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

Breast Cancer Clinical Trial

— monarchE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03155997
• Other study ID #: 16338
• Secondary ID: I3Y-MC-JPCF2016-
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: July 12, 2017
• Est. completion date: May 28, 2029

Study information

• Verified date: May 2024
• Source: Eli Lilly and Company
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 5637
• Est. completion date: May 28, 2029
• Est. primary completion date: March 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Abemaciclib
Administered orally.
• Standard Adjuvant Endocrine Therapy
Administered according to label instructions.

Locations

Country	Name	City	State
Argentina	Centro de Oncologia e Investigacion Buenos Aires	Berazategui	Buenos Aires
Argentina	Hospital Aleman	Buenos Aires	Ciudad Autónoma De Buenos Aires
Argentina	Instituto de Investigaciones Metabolicas	Buenos Aires
Argentina	Fundacion CENIT para la Investigacion en Neurociencias	Caba	Ciudad Autonoma Buenos Aires
Argentina	Clinica Adventista de Belgrano	Ciudad Autonoma Buenos Aires
Argentina	Alexander Fleming	Ciudad Autónoma de Buenos Aires
Argentina	Fundación CORI para la Investigación y Prevención del Cáncer	La Rioja
Argentina	Instituto de Investigaciones Clinicas Mar del Plata	Mar del Plata	Buenos Aires
Argentina	Hospital Universitario Austral	Pilar	Buenos Aires
Argentina	Instituto de Oncologia de Rosario	Rosario	Santa Fe
Argentina	Consultorio Dr. Miguel Ángel Escudero	Salta
Argentina	CER San Juan	San Juan
Argentina	Centro Para la Atención Integral del Paciente Oncologico (CAIPO)	San Miguel de Tucuman	Tucumán
Argentina	Centro Medico San Roque	Tucuman
Argentina	Clinica Viedma	Viedma	Rio Negro
Australia	Box Hill Hospital	Box Hill	Victoria
Australia	Mater Misericordiae Limited	Brisbane	Queensland
Australia	Chris O'Brien Lifehouse	Camperdown	New South Wales
Australia	St Vincent's Hospital	Darlinghurst	New South Wales
Australia	Epworth Research Institute	East Melbourne	Victoria
Australia	Lyell McEwin Hospital	Elizabeth Vale	South Australia
Australia	Ashford Cancer Centre Research	Kurralta Park	South Australia
Australia	Launceston General Hospital	Launceston	Tasmania
Australia	Lismore Base Hospital	Lismore	New South Wales
Australia	Liverpool Hospital	Liverpool	New South Wales
Australia	Maroondah Hospital	Melbourne	Victoria
Australia	Peter MacCallum Cancer Centre	Melbourne	Victoria
Australia	Breast Cancer Research Centre WA	Nedlands
Australia	Calvary Mater Newcastle	Newcastle	New South Wales
Australia	Gold Coast University Hospital	Southport	Queensland
Australia	St John of God Hospital - Subiaco	Subiaco	Western Australia
Australia	Mater Hospital Sydney	Sydney	New South Wales
Australia	The Townsville Hospital	Townsville	Queensland
Australia	Westmead Hospital	Westmead	New South Wales
Australia	Southern Medical Day Care Centre	Wollongong	New South Wales
Austria	Medizinische Universität Graz	Graz	Steiermark
Austria	Medizinische Universitaet Innsbruck	Innsbruck	Tirol
Austria	Universitätsklinikum Salzburg	Salzburg
Austria	Private Practice - Dr. Hubalek	Schwaz	Tirol
Austria	Klinik Hietzing	Vienna	Wien
Austria	Medizinische Universität Wien	Vienna	Wien
Belgium	Algemeen Ziekenhuis klina	Brasschaat	Antwerpen
Belgium	AZ Sint-Jan Brugge-Oostende AV	Brugge	West-Vlaanderen
Belgium	Cliniques Universitaires Saint-Luc	Brussels	Bruxelles-Capitale, Région De
Belgium	Antwerp University Hospital	Edegem	Antwerpen
Belgium	Jessa Ziekenhuis	Hasselt	Limburg
Belgium	Jan Yperman ziekenhuis	Ieper	West-Vlaanderen
Belgium	AZ Groeninge Campus Kennedylaan	Kortrijk	West-Vlaanderen
Belgium	Groupe Jolimont	La Louvière	Wallonne, Région
Belgium	UZ Leuven	Leuven	Vlaams-Brabant
Belgium	Centre Hospitalier D'Ardenne - Forget	Libramont	Luxembourg
Belgium	Centre Hospitalier Universitaire de Liège - Domaine Universitaire du Sart Tilman	Liege	Liège
Belgium	Clinique St Joseph	Liege
Belgium	CHU de Charleroi - Hopital Civil Marie Curie	Lodelinsart	Hainaut
Belgium	CHU UCL Namur/Site Sainte Elisabeth	Namur
Belgium	Clinique Saint Pierre Ottignies	Ottignies	Wallonne, Région
Belgium	AZ Nikolaas, Campus Moerland	Sint-Niklaas	Oost-Vlaanderen
Belgium	CHU Dinant Godinne - UCL Namur	Yvoir
Brazil	Fundação PIO XII	Barretos	Sao Paulo
Brazil	Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul	Brasilia	District Federal
Brazil	CIONC - Centro Integrado de Oncologia de Curitiba	Curitiba	Paraná
Brazil	Centro de Pesquisa Clínica do Instituto do Câncer do Ceará	Fortaleza	Ceara
Brazil	Hospital Araújo Jorge	Goiania	Goias
Brazil	ONCOSITE - Centro de Pesquisa Clinica em Oncologia	Ijui	Rio Grande Do Sul
Brazil	Hospital Bruno Born de Lajeado	Lajeado	RS
