AzTrials
AzTrials

Early Breast CancerPhase 3NCT04961996

A Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Participants With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer (lidERA Breast Cancer)

A Phase 3 study testing Giredestrant, Physician's Choice of Endocrine Therapy and LHRH Agonist in people with Early Breast Cancer, run by Hoffmann-La Roche at 621 sites in 54 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record

Search all trials

Trial summary

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Early Breast Cancer
What is being tested?
Giredestrant, Physician's Choice of Endocrine Therapy and LHRH Agonist
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
4,170 participants
Where
621 sitesin 54 countries
Study dates
27 Aug 2021to 30 Sep 2033
Phase
Phase 3

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

  • Documented estrogen receptor (ER)-positive and HER2-negative breast tumor, as assessed locally on a primary disease specimen
  • Participants who have multicentric (the presence of two of more tumor foci within different quadrants of the same breast) and/or multifocal (the presence of two or more tumor foci within a single quadrant of the breast) breast cancer are also eligible if all examined tumors meet pathologic criteria for ER positivity and HER2 negativity
  • Participants must have undergone definitive surgery of their primary breast tumor(s) and axillary lymph nodes (axillary lymph node dissection [ALND] and/or sentinel lymph node biopsy [SLNB])
  • Participants who received or will be receiving adjuvant chemotherapy must have completed adjuvant chemotherapy prior to randomization. Participants may also have received neoadjuvant chemotherapy. A washout period of at least 21 days is required between last adjuvant chemotherapy dose and randomization.
  • Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE v5.0 Grade 1 or better (except alopecia, Grade ≤2 peripheral neuropathy, arthralgia or other toxicities not considered a safety risk for the participant per the investigator's judgment)
  • Participants have received (neo)adjuvant chemotherapy and/or had surgery and had no prior endocrine therapy are eligible, provided that they are enrolled within 12 months following definitive breast cancer surgery
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  • Participants who have confirmed availability of an untreated primary breast tumor tissue specimen suitable for biomarker testing (i.e., representative archived formalin-fixed, paraffin-embedded [FFPE] tissue block [preferred] or 15-20 slides containing unstained, freshly cut, serial sections), with associated de-identified pathology report is required. Although 15-20 slides are preferred, if only 10-14 slides are available, the individual may still be eligible for the study.
  • Participants with node-positive and node-negative disease are eligible provided they meet additional risk criteria as defined in the protocol
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0, 1, or 2
  • Able and willing to swallow, retain, and absorb oral medication
  • Adequate organ function

Who cannot join

  • Pregnant or breastfeeding, or intending to become pregnant during the study or within 10 days after the final dose of giredestrant, or within the time period specified per local prescribing guidelines after the final dose of the endocrine therapy of physician's choice
  • Received treatment with investigational therapy within 28 days prior to initiation of study treatment or is currently enrolled in any other type of medical research judged by the sponsor not to be scientifically or medically compatible with this study
  • Receiving or planning to receive a CDK4/6 inhibitor as (neo)adjuvant therapy. A short course of up to 12 weeks of neoadjuvant or adjuvant treatment with CDK4/6 inhibitor therapy prior to randomization is allowed.
  • Active cardiac disease or history of cardiac dysfunction
  • Diagnosed with Stage IV breast cancer
  • A history of any prior (ipsilateral and/or contralateral) invasive breast cancer or ductal carcinoma in situ (DCIS). Participants with a history of contralateral DCIS treated by only local regional therapy at any time may be eligible.
Show all 18Show fewer
  • A history of any other malignancy within 3 years prior to screening, except for appropriately treated carcinoma in situ of the cervix, nonmelanoma skin carcinoma, or Stage I uterine cancer
  • Any prior endocrine treatment with selective ER modulators (e.g., tamoxifen), degraders, or aromatase inhibitors. A short course of neoadjuvant or adjuvant endocrine therapy (up to 12 weeks) is allowed.
  • Clinically significant liver disease consistent with Child-Pugh Class B or C, including active hepatitis (e.g., hepatitis B virus [HBV] or hepatitis C virus [HCV]), current alcohol abuse, cirrhosis, or positive test for viral hepatitis
  • Treatment with strong CYP3A4 inhibitors or inducers within 14 days or 5 drug elimination half-lives (whichever is longer) prior to initiation of study treatment
  • Known allergy or hypersensitivity to any of the study drugs or any of their excipients
  • Pre- and perimenopausal participants or male participants who have a known hypersensitivity to LHRH agonists
  • A documented history of hemorrhagic diathesis, coagulopathy, or thromboembolism
  • Renal dysfunction that requires dialysis
  • A major surgical procedure unrelated to breast cancer within 28 days prior to randomization
  • A serious infection requiring oral or IV antibiotics within 14 days prior to screening or other clinically significant infection (e.g., COVID-19) within 14 days prior to screening
  • Any serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes an individual's safe participation in and completion of the study
  • Unable or unwilling to comply with the requirements of the protocol in the opinion of the investigator

Trial locations and contacts

621 sites in 54 countries.

621 sites in 54 countries

United States72 sites

  • University Of Michigan

    Ann Arbor, Michigan, 48109

  • Messino Cancer Centers

    Asheville, North Carolina, 28806

  • CBCC Global Research Inc., at Comprehensive Blood and Cancer Center

    Bakersfield, California, 93309

  • Hematology/Oncology Clinic, LLP

    Baton Rouge, Louisiana, 70809

  • St. Vincent Frontier Cancer Center

    Billings, Montana, 59102

  • Lahey Clinic Med Ctr

    Burlington, Massachusetts, 01805

  • Aultman Hospital

    Canton, Ohio, 44710

  • University of Chicago Hospital

    Chicago, Illinois, 60637

  • University Hospitals Cleveland Medical Center

    Cleveland, Ohio, 44106

  • University of Missouri-Columbia

    Columbia, Missouri, 65203

  • Columbus NCORP

    Columbus, Ohio, 43125

  • Stefanie Spielman Comprehensive Breast Center

    Columbus, Ohio, 43212

  • Southern Cancer Center

    Daphne, Alabama, 36526

  • Texas Oncology (Grandview) - USOR

    El Paso, Texas, 79902-5113

  • Oncology Associates of Oregon, P.C.

    Eugene, Oregon, 97401

  • Hunterdon Hematology Oncology

    Flemington, New Jersey, 08822

  • Texas Oncology (Flower Mound) - USOR

    Flower Mound, Texas, 75028

  • Texas Oncology-Fort Worth Cancer Center

    Fort Worth, Texas, 76104

  • St Joseph Heritage Healthcare

    Fullerton, California, 92835

  • West Cancer Center & Research Institute

    Germantown, Tennessee, 38138-1762

  • Pinnacle Health

    Harrisburg, Pennsylvania, 17109

  • Penn State Univ. Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Memorial Healthcare System - Memorial Regional Hospital

