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

About this trial
This is an interventional treatment trial for Breast Cancer focused on measuring early stage breast cancer, cyclin-dependent kinase (CDK)
Eligibility Criteria
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.
Sites / Locations
- University of Alabama Birmingham
- Southern Cancer Center, P.C.
- Banner MD Anderson Cancer Center
- University of Arizona Cancer Center
- Mayo Clinic Hospital
- Arizona Oncology Associates, P.C.
- Arizona Oncology Associates, P.C.
- The University of Arizona Cancer Center
- Yuma Regional Cancer Center
- Highlands Oncology Group
- St. Bernards Medical Center
- Beverly Hills Cancer Center
- Providence St. Joseph's Medical Center
- City of Hope National Medical Center
- California Cancer Associates Research and Excellence (cCARE)
- Loma Linda University School of Medicine
- Cedars Sinai Medical Center
- Pacific Cancer Care
- St. Joseph Hospital
- University of California, Davis - Health Systems
- Kaiser Permanente Medical Group
- Univ of California San Francisco
- California Cancer Associates in Research and Excellence
- Sansum Clinic
- Dominican Hospital
- Kaiser Permanente
- Rocky Mountain Cancer Center
- Yale University School of Medicine
- Florida Cancer Specialists
- University of Southern Florida School of Medicine
- Millennium Oncology
- Mayo Clinic-Jacksonville
- Miami Cancer Institute at Baptist Health, Inc.
- Ocala Oncology, P.A.
- Cancer Specialists of North Florida -St Augustine
- Florida Cancer Specialists
- Tallahassee Memorial Cancer Center
- H Lee Moffitt Cancer Center
- Florida Cancer Specialists
- Northeast Georgia Cancer Care, LLC
- Northside Hospital Cancer Institute
- Northwest Georgia Oncology Centers
- Summit Cancer Care
- University of Hawaii Cancer Center
- John H. Stroger Hospital of Cook County
- Rush University Medical Center
- Edward Cancer Center
- Illinois Cancer Specialists-Niles
- Quincy Medical Group
- Franciscan St. Francis Health
- Community Howard Oncology Center
- Cancer Center of Kansas
- Univ of Louisville School of Medicine
- Lady of the Lake Physicians' Group
- Terrebonne General Medical Center
- Eastern Maine Medical Center
- Central Maine Healthcare Corporation
- New England Cancer Specialists - Scarborough
- Maryland Oncology Hematology, P.A.
- Meritus John Marsh Cancer Center
- Dana Farber Cancer Institute
- Reliant Medical Group, Inc.
- Minnesota Oncology/Hematology PA
- Mayo Clinic
- Jackson Oncology Associates PLLC
- Research Medical Center
- Cancer Alliance of Nebraska
- Nebraska Methodist Cancer Center
- NCCA- National Cancer Care Alliance
- Oncology Hematology West
- Comprehensive Cancer Centers of Nevada
- Renown Medical Group
- Dartmouth Hitchcock Medical Center
- Summit Medical Group PA
- Newark Beth Israel Medical Center
- The Valley Hospital - Luckow Pavilion
- Community Medical Center
- New York Oncology Hematology, P.C
- Broome Oncology LLC
- Memorial Sloan Kettering Cancer Center
- Weill Cornell Medical College
- Vassar Brothers Medical Center
- SUNY At Stony Brook
- White Plains Hospital
- Waverly Hematology Oncology
- Margaret R. Pardee Memorial Hospital
- Wake Forest University School of Medicine
- Aultman Hospital
- University Hospitals Case Medical Center
- Cleveland Clinic Foundation
- Columbus Community Clinical Oncology Program
- Oncology Hematology Care Inc
- Hematology Oncology Associates, PC
- OHSU Knight Cancer Institute
- Providence Cancer Center Oncology Hematology Care
- Northwest Cancer Specialists PC
- Willamette Valley Cancer Institute & research Ctr.