Brazil	Hospital de Cancer de Londrina	Londrina	Parana
Brazil	Hospital São Lucas - PUCRS - ONCOLOGY	Porto Alegre	Rio Grande Do Sul
Brazil	Hospital de Clínicas de Ribeirão Preto	Ribeirao Preto	São Paulo
Brazil	Grupo COI - Clínicas Oncológicas Integradas	Rio de Janeiro	RJ
Brazil	INCA - Instituto Nacional Do Cancer	Rio De Janeiro
Brazil	Faculdade de Medicina do ABC	Santo André	São Paulo
Brazil	Hospital de Base Fac de Medicina de Sao Jose do Rio Preto	Sao Jose Rio Preto	Sao Paulo
Brazil	Icesp - Instituto Do Câncer Do Estado de São Paulo	Sao Paulo
Brazil	Hospital Perola Byington	São Paulo
Brazil	Hospital Sírio Libanês	São Paulo
Brazil	Instituto de Assistência Médica ao Servidor Público Estadual	São Paulo
Brazil	Instituto do Cancer do Estado de Sao Paulo - ICESP	São Paulo	SP
Brazil	Núcleo de Pesquisa Clínica da Rede São Camilo	São Paulo
Canada	Centre Hospitalier de l'Universite de Montreal	Montreal	Quebec
Canada	Centre intégré universitaire de santé et de services sociaux du Nord-de-l'Île-de-Montréal (CIUSSS NÎM) - H -T	Montreal	Quebec
Canada	Jewish General Hospital	Montreal	Quebec
Canada	The Ottawa Hospital	Ottawa	Ontario
Canada	CHU de Quebec-Hopital de Saint-Sacrement	Quebec City	Quebec
Canada	Centre intégré universitaire de santé et de services sociaux de l'Estrie - Centre Hospitalier Universitair -T	Sherbrooke	Quebec
Canada	Humber River Regional Hospital	Toronto	Ontario
Canada	North York General Hospital	Toronto	Ontario
Canada	Unity Health Toronto, St. Michael's Hospital	Toronto	Ontario
China	Beijing Cancer Hospital	Beijing
China	The Fifth Medical Center of PLA General Hospital	Beijing	Beijing
China	Hunan Cancer Hospital	Changsha	Hunan
China	Fujian Medical University Union Hospital-1 Bingfanglou	Fuzhou	Fujian
China	Guangdong Provincial People's Hospital	Guangzhou	Guangdong
China	Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University	Guangzhou	Guangdong
China	The First Affiliated Hospital, Sun-Yat Sen University	Guangzhou	Guangdong
China	Zhejiang Cancer Hospital	Hang Zhou	Zhejiang
China	The Second Affiliated Hospital of Zhejiang University School of Medicine	Hangzhou	Zhejiang
China	Harbin Medical University Cancer Hospital	Harbin	Heilongjiang
China	Shandong Cancer Hospital	Jinan	Shandong
China	Jiangsu Cancer Hospital	Nanjing	Jiangsu
China	Jiangsu Province Hospital	Nanjing	Nanjing
China	Fudan University Shanghai Cancer Center	Shanghai
China	Shanghai Jiaotong University School of Medicine Ruijin Hospital	Shanghai	Shanghai
China	Henan Cancer Hospital	Zhengzhou	Henan
Czechia	Masarykuv onkologicky ustav	Brno	Brno-mesto
Czechia	Nemocnice Horovice	Horovice
Czechia	Fakultni Nemocnice Ostrava	Ostrava
Czechia	Multiscan	Pardubice	Pardubický Kraj
Czechia	FN Plzen Lochotin	Plzen
Czechia	Fakultni Thomayerova nemocnice	Prague	Praha 4
Denmark	Aalborg Universitetshospital, Syd	Aalborg	Nordjylland
Denmark	Aarhus Universitetshospital, Aarhus Sygehus	Aarhus C	Midtjylland
Denmark	Herlev and Gentofte Hospital	Copenhagen	Hovedstaden
Denmark	Sydvestjysk Sygehus Esbjerg	Esbjerg	Syddanmark
Denmark	Regionshospitalet Herning	Herning	Midtjylland
Denmark	Rigshospitalet	København Ø	Hovedstaden
Denmark	Næstved Sygehus	Næstved	Sjælland
Denmark	Odense Universitetshospital	Odense	Syddanmark
Denmark	Sygehus Soenderjylland	Soenderborg	Syddanmark
Denmark	Vejle Sygehus	Vejle	Syddanmark
Finland	Keski-Suomen Keskussairaala	Jyväskylä	Mellersta Finland
Finland	Kuopion Yliopistollinen Sairaala	Kuopio	Pohjois-Savo
Finland	Päijät-Häme Central hospital	Lahti
Finland	Oulun yliopistollinen sairaala	Oulu	Pohjois-Pohjanmaa
Finland	Satakunnan Keskussairaala	Pori	Satakunta
Finland	Tampereen yliopistollinen sairaala	Tampere	Pirkanmaa
Finland	Turku University Central Hospital	Turku	Varsinais-Suomi
Finland	Docrates Syöpäsairaala	Uusimaa
Finland	Vaasan Keskussairaala	Vaasa	Pohjanmaa
France	Sainte Catherine Institut du Cancer Avignon Provence	Avignon Cedex 9	Vaucluse
France	CHU de Besancon Hopital Jean Minjoz	Besancon	Doubs
France	CHRU de Brest - Hôpital Morvan	Brest	Bretagne
France	Centre Jean Perrin	Clermont-Ferrand	Puy-de-Dôme
France	CHU Henri Mondor	Creteil Cedex	Seine-et-Marne
France	Centre Georges Francois Leclerc	Dijon Cedex	Côte-d'Or
France	Polyclinique De Blois	La Chaussee Saint Victor	Centre
France	Centre Hospitalier de Vendee Les Oudairies	La Roche Sur Yon	Vendée
France	Clinique Victor Hugo Le Mans	Le Mans	Pays-de-la-Loire
France	Centre Leon Berard	Lyon	Rhône-Alpes
France	Centre de Cancérologie du Grand Montpellier	Montpellier	Languedoc-Roussillon
France	Polyclinique de Gentilly	Nancy	Meurthe-et-Moselle
France	Institut Curie	Paris CEDEX 05
France	Hôpital Privé des Côtes d'Armor- HPCA	Plérin	Côtes-d'Armor
