka International Cancer Institute
    • Aichi
      • Nagoya, Aichi, Japan, 464-8681
        • Aichi Cancer Center Hospital
    • Chiba
      • Chiba-shi, 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
        • JCHO Kurume General Hosp
    • Gunma
      • Ohta, Gunma, Japan, 373-0828
        • Gunma Prefectural Cancer Center
    • Hiroshima-ken
      • Hiroshima-shi, Hiroshima-ken, Japan, 734-8551
        • Hiroshima University Hospital
    • Hokkaido
      • Sapporo, Hokkaido, Japan, 003-0804
        • National Hospital Organization Hokkaido Cancer Center
    • Hyogo
      • Nishinomiya, Hyogo, Japan, 663-8501
        • The Hospital of Hyogo College of Medecine
    • Ibaragi
      • Tsukuba-shi, Ibaragi, Japan, 305-8576
        • University of Tsukuba Hospital
    • Kanagawa
      • Isehara, Kanagawa, Japan, 259-1143
        • Tokai University Hospital
      • Kawasaki, Kanagawa, Japan, 216-8511
        • St Marianna University School of Medicine Toyoko Hospital
      • Yokohama, Kanagawa, Japan, 241 8515
        • Kanagawa Cancer Center
    • Miyagi
      • Aoba-ku, Sendai-shi, Miyagi, Japan, 980-0803
        • KKR Tohoku Kosai Hospital
    • Niigata
      • Niigata-shi, Niigata, Japan, 951-8566
        • Niigata Cancer Center Hospital
    • Osaka
      • Osaka Sayama-shi, Osaka, Japan, 589 8511
        • Kindai University Hospital
    • Saitama
      • Hidaka, Saitama, Japan, 350-1298
        • Saitama Medical University International Medical Center
      • Ina-machi, Saitama, Japan, 362-0806
        • Saitama Cancer Center
    • Shizuoka
      • Nagaizumi, Shizuoka, Japan, 411-8777
        • Tominaga Hospital
    • Tochigi
      • Shimotsuke, Tochigi, Japan, 329-0498
        • Jichi Medical University Hospital
      • Utsunomiya, Tochigi, Japan, 320-0834
        • Tochigi Cancer Center
    • Tokyo
      • Bunkyo-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
  • Korea, Republic of
    • Chungcheongbuk-do [Chungbuk]
      • Cheongju-si, Chungcheongbuk-do [Chungbuk], Korea, Republic of, 28644
        • Chungbuk National University Hospital
    • Chungcheongnam-do [Chungnam]
      • Cheonan-si, Chungcheongnam-do [Chungnam], Korea, Republic of, 31151
        • Soonchunhyang University Hospital Cheonan
    • Gyeonggi-do
      • Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
        • National Cancer Center
    • Incheon-gwangyeoksi [Incheon]
      • Incheon, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 22332
        • Inha University Hospital
      • Namdong-gu, Incheon-gwangyeoksi [Incheon], Korea, Republic of, 21565
        • Gachon University Gil Medical Center
    • Kyǒnggi-do
      • Seongnam, Kyǒnggi-do, Korea, Republic of, 13620
        • Seoul National University Bundang Hospital
    • Pusan-Kwangyǒkshi
      • Busan, Pusan-Kwangyǒkshi, Korea, Republic of, 46033
        • Dongnam Institute of Radiological and Medical Sciences
      • Haeundae-gu, Pusan-Kwangyǒkshi, Korea, Republic of, 48108
        • Inje University Haeundae Paik Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 3080
        • Seoul National University Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 6351
        • Samsung Medical Center
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 8308
        • Korea University Guro Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 2841
        • Korea University Anam Hospital
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 3722
        • Severance Hospital Yonsei University Health System
      • Seoul, Seoul-teukbyeolsi [Seoul], Korea, Republic of
        • Ewha Womans University Mokdong Hospital
      • Songpa-gu, Seoul-teukbyeolsi [Seoul], Korea, Republic of, 5505
        • Asan Medical Center
    • Taegu-Kwangyǒkshi
      • Daegu, Taegu-Kwangyǒkshi, Korea, Republic of, 41404