- Abington Memorial Hospital
- St. Luke's Hospital & Health Network
- PinnacleHealth Cancer Institute
- Albert Einstein Healthcare Network
- Allegheny General Hospital
- NSABP Foundation
- Univ of Pittsburgh Cancer Inst. (UPCI)
- WellSpan Health/York Cancer Center Oncology Research
- McLeod Regional Medical Center
- Bon Secours Saint Francis Cancer Center
- Spartanburg Regional Medical Center
- Sanford Research/USD
- UT/Erlanger Oncology & Hematology
- Sarah Cannon Research Institute SCRI
- The West Clinic
- Indian Path Community Hospital
- Brig Center For Cancer Care and Survivorship
- University of Tennessee Medical Center
- Baptist Cancer Center
- Sarah Cannon Cancer Center
- Tennessee Oncology PLLC
- Texas Oncology - Amarillo
- Texas Oncology-Arlington South
- Texas Oncology Cancer Center
- Texas Oncology - Carrollton
- Texas Oncology - Methodist Dallas Cancer Center
- Texas Oncology - Medical City Dallas
- Texas Oncology - Dallas Presbyterian Hospital
- Texas Oncology-Baylor Charles A. Sammons Cancer Center
- University of Texas Southwestern Medical Center at Dallas
- Texas Oncology Denton
- Texas Oncology-El Paso Cancer Treatment Center
- Texas Oncology Fort Worth
- Oncology Consultants, P.A.
- Texas Oncology - Tyler
- Texas Oncology - McAllen
- Texas Oncology-McKinney
- Texas Oncology- Mesquite
- Texas Oncology - Paris
- Texas Oncology-Plano East
- Texas Oncology-Plano West
- University of Texas Health Science Center - San Antonio
- Texas Oncology - San Antonio Medical Center
- Texas Oncology-Sherman
- Texas Oncology - The Woodlands
- US Oncology
- Texas Oncology Cancer Care and Research Center
- Texas Oncology-Deke Slayton Cancer Center
- Utah Cancer Specialists
- University of Vermont Medical Center
- Virginia Cancer Specialists
- Hematology Oncology Associates of Fredericksburg Inc.
- Virginia Oncology Associates
- Virginia Commonwealth University
- Oncology and Hematology Associates of Southwest Virginia Inc
- Shenandoah Oncology, P.C.
- Swedish Medical Center
- Multicare Health System
- Centro de Oncologia e Investigacion Buenos Aires
- Instituto de Investigaciones Clinicas Mar del Plata
- Hospital Universitario Austral
- Fundacion CENIT para la Investigacion en Neurociencias
- Centros de Investigaciones Cli-nicas. Clinica Viedma
- Instituto de Oncologia de Rosario
- Centro Medico San Roque
- Instituto Médico Especializado Alexander Fleming
- Instituto de Investigaciones Metabolicas
- Hospital Aleman
- Clinica Adventista de Belgrano
- Centro Oncologico Riojano Integral
- Sanatorio Parque
- Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
- Centro para la Atencion Integral del Paciente Oncologico
- Chris O'Brien Lifehouse
- Lismore Base Hospital
- Liverpool Hospital
- Calvary Mater Newcastle
- Mater Private Hospital
- St Vincent's Hospital
- Westmead Hospital
- Southern Medical Day Care Centre
- The Townsville Hospital
- Mater Adult Hospital Brisbane
- Gold Coast University Hospital
- Lyell McEwin Hospital
- Ashford Cancer Centre Research
- Launceston General Hospital
- Box Hill Hospital
- Peter MacCallum Cancer Centre
- Epworth Research Institute
- Eastern Health, Maroondah Hospital
- St John of God Hospital - Subiaco
- Breast Cancer Research Centre WA
- Universitätsklinikum Graz
- Universitätsklinik Innsbruck
- Ordination Dr. Hubalek - Brustzentrum Schwaz
- Universitätsklinikum Salzburg
- AKH
- KH Hietzing mit neurologischem Zentrum Rosenhügel
- Jessa Ziekenhuis
- AZ Nikolaas, Campus Moerland
- Vivalia St Joseph
- AZ Klina
- Algemeen Ziekenhuis St Jan Brugge
- Cliniques Universitaires Saint-Luc