France	Centre Eugene Marquis	Rennes Cedex	Ille-et-Vilaine
France	Centre de Lutte Contre le Cancer - Centre Henri Becquerel Normandie Rouen	Rouen Cedex	Seine-Maritime
France	Institut de Cancérologie de l'Ouest Centre René Gauducheau	Saint Herblain Cedex	Loire-Atlantique
Germany	Klinikum St. Marien Amberg	Amberg	Bayern
Germany	Gemeinschaftspraxis hop-augsburg	Augsburg	Bayern
Germany	Helios Klinikum Berlin-Buch	Berlin
Germany	Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim	Berlin
Germany	Universitätsklinikum Bonn	Bonn	Nordrhein-Westfalen
Germany	Universitätsklinikum Carl Gustav Carus	Dresden	Sachsen
Germany	Universitätsklinikum Düsseldorf	Düsseldorf	Nordrhein-Westfalen
Germany	Universitätsklinikum Erlangen	Erlangen	Bayern
Germany	Kliniken Essen-Mitte, Evangelische Huyssens-Stiftung	Essen	Nordrhein-Westfalen
Germany	Agaplesion Markus Krankenhaus	Frankfurt	Hessen
Germany	Praxis für interdisziplinäre Onkologie & Hämatologie	Freiburg im Breisgau	Baden-Württemberg
Germany	Universitätsklinikum Freiburg	Freiburg im Breisgau	Baden-Württemberg
Germany	Private Practice - Dr. Helmut Oettle und Prof.Dr.med. Frank Mayer	Friedrichshafen	Baden-Württemberg
Germany	Franziskus-Hospital Harderberg	Georgsmarienhütte	Niedersachsen
Germany	SRH Wald-Klinikum Gera gGmbH	Gera	Thüringen
Germany	Asklepios Kliniken Hamburg	Hamburg
Germany	Kath. Marienkrankenhaus gGmbH	Hamburg
Germany	Mammazentrum Hamburg Brustklinik am Krankenhaus Jerusalem	Hamburg
Germany	Gynäkologisch-Onkologische Praxis am Pelikanplatz	Hannover	Niedersachsen
Germany	Medizinische Hochschule Hannover	Hannover	Niedersachsen
Germany	Universitaetsklinikum Schleswig-Holstein Campus Kiel	Kiel	Schleswig-Holstein
Germany	Zentrum fuer ambulante gynaekologische Onkologie (ZAGO)	Krefeld	Nordrhein-Westfalen
Germany	Private Practice - Dres. Andreas Köhler und Roswitha Fuchs	Langen	Hesse
Germany	Klinikum Ludwigsburg	Ludwigsburg	Baden-Württemberg
Germany	Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH	Mönchengladbach	Nordrhein-Westfalen
Germany	Klinikum der Universität München	München	Bayern
Germany	Klinikum Rechts der Isar der TU München	München	Bayern
Germany	Rotkreuzklinikum München gemeinnützige GmbH	München	Bayern
Germany	Universitätsklinikum Münster - Albert Schweitzer Campus	Münster	Nordrhein-Westfalen
Germany	Sana Klinikum Offenbach	Offenbach	Hessen
Germany	Universitätsklinikum Tübingen	Tübingen	Baden-Württemberg
Germany	Universitätsklinikum Ulm	Ulm	Baden-Württemberg
Germany	St. Elisabeth Gruppe - Marien Hospital Witten	Witten	Nordrhein-Westfalen
Greece	Agios Savvas Regional Cancer Hospital	Athens	Attikí
Greece	Errikos Dunant Hospital Center	Athens	Attikí (Region)
Greece	Metropolitan Hospital	Athens	Attikí
Greece	General Hospital of Athens 'Alexandra'	Athina	Attikí
Greece	Attikon' University Hospital	Chaidari	Attikí
Greece	University General Hospital of Heraklion	Heraklion	Krítí
Greece	University Hospital of Ioannina	Ioannina	Ípeiros
Greece	Gen Onc Hosp Ag. Anargyroi	N. Kifissia	Attikí
Greece	University General Hospital of Patras	Patras	Achaia
Greece	Bioclinic of Thessaloniki	Thessaloniki	Kentrikí Makedonía
Greece	Euromedica - General Clinic of Thessaloniki	Thessaloniki
Greece	European Interbalkan Medical Center	Thessaloniki	Thessaloníki
Greece	Papageorgiou General Hospital of Thessaloniki	Thessaloniki
Hong Kong	Pamela Youde Nethersole Eastern Hospital	Chai Wan
Hong Kong	Queen Mary Hospital	Hksar
Hong Kong	Tuen Mun Hospital	Tuen Mun
Hong Kong	Queen Elizabeth Hospital	Yau Ma Tei
Hungary	Magyar Honvedseg Egeszsegugyi Kozpont	Budapest
Hungary	Semmelweis University	Budapest
Hungary	Szent Imre Egyetemi Oktatokorhaz	Budapest
Hungary	Szent Margit Kórház	Budapest
Hungary	Uzsoki Utcai Kórház	Budapest
Hungary	Bacs-Kiskun Varmegyei Oktatokorhaz	Kecskemet	Bacs-Kiskun
Hungary	Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz	Szolnok	Jász-Nagykun-Szolnok
India	HCG Cancer Centre	Ahmedabad	Gujarat
India	Manipal Hospital	Bangalore	Karmnataka
India	Post Graduate Institute of Medical Education & Research	Chandigarh
India	Apollo Speciality Hospital - Teynampet	Chennai	Tamil Nadu
India	Artemis Hospital	Gurgaon	Haryana
India	MNJ Institute of Oncology	Hyderabad	Andhra Pradesh
India	Apollo Gleneagles Hospitals	Kolkata	West Bengal
India	Medica Superspecialty Hospital	Kolkata	West Bengal
India	Tata Memorial Hospital	Mumbai	Maharashtra
India	HCG Manavata Cancer Centre	Nasik	Maharashtra
India	Dr. B. L. Kapur Memorial Hospital	New Delhi	Delhi
India	Deenanth Mangeshkar Hospital and Research Centre	Pune	Maharashtra
India	Ruby Hall Clinic and Grant Medical Foundation	Pune	Maharashtra
India	Regional Cancer Centre	Trivandrum	Kerala
India	HCG Cancer Centre	Vadodara	Gujarat
