Breast CancerPhase 3ELEGANTNCT06492616
A Study of Elacestrant Versus Standard Endocrine Therapy in Women and Men With ER+,HER2-, Early Breast Cancer With High Risk of Recurrence
A Phase 3 study testing Elacestrant, Anastrozole and Letrozole in people with Breast Cancer, run by Stemline Therapeutics, Inc. at 555 sites in 28 countries.
Trial summary
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Elacestrant, Anastrozole and Letrozole
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,556 participants
- Where
- 555 sitesin 28 countries
- Study dates
- 27 Sep 2024to Oct 2032
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry [IHC]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization [ISH]-negative [not amplified]). ISH-negative without IHC testing will also be eligible on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology/College of American Pathologists guidelines.
- Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria:
- ≥4 positive axillary lymph nodes or
- 1-3 positive axillary lymph nodes and
- Histologic grade 3 disease and/or
- Tumor size ≥5 centimeters and/or
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- High genomic risk (identified by Oncotype, MammaPrint, EndoPredict, PAM50)
- Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 [C1D1]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist.
- Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase inhibitor must have already completed or discontinued these treatments.
Who cannot join
- Participants with inflammatory breast cancer.
- History of any prior (ipsilateral and/or contralateral) invasive breast cancer.
- Participant with history of non-breast malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
- Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Trial locations and contacts
555 sites in 28 countries.
555 sites in 28 countries
United States170 sites
Hendrick Cancer Center
Abilene, Texas, 79601
Mayo Clinic Health System - Albert Lea
Albert Lea, Minnesota, 56007
Exigent Research LLC/New Mexico Oncology Hematology Consultants Ltd.
Albuquerque, New Mexico, 87109
Lehigh Valley Health Network - Cedar Crest
Allen, Pennsylvania, 18103
Texas Oncology-Northeast Texas
Allen, Texas, 75013
Illinois Cancer Specialists
Arlington Heights, Illinois, 60005
University Blood & Cancer Center, LLC
Athens, Georgia, 30607
Winship Cancer Institute
Atlanta, Georgia, 30322
Northside Hospital
Atlanta, Georgia, 30341
Mercy Medical Center
Baltimore, Maryland, 21202
Ascension St. Agnes Hospital
Baltimore, Maryland, 21229
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Baltimore, Maryland, 21287
UCSF Cancer Center Berkeley
Berkeley, California, 94702
Cedars-Sinai Cancer Beverly Hills
Beverly Hills, California, 90211
Massachusetts General Hospital
Boston, Massachusetts, 02114
Boston Medical Center
Boston, Massachusetts, 02118
Dana Farber Cancer Institute
Boston, Massachusetts, 02215
Kings County Hospital Center
Brooklyn, New York, 11203
Consultants In Medical Oncology and Hematology, P.C.
Broomall, Pennsylvania, 19008
University of Vermont Medical Center
Burlington, Vermont, 05401
MD Anderson Cancer Center at Cooper
Camden, New Jersey, 08103
Miami Valley Hospital South
Centerville, Ohio, 45459
Ironwood Cancer and Research Centers
Chandler, Arizona, 85224
Hollings Cancer Center
Charleston, South Carolina, 29425
Northwestern Memorial Hospital
Chicago, Illinois, 60611
RUSH MD Anderson Cancer Center
Chicago, Illinois, 60612-3841
MetroHealth
Cleveland, Ohio, 44109
Cleveland Clinic
Cleveland, Ohio, 44195
Maryland Oncology Hematology, P.A.
Columbia, Maryland, 21044
Texas Oncology - DFW
Dallas, Texas, 75246
Mass General North Shore Cancer Center
Danvers, Massachusetts, 01923-3623
Southern Cancer Center, PC
Daphne, Alabama, 36526
St. Joseph Hospital-Cancer Centers of Colorado
Denver, Colorado, 80218-1122
Mission Cancer and Blood
Des Moines, Iowa, 50309
City of Hope National Medical Center
Duarte, California, 91010
Duke Cancer Institute
Durham, North Carolina, 27710
Northwest Cancer Centers, PC
Dyer, Indiana, 46311
Hematology Oncology Associates of Central New York, PC
East Syracuse, New York, 13057
Mayo Clinic Health System - Eau Claire
Eau Claire, Wisconsin, 54703
Swedish Cancer Institute - Edmonds
Edmonds, Washington, 98206
Inova Schar Cancer Institute
Fairfax, Virginia, 22031
Virginia Cancer Specialists
Fairfax, Virginia, 22031
Oncology Hematology Care Clinical Trials, LLC
Fairfield, Ohio, 45014
Cape Fear Valley Medical Center
Fayetteville, North Carolina, 28304
Summit Medical Group
Florham Park, New Jersey, 07932
Florida Cancer Specialists
Fort Myers, Florida, 33901
Dana Farber Cancer Institute at Foxborough
Foxborough, Massachusetts, 02035
UCSF Wash Cancer CNTR
Fremont, California, 94538
Banner MD Anderson Cancer Center
Gilbert, Arizona, 85234-2165
The Cancer & Hematology Centers
Grand Rapids, Michigan, 49503
Cone Health Cancer Center at Wesley Long
Greensboro, North Carolina, 27403
John Theurer Ctr-Hackensack UMC
Hackensack, New Jersey, 07601
Penn State Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
Kaiser Permanente Hawaii Moanalua Medical Center
Honolulu, Hawaii, 96819
Oncology Consultants, P.A.
Houston, Texas, 77024
The University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009
Harris Health System - Smith Clinic
Houston, Texas, 77054
O'Quinn Medical Tower - McNair Campus
Houston, Texas, 77054
City of Hope at Irvine Lennar
Irvine, California, 92618
Swedish Cancer Institute - Issaquah
Issaquah, Washington, 98029
Cayuga Medical Center
Ithaca, New York, 14850
Mayo Clinic
Jacksonville, Florida, 32224
Fred Hutch CC at Evergreen HMC
Kirkland, Washington, 98034
Mayo Clinic Health System - La Crosse
La Crosse, Wisconsin, 54601
UC San Diego Moores Cancer Center
La Jolla, California, 92037
NHO Revive Research Institute LLC
Lincoln, Nebraska, 68506
Rocky Mountain Cancer Centers, LLP
Lone Tree, Colorado, 80124
Helios Clinical Research
Long Beach, California, 90805
Cancer and Blood Research Center, LLC
Los Alamitos, California, 90720
USC/Norris Comprehensive Cancer Center
Los Angeles, California, 90033
UCLA Department of Medicine - Hematology/Oncology
Los Angeles, California, 90095
UofL Health Brown Cancer Center
Louisville, Kentucky, 40202
Covenant Children's Hospital- Joe Arrington Cancer Research and Treatment Center
Lubbock, Texas, 79410
University of Wisconsin Carbone Cancer Center- University Hospital
Madison, Wisconsin, 53792
Mayo Clinic - Mankato
Mankato, Minnesota, 56001-4752
Holy Redeemer Hospital And Medical Center
Meadowbrook, Pennsylvania, 19046
Alliance Cancer Specialists, PC
Media, Pennsylvania, 19044-1134
Baptist Cancer Center
Memphis, Tennessee, 38120
Dana Farber Cancer Institute - Merrimack Valley
Methuen, Massachusetts, 01844
Miami Cancer Institute at Baptist Health Inc.