- Universitair Ziekenhuis Antwerpen
- Hopital De Jolimont
- VZW REgional Ziekenhuis Jan Yperman
- AZ Groeninge
- Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
- Centre Hospitalier Universitaire Sart Tilman
- Clinique St Joseph
- Hôpital Civil Marie Curie
- Clinique St Elisabeth Namur
- Clinique Saint Pierre Ottignies
- CHU Dinant Godinne - UCL Namur
- Instituto do Cancer do Ceara
- Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
- Hospital Araujo Jorge da Assoc. Combate ao Cancer em Goias
- Instituto de Cancer de Londrina
- CIONC - Centro Integrado de Oncologia de Curitiba
- Hospital de Caridade Ijui
- Hospital São Lucas - PUCRS - ONCOLOGY
- Instituto COI de Pesquisa Educação e Gestão
- Hospital Bruno Born de Lajeado
- Fundação PIO XII
- Hospital de Base Fac de Medicina de Sao Jose do Rio Preto
- Instituto do Cancer do Estado de Sao Paulo - ICESP
- Hospital das Clinicas da FMRP
- Faculdade de Medicina do ABC
- INCA - Instituto Nacional Do Cancer
- Clinica Onco Star
- Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology
- Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária
- Ibcc-Instituto Brasileiro de Controle Do Câncer
- Instituto de Assistência Médica ao Servidor Público Estadual
- The Ottawa Hospital
- North York General Hospital
- Humber River Regional Hospital
- St Michaels Hospital
- Centre Hospitalier de l'Universite de Montreal
- Jewish General Hospital
- Hopital du Sacre-Coeur de Montreal
- CHU de Quebec-Hopital de Saint-Sacrement
- Centre Hospitalier Universitaire de Sherbrooke - CHUS
- The Fifth Medical Center of PLA General Hospital
- Fujian Medical University Union Hospital
- Guangdong Provincial People's Hospital
- Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
- The First Affiliated Hospital, Sun-Yat Sen University
- Harbin Medical University Cancer Hospital
- Henan Cancer Hospital
- Hunan Cancer Hospital
- Jiangsu Cancer Hospital
- Jiangsu Province Hospital
- Shandong Cancer Hospital
- Zhejiang Cancer Hospital
- The Second Affiliated Hospital of Zhejiang University School of Medicine
- Beijing Cancer Hospital
- Ruijin Hospital Affiliated to Shanghai Jiao Tong University
- Fudan University Shanghai Cancer Center
- Masarykuv onkologicky ustav
- Nemocnice Horovice
- Fakultni Nemocnice Ostrava
- Multiscan, s.r.o.
- FN Plzen Lochotin
- Thomayerova Nemocnice
- Odense Universitetshospital
- Aalborg Universitets hospital
- Aarhus Universitetshospital, Aarhus Sygehus
- Sydvestjysk Sygehus Esbjerg
- Herlev Hospital
- Regionshospitalet Herning
- Rigshospitalet
- Næstved Sygehus
- Soenderborg Sygehus
- Vejle Sygehus
- Tampere University Hospital TAYS
- Satakunta Central Hospital - Oncology
- Helsinki Docrates Cancer Clinic
- Keski-Suomen Keskussairaala
- Kuopio University Hospital
- Päijät-Häme Central hospital
- Oulu University Hospital - Oncology
- Turku University Central Hospital
- Vaasa Central Hospital
- Centre Jean Perrin
- Institut Sainte Catherine
- CHU de Besancon Hopital Jean Minjoz
- CHRU de Brest - Hôpital Morvan
- CHU Henri Mondor
- Centre Georges Francois Leclerc
- Polyclinique De Blois
- Centre Hospitalier de Vendee Les Oudairies
- Clinique Victor Hugo - Centre Jean Bernard
- Centre de Lutte Contre le Cancer Leon Berard
- Centre de Cancérologie du Grand Montpellier
- Polyclinique de Gentilly
- Institut Curie
- Hôpital Privé des Côtes d'Armor- HPCA
- Centre Eugene Marquis
- Centre Henri Becquerel
- Institut de Cancérologie de l'Ouest Centre René Gauducheau
- Universitätsklinikum Freiburg
- Onkologische Schwerpunktpraxis