Israel	Soroka Medical Center	Beer Sheva	HaDarom
Israel	Rambam Medical Center	Haifa	?eifa
Israel	Hadassah Medical Center	Jerusalem	Yerushalayim
Israel	Shaare Zedek Medical Center	Jerusalem	Yerushalayim
Israel	Meir Medical Center	Kfar Saba	HaMerkaz
Israel	Rabin Medical Center	Petach Tikva	HaMerkaz
Israel	Sheba Medical Center	Ramat Gan	HaMerkaz
Israel	Kaplan Medical Center	Rehovot	HaMerkaz
Israel	Yitzhak Shamir Medical Center	Zerifin	HaMerkaz
Italy	Ospedale Bellaria - Azienda USL di Bologna	Bologna
Italy	Ospedale Perrino	Brindisi	BR
Italy	Azienda Ospedaliero Universitaria S.Anna	Cona	Emilia-Romagna
Italy	Ospedale San Martino	Genova
Italy	Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori	Meldola	Emilia-Romagna
Italy	Ospedale Fatebenefratelli-Oftalmico	Milan	Milano
Italy	Azienda Ospedaliero Universitaria	Modena
Italy	Ospedale San Gerardo-ASST Monza	Monza	Monza E Brianza
Italy	Istituto Nazionale Tumori IRCCS Fondazione Pascale	Napoli
Italy	University of Naples Federico II	Napoli	Campania
Italy	Istituto Oncologico Veneto	Padova
Italy	Azienda Ospedaliera Di Parma	Parma
Italy	Azienda Ospedaliera Sant'Andrea	Rome	Roma
Italy	I.F.O. Istituto Nazionale Tumori Regina Elena	Rome	Roma
Italy	Humanitas	Rozzano	Milano
Italy	Azienda Ospedaliera Santa Maria	Terni	TR
Italy	Azienda Ospedaliero-Universitaria S.Giovanni Battista	Torino
Italy	Presidio Ospedaliero Santa Chiara	Trento
Japan	KKR Tohoku Kosai Hospital	Aoba-ku, Sendai-shi	Miyagi
Japan	Juntendo University Hospital	Bunkyo-Ku	Tokyo
Japan	Chiba Cancer Center	Chiba-shi	Chiba
Japan	National Cancer Center Hospital	Chuo Ku	Tokyo
Japan	St. Lukes International Hospital	Chuo-Ku	Tokyo
Japan	National Hospital Organization Kyushu Cancer Center	Fukuoka
Japan	Saitama Medical University International Medical Center	Hidaka	Saitama
Japan	Hiroshima University Hospital	Hiroshima-shi	Hiroshima-ken
Japan	Saitama Cancer Center	Ina-machi	Saitama
Japan	Tokai University Hospital- Isehara Campus	Isehara	Kanagawa
Japan	Sagara Hospital	Kagoshima
Japan	National Cancer Center Hospital East	Kashiwa	Chiba
Japan	St Marianna University School of Medicine Toyoko Hospital	Kawasaki	Kanagawa
Japan	Japanese Foundation for Cancer Research	Koto	Tokyo
Japan	Kumamoto Shinto General hospital	Kumamoto
Japan	Kumamoto University Hospital	Kumamoto
Japan	Kurume General Hospital	Kurume	Fukuoka
Japan	Kyoto University Hospital	Kyoto
Japan	National Hospital Organization Shikoku Cancer Center	Matsuyama	Ehime
Japan	Tominaga Hospital	Nagaizumi	Shizuoka
Japan	Aichi Cancer Center Hospital	Nagoya	Aichi
Japan	Niigata Cancer Center Hospital	Niigata-shi	Niigata
Japan	The Hospital of Hyogo College of Medecine	Nishinomiya	Hyogo
Japan	Gunma Prefectural Cancer Center	Ohta	Gunma
Japan	National Hospital Organization Osaka National Hospital	Osaka
Japan	Osaka International Cancer Institute	Osaka
Japan	Kindai University Hospital	Osaka Sayama-shi	Osaka
Japan	National Hospital Organization Hokkaido Cancer Center	Sapporo	Hokkaido
Japan	Jichi Medical University Hospital	Shimotsuke	Tochigi
Japan	Showa University Hospital	Shinagawa-ku	Tokyo
Japan	National Center for Global Health and Medicine	Shinjuku-ku	Tokyo
Japan	Tokyo Medical University Hospital	Shinjuku-ku	Tokyo
Japan	University of tsukuba hospital	Tsukuba-shi	Ibaragi
Japan	Tochigi Cancer Center	Utsunomiya	Tochigi
Japan	Kanagawa Cancer Center	Yokohama	Kanagawa
Korea, Republic of	Dongnam Institute of Radiological and Medical Sciences	Busan	Pusan-Kwangyokshi
Korea, Republic of	Soonchunhyang University Hospital Cheonan	Cheonan-si	Chungcheongnam-do [Chungnam]
Korea, Republic of	Chungbuk National University Hospital	Cheongju-si	Chungcheongbuk-do [Chungbuk]
Korea, Republic of	Kyungpook National University Medical Center Chilgok Hospital	Daegu	Taegu-Kwangyokshi
Korea, Republic of	National Cancer Center	Goyang-si	Gyeonggi-do
Korea, Republic of	Inje University Haeundae Paik Hospital	Haeundae-gu	Pusan-Kwangyokshi
Korea, Republic of	Inha University Hospital	Incheon	Incheon-gwangyeoksi [Incheon]
Korea, Republic of	Gachon University Gil Medical Center	Namdong-gu	Incheon-gwangyeoksi [Incheon]
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam	Kyonggi-do
Korea, Republic of	Ewha Womans University Mokdong Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Korea University Anam Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Korea University Guro Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Samsung Medical Center	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Seoul National University Hospital	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Severance Hospital Yonsei University Health System	Seoul	Seoul-teukbyeolsi [Seoul]
Korea, Republic of	Asan Medical Center	Songpa-gu	Seoul-teukbyeolsi [Seoul]