Miami, Florida, 33176
University of Miami
Miami, Florida, 33176
Dana-Farber Cancer Institute at Milford Regional
Milford, Massachusetts, 01757
Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226
NYU Langone Hospital-Long Island
Mineola, New York, 11501
Allina Health Cancer Institute - Abbott Northwestern Hospital
Minneapolis, Minnesota, 55407
Pacific Cancer Care - Oncology
Monterey, California, 93940
SCRI Oncology Partners
Nashville, Tennessee, 37203
Tennessee Oncology, PLLC
Nashville, Tennessee, 37203
Henry - Joyce Cancer Clinic
Nashville, Tennessee, 37232
Texas Oncology - San Antonio
New Braunfels, Texas, 78130
Rutgers Cancer Institute
New Brunswick, New Jersey, 08903
Yale New Haven Hospital- Yale Cancer Center
New Haven, Connecticut, 06510
University Medical Center-New Orleans
New Orleans, Louisiana, 70112
The Blavatnik Family - Chelsea Medical Center at Mount Sinai
New York, New York, 10011
Laura and Isaac Perlmutter Cancer Center/NYU Langone Health
New York, New York, 10016
Mount Sinai West
New York, New York, 10019
Icahn School of Medicine Mount Sinai
New York, New York, 10029
Columbia University Medical Center
New York, New York, 10032-3729
Hoag Memorial Hospital Presbyterian
Newport Beach, California, 92663
Virginia Oncology Associates
Newport News, Virginia, 23606
Mass General Cancer Center at Newton-Wellesley Hospital's Vernon Cancer Center
Newton, Massachusetts, 02462
Vista Oncology
Olympia, Washington, 98506
Oncology Hematology West, PC dba Nebraska Cancer Specialists - Legacy
Omaha, Nebraska, 68130
University of Nebraska Medical Center
Omaha, Nebraska, 68198
UC Irvine Health, Chao Family Comprehensive Cancer Center
Orange, California, 92868-3201
AdventHealth Orlando Infusion Center
Orlando, Florida, 32804
Baptist Clinical Research Institution
Oxford, Mississippi, 38655
Cancer Care Centers of Brevard (CCCB) - Palm Bay
Palm Bay, Florida, 32909
Stanford Women's Cancer Center
Palo Alto, California, 94304
AHMG Hematology and Oncology
Parker, Colorado, 80138
Texas Oncology-Gulf Coast
Pearland, Texas, 77584
Memorial Healthcare System
Pembroke Pines, Florida, 33026
Ascension Sacred Heart
Pensacola, Florida, 32504
Fox Chase Cancer Center
Philadelphia, Pennsylvania, 19111
Banner University Medical Center - Phoenix Campus (Banner Good Samaritan Medical Center)
Phoenix, Arizona, 85006
Avera St. Mary's Hospital
Pierre, South Dakota, 57501
Miami Cancer Institute at Plantation
Plantation, Florida, 33324
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97213
Providence Cancer Institute Franz Clinic
Portland, Oregon, 97225
Rhode Island Hospital
Providence, Rhode Island, 02903
Virginia Cancer Institute
Richmond, Virginia, 23229
Mayo Clinic
Rochester, Minnesota, 01842
University of Rochester Medical
Rochester, New York, 14642
Dignity Health dba Health Research Institute
Sacramento, California, 95816
Sutter Institute for Medical Research
Sacramento, California, 95816
Metro-MN Comm. Onc. Res Consortium
Saint Louis Park, Minnesota, 55416
Oregon Oncology Specialists
Salem, Oregon, 97301
Utah Cancer Specialists
Salt Lake City, Utah, 84106
Huntsman Cancer Institute, University of Utah
Salt Lake City, Utah, 84112
Mays Cancer Center
San Antonio, Texas, 78229
UCSF Zuckerberg SF General
San Francisco, California, 94143
University of California, San Francisco (UCSF)
San Francisco, California, 94158
Southern California Kaiser Medical Center-San Marcos Medical
San Marcos, California, 92069
UCSF Cancer Center San Mateo
San Mateo, California, 94402
Mayo Clinic
Scottsdale, Arizona, 85259-5452
Virginia Mason Medical Center
Seattle, Washington, 98101
Swedish Cancer Institute
Seattle, Washington, 98104
Fred Hutchinson Cancer Center
Seattle, Washington, 98109
Fred Hutch CC at UWMC-Northwest
Seattle, Washington, 98133
Avera Cancer Institute
Sioux Falls, South Dakota, 57105
Sansum Clinic
Solvang, California, 93463
Dana-Farber/Brigham and Women's Cancer Center (DF/BWCC) in Clinical Affiliation with South Shore Hospital
South Weymouth, Massachusetts, 02190
MultiCare Deaconess Hospital
Spokane, Washington, 99204
Cancer Care Northwest
Spokane Valley, Washington, 99216
Highlands Oncology Group, PA
Springdale, Arkansas, 72762
Siteman Cancer Center
St Louis, Missouri, 63108
Florida Cancer Specialists
St. Petersburg, Florida, 33705
Comprehensive Hematology Oncology
St. Petersburg, Florida, 33709
Stony Brook University Cancer Center
Stony Brook, New York, 11794
MultiCare Cancer Institute - Tacoma
Tacoma, Washington, 98405
Northwest Medical Specialties PLLC
Tacoma, Washington, 98405
Moffitt Cancer Center
Tampa, Florida, 33612
Northwest Cancer Specialists, P.C.
Tigard, Oregon, 97223
Torrance Memorial Physician Network- Cancer Care
Torrance, California, 90505
Arizona Clinical Research Center, Inc.
Tucson, Arizona, 85715
University of Arizona Cancer Center
Tucson, Arizona, 85719
Oklahoma Cancer Specialists and Research Institute (OCSRI) - Tulsa Cancer Center
Tulsa, Oklahoma, 74146
Mass General - North Shore Cancer Center
Waltham, Massachusetts, 02451
Georgetown University Medical Center
Washington D.C., District of Columbia, 20007
MedStar Washington Hospital Center
Washington D.C., District of Columbia, 20010-3017
Sibley Memorial Hospital
Washington D.C., District of Columbia, 20016
The George Washington Medical Faculty Associates
Washington D.C., District of Columbia, 20037
Texas Oncology- Central South
Weslaco, Texas, 78596
Florida Cancer Specialists
West Palm Beach, Florida, 33401
Clinical Research Alliance, Inc.
Westbury, New York, 11590
Cleveland Clinic Florida
Weston, Florida, 33331-3609
Cancer Center of Kansas
Wichita, Kansas, 67214
Lankenau Medical Center
Wynnewood, Pennsylvania, 19096
Oncology & Hematology Associates of Southwest Virginia, Inc
Wytheville, Virginia, 24382
Cancer Care Associates of York, Inc.