- Praxis für Onkologie
- Klinikum Ludwigsburg
- Universitätsklinikum Tübingen
- Universitätsklinikum Ulm
- Hämatologisch-Onkologische Praxis Augsburg
- Gesundheitszentrum St. Marien Amberg
- Universitätsklinikum Erlangen
- Klinikum der Universität München
- Rotkreuzklinikum München - Frauenklinik
- Klinikum Rechts der Isar der TU München
- Agaplesion Markus Krankenhaus
- Städtische Kliniken Offenbach am Main
- Gemeinschaftspraxis für Hämatologie und Onkologie
- Franziskus-Hospital Harderberg
- Gynäkologisch-onkologische Schwerpunktpraxis am Pelikanplatz
- Medizinische Hochschule Hannover
- Universitätsklinikum Bonn
- Universitätsklinikum Düsseldorf
- Kliniken Essen-Mitte Ev. Huyssens-Stiftung
- HELIOS Klinikum Krefeld
- Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH
- Universitätsklinikum Münster
- St. Elisabeth Gruppe - Marien Hospital Witten
- Universitätsklinikum Carl Gustav Carus
- Universitätsklinikum Schleswig-Holstein
- SRH Wald-Klinikum Gera gGmbH
- HELIOS Klinikum Emil von Behring
- Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim
- Mammazentrum Hamburg Brustklinik am Krankenhaus Jerusalem
- Kath. Marienkrankenhaus gGmbH
- MVZ Onkologie Barmbek - Asklepios Klinik Barmbek
- University General Hospital of Patras
- Metropolitan Hospital
- General Hospital of Athens 'Alexandra'
- Ag. Savvas Hospital
- Gen Onc Hosp Ag. Anargyroi
- University General Hospital of Heraklion
- Bioclinic of Thessaloniki
- General Hospital of Thessaloniki Papageorgiou
- Errikos Dynan
- Attikon' University Hospital
- University Hospital of Ioannina
- Interbalkan Medical Center
- Euromedica - General Clinic of Thessaloniki
- Pamela Youde Nethersole Eastern Hospital
- Queen Mary Hospital
- Tuen Mun Hospital
- Queen Elizabeth Hospital
- Bacs-Kiskun Megyei Korhaz
- Fovarosi Onkormanyzat Szent Margit Korhaza
- Magyar Honvedseg Egeszsegugyi Kozpont
- Szent Imre Egyetemi Oktatokorhaz
- Semmelweis Egyetem III. sz Belgyogyaszati Klinika
- Fovarosi Onkormanyzat Uzsoki utcai Korhaz
- Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
- MNJ Institute of Oncology
- Dr. B. L. Kapur Memorial Hospital
- HCG Cancer Centre
- Artemis Hospital
- Manipal Hospital
- Regional Cancer Centre
- Tata Memorial Hospital
- HCG Manavata Cancer Centre
- Ruby Hall Clinic and Grant Medical Foundation
- Deenanth Mangeshkar Hospital and Research Centre
- Apollo Speciality Hospital
- Apollo Gleneagles Hospitals
- Medica Superspecialty Hospital
- HCG Cancer Centre
- Post Graduate Institute of Medical Education & Research
- Soroka Medical Center
- Rambam Medical Center
- Shaare Zedek Medical Center
- Hadassah Medical Center
- Meir Medical Center
- Rabin Medical Center
- Sheba Medical Center
- Kaplan Medical Center
- Assaf Harofeh Medical Center
- Ospedale Perrino
- Azienda Ospedaliero Universitaria di Ferrara
- Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
- Istituto Clinico Humanitas
- Istituto Tumori Fondazione G. Pascale IRCCS
- Azienda Ospedaliera Santa Maria
- Ospedale Bellaria
- Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
- Ospedale Fatebenefratelli-Oftalmico
- ASST Monza - Presidio Ospedaliero di Monza
- Azienda Ospedaliera Universitaria Policlinico de Modena
- Azienda Ospedaliera Universitaria Federico II
- Istituto Oncologico Veneto
- Azienda Ospedaliera Di Parma
- I.F.O. Istituto Nazionale Tumori Regina Elena
- Policlinico Ospedale S. Andrea
- Azienda Ospedaliero-Universitaria S.Giovanni Battista
- Presidio Ospedaliero Santa Chiara
- Aichi Cancer Center Hospital
- National Cancer Center Hospital East