Mexico	Unidad de Investigacion en Salud de Chihuahua S.C.	Chihuahua
Mexico	Health Pharma Professional Research, S.A. de C.V.	Ciudad de México	Federal District
Mexico	Neurociencias Estudios Clinicos S.C.	Culiacan	Sinaloa
Mexico	Centro Oncológico Internacional (COI)	Guadalajara	Jalisco
Mexico	Hospital Civil De Guadalajara Fray Antonio Alcalde	Guadalajara	Jalisco
Mexico	Centro de Estudios y Prevencion del Cancer A.C.	Juchitan	Oaxaca
Mexico	Centro de Atención e Investigación Clínica en Oncología	Merida	Yucatan
Mexico	Medical Care and Research, S.A. de C.V.	Merida	Yucatan
Mexico	Grupo Medico Camino S.C.	México City	Distrito Federal
Mexico	CRI Centro Regiomontano de Investigacion S.C.	Monterrey	Nuevo Leon
Mexico	Filios Alta Medicina	Monterrey	Nuevo Leon
Mexico	Joaquin Gabriel Reinoso Toledo (Consultorios de Medicina Especializada)	Monterrey	Nuevo León
Mexico	Oaxaca Site Management Organization SC	Oaxaca
Mexico	Unidad Médica Onco-hematológica	Puebla
Mexico	Consultorio Centro Hemato Oncologico Privado	San Bernardino	Toluca
Mexico	Oncológico Potosino	San Luis Potosí
Mexico	CIMAB S.A. de C.V.	Torreon	Coahuila
Netherlands	Onze Lieve Vrouwe Gasthuis (OLVG)	Amsterdam	Noord-Holland
Netherlands	HagaZiekenhuis	Den Haag	Zuid-Holland
Netherlands	Albert Schweitzer Ziekenhuis	Dordrecht	Zuid-Holland
Netherlands	Maastricht UMC+	Maastricht	Limburg
New Zealand	Auckland City Hospital	Auckland
New Zealand	Waikato Hospital	Hamilton	Waikato
New Zealand	Palmerston North Hospital	Palmerston North	Wanganui
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk	Pomorskie
Poland	Szpitale Pomorskie Sp. z o. o.	Gdynia	Pomorskie
Poland	Przychodnia Lekarska "Komed"	Konin	Wielkopolskie
Poland	Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.	Lodz	Lódzkie
Poland	Centrum Onkologii Ziemii Lubelskiej im. sw. Jana z Dukli	Lublin	Lubelskie
Poland	Olsztynski Osrodek Onkologiczny	Olsztyn	Warminsko-mazurskie
Poland	Opolskie Centrum Onkologii	Opole	Opolskie
Poland	Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie	Poznan	Wielkopolskie
Poland	Luxmed Onkologia sp. z o. o.	Warszawa	Mazowieckie
Poland	Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut	Warszawa	Mazowieckie
Poland	Dolnoslaskie Centrum Onkologii we Wroclawiu	Wroclaw	Dolnoslaskie
Portugal	Instituto Português de Oncologia Dr. Francisco Gentil	Coimbra
Portugal	Centro Hospitalar Lisboa Norte - Hospital de Santa Maria	Lisboa
Portugal	Fundação Champalimaud	Lisboa
Portugal	Centro Hospitalar do Porto - Hospital de Santo António	Porto
Portugal	IPOFG - Porto	Porto
Puerto Rico	Puerto Rico Hematology/Oncology Group	Bayamon
Puerto Rico	UPR Comprehensive Cancer Center	San Juan
Romania	SC Oncopremium Team SRL	Baia Mare	Maramure?
Romania	Institutul Oncologic Dr Trestioreanu Bucuresti	Bucuresti	Sector 2
Romania	Spitalul Clinic Filantropia	Bucuresti
Romania	Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca	Cluj-Napoca	Cluj
Romania	Centrul de Oncologie Sf. Nectarie SRL	Craiova	Dolj
Romania	S.C. R.T.C. Radiology Therapeutic Center S.R.L.	Otopeni	Ilfov
Romania	Ovidius Clinical Hospital OCH	Ovidiu	Constanta
Russian Federation	Chelyabinsk Regional Oncology Dispensary	Chelyabinsk
Russian Federation	Kaluga Regional Clinical Oncology Center	Kaluga	Kalužskaja Oblast'
Russian Federation	Republican Clinical Oncology Dispensary	Kazan	Tatarstan Republic
Russian Federation	Kursk Regional Oncology Dispensary	Kursk	Kurskaya Oblast'
Russian Federation	Blokhin Cancer Research Center	Moscow
Russian Federation	Burdenko Main Military Hospital	Moscow	Moskva
Russian Federation	Fed State Budgetary Inst "N.N. Blokhin Med Center of Oncology" MHRF	Moscow	Moskva
Russian Federation	Orenburg Regional Clinical Oncology Dispensary	Orenburg	Orenburgskaya Oblast'
Russian Federation	Leningrad Regional Oncology Dispensary	Saint Petersburg	Sankt-Peterburg
Russian Federation	St. Petersburg City Clinical Oncological Dispensary	Saint-Petersburg
Russian Federation	Samara Regional Clinical Oncology Dispensary	Samara	Samarskaya Oblast'
Russian Federation	N.N.Petrov Research Institute of Oncology	St. Petersburg
Russian Federation	North-Western State Medical University named after I.I.Mechnikov	St. Petersburg
Russian Federation	St-Petersburg scientifical practical cente spec medical care	St. Petersburg
Russian Federation	Volgograd regional clinical oncology dispensary	Volzhsky	Volgogradskaya Oblast'
Russian Federation	Yaroslavl region regional clinical oncology hospital	Yaroslavl	Yaroslavskaya Oblast'
Saudi Arabia	King Fahad Specialist Hospital-Dammam	Dammam	Ash Sharqiyah
Saudi Arabia	King Abdulaziz Medical City - National Guard Hospital	Riyadh	Ar Riya?
Saudi Arabia	King Fahad Medical City	Riyadh	Ar Riya?