    Hollywood, Florida, 33021

  • Baylor College of Medicine Medical Center

    Houston, Texas, 77030

  • Houston Methodist Cancer Center

    Houston, Texas, 77030

  • Baptist - MD Anderson Cancer Center

    Jacksonville, Florida, 32207

  • Cancer Center of Kansas - Kingman

    Kingman, Kansas, 67068

  • Comprehensive Cancer Centers of Nevada

    Las Vegas, Nevada, 89135

  • University of Kentucky

    Lexington, Kentucky, 40536

  • Massachusetts General Hospital

    Lexington, Massachusetts, 02421

  • Long Beach Memorial Medical Center

    Long Beach, California, 90806

  • Rocky Mountain Cancer Centers (Longmont) - USOR

    Longmont, Colorado, 80501

  • Cancer and Blood Specialty Clinic-California-Katella Ave

    Los Alamitos, California, 90720

  • Norton Cancer Institute - MDC

    Louisville, Kentucky, 40202

  • Joe Arrington Cancer Research & Treatment Center

    Lubbock, Texas, 79410

  • Centra Alan B. Pearson Regional Cancer Center

    Lynchburg, Virginia, 24501

  • University of Wisconsin

    Madison, Wisconsin, 53792

  • Texas Oncology (McAllen) - USOR

    McAllen, Texas, 78503

  • Mount Sinai Comprehensive Cancer Center

    Miami Beach, Florida, 33140

  • Bon Secours Mercy Health

    Midlothian, Virginia, 23114

  • West Virginia University Hospitals Inc

    Morgantown, West Virginia, 26056

  • Sarah Cannon Research Institute / Tennessee Oncology

    Nashville, Tennessee, 37203

  • Rutgers Cancer Institute of New Jersey

    New Brunswick, New Jersey, 08901

  • University Medical Center New Orleans

    New Orleans, Louisiana, 70112

  • New York University Cancer Cen

    New York, New York, 10016

  • Virginia Oncology Associates

    Norfolk, Virginia, 23502

  • Nebraska Cancer Specialists

    Omaha, Nebraska, 68130-2042

  • The Center for Cancer Prevention and Treatment at St.Joseph Hospital of Orange

    Orange, California, 92868

  • Allegheny Cancer Center

    Pittsburgh, Pennsylvania, 15212-4737

  • Magee Womens Hospital

    Pittsburgh, Pennsylvania, 15213

  • Kaiser Permanente-Northwest Region

    Portland, Oregon, 97227

  • Women & Infants Hospital

    Providence, Rhode Island, 02905

  • Rex Cancer Center

    Raleigh, North Carolina, 27607

  • Virginia Commonwealth University - Massey Cancer Center

    Richmond, Virginia, 23298

  • Oncology and Hematology Associates of Southwest Virginia, Inc.,-Blacksburg

    Roanoke, Virginia, 24014

  • Metro-Minnesota Community Oncology Research Consortium

    Saint Louis Park, Minnesota, 55426

  • USOR - Texas Oncology - San Antonio Northeast

    San Antonio, Texas, 78217

  • Kaiser Permanente - San Diego

    San Diego, California, 92120

  • Sansum Clinic

    Santa Barbara, California, 93105

  • UCLA Hematology/Oncology

    Santa Monica, California, 90404

  • Swedish Cancer Institute

    Seattle, Washington, 98104

  • Avera Cancer Institute

    Sioux Falls, South Dakota, 57105

  • Stamford Hospital

    Stamford, Connecticut, 06902

  • Stony Brook Univ Cancer Ctr

    Stony Brook, New York, 11794

  • Duly Health and Care

    Tinley Park, Illinois, 60487

  • Torrance Memorial Physician Network/Cancer Care

    Torrance, California, 90505

  • University of Maryland

    Towson, Maryland, 21204

  • Texas Oncology (Tyler) - USOR

    Tyler, Texas, 75702-8363

  • Kaiser Permanente - Vallejo

    Vallejo, California, 94589

  • Texas Oncology (Waco) - USOR

    Waco, Texas, 76712

  • Reading Hospital

    West Reading, Pennsylvania, 19611

  • Atrium Health Wake Forest Baptist Medical Center - PPDS

    Winston-Salem, North Carolina, 27157

Other trials in United States

Spain62 sites

  • Hospital Universitario A Coruña

    A Coruña, LA Coruna, 15006

  • Complejo Hospitalario Universitario de Albacete

    Albacete, 2006

  • Hospital Universitario Fundación Alcorcón

    Alcorcón, Madrid, 28922

  • Hospital General Universitario de Alicante

    Alicante, 03010

  • Hospital Universitario San Juan

    Alicante, 03550

  • Hospital Nuestra Señora de Sonsoles

    Ávila, 05004

  • ICO Badalona-H.U. Germans Trias i Pujol

    Badalona, Barcelona, 08916

  • Hospital del Mar

    Barcelona, 08003

  • Clinica Tres Torres

    Barcelona, 08017

  • Hospital Universitario Quiron Dexeus

    Barcelona, 08028

  • Hospital Clinic de Barcelona

    Barcelona, 08036

  • Hospital de la Santa Creu i Sant Pau

    Barcelona, 8041

  • Hospital Universitario Basurto

    Bilbao, Vizcaya, 48013

  • Hospital de San Pedro de Alcantara

    Cáceres, 10003

  • Hospital Puerta del Mar

    Cadiz, 11009

  • Consorcio Hospitalario Provincial de Castellon

    Castellon de LA Plana/castello de LA Plana, Castellon, 12002

  • Hospital General Universitario Reina Sofia

    Córdoba, 14004

  • Hospital Universitario de Donostia

    Donostia / San Sebastian, Guipuzcoa, 20080

  • Hospital General Universitario de Elche

    Elche, Alicante, 03203

  • Institut Catala d'Oncologia Girona

    Girona, 17007

  • Hospital Universitario Clínico San Cecilio

    Granada, 18007

  • Hospital Universitario Virgen de Las Nieves

    Granada, 18012

  • Hospital Universitario Juan Ramon Jimenez

    Huelva, 21005

  • Hospital Universitario de Jaen

    Jaén, 23007

  • Hospital de Jerez

    Jerez de la Frontera, Cadiz, 11407

  • Hospital Universitario Insular de Gran Canaria

    Las Palmas de Gran Canaria, LAS Palmas, 35016

  • Hospital Universitari Arnau de Vilanova

    Lleida, Lerida, 25198

  • Hospital General Universitario Gregorio Marañon

    Madrid, 28007

  • IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus

    Madrid, 28007

  • Hospital Universitario La Paz

    Madrid, 280146

  • Clinica Universidad Navarra

    Madrid, 28027

  • Hospital Universitario Infanta Leonor

    Madrid, 28031

  • MD Anderson Cancer Center Madrid ? Espana

    Madrid, 28033

  • Hospital Universitario Ramon y Cajal

    Madrid, 28034

  • Hospital Clinico San Carlos

    Madrid, 28040

  • Hospital Universitario Fundacion Jimenez Diaz.

    Madrid, 28040

  • Hospital Universitario 12 De Octubre

    Madrid, 28041

  • Hospital Universitario HM Sanchinarro ? CIOCC

    Madrid, 28050

  • Hospital Universitario Puerta de Hierro - Majadahonda

    Madrid, 28222

  • Hospital Universitario de Fuenlabrada

    Madrid, 28942

  • Hospital Universitario Virgen de la Victoria

    Málaga, 29010

  • ALTHAIA Xarxa Assistencial de Manresa

    Manresa, Barcelona, 08243

  • Hospital General Universitario Morales Meseguer

    Murcia, 30008

  • Hospital Universitario Virgen de La Arrixaca

    Murcia, 30120

  • Hospital Universitario Son Espases

    Palma de Mallorca, Balearic Islands, 07120

  • Hospital Son Llatzer

    Palma de Mallorca, Balearic Islands, 07198

  • Complejo Hospitalario de Navarra

    Pamplona, Navarre, 31008

  • Hospital Universitari Sant Joan de Reus

    Reus, Tarragona, 43204

  • Hospital Universitario de Canarias

    S. Cristobal de La Laguna, Tenerife, 38320

  • Corporacio Sanitaria Parc Tauli

    Sabadell, Barcelona, 08208

  • Hospital HM Nuestra Señora de la Esperanza

    Santiago de Compostela, Burgos, 15705

  • CHUS H Clinico U de Santiago

    Santiago de Compostela, LA Coruna, 15706

  • Hospital Universitario Virgen Macarena

    Seville, Sevilla, 41071

  • Hospital Universitario Virgen del Rocío

    Seville, 41013

  • Hospital Nuestra Senora de Valme

    Seville, 41014

  • Fundacion Instituto Valenciano de Oncologia (IVO)