York, Pennsylvania, 17403
Italy39 sites
Centro di Riferimento Oncologico, IRCCS
Aviano, Pordenone, 33081
SSD Oncologia Medica Zamagni, IRCCS Azienda Ospedaliero- Universitaria di Bologna, Policlinico di Sant'Orsola
Bologna, Emilia-Romagna, 40138
Divisione di Oncologia Medica ASST Spedali Civili di Brescia
Brescia, 25123
Fond. Piemonte per l'Oncologia - Istituto di Candiolo IRCCS
Candiolo, Torino, 10060
Ospedale di Cremona, ASST Cremona
Cremona, 26100
SOD Radioterapia Oncologica, AOU Careggi
Florence, 50134
Azienda Sanitaria Locale Napoli 2 Nord
Frattamaggiore, Napoli, 80027
Ospedale San Martino IRCCS
Genova, 16132
Azienda Unità Sanitaria Locale Toscana Nord Ovest
Livorno, 57124
IRST Dino Amadori IRCCS
Meldola, Forli-Cesena, 47014
Ospedale San Raffaele, IRCCS - Oncologia Medica
Milan, 20132
Istituto Nazionale dei Tumori,IRCCS
Milan, 20133
Istituto Europeo di Oncologia IRCCS
Milan, 20141
S. C. Oncologia, Centro Oncologico Modenese (COM) - A.O.U. di Modena -Policlinico di Modena
Modena, 41124
AOU Cagliari
Monserrato, Cagliari, 9042
IRCCS San Gerardo dei Tintori
Monza, Monza E Brianza, 20900
Azienda Ospedaliera Universitaria Federico II
Naples, 80131
IRCCS Istituto Nazionale Tumori Fondazione Pascale
Naples, 80131
UOC Oncologia - A.O.R.N. "A. Cardarelli"
Naples, 80131
AOU Maggiore della Carità - Oncologia
Novara, 28100
Istituto Oncologico Veneto
Padova, 35128
IRCCS ICS Maugeri
Pavia, 27100
IRCCS Policlinico San Matteo, Università degli studi di Pavia
Pavia, 27100
Ospedale Santa Maria Della Misericordia
Perugia, 06129
PO S.Chiara, AOU Pisana
Pisa, 56126
PO S Carlo, Azienda Ospedaliera Regionale San Carlo - Oncologia
Potenza, 85100
Azienda USL Toscana Centro
Prato, 59100
Ospedale Generale Provinciale di Macerata
Province of Macerata, 62100
Azienda Unita Sanitaria Locale della Romagna
Rimini, 47923
Irccs Crob
Rionero in Vulture, 85028
Fondazione PU Campus Biomedico
Roma, 00128
U.O. Ginecologia Oncologica - Fondazione Policlinico A. Gemelli
Roma, 00136
IRCCS Istituto Nazionale Tumori Regina Elena,UOSD Sperimentazioni di fase IV
Roma, 00144
Ospedale Casa Sollievo della Sofferen IRCCS, Opera di San Pio da Pietrelcina
San Giovanni Rotondo, Apulia, 71013
Azienda Ospedaliero Universitaria Di Sassari
Sassari, 07100
Azienda Ospedaliera Universitaria Senese
Siena, 53100
SOC Oncologia - P.O. "Santa Maria della Misericordia"
Udine, 33100
Ospedale Sacro cuore Don Calabria- Negrar di Valpolicella
Verona, 37024
Ist.Oncologico del Mediterraneo
Viagrande, Catania, 039021
Spain35 sites
Complexo Hospitalario Universitario A Coruña
A Coruña, 15006
ICO Badalona-Hospital Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital Universitari Vall D Hebron
Barcelona, 08035
Hospital Clinic De Barcelona - Oncología Médica
Barcelona, 08036
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Caceres Hospital Complex - San Pedro de Alcantara General Hospital
Cáceres, Extremadura, 10002
Hospital Universitario Reina Sofia
Córdoba, 14004
Hospital Clínico Universitario Virgen De La Arrixaca
El Palmar, Murcia, 30120
Hospital Universitario de Jaén
Jaén, 23007
H.U. Insular Gran Canaria
Las Palmas de Gran Canaria, 35010
H.U Arnau De Vilanova Lleida
Lleida, 25198
Hospital Universitario Lucus Augusti
Lugo, 27003
Hospital Universitario De La Princesa - Oncología Médica
Madrid, 28006
Hospital Beata Maria Ana
Madrid, 28007
Hospital General Universitario Gregorio Marañón - Oncology
Madrid, 28009
Hospital Universitario Ramón y Cajal
Madrid, 28034
Hospital Clínico San Carlos
Madrid, 28040
Hospital Universitario Fundacion Jimenez Diaz
Madrid, 28040
Hospital Universitario 12 de Octubre
Madrid, 28041
Hospital Universitario La Paz
Madrid, 28046
Hospital Universitario Virgen De La Victoria
Málaga, 29010
Hospital Regional Universitario de Málaga (Hospital Civil)
Málaga, 29011
Hospital Universitario Rey Juan Carlos
Móstoles, Madrid, 28935
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Canary Islands, 38320
Hospital Universitari General de Catalunya
Sant Cugat del Vallès, Barcelona, 08195
Hospital de Sant Joan Despi Moises Broggi
Sant Joan Despí, Barcelona, 08970
Hospital Universitario de Santiago
Santiago de Compostela, 15706
Hospital Universitario Virgen del Rocío
Seville, Andalusia, 41013
H. Virgen de Valme
Seville, Andalusia, 41014
Hospital Universitario Virgen de la Macarena - Oncología Médica
Seville, 41009
Fundación Instituto Valenciano Oncologia
Valencia, Navarre, 46009
Hospital Clinico Universitario De Valencia
Valencia, 46010
Hospital Quironsalud Valencia
Valencia, 46010
Hospital Alvaro Cunqueiro
Vigo, A Coruña, 36312
Hospital Clínico Universitario Lozano Blesa - Oncología Médica
Zaragoza, 50009
Brazil30 sites
Fundação Pio XII - Hospital de Amor de Barretos
Barretos, São Paulo, 14784-400
Instituto do Cancer do Estado de Sao Paulo (ICESP)
Barueri, São Paulo, 01246-000
CTO Centro de Tratamento Oncologico LTDA
Belém, Pará, 66073-005
CETUS Oncologia S.A
Belo Horizonte, Minas Gerais, 30150-270
Impar Servicos Hospitalares S/A - Hospital Brasília
Brasília, Federal District, 71635-580
Centro de Pesquisas Clínicas em Oncologia
Cachoeiro de Itapemirim, Espírito Santo, 29308-014
Hospital Santa Cruz Sociedade Anonima
Curitiba, Paraná, 80420-090
Centro Integrado Oncologia Curitiba
Curitiba, Paraná, 80810-050
Centro de Pesquisas Oncologicas - CEPON
Florianópolis, Santa Catarina, 88034000
Instituto D'Or de Pesquisa e Ensino (Oncocentro Servicos Medicos e Hospitalares LTDA)
Fortaleza, Ceará, 61160-070
Hospital Araujo Jorge
Goiânia, Goiás, 74605-070
Clinica de Neoplasias Litoral
Itajaí, Santa Catarina, 88301-220
Sociedade Beneficência e Caridade de Lajeado (Hospital Bruno Born)
Lajeado, Rio Grande do Sul, 95900-000
Instituto de Câncer de Londrina
Londrina, Paraná, 86015-520
Futtura Oncologia
Porto Alegre, Rio Grande do Sul, 055026
Centro Gaucho Integrado de Oncologia, Hematologia, Ensino e Pesquisa - Hospital Mae de Deus
Porto Alegre, Rio Grande do Sul, 90110-270
PUCRS - Hospital São Lucas
Porto Alegre, 90610-000
Fundação PIO XII - Hospital de Amor Amazônia
Porto Velho, Rondônia, 76834-899
Universidade de Sao Paulo (USP) - Hospital das Clinicas da Faculdade de Medicina de Ribeirao Preto (HCFMRP)
Ribeirão Preto, São Paulo, 14048-900
Instituto Nacional do Cancer - INCA-HC III
Rio de Janeiro, 20560-120
Instituto de Educacao, Pesquisa e Gestao em Saude
Rio de Janeiro, 22775-001
Hospital de Base de São José do Rio Preto - CIP
São José do Rio Preto, São Paulo, 15090-000
Instituto Brasileiro de Controle do Cancer - ibcc - Hematology / Oncology
São Paulo, São Paulo, 03102-002
Clínica de Pesquisas e Centro de Estudos em Oncologia Ginecológica e Mamária Ltda
São Paulo, 01317-904
A.C.Camargo Cancer Center
São Paulo, 01509-010
Instituto de Assistencia Medica ao Servidor Publico Estadual (IAMSPE)
São Paulo, 04039-901
Onco Star SP Oncologia LTDA (Onco Star)
São Paulo, 04062-001
Hospital Universitario y Politecnico La Fe - Oncología Médica
Valência, 46026
CEDOES - Centro de Pesquisa Clinica e Diagnostico do Espirito Santo LTDA
Vitória, Espírito Santo, 29.055-450
Hospital da Fundacao Oswaldo Aranha
Volta Redonda, Rio de Janeiro, 27251-260
Germany30 sites
Hämatologie-Onkologie Zentrum MVZ
Augsburg, Bavaria, 049017
Universitätsklinikum Augsburg
Augsburg, Bavaria, 86156
Praxisklinik Krebsheilkunde
Berlin, 10367
Helios Klinikum Berlin-Buch
Berlin, 13125
Charite-Universitaetsmedizin Berlin - Campus Charite Mitte (CCM)
Berlin
Marienhospital Bottrop gGmbH
Bottrop, North Rhine-Westphalia, 46236
'Schwerpunktpraxis Fuer Gynaekologie und Onkologie
Brandenburg, Fuerstenwalde /Spree, 15517
Staedtisches Klinikum Dessau
Dessau, 06847
Gemeinschaftspraxis Haematologie - Onkologie
Dresden, Saxony, 01307
GynOnco Duesseldorf
Düsseldorf, North Rhine-Westphalia, 40235
Studienzentrale für das MVZ e.K
Eggenfelden, Bavaria, 84307
Universitaetsklinikum Erlangen
Erlangen, Bavaria, 91054
Evang. Kliniken Essen-Mitte
Essen, North Rhine-Westphalia, 45136
'Klinikum Esslingen GmbH
Esslingen am Neckar, Esslingen a.N., 73730
Agaplesion Markus Krankenhaus - Klinik fuer Gynaekologie und Geburtshilfe
Frankfurt am Main, Hesse, 60431
Klinikum Frankfurt Höchst GmbH
Frankfurt am Main, Hesse, 65929
Mammazentrum Hamburg MVZ GbR
Hamburg, 20357
Universitätsklinikum des Saarlandes
Homburg/Saar, Saarland, 66421
University Hospital Of Leipzig - Frauen- und Kindermedizin
Leipzig, Saxony, 04103
Universitätsklinikum Schleswig-Holstein, Campus Lübeck
Lübeck, Schleswig-Holstein, 23538
Praxisklinik am Rosengarten
Mannheim, Baden-Wurttemberg, 68165
Universitätsmedizin Mannheim (UMM)
Mannheim, Baden-Wurttemberg, 68167
Evangelisches Krankenhaus Bethesda
Mönchengladbach, North Rhine-Westphalia, 41061
LMU - Klinikum Innenstadt
München, Bavaria, 80336
Klinikum rechts der Isar, TUM München
München, Bavaria, 81675
Caritas-Krankenhaus St. Josef - Frauenheilkunde und Geburtshilfe
Regensburg, Bavaria, 93053
Immanuel Klinik Rüdersdorf
Rüdersdorf, Brandenburg, 15562
universitaet Hospital Of Ulm
Ulm, Baden-Wurttemberg, 89075
Marien Hospital Witten
Witten, North Rhine-Westphalia, 58452
Klinikum Worms gGmbH
Worms, Rhineland-Palatinate, 67550
Turkey (Türkiye)27 sites
Baskent Universitesi Adana Uygulama ve Arastirma Merkezi
Adana, Adana/ Yuregir, 01250
Medical Park Seyhan Hospital
Adana, Seyhan/Adana, 01140
Adana Sehir Egitim ve Arastirma Hastanesi
Adana, Yüregir, 1220
Dr Abdurrahman Yurtaslan EAH
Ankara, Ankara/ Yenimahalle, 06200
Memorial Ankara Hastanesi
Ankara, Ankara/Cankaya, 06520
Ankara City Hospital - Medical Oncology
Ankara, Cankaya/Ankara, 06800
Gazi Uni Hast
Ankara, Yenimahalle/Ankara, 06560
Ankara Etlik Sehir Hastanesi - Tıbbi Onkoloji
Ankara, 06170
Hacettepe University Medical Faculty - Medical Oncology
Ankara, 06230
Gulhane Training and Research Hospital
Ankara, 6010
Ankara Universitesi Tip Fakultesi Cebeci Arastirma Ve Uygulama Hastanesi
Ankara, 6590
Adnan Menderes Universitesi - Uygulama ve Arastirma Hastanesi
Aydin, 9010
Dokuz Eylul Universitesi - Tip Fakultesi
Balçova, İzmir, 35330
Dicle Universitesi Hastanesi
Diyarbakır, 21280
Gaziantep University Sahinbey Practise and Research Hospital - Internal Medicine- Endocrinology and Metobolism
Gaziantep, 27310
Medipol Mega Hospital - Medical Oncology
Istanbul, Samsun, 34214
Acibadem Maslak Hospital
Istanbul, Samsun, 34457
Acibadem Atasehir Hospital
Istanbul, Samsun, 34758
Medical Park Florya Hastanesi
Istanbul, 34295
Acibadem Altunizade Hospital
Istanbul, 34662
Medical Point Izmir Hospital
Izmir, 35575
Kocaeli Uni Egt ve Uyg Hast
İzmit, Kocaeli, 41001
Prof. Dr. Suleyman Yalcin Sehir Hastanesi
Kadıköy, Istanbul, 34722
Necmettin Erbakan Universitesi Tip Fakultesi Hastanesi
Konya, Meram/Konya, 42080
VM Medical Park Mersin Hastanesi
Mersin, Mersin/Mezitli, 33200
Sakarya Egit ve Aras Hast
Sakarya, Adapazari, 54100
VM Medical Park Samsun Hospital - Medical oncology
Samsun, 55000
Australia25 sites
Cancer Research SA
Adelaide, South Australia, 5000
Royal Adelaide Hospital - Oncology
Adelaide, South Australia, 5000
Icon Cancer Centre Wesley
Auchenflower, Queensland, 4066
Flinders Medical Centre
Bedford Park, South Australia, 5042
Box Hill Hospital
Box Hill, Victoria, 3128
Monash Medical Centre
Clayton, Victoria, 3168
St Vincent's Hospital Sydney
Darlinghurst, New South Wales, 2010
Northern Hospital
Epping, Victoria, 3076
Lake Macquarie Private Hospital - Oncology
Gateshead, New South Wales, 2290
Austin Health
Heidelberg, VIC 3084
Icon Cancer Centre Hobart
Hobart, 7000
Icon Cancer Centre Townsville
Hyde Park, Queensland, 4812
St George Hospital - Medical Oncology
Kogarah, New South Wales, 2217
Icon Cancer Centre Kurralta Park
Kurralta Park, South Australia, 5037
Launceston General Hospital - Medical Oncology
Launceston, Tasmania, 7250
Lismore Base Hospital - Cancer Care , Haematology Unit
Lismore, New South Wales, 2480
Macquarie University
Macquarie Park, New South Wales, 2109
Maroondah Hospitals - Medical Oncology
Melbourne, Victoria, 3135
Breast Cancer Research Centre
Nedlands, Western Australia, 6009
Mater Hospital Sydney
North Sydney, New South Wales, 2060
Mid North Coast Cancer Institute
Port Macquarie, 2444
Goulburn Valley Health
Shepparton, Victoria, 3630
Icon Cancer Centre Southport
Southport, Queensland, 4215
Westmead Hospital
Westmead, New South Wales, 2145
The Queen Elizabeth Hospital
Woodville, South Australia, 5011
France21 sites
CHU Amiens - Picardie Site Sud
Amiens, Somme, 80000
Institut Sainte Catherine
Avignon, Vaucluse, 84000
ICONE
Bezannes, Marne, 51430
Ct Oncologie Radiotherapie CORT 37
Chambray-lès-Tours, Indre-et-Loire, 37170
Centre Jean Perrin
Clermont-Ferrand, Puy-de-Dôme, 63011
Institut de Cancerologie Bourgogne
Dijon, Saône-et-Loire, 21000
CHI De Fréjus / Saint-Raphael
Fréjus, Var, 83600
CHU de Grenoble
Grenoble, Auvergne-Rhône-Alpes, 38043
Polyclinique de Blois
La Chaussée-Saint-Victor, Loir-et-Cher, 41260
CHD Vendee
La Roche-sur-Yon, Vendée, 85925
Hopital Universitaire Dupuytren
Limoges, Limousin, 87000
Centre de Cancérologie du Grand Montpellier
Montpellier, Hérault, 34070
Hopital Tenon
Paris, Île-de-France Region, 75970
Centre Hospitalier De Pau
Pau, Pyrénées-Atlantiques, 64046
Centre Hospitalier Universitaire De Poitiers - Pôle Régional de Cancérologie
Poitiers, 86000
CRLCC Jean Godinot
Reims, Marne, 51100
Institut de Cancerologie de l'Ouest - Oncology
Saint-Herblain, Loire-Atlantique, 44805
Inst Cancerologie Strasbourg Europe
Strasbourg, Alsace, 67200
Centre de cancerologie Les Dentellieres
Valenciennes, Hauts-de-France, 59300
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, 54511
Institut Gustave Roussy
Villejuif, Val-de-Marne, 94805
South Korea16 sites
Inje University Haeundae Paik Hospital
Busan, 48108
Chungbuk National University Hospital
Cheongju-si, Chungcheongbugdo [Ch'ungch'ongbuk-do], 28644
Kyungpook National University Chilgok Hospital
Daegu, 41404
National Cancer Center
Gyeonggi-do, 10408
Ajou University Hospital
Gyeonggi-do, 16499
Gachon University Gil Medical Center
Incheon, Incheon Gwang'yeogsi [Inch'n-Kwangyokshi], 21565
CHA Bundang Medical Center, CHA University
Seongnam-si, Gyeonggido, 13496
Severance Hospital, Yonsei University Health System
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 03722
Asan Medical Center
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 05505
Gangnam Severance Hospital - Oncology
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 06273
Korea University Guro Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 08308
Korea University Anam Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 2841
Ewha Womans University Mokdong Hospital
Seoul, Seoul Teugbyeolsi [Seoul-T'ukpyolshi], 7985
Seoul National University Hospital
Seoul, 03080
The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, 06591
Ulsan University Hospital
Ulsan, 44033
United Kingdom16 sites
Blackpool Victoria Hospital
Blackpool, Lancashire, FY3 8NR
University Hospitals Sussex NHS Foundation Trust - Royal Sussex County Hospital
Brighton, East Sussex, BN2 5BE
Cheltenham General Hospital
Cheltenham, Gloucestershire, GL53 7AN
Western General Hospital
Edinburgh, EH4 2XU
Leeds Cancer Centre
Leeds, LS9 7TF
St John's Hospital - NHS Lothian
Livingston, Scotland, EH54 6PP
Whittington Health NHS Trust - Whittington Hospital
London, England, N19 5NF
University College London Hospitals
London, London, City of, NW1 2PG
The Royal Marsden NHS Foundation Trust - The Royal Marsden Hospital Fulham Road
London, London, City of, SW3 6JJ
St Bartholomew's Hospital
London, EC1A 7BE
Maidstone Hospital Kent Oncology Centre
Maidstone, ME16 9QQ
Mount Vernon Cancer Centre - Main Site
Northwood, Greater London, HA6 2RN
Royal Preston Hospital
Preston, Lancashire, PR2 9HT
The Royal Marsden NHS Foundation Trust - The Royal Marsden Sutton
Sutton, Surrey, SM2 5PT
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
Royal Cornwall Hospital (RCH) - Sunrise Centre
Truro, Cornwall, TR1 3LJ
Belgium13 sites
Edith Cavell Inter-regional Hospital Centre (CHIREC) - Delta Hospital
Aalst, Brussels Capital, 1160
Algemeen Ziekenhuis Klina
Brasschaat, Antwerpen, 2930
CHU Saint-Pierre
Brussels, Brussels Capital, 1000
Association Hospitaliere De Bruxelles Et De Schaerbeek - Centre Hospitalier Universitaire Brugmann
Brussels, Brussels Capital, 1020
Institut Jules Bordet
Brussels, 1070
Grand Hopital de Charleroi - Site Les Viviers
Charleroi, Hainaut, 6060
Jessa Ziekenhuis - Campus Virga Jesse - Medische Oncologie
Hasselt, Limburg, 3500
UZ Leuven
Leuven, Vlaams Brabant, 3000
CHU De Liège - Oncologie Médicale
Liège, 04000
CHC - Oncologie - Hémato-Immunopatho
Liège, 4000
CHU UCL Namur - Site Ste Elisabeth - Oncologie
Namur, 5000
Clnique Saint Pierre Ottignies - Oncologie-Hématologie
Ottignies, Brabant Wallon, 1340
VITAZ Campus Sint-Niklaas Moerland
Sint-Niklaas, Oost-Vlaanderen, 9100
Portugal13 sites
CHUC - Centro Hospitalar e Universitário de Coimbra
Coimbra, 3000-075
Unidade Local de Saúde do Algarve, E. P. E.
Faro, 8000-386
Instituto Portugues de Oncologia de Lisboa Francisco Gentil - Oncologia Medica
Lisbon, 1099-023
ULS Lisboa Ocidental (ULSLO)
Lisbon, 1449-005
Hospital CUF Descobertas
Lisbon, 1998-018
Hospital Beatriz Ângelo. Hospital de Loures - Oncologia Medica
Loures, Lisbon District, 2674-514
IPO Porto FG, EPE
Porto, Madeira, 4200-072
Unidade Local De Saude De Santo Antonio E.P.E.
Porto, 4099-001
Hospital da Luz de Setubal
Setúbal, 2900-722
Unidade Local de Saúde de Arrábida
Setúbal, 2910-446
Hospital De Vila Franca De Xira E.P.E.
Vila Franca de Xira, Lisbon District, 2600-009
C.H. de Vila Nova de Gaia/Espinho - Oftalmologia
Vila Nova de Gaia, Porto District, 4434-502
Centro Hospitalar de Trás-os-Montes e Alto Douro, EPE
Vila Real, 5000-508
Malaysia12 sites
Hospital Pulau Pinang - Rheumatology
George Town, Pulau Pinang
Hospital Raja Permaisuri Bainun
Ipoh, Perak, 30990
Hospital Sultan Ismail
Johor Bahru, 81100
Institut Perubatan & Pergigian Termaju (IPPT) - USM (Kepala Batas, Pulau Pinang)
Kepala Batas, Pulau Pinang, 13200
Universiti Sains Malaysia /ID# 200101
Kota Bharu, Kelantan, 16150
Pantai Hospital Kuala Lumpur
Kuala Lumpur, Kuala Lumpur, 50603
UKM Medical Centre
Kuala Lumpur, Kuala Lumpur, 56000
Beacon Hospital
Kuala Lumpur, Kuala Lumpur, 59100
Universiti Malaya Medical Centre
Kuala Lumpur, Kuala Lumpur, 59100
Hospital Kuala Lumpur
Kuala Lumpur, 50000
Mahkota Medical Center
Malacca
Institut Kanser Negara
Putrajaya, Kuala Lumpur, 62250
Switzerland12 sites
Tumor Zentrum Aarau
Aarau, Aargau (de), 5000
Kantonsspital Badenv
Baden, Aargau (de), 5404
Universitätsspital Basel
Basel, Basel-Stadt (de), 4031
Inselspital, Universitätsspital Bern
Bern, 3010
Hopitaux Universitaires de Geneve (HUG) - Hopital Cantonal
Geneva, 1211
Centre Hospitalier Universitaire Vaudois (CHUV)Département d'oncologie
Lausanne, Vaud (fr), CH-1011
Kantonsspital Baselland
Liestal, Basel-Landschaft (de), 4410
HOCH Health Ostschweiz - Kantonsspital St.Gallen
Sankt Gallen, Sankt Gallen (de), 9007
Spitaeler Schaffhausen Kantonspital
Schaffhausen, 8208
Kantonsspital Winterthur
Winterthur, Zürich (de), CH-8401
Brust-Zentrum AG Zurich
Zurich, Zürich (de), 8008
Universitätsspital Zürich
Zurich, 8091
Taiwan12 sites
Changhua Christian Medical Foundation Changhua Christian Hospital
Changhua, 500209
Taipei Tzu Chi Hospital, Buddhist Tzu Chi Medical Foundation
New Taipei City, Taipei, 231020
Taipei Medical University - Shuang Ho Hospital Ministry of Health and Welfare - Hematology & Oncology
New Taipei City, Taipei, 235041
Kuang Tien General Hospital - Shalu Xiangshang Division - Hemato-Oncology
Taichung, Taichung, 433004
China Medical University Hospital - Breast Surgery
Taichung, 404327
National Cheng Kung University Hospital
Tainan, 704302
Chi Mei Medical Center - Liouying - Oncology
Tainan, 736402
Koo Foundation Sun Yat-Sen Cancer Center - Hematology
Taipei, Taoyuan, 112019
National Taiwan University Hospital - Surgery
Taipei, 100225
Taipei Veterans General Hospital - Hematology
Taipei City, Taipei, 112201
National Defense Medical Center (NDMC) - Tri-Service General Hospital - Neihu Branch
Taipei City, Taipei, 114202
Chang Gung Medical Foundation - LinKou Chang Gung Memorial Hospital - Breast Surgery
Taiyuan, Taoyuan, 333423
Argentina11 sites
(COIBA)Centro de Oncologia e Investigacion Buenos Aires
Berazategui, Buenos Aires, B1884BBF
Fundacion Respirar
Buenos Aires, Buenos Aires F.D., 1426
Organizacion Medica de Investigacion (OMI)
Buenos Aires, Buenos Aires F.D., C1015ABO
Clinica Adventista Belgrano
Buenos Aires, Tucumán Province, 1430
Instituto Argentino de Diagnostico y Tratamiento
Buenos Aires, 054002
Centro de Investigación CIPREC
C.a.b.a., Buenos Aires F.D., 1061
Centro Oncológico Korben
CABA, Buenos Aires F.D., C1426AGE
Centro Medico Privado CEMAIC
Córdoba, Córdoba Province, X5008HHW
Inst Med Fund Estudios Clinicos
Rosario, Santa Fe Province, S2000DEJ
Instituto de Oncologia de Rosario
Rosario, Santa Fe Province, S2000KZE
Centro Oncologico de Excelencia
San Juan, J5400
Romania11 sites
Spitalul Clinic Filantropia
Bucharest, 011171
Spitalul Clinic CF Nr 2 Bucuresti
Bucharest, 011464
Spitalul Clinic Colentina - Policlinica Dr Grozovici - Medical Oncology
Bucharest, 021106
Memorial Healthcare International
Bucharest, 13823
Institutul Oncologic Prof Dr Ion Chiricuta Cluj-Napoca
Cluj-Napoca, Cluj, 400015
Oncolab - Medical Oncology
Craiova, Dolj, 200385
Onco Clinic Consult - Ambulatory
Craiova, Dolj, 200508
Centrul de Oncologie Sf. Nectarie
Craiova, Dolj, 200746
Radiotherapy Center Cluj
Floreşti, 407280
Institutul Regional de Oncologie Iasi - Medical Oncology
Iași, 700483
Oncomed - Medical Oncology
Timișoara, Timiș County, 300239
Canada10 sites
Royal Victoria Regional Health Centre; c/o Oncology Clinical Trials
Barrie, Ontario, L4M 6M2
London Health Sciences Centre
London, Ontario, N6A 4G5
Jewish General Hospital
Montreal, Quebec, H3T 1E2
Hôpital du Saint-Sacrement
Québec, G1S 4L8
Centre hospitalier régional de Lanaudière
Saint-Charles-Borromée, Quebec, J6E 6J2
Regional Hospital Saint-Jerome
Saint-Jérôme, Quebec, J7Z 5T3
BC Cancer -Surrey
Surrey, British Columbia, V3V 1Z2
St. Michaels Hospital
Toronto, Ontario, M5B 1W8
Mount Sinai Hospital - Study Supplies
Toronto, Ontario, M5G 1X5
BC Cancer Agency
Vancouver, British Columbia, V5Z 4E6
Hungary8 sites
Észak-Pesti Centrumkórház - Honvédkórház
Budapest, 1062
Budapesti Uzsoki Utcai Korhaz
Budapest, H-1145
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hajdú-Bihar, 4032
Békés Megyei Központi Kórház Pándy Kálmán Tagkórház - Oncology
Gyula, Bekes County, 5700
Bacs-Kiskun Varmegyei Oktatakorhaz
Kecskemét, Bács-Kiskun county, H-6000
University Of Pécs - Oncology dept.
Pécs, Baranya, 7624
Nograd Varmegyei Szent Lazar Korhaz
Salgótarján, Szabolcs-Szatmár-Bereg, 3100
Zala Vármegyei Szent Rafael Korhaz - Onkologiai Osztaly
Zalaegerszeg, Zala County, H-8900
Georgia7 sites
LTD "High technology hospital MEDCENTER"
Batumi, Adjara, 6000
LTD Brothers
Batumi, Adjara, 6010
LTD "Israel-Georgian Medical Research Clinic Healthycore"
Tbilisi, 0112
"Pineo Medical Ecosystem" LTD
Tbilisi, 0114
LLC "Todua Clinic"
Tbilisi, 0119
LTD Institute of Clinical Oncology
Tbilisi, 0159
LLC "Caucasus Medical Center"
Tbilisi, 0186
Poland7 sites
Szpitale Pomorskie Sp. z o.o. Oddzial Onkologii Klinicznej
Gdynia, Pomeranian Voivodeship, 81-519
IP Clinic Sp. z o.o.
Lodz, Łódź Voivodeship, 90-752
Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli - I Oddzial Onkologii Klinicznej
Lublin, Lubusz Voivodeship, 20-090
Europejskie Centrum Zdrowia Otwock, Szpital im. F. Chopina - Oddział Onkologii Klinicznej
Otwock, Masovian Voivodeship, 05-400
Wielkopolskie Centrum Onkologii Oddzial Onkologii Klinicznej i Immunoonkologii
Poznan, Greater Poland Voivodeship, 61-866
Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie Panstwowy Instytut Badawczy
Warsaw, Masovian Voivodeship, 02-781
Dolnoslaskie Centrum Onkologii, Pulmonologii i Hematologii - Oddzial Onkologii Klinicznej/Chemioterapii
Wroclaw, Lower Silesian Voivodeship, 53-413
Austria6 sites
Medizinische Universität Graz
Graz, Styria, 8010
Universitätsklinikum Krems
Krems, Lower Austria, 3500
LKH Hochsteiermark
Leoben, Styria, 8700
Universitatsklinikum St. Polten
Sankt Pölten, Lower Austria, 3100
Hanusch Krankenhaus
Vienna, 1140
Brustgesundheitszentrum Süd
Weiz, Styria, 8160
Finland6 sites
Docrates Mehiläinen Syöpäsairaala, Mehiläinen Oy
Helsinki, Etelä-Suomen Lääni, 00180
Helsinki University Central Hospital (HUCH) - Meilahden Sair
Helsinki, Länsi-Suomen Lääni, 00290
Kuopio University Hospital, Pohjois-Savon hyvinvointialue
Kuopio, Northern Savonia, 70211
Tampere University Hospital
Tampere, Etelä-Suomen Lääni, 33520
Turku University Hospital
Turku, Etelä-Suomen Lääni, 20520
Vaasa Central Hospital
Vaasa, Länsi-Suomen Lääni, 65130
Hong Kong4 sites
Hong Kong Sanatorium & Hospital (HKSH)
Happy Valley
Pamela Youde Nethersole Eastern Hospital
Hong Kong
Queen Mary Hospital - Clinical Oncology
Hong Kong
Prince of Wales Hospital (PWH) - The Chinese University of Hong Kong (CUHK) - Clinical Oncology
Shatin
Netherlands4 sites
Albert Schweitzer Ziekenhuis Locatie Dordwijk
Dordrecht, South Holland, 3318 AT
Catharina Ziekenhuis
Eindhoven, 5623 EJ
Haga Ziekenhuis - Internal Medicine
The Hague, South Holland, 2545 AA
Elisabeth-TweeSteden Ziekenhuis
Tilburg, North Brabant, 5022 GC
Singapore4 sites
National University Hospital
Singapore, Central Singapore, 119074
OncoCare Cancer Centre
Singapore, North East, 258499
Raffles Hospital
Singapore, 065001
Curie Oncology (Farrer)
Singapore, 217562
Czechia3 sites
Masarykuv onkologicky ustav - Klinika komplexni onkol. pece
Brno, Brno-město, 656 53
Multiscan s.r.o.
Hořovice, Stredoceský Kraj, 268 31
Fakultni Thomayerova nemocnice - Onkologicka klinika
Prague, 140 59
Denmark3 sites
Hillerod Hospital
Hillerød, Capital, 3400
Odense Universitetshospital - Oncology
Odense, Region Syddanmark, 5000
Soenderborg Sygehus
Sønderborg, Region Syddanmark, 6400
About this study
Official title: Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
- Conditions
- Breast Cancer
- Being tested
- Elacestrant, Anastrozole, Letrozole, Exemestane, Tamoxifen
- Keywords
- ELEGANT, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Female, Breast Cancer, Male, High-Risk Breast Cancer, High Risk Breast Carcinoma, ER-positive Breast Cancer, ER-positive HER-2 Negative Breast Cancer, ER Positive/HER2 Low Breast Cancer, Breast Cancer, ER+, HER2-, Adjuvant, Adjuvant Therapy
- Medical subject headings
- Breast Neoplasms, Breast Neoplasms, Male
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ElacestrantDrug
Administered as oral tablets
AnastrozoleDrug
Administered as oral tablets
LetrozoleDrug
Administered as oral tablets
ExemestaneDrug
Administered as oral tablets
TamoxifenDrug
Administered as oral tablets
| Study group | Role | What they receive |
|---|---|---|
| Elacestrant | Experimental | Participants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years. Receives: Drug: Elacestrant |
| Standard of Care (SoC) Endocrine Therapy | Experimental | Participants will receive the SoC endocrine therapy that was used prior to randomization:
* AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or
* Tamoxifen 20 mg QD Receives: Drug: Anastrozole; Drug: Letrozole; Drug: Exemestane; Drug: Tamoxifen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Invasive Breast Cancer-Free Survival (IBCFS)
Assessed by the time from date of randomization to the date of first occurrence of:
- Ipsilateral invasive breast tumor recurrence
- Local/regional invasive breast cancer recurrence
- Distant recurrence
- Contralateral invasive breast cancer, or
- Death attributable to any cause
Measured: Up to 5 years
Secondary outcomes (10)
Distant Relapse-Free Survival (DRFS)
Assessed by the time from date of randomization to the date of first occurrence of:
- Distant recurrence, or
- Death attributable to any cause
Measured: Up to 5 years
Overall Survival (OS)
Measured: Up to 5 years
Invasive Disease-Free Survival (IDFS)
Assessed by the time from date of randomization to the date of first occurrence of:
- Local/regional recurrence
- Contralateral recurrence
- Second primary non-breast invasive cancer
- Distant recurrence, or
- Death attributable to any cause
Measured: Up to 5 years
Number of Participants With Adverse Events (AEs)
Measured: Up to 5 years plus 28 days
Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Measured: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30
Measured: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42)
Measured: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168)
Measured: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant
Measured: Predose up to 4 hours postdose
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant
Measured: Predose up to 4 hours postdose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start27 Sep 2024
- Primary completionAug 2029 (estimated)
- Study completionOct 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Stemline Therapeutics, Inc.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 4,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stemline Therapeutics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Medical Director, Study director, Stemline Therapeutics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06492616
- Sponsor's protocol ID
- STML-ELA-0422
- Other IDs
- 2024-515445-42-00
- Acronym
- ELEGANT
- Status last verified
- Nov 2026
- First submitted
- 1 Jul 2024
- Last updated
- 4 Nov 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Elacestrant Versus Standard Endocrine Therapy in Women and Men With Node-positive, Estrogen Receptor-positive, HER2-negative, Early Breast Cancer With High Risk of Recurrence-A Global, Multicenter, Randomized, Open-label Phase 3 Study
- ClinicalTrials.gov ID
- NCT06492616
- Acronym / sponsor ID
- ELEGANT / STML-ELA-0422
- Conditions
- Breast Cancer
- Keywords
- ELEGANT, Breast Cancer Stage II, Breast Cancer Stage III, Breast Cancer Female, Breast Cancer, Male, High-Risk Breast Cancer, High Risk Breast Carcinoma, ER-positive Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 4,556 participants (actual)
- Lead sponsor
- Stemline Therapeutics, Inc.Industry (pharma, biotech, devices)
- Study start
- 27 Sep 2024 (actual)
- Primary completion
- Aug 2029 (estimated)
- Study completion
- Oct 2032 (estimated)
- First posted
- 9 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary goal of this study is to evaluate the effectiveness of elacestrant versus standard endocrine therapy in participants with node-positive, Estrogen Receptor-positive (ER+), Human Epidermal Growth Factor-2 negative (HER2-) early breast cancer with high risk of recurrence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Elacestrant | Experimental | Drug: ElacestrantParticipants will receive 345 milligrams (mg) elacestrant once daily (QD) for 5 years. |
| Standard of Care (SoC) Endocrine Therapy | Experimental | Drug: Anastrozole, Drug: Letrozole, Drug: Exemestane, Drug: TamoxifenParticipants will receive the SoC endocrine therapy that was used prior to randomization: * AI (anastrozole 1 mg QD, letrozole 2.5 mg QD, or exemestane 25 mg QD); or * Tamoxifen 20 mg QD |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Histopathologically or cytologically confirmed ER+ (≥10% by immunohistochemistry [IHC]), HER2- (tumors with an IHC score of 0, 1+, or 2+ with in situ hybridization [ISH]-negative [not amplified]). ISH-negative without IHC testing will also be eligible on tumor biopsy or final surgical pathology specimen early stage resected invasive breast cancer without evidence of recurrence or distant metastases, per local laboratory, according to the American Society of Clinical Oncology/College of American Pathologists guidelines.
- Participants must be node positive (microscopic and macroscopic tumor involvement are allowed) and fulfill one of the following criteria:
- Participants who are currently taking endocrine therapy (aromatase inhibitors or tamoxifen) and have received at least 24 months but not more than 60 months of endocrine therapy at the time of randomization (Cycle 1 Day 1 [C1D1]) with or without a CDK 4 and CKD 6 inhibitor (CDK4/6i) and with or without a luteinizing hormone-releasing hormone agonist.
- Participants who received prior CDK4/6i or a poly adenosine diphosphate-ribose polymerase inhibitor must have already completed or discontinued these treatments.
Key exclusion criteria (5 listed)
- Participants with inflammatory breast cancer.
- History of any prior (ipsilateral and/or contralateral) invasive breast cancer.
- Participant with history of non-breast malignancy within 3 years of the date of randomization, except for adequately treated basal or squamous cell skin cancer, superficial bladder cancer or carcinoma in situ of the cervix.
- Participants who have had more than a 6-month continuous interruption of prior SoC adjuvant endocrine therapy or who are off current adjuvant endocrine therapy more than 6 months prior to randomization.
- Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ElacestrantAdministered as oral tablets | Drug | Elacestrant |
| AnastrozoleAdministered as oral tablets | Drug | Standard of Care (SoC) Endocrine Therapy |
| LetrozoleAdministered as oral tablets | Drug | Standard of Care (SoC) Endocrine Therapy |
| ExemestaneAdministered as oral tablets | Drug | Standard of Care (SoC) Endocrine Therapy |
| TamoxifenAdministered as oral tablets | Drug | Standard of Care (SoC) Endocrine Therapy |
Primary outcome
Invasive Breast Cancer-Free Survival (IBCFS)
Time frame: Up to 5 years
Assessed by the time from date of randomization to the date of first occurrence of: * Ipsilateral invasive breast tumor recurrence * Local/regional invasive breast cancer recurrence * Distant recurrence * Contralateral invasive breast cancer, or * Death attributable to any cause
10 secondary outcomes
Distant Relapse-Free Survival (DRFS)
Time frame: Up to 5 years
Overall Survival (OS)
Time frame: Up to 5 years
Invasive Disease-Free Survival (IDFS)
Time frame: Up to 5 years
Number of Participants With Adverse Events (AEs)
Time frame: Up to 5 years plus 28 days
Change from Baseline in Global Health Status Quality of Life Scale score, as Assessed by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30)
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change from Baseline in the Physical Functioning Sub-Scale Score as Assessed by EORTC QLQ-C30
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change From Baseline in the Breast Cancer Endocrine Therapy Symptoms Sub-Scale Score, as Assessed by the EORTC Quality of Life Breast Cancer Questionnaire module (EORTC QLQ-BR42)
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Change From Baseline in Side Effects, as Assessed by the Question 168 of the European Organization for the Research and Treatment of Cancer Question Library (EORTC Q168)
Time frame: Baseline, Month 6, Annually at Years 1, 2, 3, 4, 5
Area Under the Plasma Concentration Versus Time Curve at Steady State (AUCss) of Elacestrant
Time frame: Predose up to 4 hours postdose
Maximum Plasma Concentration at Steady State (Cmaxss) of Elacestrant
Time frame: Predose up to 4 hours postdose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Medical Director study director
Stemline Therapeutics, Inc.
555 sites in 28 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Elacestrant, Anastrozole and Letrozole in people with Breast Cancer, run by Stemline Therapeutics, Inc. at 555 sites in 28 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 4 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 555 sites in United States, Italy, Spain, Brazil, Germany and 23 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Invasive Breast Cancer-Free Survival (IBCFS) (time frame: Up to 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Nov 2026.