Saudi Arabia	King Faisal Specialist Hospital & Research Center	Riyadh
Singapore	National Cancer Center	Singapore	Central Singapore
Singapore	National University Hospital	Singapore
South Africa	Cancercare Rondebosch Oncology	Cape Town	Western Cape
South Africa	GVI Oncology	George	Western Cape
South Africa	Cancercare Langenhoven Drive Oncology Centre	Port Elizabeth	Eastern Cape
South Africa	Eastleigh Breast Care Center	Pretoria	Gauteng
South Africa	Life Groenkloof	Pretoria	Gauteng
South Africa	Sandton Oncology Medical Group (Pty) Ltd	Sandton	Gauteng
Spain	Hospital Universitario Fundacion ALcorcon	Alcorcón	Madrid
Spain	Hospital Clínic de Barcelona	Barcelona	Catalunya [Cataluña]
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona	Catalunya [Cataluña]
Spain	Hospital Quiron Barcelona	Barcelona	Barcelona [Barcelona]
Spain	Hospital Universitari Vall d'Hebron	Barcelona
Spain	Parc de Salut Mar - Hospital del Mar	Barcelona
Spain	Hospital Universitario Reina Sofia	Cordoba	Andalucía
Spain	Hospital Clinico Universitario San Cecilio	Granada
Spain	Complejo Hospitalario Ciudad De Jaen	Jaen
Spain	Hospital Universitario de Canarias	La Laguna	Santa Cruz De Tenerife
Spain	Hospital Universitari Arnau de Vilanova	Lleida	Cataluña
Spain	Hospital Clinico San Carlos	Madrid
Spain	Hospital General Universitario Gregorio Marañon	Madrid
Spain	Hospital La Princesa	Madrid
Spain	Hospital Universitario 12 de Octubre	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario HM Sanchinarro	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid	Madrid, Comunidad De
Spain	Hospital Universitario Virgen de la Victoria	Malaga	Málaga
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon	Madrid
Spain	Hospital Clinico De Salamanca	Salamanca
Spain	CHUS - Hospital Clinico Universitario	Santiago de Compostela	La Coruna
Spain	Hospital Universitario Virgen de Valme	Sevilla
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Spain	Hospital Universitario Virgen Macarena	Sevilla
Spain	Hospital Clínico Universitario de Valencia	Valencia	Valenciana, Comunitat
Spain	Hospital Quirón Salud Valencia	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza
Sweden	Skånes universitetssjukhus Lund	Lund
Sweden	Sundsvalls Sjukhus	Sundsvall	Västernorrlands Län [se-22]
Sweden	Norrlands universitetssjukhus	Umeå	Västerbottens Län [se-24]
Sweden	Västmanlands sjukhus Västerås	Västerås	Västmanlands Län [se-19]
Sweden	Växjö Centrallasarettet	Växjö
Taiwan	Changhua Christian Hospital	Changhua
Taiwan	Kaohsiung Medical University Chung-Ho Memorial Hospital	Kaohsiung City
Taiwan	Chang Gung Memorial Hospital - Kaohsiung	Kaohsiung Niao Sung Dist	Kaohsiung
Taiwan	Tri-Service General Hospital	Neihu Taipei
Taiwan	Taipei Medical University Hospital	New Taipei City
Taiwan	China Medical University Hospital	Taichung
Taiwan	Koo Foundation Sun Yat-Sen Cancer Center	Taipei
Taiwan	National Taiwan University Hospital	Taipei
Taiwan	Taipei Veterans General Hospital	Taipei
Taiwan	MacKay Memorial Hospital	Taipei City
Taiwan	Chang Gung Medical Foundation-Linkou Branch	Taoyuan City
Turkey	Baskent University Dr. Turgut Noyan Research and Training Center	Adana
Turkey	Ankara Universitesi Tip Fakultesi Hastanesi	Ankara
Turkey	Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp	Ankara
Turkey	Gulhane Egitim Arastirma Hastanesi	Ankara	Kecioren
Turkey	Hacettepe Universitesi	Ankara
Turkey	Akdeniz Universitesi Hastanesi	Antalya
Turkey	Ege Universitesi Hastanesi	Bornova	Izmir
Turkey	Trakya University Faculty of Medicine	Edirne
Turkey	TC Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin Sehir Hastanesi	Istanbul
Turkey	Istanbul Universitesi Cerrahpasa	Istanbul- Fatih	Istanbul
Turkey	Izmir Medical Park Hospital	Izmir, Karsiyaka	Izmir
Turkey	Kocaeli Üniversitesi	Kocaeli
Turkey	Inönü Üniversitesi Turgut Özal Tip Merkezi Egitim ve Arastirma Hastanesi	Malatya
Turkey	Acibadem Altunizade Hospital	Üsküdar / Stanbul	Istanbul
Ukraine	Municipal Non-profit Enterprise "City Clinical Hospital #4" of Dnipro City Council	Dnipro	Dnipropetrovska Oblast
Ukraine	Communal Enterprise 'Kryvyi Rih Oncology Dispensary' of the Dnipropetrovsk Regional Council	Kriviy Rig	Dnipropetrovska Oblast
Ukraine	Municipal Enterprise "Volyn Regional Medical Oncology Centre" of the Volyn Regional Council	Lutsk	Volynska Oblast
Ukraine	Municipal non-profit enterprise'Odesa Regional Clinical Hospital'of Odesa Regional Council	Odesa	Odeska Oblast
Ukraine	Poltava Regional Clinical Oncology Center	Poltava	Poltavska Oblast
Ukraine	Uzhgorod Central City Clinical Hospital	Uzhhorod	Zakarpatska Oblast
Ukraine	Communal Noncommercial Enterprise "Podillia Regional Oncology Center Of Vinnytsia Regional Council"	Vinnytsia	Vinnytska Oblast
United Kingdom	Victoria Hospital	Blackpool	Lancashire
United Kingdom	Boston Pilgrim Hospital	Boston	Lincolnshire
United Kingdom	Airedale General Hospital	Bradford
United Kingdom	James Cook University Hospital	Central Middlesbrough	Middlesbrough
United Kingdom	Mid Essex Hospital Services NHS Trust	Chelmsford	Essex
United Kingdom	Charing Cross Hospital	Chelsea	Hammersmith And Fulham
United Kingdom	Western General Hospital	Edinburgh	Midlothian
United Kingdom	Royal Surrey County Hospital	Guildford	Surrey
United Kingdom	Guys/St. Thomas Hospital	London	Surrey
United Kingdom	North Middlesex Hospital	London	Greater London
United Kingdom	Sarah Canon Research Institute UK	London	Surrey
United Kingdom	The Christie	Manchester
United Kingdom	Mount Vernon Hospital	Northwood	Hertfordshire
United Kingdom	Nottingham City Hospital	Nottingham	Nottinghamshire
United Kingdom	The Churchill Hospital	Oxford	Oxfordshire
United Kingdom	Royal Preston Hospital	Preston	Lancashire
United Kingdom	Royal Marsden Hospital	Sutton	Surrey
United Kingdom	Musgrove Park Hospital	Taunton	Somerset
United Kingdom	Royal Cornwall Hospital	Truro	England
United States	Abington Medical Specialists	Abington	Pennsylvania
United States	Providence Alaska Medical Center	Anchorage	Alaska
United States	University Cancer & Blood Center, LLC	Athens	Georgia
United States	Northside Hospital	Atlanta	Georgia
United States	MultiCare Regional Cancer Center - Auburn	Auburn	Washington
United States	Texas Oncology Cancer Care and Research Center	Austin	Texas