    Valencia, 46009

  • Hospital Clinico Universitario de Valencia

    Valencia, 46010

  • Consorcio Hospital General Universitario de Valencia

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe de Valencia

    Valencia, 46026

  • Hospital Clinico Universitario de Valladolid

    Valladolid, 47005

  • CHUVI ? H.U. Alvaro Cunqueiro

    Vigo, Pontevedra, 36312

  • Hospital Universitario Miguel Servet

    Zaragoza, 50009

Other trials in Spain

China31 sites

  • Peking University People's Hospital

    Beijing, 100044

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • Jilin Cancer Hospital

    Changchun, 132013

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, 116027

  • Fujian Provincial Cancer Hospital

    Fuzhou, 350014

  • Guangdong Provincial Maternity and Child Care Cent

    Guangzhou, 510010

  • Sun yat-sen University Cancer Center

    Guangzhou, 510060

  • The First Affiliated Hospital, Zhejiang University School of Medicine - Chengzhan Campus - PPDS

    Hangzhou, Zhejiang, 310002

  • Zhejiang Cancer Hospital

    Hangzhou, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, 150040

  • Anhui Province Cancer Hospital

    Hefei, 230001

  • Jinan Central Hospital

    Jinan, 250013

  • Linyishi Cancer Hospital

    Linyi, 273316

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi, 330006

  • The Third Hospital of Nanchang

    Nanchang, 330009

  • Guangxi Cancer Hospital of Guangxi Medical University

    Nanning, 530021

  • The Second People's Hospital of Neijiang

    Neijiang, 641000

  • Fudan University Shanghai Cancer Center - Xuhui Campus

    Shanghai, Shanghai Municipality, 200032

  • Shengjing Hospital of China Medical University

    Shenyang, 110004

  • Tianjin Medical University Cancer Institute & Hospital

    Tianjin, 300060

  • Wenzhou Medical College - The First Affiliated Hospital GCP

    Wenzhou, 325000

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430023

  • Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan, 430030

  • Hubei Cancer Hospital

    Wuhan, 430079

  • Air Force Military Medical University Xijing Hospital

    Xi'an, 710032

  • First Affiliated Hospital of Medical College of Xi'an Jiaotong University

    Xi'an, 710061

  • The First Affiliated Hospital of Xiamen University

    Xiamen, 361003

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008

Other trials in China

Brazil28 sites

  • *X*Fundação Pio XII Hospital de Câncer de Barretos

    Barretos, São Paulo, 14784-400

  • Cenantron - Centro Avancado de Tratamento Oncologico

    Belo Horizonte, Minas Gerais, 30130-090

  • Oncoclinicas do Brasil Servicos Medicos As

    Belo Horizonte, Minas Gerais, 30360-680

  • Centro de Pesquisas Clinicas em Oncologia - CPCO

    Cachoeiro de Itapemirim, Espírito Santo, 29308-014

  • Universidade de Caxias do Sul - Rio Grande do Sul

    Caixas Do Sul, Rio Grande do Sul, 95070-560

  • Hospital Araujo Jorge

    Goiânia, Goiás, 74605-070

  • ONCOSITE Centro de Pesquisa Clínica Em Oncologia

    Ijuí, Rio Grande do Sul, 98700-000

  • Clinica de Neoplasias Litoral

    Itajaí, Santa Catarina, 88301-220

  • Hospital Amaral Carvalho

    Jaú, São Paulo, 17210-120

  • Hospital Bruno Born

    Lajeado, Rio Grande do Sul, 95900-000

  • Hospital São Vicente de Paulo X

    Passo Fundo, Rio Grande do Sul, 99001-970

  • Instituto de Oncologia Clínica de Piracicaba

    Piracicaba, São Paulo, 13419-160

  • Hospital de Clinicas de Porto Alegre HCPA PPDS

    Porto Alegre, Pará, 90035-903

  • Hospital Moinhos de Vento

    Porto Alegre, Rio Grande do Sul, 90035-001

  • Irmandade Da Santa Casa de Misericordia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90050-170

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000

  • Hospital Nossa Senhora da Conceição

    Porto Alegre, Rio Grande do Sul, 91350-200

  • Hospital Mae de Deus

    Pôrto Alegre, Mato Grosso do Sul, 90110-270

  • Hospital do Cancer de Pernambuco - HCP

    Recife, Pernambuco, 50040-000

  • Instituto Nacional de Cancer - INCa

    Rio de Janeiro, 20560-120

  • Nucleo de Oncologia da Bahia - NOB

    Salvador, Bahia, Estado de Bahia, 40170-380

  • Centro de Oncologia da Bahia

    Salvador/BA, Estado de Bahia, 41820-021

  • Faculdade de Medicina do ABC - FMABC

    Santo André, São Paulo, 09060-650

  • Fundação Faculdade Regional de Medicina de São José do Rio Preto

    São José do Rio Preto, São Paulo, 15090-000

  • Instituto Do Câncer Do Estado de São Paulo Octávio Frias de Oliveira - ICESP

    São Paulo, 01246-000

  • Instituto Brasileiro De Controle Do Câncer - IBCC

    São Paulo, 03102-002

  • Clinica de Pesquisas e Centro de Estudos Oncologia Ginecologica e Mamaria Ltda

    São Paulo, 0317-0001

  • Onco Star Sp Oncologia Ltda

    São Paulo, 04543-000

Other trials in Brazil

Australia25 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • St Andrews Medical Centre

    Adelaide, South Australia, 5000

  • Border Medical Oncology Research Unit

    Albury, New South Wales, 2640

  • Wesley Medical Centre

    Auchenflower, Queensland, 4066

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Bendigo Hospital

    Bendigo, Victoria, 3550

  • Mater Cancer Care Centre

    Brisbane, Queensland, 4101

  • Cairns Hospital

    Cairns, Queensland, 4870

  • Campbelltown Hospital

    Campbelltown, New South Wales, 2560

  • Northern Hospital

    Epping, Victoria, 3076

  • Frankston Hospital

    Frankston, Victoria, 3199

  • ICON Cancer Care Hobart

    Hobart, Tasmania, 7000

  • Ashford Cancer Centre Research

    Kurralta Park, South Australia, 5037

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Sir Charles Gairdner Hospital

    Nedlands, Western Australia, 6009

  • Westmead Hospital

    Northmead, New South Wales, 2152

  • North Coast Cancer Institute - Port Macquarie

    Port Macquarie, New South Wales, 2444

  • Maroondah Hospital

    Ringwood East, Victoria, 3135

  • Goulburn Valley Health

    Shepparton, Victoria, 3630

  • Sunshine Hospital

    St Albans, Victoria, 3021

  • Townsville Hospital

    Townsville, Queensland, 4810

  • South West Healthcare

    Warrnambool, Victoria, 3280

  • Ballarat Oncology & Haematology

    Wendouree, Victoria, 3355

  • Mater Hospital

    Wollstonecraft, New South Wales, 2065

  • Princess Alexandra Hospital

    Woolloongabba, Queensland, 4102

Other trials in Australia

Argentina24 sites

  • Hospital Italiano Regional del Sur

    Bahía Blanca, 8000

  • Fundacion Intectus

    Bariloche, Río Negro Province, 8400

  • Centro de Investigaciones Médicas y Desarrollo LC S.R.L

    Buenos Aires, Ciudad Autónoma de BuenosAires, C1113AAE

  • Instituto de Investigaciones Clinicas-Mar del Plata

    Buenos Aires, B7600FZN

  • Instituto de Investigaciones Metabólicas (IDIM)

    Buenos Aires, C1012

  • Centro Oncologico Korben

    Caba, C1426AGE

  • Fundacion Medica de Rio Negro Y Nuequen

    Cipolletti, 8324

  • Consultorios Médicos Dr. Doreski

    Ciudad Autonoma Buenos Aires, C1426ABP

  • Sanatorio Allende Servicio Nefrología

    Córdoba, 5000

  • Centro Medico Privado CEMAIC

    Córdoba, X5008HIS

  • Centro Oncologico Riojano Integral (CORI)