- National Hospital Organization Shikoku Cancer Center
- JCHO Kurume General Hosp
- Gunma Prefectural Cancer Center
- Hiroshima University Hospital
- National Hospital Organization Hokkaido Cancer Center
- The Hospital of Hyogo College of Medecine
- University of tsukuba hospital
- Tokai University Hospital
- St Marianna University School of Medicine Toyoko Hospital
- Kanagawa Cancer Center
- KKR Tohoku Kosai Hospital
- Kindai University Hospital
- Saitama Medical University International Medical Center
- Saitama Cancer Center
- Shizuoka Cancer Center
- Jichi Medical University Hospital
- Tochigi Cancer Center
- Juntendo University Hospital
- St. Lukes International Hospital
- National Cancer Center Hospital
- The Cancer Institute Hospital of JFCR
- Showa University Hospital
- Tokyo Medical University Hospital
- National Center for Global Health and Medicine
- Chiba Cancer Center
- Kyushu Cancer Center
- Sagara Hospital
- Kumamoto University Hospital
- Kumamoto Shinto General hospital
- Kyoto University Hospital
- Niigata Cancer Center Hospital
- National Hospital Organization Osaka National Hospital
- Osaka International Cancer Institute
- Chungbuk National University Hospital
- Soonchunhyang University Hospital Cheonan
- National Cancer Center
- Seoul National University Bundang Hospital
- Dongnam Institute of Radiological and Medical Sciences
- Gachon University Gil Medical Center
- Samsung Medical Center
- Korea University Guro Hospital
- Asan Medical Center
- Ewha University Mokdong Hospital
- Inje University Haeundae Paik Hospital
- Kyungpook National University Medical Center Chilgok Hospital
- Inha University Hospital
- Korea University Anam Hospital
- Seoul National University Hospital
- Severance Hospital Yonsei University Health System
- Centro de Estudios y Prevencion del Cancer A.C.
- CIMAB S.A. de C.V.
- Grupo Medico Camino S.C.
- Health Pharma Professional Research, S.A. de C.V.
- COI Centro Oncológico Internacional S.A.P.I de C.V.
- Hospital Civil De Guadalajara Fray Antonio Alcalde
- COI Centro Oncológico Internacional S.A.P.I de C.V.
- CRI Centro Regiomontano de Investigacion S.C.
- Christus Muguerza Clinica Vidriera
- Joaquin Gabriel Reinoso Toledo (Consultorios de Medicina Especializada)
- Neurociencias Estudios Clinicos S.C.
- Consultorio Centro Hemato Oncologico Privado
- Medical Care and Research, S.A. de C.V.
- Centro de Atención e Investigación Clínica en Oncología
- Unidad de Investigacion en Salud de Chihuahua S.C.
- Oaxaca Site Management Organization SC
- Oncológica de Puebla
- Oncológico Potosino
- Onze Lieve Vrouwe Gasthuis (OLVG)
- HagaZiekenhuis
- Albert Schweitzer Ziekenhuis
- Universitair Medisch Centrum Maastricht
- Palmerston North Hospital
- Auckland City Hospital
- Waikato Hospital
- Uniwersyteckie Centrum Kliniczne
- Szpital Morski im. PCK Sp. z o.o.
- Przychodnia Lekarska "Komed"
- Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
- Centrum Onkologii Ziemii Lubelskiej im. sw. Jana z Dukli
- Olsztynski Osrodek Onkologiczny
- Opolskie Centrum Onkologii
- Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
- MAGODENT Szpital Onkologiczny Elblaska
- Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut
- Dolnoslaskie Centrum Onkologii
- Instituto Português de Oncologia Dr. Francisco Gentil
- Fundação Champalimaud
- Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
- Hospital Geral de Santo Antonio
- IPOFG - Porto
- Puerto Rico Hematology/Oncology Group
- University Of Puerto Rico
- Centrul de Oncologie Sf. Nectarie SRL
- S.C. R.T.C. Radiology Therapeutic Center S.R.L.
- SC Oncopremium Team SRL
- Institutul Oncologic Dr Trestioreanu Bucuresti
- Spitalul Clinic Filantropia
- Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
- Spitalul Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
- Kazan Oncology Dispensary
- Chelyabinsk Regional Oncology Dispensary
- SHI Kaluga Regional Hospital
- Kursk Regional Oncology Dispensary
- Leningrad Regional Oncology Dispensary
- Principal Military Clinical Hospital n.a. N. N. Burdenko
- Blokhin Cancer Research Center
- Russian Oncological Research Center
- Orenburg Regional Clinical Oncology Dispensary
- St. Petersburg City Clinical Oncological Dispensary
- Samara Regional Clinical Oncology Dispensary
- GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health
- FGU Research Institution of Oncology
- St-Petersburg scientifical practical cente spec medical care
- Volgograd regional clinical oncology dispensary
- Yaroslavl region regional clinical oncology hospital
- King Fahad Specialist Hospital-Dammam
- King Faisal Specialist Hospital & Research Center
- King Abdulaziz Medical City - National Guard Hospital
- King Fahad Medical City
- National Cancer Center
- National University Hospital
- Eastleigh Breast Care Center
- Cancercare Rondebosch Oncology
- Cancercare
- Sandton Oncology Centre
- Langenhoven Drive Oncology Centre
- Mary Potter Oncology Center
- Hospital Clinico Universitario Virgen de la Victoria
- Hospital Universitario Virgen del Rocio
- Hospital Universitario Central de Asturias
- Hospital Universitari Arnau de Vilanova
- Hospital Clinico Universitario de Santiago
- Hospital Fundación Alcorcón
- Hospital Universitario Quironsalud Madrid
- Hospital Universitario de Canarias
- Hospital del Mar
- Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
- Hospital Universitari Vall d'Hebron
- Hospital Clinic I Provincial
- Hospital de la Santa Creu i Sant Pau
- Hospital Reina Sofia
- Hospital Clinico Universitario San Cecilio
- Complejo Hospitalario Ciudad De Jaen
- Hospital De La Princesa
- Hospital General Universitario Gregorio Marañon
- Hospital Universitario Ramon y Cajal
- Hospital Clinico San Carlos
- Hospital Universitario 12 de Octubre
- Hospital Madrid Norte Sanchinarro
- Hospital Clinico De Salamanca
- Hospital Universitario Virgen Macarena
- Hospital Universitario Nuestra Señora de Valme
- Hospital Clínico Universitario de Valencia
- Hospital Quirón Salud Valencia
- Hospital Universitario Miguel Servet
- Norrlands universitetssjukhus
- Skånes universitetssjukhus Lund
- Länssjukhuset Sundsvall
- Västmanlands sjukhus Västerås
- Växjö Centrallasarettet
- Changhua Christian Hospital
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Chang Gung Memorial Hospital - Kaohsiung
- Tri-Service General Hospital
- Taipei Medical University- Shuang Ho Hospital
- China Medical University Hospital
- MacKay Memorial Hospital
- National Taiwan University Hospital
- Taipei Veterans General Hospital
- Sun Yat-Sen Cancer Center
- Chang Gung Memorial Hospital - Linkou
- Ankara Gulhane Training ve Research Hospital
- Baskent Adana Educational Hospital
- Ankara University Medicine Hospital
- Hacettepe University Faculty of Medicine
- Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
- Akdeniz University Medical Faculty
- Trakya University Faculty of Medicine
- Istanbul University
- Acibadem Altunizade Hastanesi
- Istanbul Medeniyet University Medical Faculty
- Ege University Faculty of Medicine
- Medical Park Izmir Hospital
- Kocaeli University Medical Faculty Hospital
- Inonu University Medical Faculty
- Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council
- Commu Instit "Krivorizhskiy oncology dispensary" Dnip reg Co
- Communal Enterprise "Volyn Regional Medical Oncology Center"
- Odesa Regional Clinical Hospital
- Poltava Regional Clinical Oncological Dispensary
- Central Municipal Clinical Hospital
- Podilskyi Regional Center of Oncology
- University Hospital of North Tees
- Royal Cornwall Hospital
- Broomfield Hospital
- North Middlesex Hospital
- Christie NHS Foundation Trust
- Victoria Hospital
- Royal Preston Hospital
- Charing Cross Hospital
- Mount Vernon Hospital
- Nottingham City Hospital
- Western General Hospital
- Musgrove Park Hospital
- Royal Surrey County Hospital
- Guys/St. Thomas Hospital
- Sarah Canon Research Institute UK
- Royal Marsden Hospital
- Airedale General Hospital
- Pilgrim Hospital
- Churchill Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Other
150 mg Abemaciclib + Endocrine Therapy
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.
Endocrine therapy (physicians' choice) standard-of-care was administered according to package label until discontinuation criteria were met.