United States	Memorial Sloan Kettering - Basking Ridge	Basking Ridge	New Jersey
United States	Mary Bird Perkins Cancer Center - Baton Rouge	Baton Rouge	Louisiana
United States	St. Luke's Hospital & Health Network	Bethlehem	Pennsylvania
United States	Beverly Hills Cancer Center	Beverly Hills	California
United States	Broome Oncology	Binghamton	New York
United States	University of Alabama Birmingham	Birmingham	Alabama
United States	Dana-Farber Cancer Institute	Boston	Massachusetts
United States	USO-Rocky Mountain Cancer Center	Boulder	Colorado
United States	Cancer Care of Maine	Brewer	Maine
United States	Roy and Patricia Disney Family Cancer Center - Providence Saint Joseph Medical Center	Burbank	California
United States	The University of Vermont Medical Center Inc.	Burlington	Vermont
United States	Aultman Hospital	Canton	Ohio
United States	WakeMed Cancer Care - Waverly Hematology & Medical Oncology	Cary	North Carolina
United States	Chattanooga Research and Medicine	Chattanooga	Tennessee
United States	Erlanger Health System	Chattanooga	Tennessee
United States	John H. Stroger Hospital of Cook County	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	Cleveland Clinic Foundation	Cleveland	Ohio
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	Columbus Community Clinical Oncology Program	Columbus	Ohio
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	Dallas	Texas
United States	University of Texas Southwestern Medical Center at Dallas	Dallas	Texas
United States	City of Hope National Medical Center	Duarte	California
United States	McLeod Regional Medical Center	Florence	South Carolina
United States	Summit Medical Group Cancer Center	Florham Park	New Jersey
United States	Florida Cancer Specialists - South	Fort Myers	Florida
United States	Texas Oncology Fort Worth	Fort Worth	Texas
United States	Hematology Oncology Associates of Fredericksburg Inc.	Fredericksburg	Virginia
United States	California Cancer Associates Research and Excellence	Fresno	California
United States	University of Florida College of Medicine	Gainesville	Florida
United States	The West Clinic	Germantown	Tennessee
United States	Banner MD Anderson Cancer Center	Gilbert	Arizona
United States	Arizona Oncology Associates, P.C. - HOPE	Goodyear	Arizona
United States	St Francis Cancer Center	Greenville	South Carolina
United States	Meritus John Marsh Cancer Center	Hagerstown	Maryland
United States	Kaiser Permanente	Harbor City	California
United States	Margaret R. Pardee Memorial Hospital	Hendersonville	North Carolina
United States	Millennium Oncology	Hollywood	Florida
United States	University of Hawaii Cancer Center	Honolulu	Hawaii
United States	Terrebonne General Medical Center	Houma	Louisiana
United States	Oncology Consultants, P.A.	Houston	Texas
United States	Franciscan St. Francis Health	Indianapolis	Indiana
United States	Jackson Oncology Associates PLLC	Jackson	Mississippi
United States	Cancer Specialists of North Florida	Jacksonville	Florida
United States	Mayo Clinic in Florida	Jacksonville	Florida
United States	St. Bernards Medical Center	Jonesboro	Arkansas
United States	HCA Midwest Kansas City, MidAmerica Division, Inc.	Kansas City	Missouri
United States	New England Cancer Specialists - Kennebunk	Kennebunk	Maine
United States	Urology Associates of Kingsport	Kingsport	Tennessee
United States	Tennessee Cancer Specialists	Knoxville	Tennessee
United States	University of Tennessee Medical Center	Knoxville	Tennessee
United States	Community Howard Oncology Center	Kokomo	Indiana
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	Central Maine Medical Center	Lewiston	Maine
United States	Texas Oncology P.A.	Lewisville	Texas
United States	Loma Linda University School of Medicine	Loma Linda	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Univ of Louisville School of Medicine	Louisville	Kentucky
United States	Northwest Georgia Oncology Centers, a Service of Wellstar Cobb Hospital	Marietta	Georgia
United States	Asante Rogue Regional Medical Center	Medford	Oregon
United States	Baptist Cancer Center	Memphis	Tennessee
United States	Pacific Cancer Care	Monterey	California
United States	Florida Cancer Specialists	Nashville	Tennessee
United States	Sarah Cannon Cancer Center	Nashville	Tennessee
United States	Tennessee Oncology Nashville	Nashville	Tennessee
United States	Yale-New Haven Hospital	New Haven	Connecticut
United States	Weill Cornell Medical College	New York	New York
United States	Newark Beth Israel Medical Center	Newark	New Jersey
United States	Ocala Oncology, P.A.	Ocala	Florida
United States	Cancer Alliance of Nebraska	Omaha	Nebraska
United States	Nebraska Methodist Hospital	Omaha	Nebraska
United States	Tennessee Cancer Specialists	Omaha	Nebraska
United States	St. Joseph Hospital	Orange	California
United States	Albert Einstein Healthcare Network	Philadelphia	Pennsylvania
United States	Mayo Clinic Hospital	Phoenix	Arizona
United States	St. Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	AHN Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	NSABP Foundation	Pittsburgh	Pennsylvania
United States	PinnacleHealth Cancer Institute	Pittsburgh	Pennsylvania
United States	Univ of Pittsburgh Cancer Inst. (UPCI)	Pittsburgh	Pennsylvania
United States	Oregon Health and Science University	Portland	Oregon
United States	Vassar Brothers Medical Center	Poughkeepsie	New York
United States	Quincy Medical Group	Quincy	Illinois
United States	Renown Medical Group	Reno	Nevada
United States	Virginia Commonwealth University (VCU) Medical Center	Richmond	Virginia
United States	The Valley Hospital	Ridgewood	New Jersey
United States	Mayo Clinic in Rochester, Minnesota	Rochester	Minnesota
United States	University of California Davis (UC Davis) Comprehensive Cancer Center	Sacramento	California
United States	Florida Cancer Specialists - North	Saint Petersburg	Florida
United States	Utah Cancer Specialists	Salt Lake City	Utah
United States	University of Texas Health Science Center - San Antonio	San Antonio	Texas
United States	UCSF Medical Center at Mission Bay	San Francisco	California
United States	California Cancer Associates in Research and Excellence	San Marcos	California
United States	Dignity Health Dominican Oncology and Hematology	Santa Cruz	California
United States	Summit Cancer Care DBA Candler Medical Oncology Practice	Savannah	Georgia
United States	Swedish Medical Center	Seattle	Washington
United States	Sanford USD Medical Center	Sioux Falls	South Dakota
United States	Spartanburg Regional Medical Center	Spartanburg	South Carolina
United States	Highlands Oncology Group	Springdale	Arkansas
United States	SUNY At Stony Brook	Stony Brook	New York
United States	Tallahassee Memorial Cancer Center	Tallahassee	Florida
United States	Moffitt Cancer Center, Richard M. Shulze Family Foundation Outpatient Center	Tampa	Florida
United States	Arizona Oncology Associates, P.C. - HOPE	The Woodlands	Texas
United States	Comprehensive Cancer Centers of Nevada	The Woodlands	Texas
United States	Illinois Cancer Specialists	The Woodlands	Texas
United States	Miami Cancer Institute at Baptist Health, Inc.	The Woodlands	Texas
United States	Minnesota Oncology/Hematology PA	The Woodlands	Texas
United States	Northwest Cancer Specialists PC	The Woodlands	Texas
United States	Oncology and Hematology Associates of Southwest Virginia Inc	The Woodlands	Texas
United States	Oncology Hematology Care Inc	The Woodlands	Texas
United States	Oncology Hematology West	The Woodlands	Texas
United States	Sansum Clinic	The Woodlands	Texas
United States	Shenandoah Oncology, P.C.	The Woodlands	Texas
United States	Texas Oncology - Dallas Presbyterian Hospital	The Woodlands	Texas
United States	Texas Oncology - Denison	The Woodlands	Texas
United States	Texas Oncology - McAllen	The Woodlands	Texas
United States	Texas Oncology - McKinney	The Woodlands	Texas
United States	Texas Oncology - Medical City Dallas	The Woodlands	Texas
United States	Texas Oncology - Methodist Dallas Cancer Center	The Woodlands	Texas
United States	Texas Oncology - Paris	The Woodlands	Texas
United States	Texas Oncology - San Antonio Medical Center	The Woodlands	Texas
United States	Texas Oncology - The Woodlands	The Woodlands	Texas
United States	Texas Oncology - Tyler	The Woodlands	Texas
United States	Texas Oncology - West Texas	The Woodlands	Texas
United States	Texas Oncology Cancer Care and Research Center	The Woodlands	Texas
United States	Texas Oncology Denton	The Woodlands	Texas
United States	Texas Oncology Fort Worth	The Woodlands	Texas
United States	Texas Oncology P.A.	The Woodlands	Texas
United States	Texas Oncology- Mesquite	The Woodlands	Texas
United States	Texas Oncology-Arlington South	The Woodlands	Texas
United States	Texas Oncology-Baylor Charles A. Sammons Cancer Center	The Woodlands	Texas
United States	Texas Oncology-Deke Slayton Cancer Center	The Woodlands	Texas
United States	Texas Oncology-Plano East	The Woodlands	Texas
United States	Texas Oncology-Plano West	The Woodlands	Texas
United States	US Oncology	The Woodlands	Texas
United States	USO - Texas Oncology, P. A.	The Woodlands	Texas
United States	USO-Maryland Oncology Hematology, P.A.	The Woodlands	Texas
United States	USO-New York Oncology Hematology, P.C	The Woodlands	Texas
United States	USO-Rocky Mountain Cancer Center	The Woodlands	Texas
United States	USO-Southern Cancer Center, P.C.	The Woodlands	Texas
United States	USO-Virginia Oncology Associates	The Woodlands	Texas
United States	Virginia Cancer Specialists	The Woodlands	Texas
United States	Willamette Valley Cancer Institute & Research Ctr.	The Woodlands	Texas
United States	USO-Rocky Mountain Cancer Center	Thornton	Colorado
United States	Community Medical Center	Toms River	New Jersey
United States	The University of Arizona Cancer Center	Tucson	Arizona
United States	Texas Oncology - Paris	Tyler	Texas
United States	Texas Oncology - Tyler	Tyler	Texas
United States	Kaiser Permanente	Vallejo	California
United States	White Plains Hospital	White Plains	New York
United States	Cancer Center of Kansas	Wichita	Kansas
United States	Wake Forest University Health Sciences	Winston-Salem	North Carolina
United States	Reliant Medical Group, Inc.	Worcester	Massachusetts
United States	WellSpan Health/York Cancer Center Oncology Research	York	Pennsylvania
United States	Yuma Regional Cancer Center	Yuma	Arizona

Sponsors (2)

Lead Sponsor	Collaborator
Eli Lilly and Company	NSABP Foundation Inc

Countries where clinical trial is conducted

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Invasive Disease Free Survival (IDFS)	IDFS, as defined by the STEEP System, was measured from the date of randomization to the date of first occurrence of one of the following events: ipsilateral invasive breast tumor recurrence, regional invasive breast cancer recurrence, distant recurrence, contralateral invasive breast cancer, second primary non-breast invasive cancer, death attributable to any cause.	Baseline to Recurrence or Death from Any Cause (Up to 32 Months)
Secondary	IDFS for Participants With Ki-67 Index =20%	Outcome data will be provided after the study is completed.	Baseline to Recurrence or Death from Any Cause (Approximately 10 Years)
Secondary	Distant Relapse-Free Survival (DRFS)	Distant relapse-free survival is defined as the time from randomization to distant recurrence or death from any cause, whichever occurs first.	Baseline to Distant Recurrence or Death from Any Cause (Up to 32 Months)
Secondary	Overall Survival (OS)	Outcome data will be provided after the study is completed.	Baseline to Death from Any Cause (Approximately 10 Years)
Secondary	Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib	Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib	Day 1 (2 hours post-dose), Days 30, 60, 90 post-dose
Secondary	Change From Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B)	Outcome data will be provided after the study is completed.	Baseline, Follow Up (Approximately 3 Years)
Secondary	Change From Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES)	Outcome data will be provided after the study is completed.	Baseline, Follow Up (Approximately 3 Years)]
Secondary	Change From Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)	Outcome data will be provided after the study is completed.	Baseline, Follow Up (Approximately 3 Years)]
Secondary	Change From Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L)	Outcome data will be provided after the study is completed.	Baseline, Follow Up (Approximately 3 Years)]

External Links

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