    La Rioja, F5300COE

  • Centro de Investigaciones Medicas Mar Del Plata

    Mar del Plata, B7600FYK

  • Hospital Privado de La Comunidad

    Mar del Plata, B7603CBM

  • Centro de Investigacion Pergamino SA

    Pergamino, B2700CPM

  • Exelsus clinica Oncologica

    Provincia de Tucumán, T4000

  • Instituto Medico de la Fundacion Estudios Clinicos

    Rosario, 2000

  • Instituto de Especialidades de la Salud Rosario - Clínica del Tórax

    Rosario, S2000DBS

  • Sanatorio Parque de Rosario

    Rosario, S2000DSV

  • Instituto de Oncologia de Rosario

    Rosario, S2013KZE

  • Centro Polivalente de Asistencia e Investigacion Clinica - CER San Juan

    San Juan, J5402DIL

  • Centro Médico Privado de Reumatología

    San Miguel de Tucumán, T4000AXL

  • Organizacion Medica de Investigacion

    San Nicolás, C1015ABO

  • Fundación Ars Medica

    San Salvador de Jujuy

  • Centro de Investigación Clínica ? Clínica Viedma

    Viedma, R8500ACE

Other trials in Argentina

Greece23 sites

  • Aretaieio Hospital ? Greece

    Athens, Anatoliki Attiki, 115 28

  • Henry Dunant Hospital

    Athens, 115 26

  • University of Athens, Hematological Clinic; First Department of Propaedeutic Medicine

    Athens, 115 27

  • Sotiria Chest Hospital of Athens

    Athens, 11527

  • General Oncology Hospital Kifissias "Oi Agioi Anargyroi"

    Athens, 145 64

  • Attikon University General Hospital

    Chaïdári, 124 62

  • Metropolitan General Hospital, A' Oncology Clinic

    Cholargós, 155 62

  • Metropolitan General Hospital

    Cholargós, 155 62

  • Metropolitan Hospital First Oncology Clinic

    Faliro, 185 47

  • Metropolitan Hospital Fourth Oncology Clinic

    Faliro, 185 47

  • University General Hospital of Heraklion

    Heraklion, 711 10

  • University General Hospital of Ioannina

    Ioannina, 455 00

  • University General Hospital of Larissa

    Larissa, 412 21

  • IASO Obstetrics Gynecology Clinic

    Marousi, 151 23

  • Medical Center of Athens

    Marousi, 151 25

  • Olympion Clinic

    Pátrai, 264 43

  • University General Hospital of Patras

    Pátrai, 265 00

  • European Interbalkan Medical Center; 3rd Department of Oncology

    Pylaia, Thessaloniki, 570 01

  • European Interbalkan Medical Center

    Pylaia, Thessaloniki, 570 01

  • Bioclinic Thessaloniki

    Thessaloniki, 546 22

  • Interbalkan Medical Center of Thessaloniki

    Thessaloniki, 546 39

  • St. Luke's Hospital

    Thessaloniki, 552 36

  • Papageorgiou General Hospital of Thessaloniki

    Thessaloniki, 564 29

Other trials in Greece

India22 sites

  • Gujarat Cancer & Research Inst.

    Ahmedabad, Gujarat, 380016

  • Sujan Surgical Cancer Hospital And Amravati Cancer Foundation

    Amravati, Maharashtra, 444606

  • KLES Dr Prabhakar Kore Hospital and Medical Research Centre

    Belagavi, Karnataka, 590010

  • Kolhapur Cancer Centre

    Kolhāpur, Maharashtra, 416234

  • Institute of Post Graduate Medical Education and Research (IPGMER) and SSKM Hospital

    Kolkata, West Bengal, 700020

  • King George Medical University (KGMU)

    Lucknow, Uttar Pradesh, 226003

  • Tata Memorial Hospital

    Mumbai, Maharashtra, 400013

  • Government Medical College

    Nagpur, Maharashtra, 440003

  • Shalinitai Meghe Medical College and Hospital

    Nagpur, Maharashtra, 441110

  • HCG Manavata Cancer Centre

    Nashik, Maharashtra, 422002

  • Chopda Medicare & Research Centre pvt. Ltd

    Nashik, Maharashtra, 422005

  • Apex Wellness Hospital

    Nashik, Maharashtra, 422009

  • State Cancer Institute, Indira Gandhi Institute of Medical Sciences (IGIMS)

    Patna, Bihar, 800014

  • Sahyadri Speciality Hospital

    Pune, Maharashtra, 411004

  • Sahyadri Super Specialty Hospital Hadapsar

    Pune, Maharashtra, 411028

  • Lokmanya Holistic Cancer Care and Research Center (LMRC)

    Pune, Maharashtra, 411033

  • Christian Medical College-Ranipet Campus

    Ratnagiri Kilminnal, Tamil Nadu, 632517

  • Nirmal Hospital

    Surat, Gujarat, 395002

  • Kiran Hospital Multi Super Speciality Hospital and Research Center

    Surat, Gujarat, 395004

  • Himalaya Cancer Hospital & Research Institute

    Vadodara, Gujarat, 390020

  • Kailash Cancer Hospital and Research Center

    Vadodara, Gujarat, 391760

  • HCG City Cancer Centre

    Vijayawada, Andhra Pradesh, 520002

Other trials in India

France18 sites

  • Hopital d'Argenteuil

    Argenteuil, 95100

  • Centre Hospitalier Regional Universitaire de Brest - Hopital de la Cavale Blanche

    Brest, 29200

  • Centre Francois Baclesse

    Caen, Calvados, 14000

  • Institut Daniel Hollard

    Grenoble, 38000

  • Centre Hospitalier Departemental de Vendee

    La Roche-sur-Yon, 85925

  • Centre de cancérologie de la Sarthe - Aile B

    Le Mans, 72015

  • Centre Oscar Lambret

    Lille, 59020

  • CHU Limoges - Dupuytren 1

    Limoges, Haute-Vienne, 87042

  • Hôpital Privé Clairval

    Marseille, 13273

  • Clinique Clémentville

    Montpellier, Hérault, 34070

  • Hôpital privé du Confluent

    Nantes, 44200

  • Hopital Universitaire Pitie Salpetriere

    Paris, 75013

  • Hopital Tenon

    Paris, 75020

  • Institut Curie

    Paris, 75248

  • Hopital privé des Côtes Armor

    Plérin, 22190

  • EDOG - Centre Eugene Marquis Centre Regional de Lutte Contre Le Cancer - PPDS

    Rennes, 35042

  • Centre Henri Becquerel

    Rouen, 76038

  • Curie Saint Cloud

    Saint-Cloud, 92210

Other trials in France

South Korea18 sites

  • Soon Chun Hyang University Cheonan Hospital

    Cheonan-si, Chungcheongnam-do, 330721

  • Chungbuk National University Hospital

    Cheongju-si, 361-711

  • Yonsei University Wonju Severance Christian Hospital

    Gangwon-do, 26426

  • National Cancer Centre

    Gyeonggi-do, 10408

  • CHA Bundang Medical Center

    Gyeonggi-do, 13496

  • Inha University Hospital

    Jemulpo-gu, Incheon, 22332

  • Gachon University Gil Medical Center

    Namdong-Gu, 21565

  • Korea University Anam Hospital

    Seongbuk-Gu, 02841

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Asan Medical Center - PPDS

    Seoul, 05505

  • Gangnam Severance Hospital, Yonsei University Health System

    Seoul, 06273

  • Korea University Guro Hospital

    Seoul, 08308

  • Severance Hospital, Yonsei University Health System

    Seoul, 3722

  • The Catholic University of Korea Seoul St. Mary?s Hospital

    Seoul, 6591

  • Samsung Medical Center - PPDS

    Seoul

  • Ulsan University Hosiptal

    Songpa-Gu, 05505

  • Ajou University Hospital

    Suwon, 443-721

Other trials in South Korea

Mexico16 sites

  • Centro de Investigacion Medica Aguascalientes

    Aguascalientes, 20116

  • Neurociencias Estudios Clinicos S.C.

    Culiacán, Sinaloa, 80020

  • Hospital Civil Fray Antonio Alcalde

    Guadalajara, Jalisco, 44280

  • Preparaciones Oncológicas S.C.

    León, Guanajuato, 37178

  • Merida | Investigacion Clinica

    Mérida, Yucatán, 97125

  • Centro de Investigación en Artritis y Osteoporosis - PPDS

    Mexicali, Estado de Baja California, 21200

  • Centro Oncologico Alianza XXI

    México

  • Health Pharma Professional Research

    Mexico City, Mexico CITY (federal District), 03100

  • Accelerium S. de R.L. de C.V.

    Monterrey, Nuevo León, 64000

  • Hospital Universitario Dr. Jose Eleuterio Gonzalez

    Monterrey, Nuevo León

  • Centro de Investigacion Clinica de Oaxaca

    Oaxaca City, Oaxaca, 68020

  • Oaxaca Site Management Organization

    Oaxaca City, 68000

  • Oncologica de Puebla S.A de C.V

    Puebla City, CP 72530

  • Investigación Médica de Alta Especialidad

    Querétaro City, Querétaro, 76000

  • Oncológico Potosino

    San Luis Potosí City, 78250

  • Centro Hemato-Oncologico Privado CHOP

    Toluca, 50080

Other trials in Mexico

Canada15 sites

  • Arthur J.E. Child Comprehensive Cancer Center-Calgary

    Calgary, Alberta, T2N 4N2

  • Centre Integre Universitaire de Sante et de Services Sociaux du Saguenay Lac Saint Jean

    Chicoutimi, Quebec, G7H 5H6

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Hopital Charles Le Moyne

    Greenfield Park, Quebec, J4V 2H1

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • CIUSSS-de-l?Est-de-l?Île-de-Montréal

    Montreal, Quebec, H1T 2M4

  • CHUM

    Montreal, Quebec, H2X 3E4

  • Sir Mortimer B Davis Jewish General Hospital

    Montreal, Quebec, H3T 1E2

  • McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • CHU de Quebec-Universite Laval

    Québec, G1S 4L8

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • St-Jérome Medical Research, Inc.

    Saint-Jérôme, Quebec, H7Z 5T3

  • Sault Area Hospital

    Sault Ste. Marie, Ontario, P6B 0A8

  • Centre Hospitalier Universitaire de Sherbrooke

    Sherbrooke, Quebec, J1H 5N4

  • British Columbia Cancer Agency

    Vancouver, British Columbia, V5Z 4R2

Other trials in Canada

Chile14 sites

  • IC La Serena Research SpA

    La Serena, 1700000

  • Patagonia Research

    Port Montt, 5480000

  • Fundacion Arturo Lopez Perez (FALP) - Providencia - Jose Manuel Infante 805

    Providencia, Región-MetropolitanadeSantiago, 7500000

  • Centro de Estudios Clínicos SAGA SpA

    Providencia, 7500000

  • Servicios Médicos URUMED SpA

    Rancagua

  • Oncovida - Santiago

    Santiago, 7510035

  • Meditek Ltda

    Santiago, 8320000

  • Centro de Estudios Clinicos E Investigaciones Medicas

    Santiago, 8330336

  • Icegclinic

    Santiago

  • Medwal

    Santiago

  • Clinica Universidad Catolica del Maule

    Talca, 3460000

  • Clinica Alemana de Temuco

    Temuco, 4810469

  • Oncocentro Apys

    Viña del Mar, 2520598

  • Centro de Investigaciones Clinicas Viña del Mar

    Viña del Mar, 2540333

Other trials in Chile

Germany14 sites

  • Hämatologisch/onkologische Gemeinschaftspraxis

    Augsburg, 86150

  • Ambulantes Tumorzentrum Spandau

    Berlin, 13581

  • Klinikum Chemnitz gGmbH

    Chemnitz, 09116

  • Universitatsklinikum Erlangen

    Erlangen, 91054

  • KEM/Evang. Kliniken Essen Mitte gGmbH

    Essen, 45136

  • Franziskus-Hospital Harderberg

    Georgsmarienhütte, 49124

  • Mammazentrum Hamburg am Krankenhaus Jerusalem

    Hamburg, 20357

  • Vincentius-Diakonissen-Kliniken gAG

    Karlsruhe, Baden-Wurttemberg, 76135

  • Universitätsklinikum Mainz

    Mainz, 55131

  • Klinikum Mannheim GmbH Universitätsklinikum

    Mannheim, 68167

  • Praxis fuer gynaekologische onkologie Prof. Dr. me

    Mönchengladbach, 41061

  • Hämatologie und Onkologie Ravensburg / Wangen

    Ravensburg, 88212

  • Leopoldina Krankenhaus Schweinfurt

    Schweinfurt, 97422

  • Praxis fur Haematologie und Internistische Onkologie

    Velbert, 42551

Other trials in Germany

Italy13 sites

  • Azienda Ospedaliera di Rilievo Nazionale e di Alta Specialita San Giuseppe Moscati

    Avellino, Campania, 83100

  • IRCCS Azienda Ospedaliero Universitaria di Bologna

    Bologna, Emilia-Romagna, 40138

  • Ospedale San Giuseppe

    Empoli, Tuscany, 50053

  • Azienda Usl Toscana nord ovest - Ospedali Riuniti di Livorno

    Livorno, Tuscany, 57123

  • Istituto Scientifico Romagnolo Per Lo Studio E La Cura Dei Tumori IRST - PPDS

    Meldola, Emilia-Romagna, 47014

  • Ospedale San Raffaele S.r.l. - PPDS

    Milan, Lombardy, 20132

  • Istituto Nazionale Tumori Regina Elena

    Milan, Lombardy, 20133

  • ASST Grande Ospedale Metropolitano Niguarda - Presidio Ospedaliero Ospedale Niguarda Ca' Granda

    Milan, Lombardy, 20162

  • Istituto Nazionale per lo Studio e la Cura dei Tumori Fondazione G. Pascale

    Naples, Campania, 80131

  • Azienda Ospedaliero Universitaria Pisana

    Pisa, Tuscany, 56126

  • Arcispedale Santa Maria Nuova

    Reggio Emilia, Emilia-Romagna, 42100

  • Fondazione Policlinico Universitario A Gemelli

    Roma, Emilia-Romagna, 00168

  • Istituto Clinico Humanitas

    Rozzano (MI), Lombardy, 20089

Other trials in Italy

Taiwan13 sites

  • Changhua Christian Medical Foundation Changhua Christian Hospital

    Changhua County, 50006

  • Hsin-Chu Branch of National Taiwan University Hospital

    Hsinchu, 300

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City, 807

  • Taipei Medical University Shuang Ho Hospital

    New Taipei City, 23561

  • China Medical University Hospital

    Taichung, 40447

  • National Cheng Kung University Hospital

    Tainan, 70457

  • Chi Mei Medical Cente

    Tainan, 71044

  • National Taiwan University Hospital

    Taipei, 100

  • Mackay Memorial Hospital - Taipei Branch

    Taipei, 10449

  • Taipei Veterans General Hospital

    Taipei, 11217

  • Koo Foundation Sun Yat-Sen Cancer Center

    Taipei, 112

  • Chang Gung Memorial Hospital - Linkou

    Taoyuan City, 33305

  • Taichung Veterans General Hospital

    Xitun Dist., 40705

Other trials in Taiwan

Turkey (Türkiye)13 sites

  • Hacettepe Universitesi Tip Fakultesi Hastanesi

    Ankara, 06100

  • Ankara City Hospital

    Ankara, 06800

  • Akdeniz University Medical Faculty

    Antalya, 07059

  • Trakya University Medical Faculty

    Edirne, 22030

  • T.C. Saglik Bakanligi Goztepe Prof. Dr. Suleyman Yalcin City Hospital

    Istanbul, 34722

  • Izmir Medical Point Hospital

    Izmir, 35101

  • Katip Celebi University- Izmir Ataturk Egitim ve Arastirma Hastanesi

    Izmir, 35360

  • Kocaeli Universitesi Tip Fakultesi Arastirma ve Uygulama Hastanesi

    Kocaeli, 41380

  • Ondokuz Mayis Universitesi Tip Fakultesi Hastanesi

    Samsun, 55239

  • Baskent Universitesi - Adana Uygulama Ve Arastirma Merkezi

    Sariçam, Adana, 01250

  • Ac?badem Adana Hospital, Oncology Department

    Seyhan/Adana, 01130

  • Acibadem Altunizade Hospital

    Üsküdar, 34662

  • Dr. Abdurrahman Yurtaslan Ankara Onkoloji Egitim ve Arastirma Hastanesi

    Yen?mahalle, 06200

Other trials in Turkey (Türkiye)

Japan12 sites

  • Fukushima Medical University Hospital

    Fukushima, 960-1295

  • Hiroshima University Hospital

    Hiroshima, 734-8551

  • Tokai University Hospital

    Isehara-Shi, Kanagawa, 259-1193

  • Social Medical Corporation Hakuaikai Sagara Hospital

    Kagoshima, 892-0833

  • The Cancer Institute Hospital of Japanese Foundation For Cancer Research

    Koto-Ku, Tokyo, 135-0063

  • Kumamoto University Hospital

    Kumamoto-Shi Chuo-Ku, Kumamoto, 860-0811

  • Nahanishi Clinic

    Naha, Okinawa, 901-0154

  • Osaka International Cancer Institute

    Osaka, 541-8567

  • National Hospital Organization Osaka National Hospital

    Osaka-Shi Chuo-Ku, Osaka, 540-0006

  • National Hospital Organization Hokkaido Cancer Center

    Sapporo, 003-0804

  • Saitama Prefectural Cancer Center

    Shinden, Saitama, 362-0806

  • St. Luke's International Hospital

    Tokyo, 104-0044

Other trials in Japan

Switzerland11 sites

  • Tumorzentrum Aarau

    Aarau, 5000

  • Kantonsspital Baden

    Baden, 5404

  • Universitätsspital Basel

    Basel, 4031

  • Universitätsspital Bern

    Bern, 3010

  • Kantonsspital Graubünden KSGR

    Chur, 7000

  • Luzerner Kantonsspital LUKS

    Lucerne, 6000

  • Hirslanden Klinik St. Anna

    Lucerne, 6006

  • Kantonsspital St. Gallen

    Sankt Gallen, 9007

  • Spital STS AG Thun - Berner Oberland

    Thun, 3600

  • Kantonsspital Winterthur Medizin Pneumologie

    Winterthur, 8400

  • Brust-Zentrum Zürich AG Seefeldstrasse 214 Zürich

    Zurich, Zürich (de), 8008

Other trials in Switzerland

Philippines10 sites

  • Riverside Medical Center, Inc.

    Bacolod City, Western Visayas (Region VI), 6100

  • Saint Louis University Hospital of Sacred Heart

    Baguio City, Benguet, 2600

  • Baguio General Hospital and Medical Center

    Baguio City, 2600

  • Metro Davao Medical and Research Center

    Davao City, 8000

  • St. Paul's Hospital

    Iloilo City, 5000

  • University of Santo Tomas Hospital

    Manila, National Capital Region, 1015

  • Cardinal Santos Medical Center

    Manila, 1503

  • The Medical City

    Pasig, 1605

  • East Avenue Medical Center

    Quezon City, 1101

  • St. Luke's Medical Center - Quezon City

    Quezon City, 1102

Other trials in Philippines

Portugal10 sites

  • Hospital Senhora da Oliveira ? Guimaraes, E.P.E

    Guimarães, 4835-044

  • Unidade Local de Saude de Santa Maria, E.P.E. - Hospital de Santa Maria

    Lisbon, Lisbon District, 1649-035

  • Instituto Português de Oncologia de Lisboa Francisco Gentil, E.P.E.

    Lisbon, 1050-034

  • Fundação Champalimaud

    Lisbon, 1400-038

  • Hospital da Luz

    Lisbon, 1500-650

  • Hospital Beatriz Angelo

    Loures, 2674-514

  • Centro Hospitalar do Porto ? Hospital de Santo António

    Porto, 4099-001

  • Instituto Portugues de Oncologia Do Porto Francisco Gentil Epe

    Porto, 4200-072

  • Centro Hospitalar de Vila Nova de Gaia / Espinho E.P.E

    Vila Nova de Gaia, Porto District, 4434-502

  • Centro Hospitalar Trás Os Montes E Alto Douro EPE

    Vila Real, 5000-508

Other trials in Portugal

Austria9 sites

  • LKH-Universitätsklinikum Klinikum Graz

    Graz, 8036

  • Medizinische Universitat Innsbruck

    Innsbruck, 6020

  • LKH Rankweil, Interne E

    Rankweil, 6830

  • Universitätsklinikum Salzburg

    Salzburg, 5020

  • Universitätsklinikum St. Pölten

    Sankt Pölten, 3100

  • A.ö. Krankenhaus der Barmherzigen Brüder

    Sankt Veit im Pongau, 9300

  • Oö. Gesundheits- und Spitals-AG/LKH Steyr

    Steyr, 4400

  • Medizinische Universitat Wien Medical University of Vienna

    Vienna, 1090

  • Klinikum Wels-Grieskirchen GmbH

    Wels, 4600

Other trials in Austria

Belgium9 sites

  • Institute Jules Bordet

    Belgium, 1000

  • Grand Hopital de Charleroi asbl

    Charleroi, 6000

  • CH de l'Ardenne (Libramont)

    Libramont, 6800

  • Centre Hospitalier Chrétien MontLégia

    Liège, 4000

  • CHR de la Citadelle, Pharmacie

    Liège, 4000

  • Chu Sart Tilman

    Liège, 4000

  • Clinique Sainte-Elisabeth

    Namur, 5000

  • Cliniques Universitaires UCL de Mont-Godinne

    Namur, 5530

  • GZA Ziekenhuizen Antwerpen campus Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Poland9 sites

  • Centrum Onkologii im. Prof. F. Lukaszczyka w Bydgoszczy

    Bydgoszcz, 85-796

  • Szpital Morski Im. Pck

    Gdynia, 81-519

  • Narodowy Instytut Onkologii im. M.Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy Oddzia? Gliwice

    Gliwice, 44-101

  • Regionalny Szpital Specjalistyczny im. W. Bieganskiego

    Grudziądz, 86-300

  • Narodowy Instytut Onkologii - Panstwowy Instytut Badawczy, Oddzia? w Krakowie

    Krakow, 31-115

  • Centrum Terapii Wspolczesnej

    Lodz, 90-338

  • Centrum Onkologii Ziemi LUBELSKIEJ im. Sw Jana z Dukli, I oddz. Chemioterapii

    Lublin, 20-090

  • Centrum Medyczne Pratia

    Poznan, 60-192

  • Narodowy Instytut Onkologii im. Marii Sk?odowskiej-Curie - Pa?stwowy Instytut Badawczy

    Warsaw, 02-781

Other trials in Poland

Georgia8 sites

  • High Technology Hospital MedCenter Ltd

    Batumi, 6000

  • Acad. F. Todua Medical Center

    Tbilisi, 0112

  • Ltd Israel-Georgia Medical Research Clinic Helsicore

    Tbilisi, 0112

  • LTD Health House

    Tbilisi, 0144

  • Institute of Clinical Oncology LTD

    Tbilisi, 0159

  • LTD TIM, Tbilisi Institute of Medicine

    Tbilisi, 0160

  • Multiprofile Clinic Consilium Medulla

    Tbilisi, 0186

  • S Khechinashvili University Clinic Ltd

    Tbilisi, 179

Other trials in Georgia

Egypt7 sites

  • Alexandria Uni

    Alexandria

  • Medical Technology Center for Research and Services

    Alexandria

  • Kasr Al Ainy School of Medicine-Cairo University

    Cairo, 11562

  • Ain Shams University Hospital

    Cairo, 11566

  • Gustave Roussy International Egypt Hospital

    Fostat, 11632

  • Mansoura University Hospital

    Markaz El Mansoura, 35516

  • Sohag Oncology Center

    Markaz Sohag, 82511

Other trials in Egypt

Hungary7 sites

  • Semmelweis Egyetem

    Budapest, 1082

  • Tolna Megyei Balassa János Kórház

    Budapest, 1136

  • Budapesti Uzsoki Utcai Kórház

    Budapest, 1145

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, 4032

  • Borsod-Abauj-Zemplen Megyei Korhaz es Egyetemi Oktato Korhaz

    Miskolc, 3526

  • Szent Borbala Korhaz

    Tatabánya, 2800

  • Zala Megyei Szent Rafael Korhaz

    Zalaegersteg, 8900

Other trials in Hungary

Ireland7 sites

  • Cork University Hospital

    Cork, T12 DC4A

  • Bon Secours Hospital

    Cork, T12 DV56

  • St Vincents University Hospital

    Dublin, D04 T6F4

  • Beaumont Hospital

    Dublin, D09 V2N0

  • Galway University Hospital

    Galway, H91 YR71

  • Mid- Western Regional Hospital Limerick

    Limerick, V94 F858

  • Waterford Regional Hospital

    Waterford, X91 ER8E

Other trials in Ireland

Malaysia7 sites

  • Sarawak General Hospital

    Buzia?, Sarawak, 305100

  • Hospital Pulau Pinang

    George Town, Pulau Pinang, 10990

  • Hospital Kuala Lumpur

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 50586

  • University Malaya Medical Centre

    Kuala Lumpur, FED. Territory of Kuala Lumpur, 59100

  • Beacon International Specialist Centre

    Petaling Jaya, Selangor, Selangor, 46050

  • National Cancer Institute IKN

    Putrajaya, Federal Territory of Putrajaya, 62250

  • Pantai Hospital Sungai Petani

    Sungai Petani, Kedah, 08000

Other trials in Malaysia

Romania7 sites

  • Spitalul Clinic de Obstetrica si Ginecologie Filantropia

    Bucure?ti, 011171

  • Prof Dr I Chiricuta Institute of Oncology

    Cluj-Napoca, 400015

  • Medisprof SRL

    Cluj-Napoca, 400641

  • Oncology Center Sf. Nectarie

    Craiova, 200347

  • Onco Clinic Consult SA

    Craiova, 200516

  • Institutul Regional de Oncologie Iasi

    Iași, 700483

  • Timisoara Emergency County Clinical Hospital

    Timi?oara, 300595

Other trials in Romania

South Africa7 sites

  • Cape Town Oncology Trials

    Cape Town, 7570

  • Cancercare Rondebosch Oncology

    Cape Town, 7700

  • Sandton Oncology Medical Group (Pty) Ltd

    City of Johannesburg, 2196

  • Excellentis Clinical Trial Consultants

    George, 6530

  • Medical Oncology Centre of Rosebank

    Johannesburg, 2196

  • Langenhoven Drive Oncology Centre

    Port Elizabeth, 6045

  • Eastleigh Breast Care Centre

    Pretoria, 0081

Other trials in South Africa

Croatia6 sites

  • General Hospital Pula

    Pula, 52100

  • University Hospital of Split

    Split, 21000

  • General Hospital Varazdin

    Varaždin, 42000

  • Clinical Hospital Sestre Milosrdnice - Medical Oncology Department

    Zagreb, 10000

  • Clinical Hospital Sestre Milosrdnice

    Zagreb, 10000

  • Klinicki bolnicki centar Zagreb

    Zagreb, 10000

Other trials in Croatia

Guatemala6 sites

  • Celan S.A.

    Guatemala City, 01010

  • INTEGRA Cancer Institute

    Guatemala City, 01010

  • Oncomedica

    Guatemala City, 01010

  • Grupo Medico Angeles

    Guatemala City, 01015

  • Clínica Médica Especializada en Hematología

    Guatemala City, 01234

  • Centro Medico Integral de Cancerologia CEMIC

    Salcajá, 09002

Other trials in Guatemala

Peru6 sites

  • Hospital Nacional Daniel A Carrion

    Bellavista, 7016

  • Hospital Militar Central

    Jesus Maria, Lima 11

  • Hospital Central Fuerza Aerea Del Peru

    Lima, 15046

  • Clínica Santa Beatriz

    Lima, 15072

  • Oncosalud Sac

    Lima, 41

  • Clinica San Antonio;Investigaciones Trujillo S.A.C.

    Trujillo, La Libertad, 13008

Other trials in Peru

Colombia5 sites

  • Hemato Oncólogos S.A

    Cali, 760042

  • FOSCAL

    Floridablanca

  • Oncomedica S.A.

    Montería, Departamento de Córdoba, 230001

  • Oncólogos Del Occidente SA

    Pereira, 660003

  • Sociedad de Oncología y hematología del Cesar Ltda

    Valledupar, 200001

Other trials in Colombia

Costa Rica5 sites

  • Consultorio Oncologico-Hospital Metropolitano Linc

    Moravia, 11401

  • Policlínico San Bosco

    San José, Alajuela Province, 20303

  • Metropolitano Research Institute Lindora

    San José, 10903

  • Centro de Cáncer y Hematología

    San José

  • Instituto de Investigación en Ciencias Médicas S.A.

    San José

Other trials in Costa Rica

Serbia5 sites

  • Institute for Oncology and Radiology of Serbia

    Belgrade, 11000

  • University Hospital Medical Center Bezanijska kosa

    Belgrade, 11080

  • Oncology Institute of Vojvodina

    Kamenitz, 21204

  • Health Center Kladovo

    Kladovo, 19320

  • General Hospital Djordje Joanovic - Zrenjanin

    Zrenjanin, 23000

Other trials in Serbia

Sweden5 sites

  • Länssjukhuset Ryhov

    Jönköping, 553 05

  • Södersjukhuset

    Stockholm, 11883

  • Sundsvalls sjukhus

    Sundsvall, 851 86

  • Akademiska Sjukhuset

    Uppsala, 751 85

  • Västmanlands sjukhus Västerås

    Västerås, 721 89

Other trials in Sweden

Czechia4 sites

  • Fakultni nemocnice Olomouc

    Olomouc, Olomouc Region, 779 00

  • Fakultni nemocnice Kralovske Vinohrady

    Prague, 100 34

  • Vseobecna Fakultni Nemocnice V Praze-U Nemocnice 499/2

    Prague, 128 08

  • Fakultni Thomayerova nemocnice

    Prague, 140 59

Other trials in Czechia

Israel4 sites

  • Shamir Medical Center Assaf Harofeh

    Beer Jacob, 0073100

  • Soroka University Medical Centre

    Beersheba, 84101

  • Sheba Medical Center - PPDS

    Ramat Gan, 52621

  • Tel-Aviv Sourasky Medical Center

    Tel Aviv, 6423906

Other trials in Israel

United Kingdom4 sites

  • Leicester Royal Infirmary

    Leicester, LE2 7LX

  • University College London Hospitals

    London

  • Nottingham City Hospital

    Nottingham, NG5 1PB

  • Royal Preston Hospital

    Preston, PR2 9HT

Other trials in United Kingdom

Bosnia and Herzegovina3 sites

  • Clinical Center Banja Luka

    Banja Luka, 78000

  • Clinical Hospital Mostar

    Mostar, 88000

  • University Clinical Center Tuzla

    Tuzla, 75000

Other trials in Bosnia and Herzegovina

Finland3 sites

  • Helsingin yliopistollinen keskussairaala

    Helsinki, 00290

  • Tays Central Hospital

    Tampere, Pirkanmaa, 33520

  • Turku University Hospital

    Turku, Southwest Finland, 20520

Other trials in Finland

Netherlands3 sites

  • Catharina Hospital

    Eindhoven, 5623 EJ

  • Hagaziekenhuis

    The Hague, 2545 AA

  • Viecuri Medisch Centrum

    Venlo, 5912 BL

Other trials in Netherlands

North Macedonia3 sites

  • PHI Clinical Hospital Dr Trifun Panovski Bitola

    Bitola, 7000

  • Acibadem Sistina Hospital

    Skopje, 1000

  • PHI University Clinic of Radiotherapy and Oncology

    Skopje, 1000

Other trials in North Macedonia

Thailand3 sites

  • Siriraj Hospital, Mahidol University

    Bangkok Noi, 10700

  • King Chulalongkorn Memorial Hospital

    Pathumwan, Bangkok Metropolis, 10330

  • Ramathibodi Hospital Mahidol University

    Ratchathewi, Bangkok Metropolis, 10400

Other trials in Thailand

Ukraine3 sites

  • Communal Non-Profit Enterprise Chernihiv Medical Center of Modern Oncology of CRC

    Chernihiv, KIEV Governorate, 14029

  • Clinic Verum Expert LLC

    Kyiv, KIEV Governorate, 03039

  • Medical Clinical Research Center of Medical Center LLC Health Clinic

    Vinnytsia, 21009

Other trials in Ukraine

Bulgaria2 sites

  • Complex Oncology Center Burgas

    Burgas, 8000

  • Multiprofile Hospital for Active Treatment Uni Hospital

    Panagyurishte, 4500

Other trials in Bulgaria

Hong Kong2 sites

  • Queen Mary Hospital

    Hong Kong

  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

Kenya2 sites

  • International Cancer Institute (ICI)

    Eldoret, 30100

  • The Aga Khan University-Kenya.

    Nairobi, 00100

Other trials in Kenya

Slovakia2 sites

  • Narodny onkologicky ustav

    Bratislava, 833 10

  • Vychodoslovensky onkologicky ustav

    Košice, 040 01

Other trials in Slovakia

Uganda2 sites

  • Uganda Cancer Institute

    Kampala, 99999

  • St Francis Hospital Nsambya

    Kampala

Other trials in Uganda

Latvia1 site

  • Pauls Stradins Clinical University Hospital

    R?ga, LV-1002

Other trials in Latvia

Slovenia1 site

  • Institute of Oncology Ljubljana

    Ljubljana, 1000

Other trials in Slovenia

About this study

Official title: A Phase III, Randomized, Open-Label, Multicenter Study Evaluating the Efficacy and Safety of Adjuvant Giredestrant Compared With Physician's Choice of Adjuvant Endocrine Monotherapy in Patients With Estrogen Receptor-Positive, HER2-Negative Early Breast Cancer

This is a Phase III, global, randomized, open-label, multicenter, study evaluating the efficacy and safety of adjuvant giredestrant compared with physician's choice of endocrine therapy in participants with medium- and high-risk Stage I-III histologically confirmed estrogen receptor (ER)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer.

Being tested
Giredestrant, Physician's Choice of Endocrine Therapy, LHRH Agonist
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GiredestrantDrug

    Also called GDC-9545, RO7197597, RG6171

    Giredestrant 30 milligrams (mg) will be administered orally once a day (QD) on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first).

  • Physician's Choice of Endocrine TherapyDrug

    The physician's choice of endocrine therapy (PCET) is limited to tamoxifen or one of the specified third generation aromatase inhibitors: letrozole, anastrozole, or exemestane. Participants will receive PCET daily on Days 1-28 of each 28-day cycle for 5 years or until disease recurrence or unacceptable toxicity (whichever occurs first). Continuing PCET after 5 years is at the discretion of the investigator and per local standard of care. Dose administration of PCET should be performed in accordance with the local prescribing information for the respective product.

  • LHRH AgonistDrug

    A luteinizing hormone-releasing hormone (LHRH) agonist will be administered to male participants and premenopausal/perimenopausal participants according to local prescribing information. LHRH agonists may include, but are not limited to, leuprolide acetate, goserelin acetate, or triptorelin pamoate. The investigator may determine and supply the appropriate LHRH agonist locally approved for use in breast cancer.

Study groups in NCT04961996
Study groupRoleWhat they receive
Arm A: GiredestrantExperimentalNot described
Receives: Drug: Giredestrant; Drug: LHRH Agonist
Arm B: Physician's Choice of Endocrine TherapyActive comparatorNot described
Receives: Drug: Physician's Choice of Endocrine Therapy; Drug: LHRH Agonist

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Invasive Disease-Free Survival (IDFS), Excluding Second Primary Non-Breast Cancers

    Measured: From randomization to first occurrence of an IDFS event (up to 10 years)

Secondary outcomes (15)

  1. Overall Survival

    Measured: From randomization to death from any cause (up to 10 years)

  2. Invasive Disease-Free Survival (IDFS), Including Second Primary Non-Breast Cancers

    Measured: From randomization to first occurrence of an IDFS event (up to 10 years)

  3. Disease-Free Survival (DFS)

    Measured: From randomization to first occurrence of a DFS event (up to 10 years)

  4. Distant Recurrence-Free Interval (DRFI)

    Measured: From randomization to first occurrence of a DFRI event (up to 10 years)

  5. Locoregional Recurrence-Free Interval (LRRFI)

    Measured: From randomization to first occurrence of a LRRFI event (up to 10 years)

  6. Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the European Organisation for the Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30)

    Measured: Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)

  7. Change from Baseline in the Mean Physical Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30

    Measured: Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)

  8. Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30

    Measured: Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)

  9. Change from Baseline in the Mean Role Functioning Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30

    Measured: Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)

  10. Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30

    Measured: Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)

  11. Change from Baseline in the Mean Global Health Status/Quality of Life (QoL) Scale Score at Specified Timepoints, Assessed Using the EORTC QLQ-C30

    Measured: Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)

  12. Change from Baseline in the EQ 5D-5L Index-Based Score at Specified Timepoints

    Measured: Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)

  13. Change from Baseline in the EQ 5D-5L Visual Analogue Scale (VAS) Score at Specified Timepoints

    Measured: Baseline (Cycle 1) and Cycles 3, 6, 9, 12, 15, 18, 21, 24, 30, 36, 42, 48, 54, and 60 (1 cycle is 28 days) of treatment, once every 6 months during the first 2 years of post-treatment follow-up and annually for 3 years thereafter (up to 10 years)

  14. Incidence and Severity of Adverse Events, with Severity Determined According to National Cancer Institute Common Terminology Criteria for Adverse Events, version 5.0 (NCI-CTCAE v5.0)

    Measured: From start of treatment until 28 days after the final dose of study treatment (up to 5 years)

  15. Plasma Concentrations of Giredestrant at Specified Timepoints

    Measured: Predose and 3-4 hours postdose on Day 1 of Cycles 1 and 2, and predose on Day 1 of Cycles 3 and 6 (1 cycle is 28 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2021
  2. Study start27 Aug 2021
  3. Primary completion8 Aug 2025
  4. Study completion30 Sep 2033 (estimated)

Resources

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
4,170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04961996
Sponsor's protocol ID
GO42784
Other IDs
2021-000129-28, 2023-507172-44-00, 2023
Status last verified
Oct 2026
First submitted
5 Jul 2021
Last updated
15 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
Expanded access
Available

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