        • Kyungpook National University Medical Center Chilgok Hospital
  • Mexico
      • Chihuahua, Mexico, 31203
        • Unidad de Investigación en Salud de Chihuahua S.C.
      • Oaxaca, Mexico, 68000
        • Oaxaca Site Management Organization SC
      • Puebla, Mexico, 72424
        • Unidad Médica Onco-hematológica
      • San Luis Potosí, Mexico, 78209
        • Oncologico Potosino
    • Coahuila
      • Torreon, Coahuila, Mexico, 27000
        • CIMAB S.A. de C.V.
    • Distrito Federal
      • México City, Distrito Federal, Mexico, 3310
        • Grupo Médico Camino S.C.
    • Federal District
      • Ciudad de México, Federal District, Mexico, 3100
        • Health Pharma Professional Research, S.A. de C.V.
    • Jalisco
      • Guadalajara, Jalisco, Mexico, 44280
        • Hospital Civil de Guadalajara Fray Antonio Alcalde
      • Guadalajara, Jalisco, Mexico, 45647
        • Centro Oncológico Internacional (COI)
    • Nuevo Leon
      • Monterrey, Nuevo Leon, Mexico, 64060
        • CRI Centro Regiomontano de Investigacion S.C.
      • Monterrey, Nuevo Leon, Mexico, 64460
        • Filios Alta Medicina
    • Nuevo León
      • Monterrey, Nuevo León, Mexico, 64320
        • Joaquin Gabriel Reinoso Toledo (Consultorios de Medicina Especializada)
    • Oaxaca
      • Juchitan, Oaxaca, Mexico, 70020
        • Centro de Estudios y Prevencion del Cancer A.C.
    • Sinaloa
      • Culiacan, Sinaloa, Mexico, 80020
        • Neurociencias Estudios Clínicos S.C.
    • Toluca
      • San Bernardino, Toluca, Mexico, 50120
        • Consultorio Centro Hemato Oncologico Privado
    • Yucatan
      • Merida, Yucatan, Mexico, 97070
        • Medical Care and Research, S.A. de C.V.
      • Merida, Yucatan, Mexico, 97134
        • Centro de Atención E Investigación Clínica En Oncología
  • Netherlands
    • Limburg
      • Maastricht, Limburg, Netherlands, 6229 HX
        • Maastricht UMC+
    • Noord-Holland
      • Amsterdam, Noord-Holland, Netherlands, 1091AC
        • Onze Lieve Vrouwe Gasthuis (OLVG)
    • Zuid-Holland
      • Den Haag, Zuid-Holland, Netherlands, 2545 AA
        • HagaZiekenhuis
      • Dordrecht, Zuid-Holland, Netherlands, 3318 AT
        • Albert Schweitzer Ziekenhuis
  • New Zealand
      • Auckland, New Zealand, 1023
        • Auckland City Hospital
    • Waikato
      • Hamilton, Waikato, New Zealand, 3240
        • Waikato Hospital
    • Wanganui
      • Palmerston North, Wanganui, New Zealand, 4414
        • Palmerston North Hospital
  • Poland
    • Dolnośląskie
      • Wroclaw, Dolnośląskie, Poland, 53-413
        • Dolnośląskie Centrum Onkologii we Wrocławiu
    • Lubelskie
      • Lublin, Lubelskie, Poland, 20-081
        • Centrum Onkologii Ziemii Lubelskiej im. sw. Jana z Dukli
    • Mazowieckie
      • Warszawa, Mazowieckie, Poland, 02-781
        • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut
      • Warszawa, Mazowieckie, Poland, 07-100
        • Luxmed Onkologia sp. z o. o.
    • Opolskie
      • Opole, Opolskie, Poland, 45-061
        • Opolskie Centrum Onkologii
    • Pomorskie
      • Gdansk, Pomorskie, Poland, 80-214
        • Uniwersyteckie Centrum Kliniczne
      • Gdynia, Pomorskie, Poland, 81-519
        • Szpitale Pomorskie Sp. z o. o.
    • Warmińsko-mazurskie
      • Olsztyn, Warmińsko-mazurskie, Poland, 82-300
        • Olsztynski Osrodek Onkologiczny
    • Wielkopolskie
      • Konin, Wielkopolskie, Poland, 62-500
        • Przychodnia Lekarska "KOMED"
      • Poznan, Wielkopolskie, Poland, 61-866
        • Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
    • Łódzkie
      • Lodz, Łódzkie, Poland, 90338
        • Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
  • Portugal
      • Coimbra, Portugal, 3000-075
        • Instituto Português de Oncologia Dr. Francisco Gentil
      • Lisboa, Portugal, 1400-038
        • Fundação Champalimaud
      • Lisboa, Portugal, 1649-028
        • Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
      • Porto, Portugal, 4099-001
        • Centro Hospitalar do Porto - Hospital de Santo António
      • Porto, Portugal, 4200-072
        • IPOFG - Porto
  • Puerto Rico
      • Bayamon, Puerto Rico, 00961
        • Puerto Rico Hematology/Oncology Group
      • San Juan, Puerto Rico, 00935
        • UPR Comprehensive Cancer Center
  • Romania
      • Bucuresti, Romania, 11171
        • Spitalul Clinic Filantropia
    • Cluj
      • Cluj-Napoca, Cluj, Romania, 400015
        • Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
    • Constanta
      • Ovidiu, Constanta, Romania, 905900
        • Ovidius Clinical Hospital OCH
    • Dolj
      • Craiova, Dolj, Romania, 200542
        • Centrul de Oncologie Sf. Nectarie SRL
    • Ilfov
      • Otopeni, Ilfov, Romania, 75100
        • S.C. R.T.C. Radiology Therapeutic Center S.R.L.
    • Maramureș
      • Baia Mare, Maramureș, Romania, 430291
        • Sc Oncopremium Team Srl
    • Sector 2
      • Bucuresti, Sector 2, Romania, 22328
        • Institutul Oncologic Dr Trestioreanu Bucuresti
  • Russian Federation
      • Chelyabinsk, Russian Federation, 454087
        • Chelyabinsk Regional Oncology Dispensary
      • Moscow, Russian Federation, 115478
        • Blokhin Cancer Research Center
      • Saint-Petersburg, Russian Federation, 197022
        • St. Petersburg City Clinical Oncological Dispensary
      • St. Petersburg, Russian Federation, 197758
        • St-Petersburg scientifical practical cente spec medical care
      • St. Petersburg, Russian Federation, 191015
        • North-Western State Medical University named after I.I.Mechnikov
      • St. Petersburg, Russian Federation, 197758
        • N.N.Petrov Research Institute of Oncology
    • Kalužskaja Oblast'
      • Kaluga, Kalužskaja Oblast', Russian Federation, 248007
        • Kaluga Regional Clinical Oncology Center
    • Kurskaya Oblast'
      • Kursk, Kurskaya Oblast', Russian Federation, 305524
        • Kursk Regional Oncology Dispensary
    • Moskva
      • Moscow, Moskva, Russian Federation, 115478
        • Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF
      • Moscow, Moskva, Russian Federation, 117198
        • Burdenko Main Military Hospital
    • Orenburgskaya Oblast'
      • Orenburg, Orenburgskaya Oblast', Russian Federation, 460021
        • Orenburg Regional Clinical Oncology Dispensary
    • Samarskaya Oblast'
      • Samara, Samarskaya Oblast', Russian Federation, 443031
        • Samara Regional Clinical Oncology Dispensary
    • Sankt-Peterburg
      • Saint Petersburg, Sankt-Peterburg, Russian Federation, 188663
        • Leningrad Regional Oncology Dispensary
    • Tatarstan Republic
      • Kazan, Tatarstan Republic, Russian Federation, 420029
        • Republican Clinical Oncology Dispensary
    • Volgogradskaya Oblast'
      • Volzhsky, Volgogradskaya Oblast', Russian Federation, 404130
        • Volgograd regional clinical oncology dispensary
    • Yaroslavskaya Oblast'
      • Yaroslavl, Yaroslavskaya Oblast', Russian Federation, 150054
        • Yaroslavl region regional clinical oncology hospital
  • Saudi Arabia
      • Riyadh, Saudi Arabia, 11211
        • King Faisal Specialist Hospital & Research Center
    • Ar Riyāḑ
      • Riyadh, Ar Riyāḑ, Saudi Arabia, 11426
        • King Abdulaziz Medical City - National Guard Hospital
      • Riyadh, Ar Riyāḑ, Saudi Arabia, 11525
        • King Fahad Medical City
    • Ash Sharqīyah
      • Dammam, Ash Sharqīyah, Saudi Arabia, 31444
        • King Fahad Specialist Hospital-Dammam
  • 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
  • Spain
      • Barcelona, Spain, 8035
        • Hospital Universitari Vall d'Hebron
      • Barcelona, Spain, 8003
        • Parc de Salut Mar - Hospital del Mar
      • Granada, Spain, 18016
        • Hospital Clinico Universitario San Cecilio
      • Jaen, Spain, 23007
        • Complejo Hospitalario Ciudad De Jaen
      • 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 Clinico de Salamanca
      • Sevilla, Spain, 41009
        • Hospital Universitario Virgen Macarena
      • Sevilla, Spain, 41013
        • Hospital Universitario Virgen del Rocio
      • Sevilla, Spain, 41014
        • Hospital Universitario Virgen de Valme
      • Valencia, Spain, 46010
        • Hospital Quiron Salud Valencia
      • Zaragoza, Spain, 50009
        • Hospital Universitario Miguel Servet
    • Andalucía
      • Cordoba, Andalucía, Spain, 14004
        • Hospital Universitario Reina Sofia
    • Asturias
      • Oviedo, Asturias, Spain, 33011
        • Hospital Universitario Central de Asturias
    • 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
    • Cataluña
      • Lleida, Cataluña, Spain, 25198
        • Hospital Universitari Arnau de Vilanova
    • La Coruna
      • Santiago de Compostela, La Coruna, Spain, 15706
        • CHUS - Hospital Clinico Universitario
    • Madrid
      • Alcorcón, Madrid, Spain, 28922
        • Hospital Universitario Fundacion Alcorcon
      • Pozuelo de Alarcon, Madrid, Spain, 28223
        • Hospital Universitario Quironsalud Madrid
    • Madrid, Comunidad De
      • Madrid, Madrid, Comunidad De, Spain, 28034
        • Hospital Universitario Ramon y Cajal
      • Madrid, Madrid, Comunidad De, Spain, 28041
        • Hospital Universitario 12 de Octubre
    • Málaga
      • Malaga, Málaga, Spain, 29010
        • Hospital Universitario Virgen de la Victoria
    • Santa Cruz De Tenerife
      • La Laguna, Santa Cruz De Tenerife, Spain, 38320
        • Hospital Universitario de Canarias
    • Valenciana, Comunitat
      • Valencia, Valenciana, Comunitat, Spain, 46010
        • Hospital Clinico Universitario de Valencia
  • Sweden
      • Lund, Sweden, 22185
        • Skånes universitetssjukhus Lund
      • Växjö, Sweden, 35234
        • Växjö Centrallasarettet
    • 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, 5006
        • Changhua Christian Hospital
      • Kaohsiung City, Taiwan, 80756
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Neihu Taipei, Taiwan, 114
        • Tri-Service General Hospital
      • New Taipei City, Taiwan, 110
        • Taipei Medical University Hospital
      • Taichung City, Taiwan, 40447
        • China Medical University Hospital
      • Taipei, Taiwan, 10002
        • National Taiwan University Hospital
      • Taipei, Taiwan, 11217
        • Taipei Veterans General Hospital
      • Taipei, Taiwan, 112
        • Koo Foundation Sun Yat-Sen Cancer Center
      • Taipei City, Taiwan, 10449
        • Mackay Memorial Hospital
      • Taoyuan City, Taiwan, 333
        • Chang Gung Medical Foundation-Linkou Branch
    • Kaohsiung
      • Kaohsiung Niao Sung Dist, Kaohsiung, Taiwan, 83301
        • Chang Gung Memorial Hospital - Kaohsiung
  • Turkey
      • Adana, Turkey, 01250
        • Baskent University Dr. Turgut Noyan Research and Training Center
      • Ankara, Turkey, 06100
        • Ankara Universitesi Tip Fakultesi Hastanesi
      • Ankara, Turkey, 6200
        • Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
      • Ankara, Turkey, 6230
        • Hacettepe Universitesi
      • Antalya, Turkey, 7070
        • Akdeniz Universitesi Hastanesi
      • Edirne, Turkey, 22030
        • Trakya University Faculty of Medicine
      • Istanbul, Turkey, 34090
        • TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi
      • Izmit, Turkey, 41380
        • Kocaeli Üniversitesi
      • Malatya, Turkey, 44280
        • İnönü Üniversitesi Turgut Özal Tıp Merkezi Eğitim ve Araştırma Hastanesi
    • Izmir
      • Bornova, Izmir, Turkey, 35100
        • Ege Universitesi Hastanesi
      • Izmir, Karsiyaka, Izmir, Turkey, 9035575
        • Izmir Medical Park Hospital
    • Kecioren
      • Ankara, Kecioren, Turkey, 6010
        • Gulhane Egitim Arastirma Hastanesi
    • İstanbul
      • Istanbul- Fatih, İstanbul, Turkey, 34098
        • Istanbul Universitesi Cerrahpasa
      • Üsküdar / Stanbul, İstanbul, Turkey, 34662
        • Acibadem Altunizade Hospital
  • Ukraine
    • Dnipropetrovska Oblast
      • Dnipro, Dnipropetrovska Oblast, Ukraine, 49102
        • Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council
      • Kriviy Rig, Dnipropetrovska Oblast, Ukraine, 50048
        • Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council
    • Odeska Oblast
      • Odesa, Odeska Oblast, Ukraine, 65025
        • Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council
    • Poltavska Oblast
      • Poltava, Poltavska Oblast, Ukraine, 36011
        • Poltava Regional Clinical Oncology Center
    • Vinnytska Oblast
      • Vinnytsia, Vinnytska Oblast, Ukraine, 21029
        • Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"
    • Volynska Oblast
      • Lutsk, Volynska Oblast, Ukraine, 43018
        • Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council
    • Zakarpatska Oblast
      • Uzhhorod, Zakarpatska 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
        • 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
      • Chelsea, 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
    • 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
      • London, Surrey, United Kingdom, SE1 9RT
        • Guys/St. Thomas Hospital
      • London, Surrey, United Kingdom, NW1 2PG
        • Sarah Canon Research Institute UK
      • Sutton, Surrey, 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, 33901
        • Florida Cancer Specialists - South
      • Gainesville, Florida, United States, 32610
        • University of Florida College of Medicine
      • Hollywood, Florida, United States, 33024
        • Millennium Oncology
      • Jacksonville, Florida, United States, 32256
        • Cancer Specialists of North Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic-Jacksonville
      • Ocala, Florida, United States, 34474
        • Ocala Oncology, P.A.
      • Saint Petersburg, Florida, United States, 33705
        • Florida Cancer Specialists
      • 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
      • 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, 64132
        • 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 Medical Group
    • 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
      • Ridgewood, New Jersey, United States, 07450
        • The Valley Hospital
      • 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
      • 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
      • 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-McKinney
      • 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

No

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)

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.

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

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 28, 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)

March 19, 2024

Last Update Submitted That Met QC Criteria

March 16, 2024

Last Verified

March 1, 2024

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

No

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.

Clinical Trials on Breast Cancer

Clinical Trials on Abemaciclib

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Singapore

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe