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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03155997
Recruitment Status : Active, not recruiting
First Posted : May 16, 2017
Last Update Posted : October 17, 2019
NSABP Foundation Inc
Information provided by (Responsible Party):
Eli Lilly and Company

Brief 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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Abemaciclib Drug: Standard Adjuvant Endocrine Therapy Phase 3

Expanded Access : An investigational treatment associated with this study is available outside the clinical trial.   More info ...

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 4580 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 12, 2017
Estimated Primary Completion Date : April 12, 2021
Estimated Study Completion Date : June 10, 2027

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Abemaciclib

Arm Intervention/treatment
Experimental: Abemaciclib + Standard Adjuvant Endocrine Therapy
Abemaciclib administered orally and standard adjuvant endocrine therapy administered according to package label.
Drug: Abemaciclib
Administered orally.
Other Name: LY2835219

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

Standard Adjuvant Endocrine Therapy
Standard adjuvant endocrine therapy administered according to package label.
Drug: Standard Adjuvant Endocrine Therapy
Administered according to label instructions.

Primary Outcome Measures :
  1. Invasive Disease Free Survival (IDFS) [ Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years) ]

Secondary Outcome Measures :
  1. IDFS for Participants with Ki-67 Index ≥20% [ Time Frame: Baseline to Recurrence or Death from Any Cause (Approximately 10 Years) ]
    IDFS for participants with Ki-67 index ≥20%

  2. Distant Relapse-Free Survival (DRFS) [ Time Frame: Baseline to Distant Recurrence or Death from Any Cause (Approximately 10 Years) ]

  3. Overall Survival (OS) [ Time Frame: Baseline to Death from Any Cause (Approximately 10 Years) ]

  4. Pharmacokinetics (PK): Minimum Steady State Concentration (Cmin,ss) of Abemaciclib [ Time Frame: Post Dose Day 1 through Month 3 ]
    PK: Cmin,ss of Abemaciclib

  5. Change from Baseline on the Functional Assessment of Cancer Therapy - Breast (FACT-B) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ]
    Change from Baseline on the FACT-B

  6. Change from Baseline on the Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ]
    Change from Baseline on the FACT-ES

  7. Change from Baseline on the Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ]
    Change from Baseline on the FACIT-F

  8. Change from Baseline on the EuroQol Five-Dimension Five-Level Questionnaire (EQ-5D-5L) [ Time Frame: Baseline, Follow Up (Approximately 3 Years) ]
    Change from Baseline on the EQ-5D-5L

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03155997

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United States, Alabama
University of Alabama Birmingham
Birmingham, Alabama, United States, 32594
Southern Cancer Center, P.C.
Daphne, Alabama, United States, 36526
United States, Arizona
Banner MD Anderson Cancer Center
Gilbert, Arizona, United States, 85234
University of Arizona Cancer Center
Phoenix, Arizona, United States, 85004
Mayo Clinic Hospital
Phoenix, Arizona, United States, 85054
Arizona Oncology Associates, P.C.
Tempe, Arizona, United States, 85284
Arizona Oncology Associates, P.C.
Tucson, Arizona, United States, 85704
The University of Arizona Cancer Center
Tucson, Arizona, United States, 85719
Yuma Regional Cancer Center
Yuma, Arizona, United States, 85364
United States, Arkansas
Highlands Oncology Group
Fayetteville, Arkansas, United States, 72703
St. Bernards Medical Center
Jonesboro, Arkansas, United States, 72401
United States, California
Beverly Hills Cancer Center
Beverly Hills, California, United States, 90211
Providence St. Joseph's Medical Center
Burbank, California, United States, 91505
City of Hope National Medical Center
Duarte, California, United States, 91010-0269
California Cancer Associates Research and Excellence (cCARE)
Fresno, California, United States, 93720
Loma Linda University School of Medicine
Loma Linda, California, United States, 92354
Cedars Sinai Medical Center
Los Angeles, California, United States, 90048-5615
Pacific Cancer Care
Monterey, California, United States, 93940
St. Joseph Hospital
Orange, California, United States, 92868
University of California, Davis - Health Systems
Sacramento, California, United States, 95817
Kaiser Permanente Medical Group
San Diego, California, United States, 92108
Univ of California San Francisco
San Francisco, California, United States, 94115
California Cancer Associates in Research and Excellence
San Marcos, California, United States, 92069
Sansum Clinic
Santa Barbara, California, United States, 93105
Dominican Hospital
Santa Cruz, California, United States, 95065
Kaiser Permanente
Vallejo, California, United States, 94589
United States, Colorado
Rocky Mountain Cancer Center
Denver, Colorado, United States, 80220
United States, Connecticut
Yale University School of Medicine
New Haven, Connecticut, United States, 06510
United States, Florida
Florida Cancer Specialists
Fort Myers, Florida, United States, 33901
University of Southern Florida School of Medicine
Gainesville, Florida, United States, 32610-0296
Millennium Oncology
Hollywood, Florida, United States, 33024
Mayo Clinic-Jacksonville
Jacksonville, Florida, United States, 32224
Miami Cancer Institute at Baptist Health, Inc.
Miami, Florida, United States, 33176
Ocala Oncology, P.A.
Ocala, Florida, United States, 34474
Cancer Specialists of North Florida -St Augustine
Saint Augustine, Florida, United States, 32086
Florida Cancer Specialists
Saint Petersburg, Florida, United States, 33705
Tallahassee Memorial Cancer Center
Tallahassee, Florida, United States, 32308
H Lee Moffitt Cancer Center
Tampa, Florida, United States, 33612
Florida Cancer Specialists
West Palm Beach, Florida, United States, 33401
United States, Georgia
Northeast Georgia Cancer Care, LLC
Athens, Georgia, United States, 30607
Northside Hospital Cancer Institute
Atlanta, Georgia, United States, 30342
Northwest Georgia Oncology Centers
Marietta, Georgia, United States, 30060
Summit Cancer Care
Savannah, Georgia, United States, 31405
United States, Hawaii
University of Hawaii Cancer Center
Honolulu, Hawaii, United States, 96813
United States, Illinois
John H. Stroger Hospital of Cook County
Chicago, Illinois, United States, 60612
Rush University Medical Center
Chicago, Illinois, United States, 60612
Edward Cancer Center
Naperville, Illinois, United States, 60540
Illinois Cancer Specialists-Niles
Niles, Illinois, United States, 60714
Quincy Medical Group
Quincy, Illinois, United States, 62301
United States, Indiana
Franciscan St. Francis Health
Indianapolis, Indiana, United States, 46237
Community Howard Oncology Center
Kokomo, Indiana, United States, 46902
United States, Kansas
Cancer Center of Kansas
Wichita, Kansas, United States, 67214
United States, Kentucky
Univ of Louisville School of Medicine
Louisville, Kentucky, United States, 40202
United States, Louisiana
Lady of the Lake Physicians' Group
Baton Rouge, Louisiana, United States, 70809
Terrebonne General Medical Center
Houma, Louisiana, United States, 70360
United States, Maine
Eastern Maine Medical Center
Brewer, Maine, United States, 04412
Central Maine Healthcare Corporation
Lewiston, Maine, United States, 04240
New England Cancer Specialists - Scarborough
Scarborough, Maine, United States, 04074
United States, Maryland
Maryland Oncology Hematology, P.A.
Columbia, Maryland, United States, 21044
Meritus John Marsh Cancer Center
Hagerstown, Maryland, United States, 21742
United States, Massachusetts
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Reliant Medical Group, Inc.
Worcester, Massachusetts, United States, 01608
United States, Minnesota
Minnesota Oncology/Hematology PA
Minneapolis, Minnesota, United States, 55404
Mayo Clinic
Rochester, Minnesota, United States, 55905-0002
United States, Mississippi
Jackson Oncology Associates PLLC
Jackson, Mississippi, United States, 39202-2002
United States, Missouri
Research Medical Center
Kansas City, Missouri, United States, 64132
United States, Nebraska
Cancer Alliance of Nebraska
Omaha, Nebraska, United States, 68106
Nebraska Methodist Cancer Center
Omaha, Nebraska, United States, 68114
NCCA- National Cancer Care Alliance
Omaha, Nebraska, United States, 68130
Oncology Hematology West
Omaha, Nebraska, United States, 68130
United States, Nevada
Comprehensive Cancer Centers of Nevada
Henderson, Nevada, United States, 89052
Renown Medical Group
Reno, Nevada, United States, 89502
United States, New Hampshire
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756-0001
United States, New Jersey
Summit Medical Group PA
Florham Park, New Jersey, United States, 07932
Newark Beth Israel Medical Center
Newark, New Jersey, United States, 07112
The Valley Hospital - Luckow Pavilion
Paramus, New Jersey, United States, 07652
Community Medical Center
Toms River, New Jersey, United States, 08755
United States, New York
New York Oncology Hematology, P.C
Albany, New York, United States, 12206
Broome Oncology LLC
Johnson City, New York, United States, 13790
Memorial Sloan Kettering Cancer Center
New York, New York, United States, 10065
Weill Cornell Medical College
New York, New York, United States, 10065
Vassar Brothers Medical Center
Poughkeepsie, New York, United States, 12601
SUNY At Stony Brook
Stony Brook, New York, United States, 11794
White Plains Hospital
White Plains, New York, United States, 10601
United States, North Carolina
Waverly Hematology Oncology
Cary, North Carolina, United States, 27518
Margaret R. Pardee Memorial Hospital
Hendersonville, North Carolina, United States, 28739
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States, 27157-1045
United States, Ohio
Aultman Hospital
Canton, Ohio, United States, 44710
University Hospitals Case Medical Center
Cleveland, Ohio, United States, 44106
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
Columbus Community Clinical Oncology Program
Columbus, Ohio, United States, 43215
Oncology Hematology Care Inc
Fairfield, Ohio, United States, 45014
United States, Oregon
Hematology Oncology Associates, PC
Medford, Oregon, United States, 97504
OHSU Knight Cancer Institute
Portland, Oregon, United States, 97210
Providence Cancer Center Oncology Hematology Care
Portland, Oregon, United States, 97213
Northwest Cancer Specialists PC
Portland, Oregon, United States, 97225
Willamette Valley Cancer Institute & research Ctr.
Springfield, Oregon, United States, 97477
United States, Pennsylvania
Abington Memorial Hospital
Abington, Pennsylvania, United States, 19001
St. Luke's Hospital & Health Network
Bethlehem, Pennsylvania, United States, 18015
PinnacleHealth Cancer Institute
Harrisburg, Pennsylvania, United States, 17109
Albert Einstein Healthcare Network
Philadelphia, Pennsylvania, United States, 19141
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
NSABP Foundation
Pittsburgh, Pennsylvania, United States, 15213
Univ of Pittsburgh Cancer Inst. (UPCI)
Pittsburgh, Pennsylvania, United States, 15213
WellSpan Health/York Cancer Center Oncology Research
York, Pennsylvania, United States, 17403
United States, South Carolina
McLeod Regional Medical Center
Florence, South Carolina, United States, 29502
Bon Secours Saint Francis Cancer Center
Greenville, South Carolina, United States, 29607
Spartanburg Regional Medical Center
Spartanburg, South Carolina, United States, 29303
United States, South Dakota
Sanford Research/USD
Sioux Falls, South Dakota, United States, 57104
United States, Tennessee
UT/Erlanger Oncology & Hematology
Chattanooga, Tennessee, United States, 37403
Sarah Cannon Research Institute SCRI
Chattanooga, Tennessee, United States, 37404
The West Clinic
Germantown, Tennessee, United States, 38138
Indian Path Community Hospital
Kingsport, Tennessee, United States, 37660
Brig Center For Cancer Care and Survivorship
Knoxville, Tennessee, United States, 37909
University of Tennessee Medical Center
Knoxville, Tennessee, United States, 37920
Baptist Cancer Center
Memphis, Tennessee, United States, 38120
Sarah Cannon Cancer Center
Nashville, Tennessee, United States, 37203
Tennessee Oncology PLLC
Nashville, Tennessee, United States, 37203
United States, Texas
Texas Oncology - Amarillo
Amarillo, Texas, United States, 79106
Texas Oncology-Arlington South
Arlington, Texas, United States, 76014
Texas Oncology Cancer Center
Austin, Texas, United States, 78731
Texas Oncology - Carrollton
Carrollton, Texas, United States, 75010
Texas Oncology - Methodist Dallas Cancer Center
Dallas, Texas, United States, 75203
Texas Oncology - Medical City Dallas
Dallas, Texas, United States, 75230
Texas Oncology - Dallas Presbyterian Hospital
Dallas, Texas, United States, 75231
Texas Oncology-Baylor Charles A. Sammons Cancer Center
Dallas, Texas, United States, 75246
University of Texas Southwestern Medical Center at Dallas
Dallas, Texas, United States, 75390-8575
Texas Oncology Denton
Denton, Texas, United States, 76210-6857
Texas Oncology-El Paso Cancer Treatment Center
El Paso, Texas, United States, 79902
Texas Oncology Fort Worth
Fort Worth, Texas, United States, 76104
Oncology Consultants, P.A.
Houston, Texas, United States, 77030
Texas Oncology - Tyler
Longview, Texas, United States, 75601
Texas Oncology - McAllen
McAllen, Texas, United States, 78503
Texas Oncology-McKinney
McKinney, Texas, United States, 75071
Texas Oncology- Mesquite
Mesquite, Texas, United States, 75150
Texas Oncology - Paris
Paris, Texas, United States, 75460
Texas Oncology-Plano East
Plano, Texas, United States, 75075
Texas Oncology-Plano West
Plano, Texas, United States, 75093
University of Texas Health Science Center - San Antonio
San Antonio, Texas, United States, 78229
Texas Oncology - San Antonio Medical Center
San Antonio, Texas, United States, 78240
Texas Oncology-Sherman
Sherman, Texas, United States, 75090-0504
Texas Oncology - The Woodlands
The Woodlands, Texas, United States, 77380
US Oncology
The Woodlands, Texas, United States, 77380
Texas Oncology Cancer Care and Research Center
Waco, Texas, United States, 76712
Texas Oncology-Deke Slayton Cancer Center
Webster, Texas, United States, 77598-4219
United States, Utah
Utah Cancer Specialists
Salt Lake City, Utah, United States, 84106
United States, Vermont
University of Vermont Medical Center
Burlington, Vermont, United States, 05401
United States, Virginia
Virginia Cancer Specialists
Fairfax, Virginia, United States, 22031
Hematology Oncology Associates of Fredericksburg Inc.
Fredericksburg, Virginia, United States, 22408
Virginia Oncology Associates
Norfolk, Virginia, United States, 23502
Virginia Commonwealth University
Richmond, Virginia, United States, 23298
Oncology and Hematology Associates of Southwest Virginia Inc
Salem, Virginia, United States, 24153
Shenandoah Oncology, P.C.
Winchester, Virginia, United States, 22601
United States, Washington
Swedish Medical Center
Seattle, Washington, United States, 98104
Multicare Health System
Tacoma, Washington, United States, 98405
Centro de Oncologia e Investigacion Buenos Aires
Berazategui, Buenos Aires, Argentina, B1884BBF
Caba, Buenos Aires, Argentina, C1440CFD
Instituto de Investigaciones Clinicas Mar del Plata
Mar del Plata, Buenos Aires, Argentina, B7600FZN
Hospital Universitario Austral
Pilar, Buenos Aires, Argentina, B1629ODT
CENIT Centro de Neurociencias, Investigación y Tratamiento
Caba, Ciudad Autonoma Buenos Aires, Argentina, C1125ABD
Centros de Investigaciones Cli-nicas. Clinica Viedma
Viedma, Rio Negro, Argentina, 8500
Instituto de Oncologia de Rosario
Rosario, Santa Fe, Argentina, 2000
Centro Medico San Roque
S.M. De Tucuman, Tucuman, Argentina, T4000IAK
Instituto Médico Especializado Alexander Fleming
Buenos Aires, Argentina, 1426
Hospital Aleman
Capital Federal, Argentina, C1118AAT
Clinica Adventista de Belgrano
Ciudad Autonoma Buenos Aires, Argentina, C1430EGF
Centro Oncologico Riojano Integral
La Rioja, Argentina, 5300
Sanatorio Parque
Salta, Argentina, 4400
Centro Polivalente de Asistencia e Inv. Clinica CER-San Juan
San Juan, Argentina, 5400
Centro para la Atencion Integral del Paciente Oncologico
Tucumain, Argentina, 4000
Australia, New South Wales
Chris O'Brien Lifehouse
Camperdown, New South Wales, Australia, 2050
Lismore Base Hospital
Lismore, New South Wales, Australia, 2480
Liverpool Hospital
Liverpool, New South Wales, Australia, 2170
Calvary Mater Newcastle
Newcastle, New South Wales, Australia, 2298
Mater Private Hospital
North Sydney, New South Wales, Australia, 2291
St Vincent's Hospital
Sydney, New South Wales, Australia, 2010
Westmead Hospital
Westmead, New South Wales, Australia, 2145
Southern Medical Day Care Centre
Wollongong, New South Wales, Australia, 2500
Australia, Queensland
The Townsville Hospital
Douglas, Queensland, Australia, 4814
Mater Adult Hospital Brisbane
South Brisbane, Queensland, Australia, 4101
Gold Coast University Hospital
Southport, Queensland, Australia, 4215
Australia, South Australia
Lyell McEwin Hospital
Elizabeth Vale, South Australia, Australia, 5112
Ashford Cancer Centre Research
Kurralta Park, South Australia, Australia, 5037
Australia, Tasmania
Launceston General Hospital
Launceston, Tasmania, Australia, 7250
Australia, Victoria
Box Hill Hospital
Box Hill, Victoria, Australia, 3128
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia, 3000
Epworth Research Institute
Richmond, Victoria, Australia, 3121
Eastern Health, Maroondah Hospital
Ringwood East, Victoria, Australia, 3135
Australia, Western Australia
St John of God Hospital - Subiaco
Subiaco, Western Australia, Australia, 6008
Breast Cancer Research Centre WA
Nedlands, Australia, 6009
Universitätsklinikum Graz
Graz, Steiermark, Austria, 8036
Universitätsklinik Innsbruck
Innsbruck, Tirol, Austria, 6020
Ordination Dr. Hubalek - Brustzentrum Schwaz
Schwaz, Tirol, Austria, 6130
Universitätsklinikum Salzburg
Salzburg, Austria, 5020
Wien, Austria, 1090
KH Hietzing mit neurologischem Zentrum Rosenhügel
Wien, Austria, 1130
Jessa Ziekenhuis
Hasselt, Limburg, Belgium, 3500
AZ Nikolaas, Campus Moerland
Sint-Niklaas, Oost-Vlaanderen, Belgium, 9100
Vivalia St Joseph
Arlon, Belgium, 6700
AZ Klina
Brasschaat, Belgium, 2930
Algemeen Ziekenhuis St Jan Brugge
Brugge, Belgium, 8000
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Universitair Ziekenhuis Antwerpen
Edegem, Belgium, 2650
Hopital De Jolimont
Haine-St.- Paul, Belgium, 7100
VZW REgional Ziekenhuis Jan Yperman
Ieper, Belgium, 8900
AZ Groeninge
Kortrijk, Belgium, 8500
Universitaire Ziekenhuizen Leuven - Campus Gasthuisberg
Leuven, Belgium, 3000
Centre Hospitalier Universitaire Sart Tilman
Liege, Belgium, 4000
Clinique St Joseph
Liege, Belgium, 4000
Hôpital Civil Marie Curie
Lodelinsart, Belgium, 6042
Clinique St Elisabeth Namur
Namur, Belgium, 5000
Clinique Saint Pierre Ottignies
Ottignies, Belgium, 1340
CHU Dinant Godinne - UCL Namur
Yvoir, Belgium, 5530
Instituto do Cancer do Ceara
Fortaleza, Ceara, Brazil, 60430-230
Sírio-Libanês Brasilia-Centro de Oncologia-Asa Sul
Brasilia, District Federal, Brazil, 70200-730
Hospital Araujo Jorge da Assoc. Combate ao Cancer em Goias
Goiania, Goias, Brazil, 74605-070
Instituto de Cancer de Londrina
Londrina, Parana, Brazil, 86015-520
CIONC - Centro Integrado de Oncologia de Curitiba
Curitiba, Paraná, Brazil, 80810-050
Hospital de Caridade Ijui
Ijui, Rio Grande Do Sul, Brazil, 98700 000
Hospital São Lucas - PUCRS - ONCOLOGY
Porto Alegre, Rio Grande Do Sul, Brazil, 90610-000
Instituto COI de Pesquisa Educação e Gestão
Rio de Janeiro, RJ, Brazil, 22793-080
Hospital Bruno Born de Lajeado
Lajeado, RS, Brazil, 95900-000
Fundação PIO XII
Barretos, Sao Paulo, Brazil, 14784700
Fundação Faculdade de Medicina do ABC
Santo André, Sao Paulo, Brazil, 09060-650
Hospital de Base Fac de Medicina de Sao Jose do Rio Preto
Sao Jose Rio Preto, Sao Paulo, Brazil, 15090-000
Hospital das Clinicas da FMRP
Ribeirao Preto, São Paulo, Brazil, 14048-900
INCA - Instituto Nacional Do Cancer
Rio De Janeiro, Brazil, 20560-120
Instituto do Cancer do Estado de Sao Paulo - ICESP
Sao Paulo, Brazil, 01246000
Soc. Beneficente de Senhoras Hospital Sirio Libanes-Oncology
São Paulo, Brazil, 01308-050
Clin. Pesq.e Centro Estudos Oncologia Ginecológica e Mamária
São Paulo, Brazil, 01317-000
Ibcc-Instituto Brasileiro de Controle Do Câncer
São Paulo, Brazil, 03102-006
Hospital de Servidor Publico Estadual
São Paulo, Brazil, 04039-901
Clinica Onco Star
São Paulo, Brazil, 04501-000
Canada, Ontario
The Ottawa Hospital
Ottawa, Ontario, Canada, K1H 8L6
North York General Hospital
Toronto, Ontario, Canada, M2K 1E1
Humber River Regional Hospital
Toronto, Ontario, Canada, M3M 0B2
St Michaels Hospital
Toronto, Ontario, Canada, M5B 1W8
Canada, Quebec
Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada, H2X 3E4
Jewish General Hospital
Montreal, Quebec, Canada, H3T 1E2
Hopital du Sacre-Coeur de Montreal
Montreal, Quebec, Canada, H4J 1C5
CHU de Quebec-Hopital de Saint-Sacrement
Quebec City, Quebec, Canada, G1S 4L8
Centre Hospitalier Universitaire de Sherbrooke - CHUS
Sherbrooke, Quebec, Canada, J1H 5N4
China, Beijing
The 307th Hospital of Chinese People's Liberation Army
Beijing, Beijing, China, 100071
China, Fujian
Fujian Medical University Union Hospital
Fuzhou, Fujian, China, 350001
China, Guangdong
Guangdong Province People's Hospital
Guangzhou, Guangdong, China, 510080
Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, China, 510080
The First Affiliated Hospital, Sun-Yat Sen University
Guangzhou, Guangdong, China, 510080
China, Heilongjiang
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150081
China, Henan
Henan Cancer Hospital
Zhengzhou, Henan, China, 450008
China, Hunan
Hunan Province Tumor Hospital
Changsha, Hunan, China, 410013
China, Jiangsu
Jiangsu Province Cancer Hospital
Nanjing, Jiangsu, China, 210009
China, Nanjing
The First Affiliated Hospital with Nanjing Medical Universit
Nanjing, Nanjing, China, 210029
China, Shandong
Tumor hospital of Shandong province
JiNan, Shandong, China
China, Zhejiang
Zhejiang Cancer Hospital
Hang Zhou, Zhejiang, China, 310022
Second Affiliate Hospital of Zhejiang Medical University
Hangzhou, Zhejiang, China, 310009
Beijing Tumor Hospital
Beijing, China, 100142
Ruijin Hospital Affiliated to Shanghai Jiao Tong University
Shanghai, China, 200025
Shanghai Tumor Hospital
Shanghai, China, 200030
Masarykuv onkologicky ustav
Brno, Czech Republic, Czechia, 656 53
Nemocnice Horovice
Horovice, Czechia, 268 31
Fakultni Nemocnice Ostrava
Ostrava, Czechia, 708 52
Multiscan, s.r.o.
Pardubice, Czechia, 532 03
FN Plzen Lochotin
Plzen, Czechia, 30460
Thomayerova Nemocnice
Praha 4 - Krc, Czechia, 140 59
Aarhus Universitetshospital
Aarhus, Aarhus N, Denmark, 8200
Odense Universitetshospital
Odense C, Syd, Denmark, 5000
Aalborg Universitets hospital
Aalborg, Denmark, 9000
Herlev Hospital
Herlev, Denmark, 2730
Regionshospitalet Herning
Herning, Denmark, 7400
København Ø, Denmark, 2100
Næstved Sygehus
Næstved, Denmark, 4700
Soenderborg Sygehus
Soenderborg, Denmark, 6400
Sydvestjysk Sygehus Esbjerg
Vejle, Denmark, 7100
Vejle Sygehus
Vejle, Denmark, 7100
Tampere University Hospital TAYS
Tampere, Pirkanmaa, Finland, 33521
Satakunta Central Hospital - Oncology
Pori, Satakunta, Finland, 28500
Helsinki Docrates Cancer Clinic
Helsinki, Finland, 00180
Keski-Suomen Keskussairaala
Jyväskylä, Finland, 40620
Kuopio University Hospital
Kuopio, Finland, 70210
Päijät-Häme Central hospital
Lahti, Finland, 15850
Oulu University Hospital - Oncology
Oulu, Finland, 90220
Turku University Central Hospital
Turku, Finland, SF-20520
Vaasa Central Hospital
Vaasa, Finland, 65130
Centre Jean Perrin
Clermont Ferrand BP 392, Cedex 1, France, 63011
Institut Sainte Catherine
Avignon Cedex 9, France, 84918
CHU de Besancon Hopital Jean Minjoz
Besancon Cedex, France, 25030
CHRU de Brest - Hôpital Morvan
Brest, France, 29200
CHU Henri Mondor
Creteil Cedex, France, 94010
Centre Georges Francois Leclerc
Dijon Cedex, France, 21000
Polyclinique De Blois
La Chaussee Saint Victor, France, 41260
Centre Hospitalier de Vendee Les Oudairies
La Roche Sur Yon, France, 85025
Clinique Victor Hugo
Le Mans, France, 72000
Centre Leon Berard
Lyon Cedex 08, France, 69373
Centre de Cancérologie du Grand Montpellier
Montpellier, France, 34070
Polyclinique de Gentilly
Nancy, France, 54000
Institut Curie
Paris CEDEX 05, France, 75248
Hôpital Privé des Côtes d'Armor- HPCA
Plérin, France, 22190
Centre Eugene Marquis
Rennes Cedex, France, 35042
Centre Henri Becquerel
Rouen Cedex, France, 76038
Centre René Gauducheau
Saint Herblain Cedex, France, 44805
Universitätsklinikum Freiburg
Freiburg im Breisgau, Baden-Württemberg, Germany, 79106
Onkologische Schwerpunktpraxis
Freiburg im Breisgau, Baden-Württemberg, Germany, 79110
Praxis für Onkologie
Friedrichshafen, Baden-Württemberg, Germany, 88045
Klinikum Ludwigsburg
Ludwigsburg, Baden-Württemberg, Germany, 71640
Universitätsklinikum Tübingen
Tübingen, Baden-Württemberg, Germany, 72076
Universitätsklinikum Ulm
Ulm, Baden-Württemberg, Germany, 89075
Hämatologisch-Onkologische Praxis Augsburg
Augsburg, Bavaria, Germany, 86150
Gesundheitszentrum St. Marien Amberg
Amberg, Bayern, Germany, 92224
Universitätsklinikum Erlangen
Erlangen, Bayern, Germany, 91054
Klinikum der Universität München
München, Bayern, Germany, 80337
Rotkreuzklinikum München - Frauenklinik
München, Bayern, Germany, 80637
Klinikum Rechts der Isar der TU München
München, Bayern, Germany, 81675
Agaplesion Markus Krankenhaus
Frankfurt am Main, Hessen, Germany, 60431
Städtische Kliniken Offenbach am Main
Offenbach am Main, Hessen, Germany, 63069
Gemeinschaftspraxis für Hämatologie und Onkologie
Langen, Hesse, Germany, 63225
Franziskus-Hospital Harderberg
Georgsmarienhütte, Niedersachsen, Germany, 49124
Gynäkologisch-onkologische Schwerpunktpraxis am Pelikanplatz
Hannover, Niedersachsen, Germany, 30177
Medizinische Hochschule Hannover
Hannover, Niedersachsen, Germany, 30625
Universitätsklinikum Bonn
Bonn, Nordrhein-Westfalen, Germany, 53105
Universitätsklinikum Düsseldorf
Düsseldorf, Nordrhein-Westfalen, Germany, 40225
Kliniken Essen-Mitte Ev. Huyssens-Stiftung
Essen, Nordrhein-Westfalen, Germany, 45136
HELIOS Klinikum Krefeld
Krefeld, Nordrhein-Westfalen, Germany, 47805
Evangelisches Krankenhaus Bethesda Mönchengladbach gGmbH
Mönchengladbach, Nordrhein-Westfalen, Germany, 41061
Universitätsklinikum Münster
Münster, Nordrhein-Westfalen, Germany, 48149
St. Elisabeth Gruppe - Marien Hospital Witten
Witten, Nordrhein-Westfalen, Germany, 58452
Universitätsklinikum Carl Gustav Carus
Dresden, Sachsen, Germany, 01307
Universitätsklinikum Schleswig-Holstein
Kiel, Schleswig-Holstein, Germany, 24105
SRH Wald-Klinikum Gera gGmbH
Gera, Thüringen, Germany, 07548
HELIOS Klinikum Emil von Behring
Berlin, Germany, 13125
Medizinisches Versorgungszentrum Onkologischer Schwerpunkt am Oskar-Helene-Heim
Berlin, Germany, 14195
Mammazentrum Hamburg Brustklinik am Krankenhaus Jerusalem
Hamburg, Germany, 20357
Kath. Marienkrankenhaus gGmbH
Hamburg, Germany, 22087
MVZ Onkologie Barmbek - Asklepios Klinik Barmbek
Hamburg, Germany, 22307
University General Hospital of Patras
Patras, Achaia, Greece, 26504
Metropolitan Hospital
Neo Faliro, Athens, Greece, 18547
General Hospital of Athens 'Alexandra'
Athens, Attica, Greece, 115 28
Ag. Savvas Hospital
Athens, Attica, Greece, 11522
Gen Onc Hosp Ag. Anargyroi
N. Kifissia, Attica, Greece, 14564
University General Hospital of Heraklion
Heraklion, Crete, Greece, 71110
Bioclinic of Thessaloniki
Thessaloniki, Macedonia, Greece, 54622
General Hospital of Thessaloniki Papageorgiou
N. Efkarpia, Thessaloniki, Greece, 56403
Errikos Dynan
Athens, Greece, 11526
Attikon' University Hospital
Haidari/Athens, Greece, 12462
University Hospital of Ioannina
Ioannina, Greece, 45500
Interbalkan Medical Center
Pylaia/Thessaloniki, Greece, 57001
Euromedica - General Clinic of Thessaloniki
Thessaloniki, Greece, 54645
Hong Kong
Pamela Youde Nethersole Eastern Hospital
Hong Kong, Hong Kong
Queen Mary Hospital
Hong Kong, Hong Kong
Tuen Mun Hospital
Hong Kong, Hong Kong
Queen Elizabeth Hospital
Kowloon, Hong Kong
Bacs-Kiskun Megyei Korhaz
Kecskemet, Bacs-Kiskun, Hungary, 6000
Fovarosi Onkormanyzat Szent Margit Korhaza
Budapest, Hungary, 1032
Magyar Honvedseg Egeszsegugyi Kozpont
Budapest, Hungary, 1062
Szent Imre Egyetemi Oktatokorhaz
Budapest, Hungary, 1115
Semmelweis Egyetem III. sz Belgyogyaszati Klinika
Budapest, Hungary, 1125
Fovarosi Onkormanyzat Uzsoki utcai Korhaz
Budapest, Hungary, 1145
Jasz-Nagykun-Szolnok Megyei Hetenyi Geza Korhaz
Szolnok, Hungary, 5000
MNJ Institute of Oncology
Hyderabad, Andhra Pradesh, India, 500004
Dr. B. L. Kapur Memorial Hospital
New Delhi, Delhi, India, 110005
HCG Cancer Centre
Vadodara, Gujarat, India, 390012
Artemis Hospital
Gurgaon, Haryana, India, 122001
Manipal Hospital
Bangalore, Karmnataka, India, 560017
Regional Cancer Centre
Trivandrum, Kerala, India, 695 011
Tata Memorial Hospital
Mumbai, Maharashtra, India, 400012
HCG Manavata Cancer Centre
Nasik, Maharashtra, India, 422001
Ruby Hall Clinic and Grant Medical Foundation
Pune, Maharashtra, India, 411001
Deenanth Mangeshkar Hospital and Research Centre
Pune, Maharashtra, India, 411004
Apollo Speciality Hospital
Chennai, Tamil Nadu, India, 600018
Apollo Gleneagles Hospitals
Kolkata, West Bengal, India, 700054
Medica Superspecialty Hospital
Kolkata, West Bengal, India, 700099
HCG Cancer Centre
Ahmedabad, India, 380060
Post Graduate Institute of Medical Education & Research
Chandigarh, India, 160012
Soroka Medical Center
Beer Sheva, Israel, 84101
Rambam Medical Center
Haifa, Israel, 3109601
Shaare Zedek Medical Center
Jerusalem, Israel, 9103102
Hadassah Medical Center Ethics Committee
Jerusalem, Israel, 9112001
Meir Medical Center Ethics Committee
Kfar Saba, Israel, 4428164
Rabin Medical Center
Petach Tikva, Israel, 4941492
Sheba Medical Center
Ramat Gan, Israel, 5262000
Kaplan Medical Center
Rehovot, Israel, 7610001
Assaf Harofeh Medical Center
Zerifin, Israel, 6093000
Ospedale Perrino
Brindisi, BR, Italy, 72100
Azienda Ospedaliero Universitaria di Ferrara
Cona, Ferrara, Italy, 44124
Istituto Scientifico Romagnolo - Studio e la Cura dei Tumori
Meldola, Forli, Italy, 47014
Azienda Ospedaliera San Gerardo
Monza, Milano, Italy, 20052
Istituto Clinico Humanitas
Rozzano, Milano, Italy, 20089
Istituto Tumori Fondazione G. Pascale IRCCS
Napoli, Naples, Italy, 80131
Azienda Ospedaliera Santa Maria
Terni, TR, Italy, 05100
Ospedale Bellaria
Bologna, Italy, 40139
Azienda Ospedaliera Universitaria Ospedale San Martino di Genova
Genova, Italy, 16132
Ospedale Fatebenefratelli-Oftalmico
Milano, Italy, 20121
Azienda Ospedaliera Universitaria Policlinico de Modena
Modena, Italy, 41124
Azienda Ospedaliera Universitaria Federico II
Napoli, Italy, 80131
Istituto Oncologico Veneto
Padova, Italy, 35128
Azienda Ospedaliera Di Parma
Parma, Italy, 43100
I.F.O. Istituto Nazionale Tumori Regina Elena
Roma, Italy, 00144
Policlinico Ospedale S. Andrea
Roma, Italy, 00189
Azienda Ospedaliero-Universitaria S.Giovanni Battista
Torino, Italy, 10126
Presidio Ospedaliero Santa Chiara
Trento, Italy, 38122
Aichi Cancer Center Hospital
Nagoya, Aichi, Japan, 464-8681
National Cancer Center Hospital East
Kashiwa, Chiba, Japan, 277 8577
National Hospital Organization Shikoku Cancer Center
Matsuyama, Ehime, Japan, 791-0280
JCHO Kurume General Hosp
Kurume, Fukuoka, Japan, 830-0013
Gunma Prefectural Cancer Center
Ohta, Gunma, Japan, 373-8550
Hiroshima University Hospital
Hiroshima-shi, Hiroshima-ken, Japan, 734-8551
National Hospital Organization Hokkaido Cancer Center
Sapporo, Hokkaido, Japan, 003-0804
The Hospital of Hyogo College of Medecine
Nishinomiya, Hyogo, Japan, 663-8501
University of tsukuba hospital
Tsukuba-shi, Ibaragi, Japan, 305-8576
Tokai University Hospital
Isehara, Kanagawa, Japan, 259-1193
St Marianna University School of Medicine Toyoko Hospital
Kawasaki, Kanagawa, Japan, 216-8511
Kanagawa Cancer Center
Yokohama, Kanagawa, Japan, 241 8515
KKR Tohoku Kosai Hospital
Aoba-ku, Sendai-shi, Miyagi, Japan, 980-0803
Kindai University Hospital
Osaka Sayama-shi, Osaka, Japan, 589 8511
Saitama Medical University International Medical Center
Hidaka, Saitama, Japan, 350-1298
Saitama Cancer Center
Kitaadachi-Gun, Saitama, Japan, 362-0806
Shizuoka Cancer Center
Sunto-Gun, Shizuoka, Japan, 411-8777
Jichi Medical University Hospital
Shimotsuke, Tochigi, Japan, 329-0498
Tochigi Cancer Center
Utsunomiya, Tochigi, Japan, 320-0834
Juntendo University Hospital
Bunkyo-ku, Tokyo, Japan, 113-8431
St. Lukes International Hospital
Chuo-Ku, Tokyo, Japan, 104 8560
National Cancer Center Hospital
Chuo-Ku, Tokyo, Japan, 104-0045
The Cancer Institute Hospital of JFCR
Koto-ku, Tokyo, Japan, 135-8550
Showa University Hospital
Shinagawa-ku, Tokyo, Japan, 142-8666
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan, 160-0023
National Center for Global Health and Medicine
Shinjuku-ku, Tokyo, Japan, 162-8655
Chiba Cancer Center
Chiba, Japan, 260-8717
Kyushu Cancer Center
Fukuoka, Japan, 811-1395
Sagara Hospital
Kagoshima, Japan, 892-0833
Kumamoto University Hospital
Kumamoto, Japan, 860-8556
Kumamoto Shinto General hospital
Kumamoto, Japan, 862-8655
Kyoto University Hospital
Kyoto, Japan, 606-8507
Niigata Cancer Center Hospital
Niigata, Japan, 951-8566
National Hospital Organization Osaka National Hospital
Osaka, Japan, 540-0006
Osaka International Cancer Institute
Osaka, Japan, 541-8567
Korea, Republic of
Chungbuk National University Hospital
Cheong Ju-City, Chung Cheong Buk-Do, Korea, Republic of, 28644
Soonchunhyang University Hospital
Cheonan, Chungcheongnam-do, Korea, Republic of, 31151
National Cancer Center
Goyang-si, Gyeonggi-do, Korea, Republic of, 10408
Seoul National University Bundang Hospital
Seongnam, Gyeonggi-do, Korea, Republic of, 13620
Dongnam Institute of Radiological and Medical Sciences
Busan, Gyeongsangnam Do, Korea, Republic of, 46033
Gachon University Gil Medical Center
Incheon, Korea, Korea, Republic of, 21565
Samsung Medical Center
Seoul, Korea, Korea, Republic of, 06351
Korea University Guro Hospital
Seoul, Korea, Korea, Republic of, 08308
Asan Medical Center
Songpa-gu, Seoul, Korea, Republic of, 05505
Ewha University Mokdong Hospital
Seoul, Yangcheon-gu, Korea, Republic of, 07985
Inje University Haeundae Paik Hospital
Busan, Korea, Republic of, 48108
Kyungpook National University Medical Center
Daegu, Korea, Republic of, 41404
Inha University Hospital
Incheon, Korea, Republic of, 22332
Korea University Anam Hospital
Seoul, Korea, Republic of, 02841
Seoul National University Hospital
Seoul, Korea, Republic of, 03080
Severance Hospital Yonsei University Health System
Seoul, Korea, Republic of, 03722
Centro de Estudios y Prevencion del Cancer
Tuxtla Gutiérrez, Chiapas, Mexico, 29067
CIMAB S.A. de C.V.
Torreon, Coahuila, Mexico, 27000
Grupo Medico Camino S.C.
México City, Distrito Federal, Mexico, 03310
Health Pharma Professional Research, S.A. de C.V.
Mexico City, Federal District, Mexico, 03810
COI Centro Oncológico Internacional S.A.P.I
Mexico, Federal District, Mexico, 04700
Hospital Civil De Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico, 44280
Centro Oncologico Internacional Guadalajara
Tlajomulco de Zuniga, Jalisco, Mexico, 45640
CRI Centro Regiomontano de Investigacion S.C.
Monterrey, Nuevo Leon, Mexico, 64060
Consultorio Dr. Reinoso
Monterrey, Nuevo Leon, Mexico, 64320
Christus Muguerza Clinica Vidriera
Monterrey, Nuevo Leon, Mexico, 64570
Neurociencias Estudios Clinicos
Culiacan, Sinaloa, Mexico, 80020
Consultorio Centro Hemato Oncologico Privado
San Bernardino, Toluca, Mexico, 50080
Medical Care and Research, S.A. de C.V.
Merida, Yucatan, Mexico, 97070
Centro de Atención e Investigación Clínica en Oncología
Merida, Yucatan, Mexico, 97138
Unidad de Investigación en Salud
Chihuahua, Mexico, 31203
Oaxaca Site Management Organization SC
Oaxaca, Mexico, 68000
Oncológica de Puebla
Puebla, Mexico, 72530
Oncológico Potosino
San Luis Potosí, Mexico, 78250
Onze Lieve Vrouwe Gasthuis (OLVG)
Amsterdam, Netherlands, 1091AC
Den Haag, Netherlands, 2545 AA
Albert Schweitzer Ziekenhuis
Dordrecht, Netherlands, 3318 AT
Universitair Medisch Centrum Maastricht
Maastricht, Netherlands, 6229 HX
New Zealand
Palmerston North Hospital
Palmerston North, Wanganui, New Zealand, 4414
Auckland City Hospital
Auckland, New Zealand, 1023
Waikato Hospital
Hamilton, New Zealand, 3204
Uniwersyteckie Centrum Kliniczne
Gdansk, Poland, 80-952
Szpital Morski im. PCK Sp. z o.o.
Gdynia, Poland, 81-519
Przychodnia Lekarska "Komed"
Konin, Poland, 62-500
Centrum Terapii Wspolczesnej J.M. Jasnorzewska S.K.A.
Lodz, Poland, 90-242
Centrum Onkologii Ziemii Lubelskiej im. sw. Jana z Dukli
Lublin, Poland, 20-090
Olsztynski Osrodek Onkologiczny
Olsztyn, Poland, 10-513
Opolskie Centrum Onkologii
Opole, Poland, 45-060
Wielkopolskie Centrum Onkologii im. M. Sklodowskiej-Curie
Poznan, Poland, 61-866
MAGODENT Szpital Onkologiczny Elblaska
Warszawa, Poland, 01-748
Centrum Onkologii-Instytut im Marii Sklodowskiej-Curie
Warszawa, Poland, 02-781
Dolnoslaskie Centrum Onkologii
Wroclaw, Poland, 53-413
Instituto Português de Oncologia Dr. Francisco Gentil
Coimbra, Portugal, 3001-651
Fundação Champalimaud
Lisboa, Portugal, 1400-038
Centro Hospitalar Lisboa Norte - Hospital de Santa Maria
Lisboa, Portugal, 1649-035
Hospital Geral de Santo Antonio
Porto, Portugal, 4099-001
IPOFG - Porto
Porto, Portugal, 4200-072
Puerto Rico
Puerto Rico Hematology/Oncology Group
Bayamon, Puerto Rico, 00961
University Of Puerto Rico
San Juan, Puerto Rico, 00935
Centrul de Oncologie Sf. Nectarie SRL
Craiova, Dolj, Romania, 200347
S.C. R.T.C. Radiology Therapeutic Center S.R.L.
Otopeni, Ilfov, Romania, 075100
SC Oncopremium Team SRL
Baia Mare, Maramureș, Romania, 430291
Institutul Oncologic Dr Trestioreanu Bucuresti
Bucuresti, Sector 2, Romania, 022328
Spitalul Clinic Filantropia
Bucuresti, Romania, 011171
Institutul Oncologic "Prof. Dr. Ion Chiricuta" Cluj-Napoca
Cluj-Napoca, Romania, 400015
Sp Clinic Judetean de Urgenta Sf.Apostol Andrei Constanta
Constanta, Romania, 900591
Russian Federation
Kazan Oncology Dispensary
Kazan, Tatarstan Republic, Russian Federation, 420029
Chelyabinsk Regional Oncology Dispensary
Chelyabinsk, Russian Federation, 454087
SHI Kaluga Regional Hospital
Kaluga, Russian Federation, 248007
Kursk Regional Oncology Dispensary
Kursk, Russian Federation, 305035
Leningrad Regional Oncology Dispensary
Leningrad Region, Russian Federation, 188663
Principal Military Clinical Hospital n.a. N. N. Burdenko
Moscow, Russian Federation, 105229
Blokhin Cancer Research Center
Moscow, Russian Federation, 115478
Russian Oncological Research Center
Moscow, Russian Federation, 115478
Orenburg Regional Clinical Oncology Dispensary
Orenburg, Russian Federation, 460021
St. Petersburg City Clinical Oncological Dispensary
Saint-Petersburg, Russian Federation, 198255
Samara Regional Clinical Oncology Dispensary
Samara, Russian Federation, 443031
GOU VPO St-Petersburg SMA n/a Mechnikov Fed. Agen of Health
St. Petersburg, Russian Federation, 195067
FGU Research Institution of Oncology
St. Petersburg, Russian Federation, 197758
St-Petersburg scientifical practical cente spec medical care
St. Petersburg, Russian Federation, 197758
Volgograd regional clinical oncology dispensary
Volgograd, Russian Federation, 400138
Yaroslavl region regional clinical oncology hospital
Yaroslavl, Russian Federation, 150054
Saudi Arabia
King Fahad Specialist Hospital—Dammam
Dammam, Saudi Arabia, 31444
King Faisal Specialist Hospital & Research Center
Riyadh, Saudi Arabia, 11211
King Abdulaziz Medical City - National Guard Hospital
Riyadh, Saudi Arabia, 11426
King Fahad Medical City
Riyadh, Saudi Arabia, 11525
National Cancer Center
Singapore, Singapore, 169610
National University Hospital
Singapore, Singapore, 669606
South Africa
Eastleigh Breast Care Center
Pretoria, Gauteng, South Africa, 0081
Cancercare Rondebosch Oncology
Cape Town, South Africa, 7700
George, South Africa, 6530
Sandton Oncology Centre
Johannesburg, South Africa, 2196
Langenhoven Drive Oncology Centre
Port Elizabeth, South Africa, 6045
Mary Potter Oncology Center
Pretoria, South Africa, 0181
Hospital Clinico Universitario Virgen de la Victoria
Malaga, Andalucia, Spain, 29010
Hospital Universitario Virgen del Rocio
Sevilla, Andalucía, Spain, 41013
Hospital Universitario Central de Asturias
Oviedo, Asturias, Spain, 33011
Hospital Universitari Arnau de Vilanova
Lleida, Cataluña, Spain, 25198
Hospital Clinico Universitario de Santiago
Santiago de Compostela, La Coruna, Spain, 15706
Hospital Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
Hospital Universitario Quiron Madrid
Pozuelo de Alarcon, Madrid, Spain, 28223
Hospital Universitario de Canarias
La Laguna, Santa Cruz De Tenerife, Spain, 38320
Hospital del Mar
Barcelona, Spain, 08003
Hospital Quirón Salud Barcelona-Instituto Oncológico Baselga
Barcelona, Spain, 08023
Hospital Universitari Vall d'Hebron
Barcelona, Spain, 08035
Hospital Clinic I Provincial
Barcelona, Spain, 08036
Hospital de la Santa Creu i Sant Pau
Barcelona, Spain, 08041
Hospital Reina Sofia
Cordoba, Spain, 14004
Hospital Clinico Universitario San Cecilio
Granada, Spain, 18016
Complejo Hospitalario Ciudad De Jaen
Jaen, Spain, 23007
Hospital De La Princesa
Madrid, Spain, 28006
Hospital General Universitario Gregorio Marañon
Madrid, Spain, 28007
Hospital Universitario Ramon y Cajal
Madrid, Spain, 28034
Hospital Clinico San Carlos
Madrid, Spain, 28040
Hospital Universitario 12 de Octubre
Madrid, Spain, 28041
Hospital Madrid Norte Sanchinarro
Madrid, Spain, 28050
Hospital Clinico De Salamanca
Salamanca, Spain, 37007
Hospital Universitario Virgen Macarena
Sevilla, Spain, 41009
Hospital Universitario Nuestra Señora de Valme
Sevilla, Spain, 41014
Hospital Clínico Universitario de Valencia
Valencia, Spain, 46010
Hospital Quirón Salud Valencia
Valencia, Spain, 46015
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Norrlands universitetssjukhus
Umeå, Vasterbotten, Sweden, 90185
Skånes universitetssjukhus Lund
Lund, Sweden, 22185
Länssjukhuset Sundsvall
Sundsvall, Sweden, 85186
Västmanlands sjukhus Västerås
Västerås, Sweden, SE-72189
Växjö Centrallasarettet
Växjö, Sweden, 35234
Changhua Christian Hospital
Changhua, Taiwan, 500
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, Taiwan, 80756
Chang Gung Memorial Hospital - Kaohsiung
Kaohsiung, Taiwan, 83301
Tri-Service General Hospital
Neihu Taipei, Taiwan, 11490
Taipei Medical University- Shuang Ho Hospital
New Taipei City, Taiwan, 235
China Medical University Hospital
Taichung City, Taiwan, 40447
MacKay Memorial Hospital
Taipei City, Taiwan, 10449
National Taiwan University Hospital
Taipei, Taiwan, 10002
Taipei Veterans General Hospital
Taipei, Taiwan, 11217
Sun Yat-Sen Cancer Center
Taipei, Taiwan, 112
Chang Gung Memorial Hospital - Linkou
Taoyuan City, Taiwan, 33305
Baskent Adana Educational Hospital
Adana, Turkey, 1250
Emrah Mah. Gen. Dr. Tevfik Saglam Cad. Gülhane Egitim ve Arastirma
Ankara, Turkey, 06010
Ankara University Medicine Hospital
Ankara, Turkey, 06100
Hacettepe University Faculty of Medicine
Ankara, Turkey, 06100
Dr.Abdurrahman Yurtaslan Ankara Oncology Training & Res Hosp
Ankara, Turkey, 06200
Akdeniz University Medical Faculty
Antalya, Turkey, 07059
Trakya University Faculty of Medicine
Edirne, Turkey, 22030
Istanbul University
Istanbul, Turkey, 34098
Acibadem Altunizade Hastanesi
Istanbul, Turkey, 34662
Istanbul Medeniyet University Medical Faculty
Istanbul, Turkey, 34722
Ege University Faculty of Medicine
Izmir, Turkey, 35100
Medical Park Izmir Hospital
Izmir, Turkey, 35575
Kocaeli University Medical Faculty Hospital
Izmit, Turkey, 41380
Inonu University Medical Faculty
Malatya, Turkey, 44280
Dnipropetrovsk City Multifunctional Clinical Hospital #4 of Dnipropetrovsk Regional Council
Dnipro, Ukraine, 49102
Commu Instit "Krivorizhskiy oncology dispensary" Dnip reg Co
Kriviy Rig, Ukraine, 50048
Communal enterprise "Volyn regional medical oncology center"
Lutsk, Ukraine, 43018
Odesa Regional Clinical Hospital
Odesa, Ukraine, 65117
Poltava Regional Clinical Oncological Dispensary
Poltava, Ukraine, 36011
Central Municipal Clinical Hospital
Uzhhorod, Ukraine, 88000
Podilskyi Regional Center of Oncology
Vinnytsia, Ukraine, 21029
United Kingdom
University Hospital of North Tees
Stockton-on-Tees, Cleveland, United Kingdom, TS19 8PE
Royal Cornwall Hospital
Truro, Cornwall, United Kingdom, TR1 3LJ
Broomfield Hospital
Chelmsford, Essex, United Kingdom, CM2 5ET
North Middlesex Hospital
London, Greater London, United Kingdom, N18 1QX
Christie NHS Foundation Trust
Manchester, Greater Manchester, United Kingdom, M20 4QL
Victoria Hospital
Blackpool, Lancashire, United Kingdom, FY3 8NR
Royal Preston Hospital
Preston, Lancashire, United Kingdom, PR2 9HT
Charing Cross Hospital
Chelsea, London, United Kingdom, W6 8RF
Mount Vernon Hospital
Northwood, Middlesex, United Kingdom, HA6 2RN
Nottingham City Hospital
Nottingham, Nottinghamshire, United Kingdom, NG5 1PB
Western General Hospital
Edinburgh, Scotland, United Kingdom, EH4 2XU
Musgrove Park Hospital
Taunton, Somerset, United Kingdom, TA1 5DA
Royal Surrey County Hospital
Guildford, Surrey, United Kingdom, GU2 7XX
Guys/St. Thomas Hospital
London, Surrey, United Kingdom, SE1 9RT
Sarah Canon Research Institute UK
London, Surrey, United Kingdom, W1G 6AD
Royal Marsden Hospital
Sutton, Surrey, United Kingdom, SM2 5PT
Airedale General Hospital
Keighley, WEST Yorkshire, United Kingdom, BD20 6TD
Pilgrim Hospital
Boston, United Kingdom, PE21 9QS
Churchill Hospital
Oxford, United Kingdom, OX3 7LJ
Sponsors and Collaborators
Eli Lilly and Company
NSABP Foundation Inc
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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

Additional Information:
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Responsible Party: Eli Lilly and Company Identifier: NCT03155997     History of Changes
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 )
First Posted: May 16, 2017    Key Record Dates
Last Update Posted: October 17, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
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.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Clinical Study Report (CSR)
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.
Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
early stage breast cancer
cyclin-dependent kinase (CDK)
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases