A Study to Evaluate Efficacy and Safety of Giredestrant Compared With Fulvestrant (Plus a CDK4/6 Inhibitor), in Participants With ER-Positive, HER2-Negative Advanced Breast Cancer Resistant to Adjuvant Endocrine Therapy (pionERA Breast Cancer)

NCT ID: NCT06065748

Last Updated: 2026-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

1050 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-12-11

Study Completion Date

2029-02-12

Brief Summary

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This is a Phase III, randomized, open-label multicenter study that will evaluate the efficacy and safety of giredestrant compared with fulvestrant, both in combination with the investigator's choice of a CDK4/6 inhibitor (palbociclib, ribociclib or abemaciclib), in participants with estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer who have developed resistance to adjuvant endocrine therapy.

Detailed Description

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Conditions

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Estrogen Receptor-Positive, HER2-Negative Advanced Breast Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Giredestrant + Investigator's Choice of CDK4/6i

Participants in the experimental arm will receive giredestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.

Group Type EXPERIMENTAL

Giredestrant

Intervention Type DRUG

Giredestrant 30 milligrams (mg) orally (PO) once a day (QD) on Days 1-28 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.

Abemaciclib

Intervention Type DRUG

If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.

Palbociclib

Intervention Type DRUG

If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

Ribociclib

Intervention Type DRUG

If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

LHRH Agonist

Intervention Type DRUG

Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.

FoundationOne Liquid CDx Assay (F1LCDx)

Intervention Type DIAGNOSTIC_TEST

F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients. It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected \[ESR1m\] vs. no mutation detected \[ESR1nmd\]).

Fulvestrant + Investigator's Choice of CDK4/6i

Participants in the control arm will receive fulvestrant plus the investigator's choice of CDK4/6 inhibitor (CDK4/6i): palbociclib, ribociclib, or abemaciclib.

Group Type ACTIVE_COMPARATOR

Fulvestrant

Intervention Type DRUG

Fulvestrant 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle until PD or unacceptable toxicity.

Abemaciclib

Intervention Type DRUG

If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.

Palbociclib

Intervention Type DRUG

If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

Ribociclib

Intervention Type DRUG

If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

LHRH Agonist

Intervention Type DRUG

Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.

FoundationOne Liquid CDx Assay (F1LCDx)

Intervention Type DIAGNOSTIC_TEST

F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients. It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected \[ESR1m\] vs. no mutation detected \[ESR1nmd\]).

Interventions

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Giredestrant

Giredestrant 30 milligrams (mg) orally (PO) once a day (QD) on Days 1-28 of each 28-day cycle until progressive disease (PD) or unacceptable toxicity.

Intervention Type DRUG

Fulvestrant

Fulvestrant 500 mg intramuscularly (IM) on Days 1 and 15 of Cycle 1 and on Day 1 of each subsequent 28-day cycle until PD or unacceptable toxicity.

Intervention Type DRUG

Abemaciclib

If chosen by the investigator as the CDK4/6i, participants will receive abemaciclib 150 mg PO twice per day (BID) on Days 1-28 of each 28-day cycle until PD or unacceptable toxicity.

Intervention Type DRUG

Palbociclib

If chosen by the investigator as the CDK4/6i, participants will receive palbociclib 125 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

Intervention Type DRUG

Ribociclib

If chosen by the investigator as the CDK4/6i, participants will receive ribociclib 600 mg PO QD on Days 1-21 of each 28-day cycle until PD or unacceptable toxicity.

Intervention Type DRUG

LHRH Agonist

Only pre/perimenopausal female participants and male participants will receive a luteinizing hormone-releasing hormone (LHRH) agonist locally approved for use in breast cancer on Day 1 of each 28-day treatment cycle.

Intervention Type DRUG

FoundationOne Liquid CDx Assay (F1LCDx)

F1LCDx is a next-generation sequencing (NGS)-based in vitro diagnostic test that detects and analyses genomic alterations in circulating cell-free DNA (cfDNA) isolated from plasma derived from the anti-coagulated peripheral whole blood of cancer patients. It will be used to determine the eligibility of participants requiring confirmation of ESR1 mutation status (mutation detected \[ESR1m\] vs. no mutation detected \[ESR1nmd\]).

Intervention Type DIAGNOSTIC_TEST

Other Intervention Names

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RO7197597 RG6171 GDC-9545 F1LCDx

Eligibility Criteria

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Inclusion Criteria

* Locally advanced or metastatic adenocarcinoma of the breast, not amenable to treatment with curative intent
* Documented estrogen receptor-positive (ER+), HER2-negative (HER2-) tumor assessed locally on the most recent tumor biopsy (or an archived tumor sample if a recent tumor sample is not available for testing)
* Confirmed ESR1 mutation status (ESR1m versus ESR1nmd) in baseline circulating tumor DNA (ctDNA) through central laboratory testing
* Resistance to prior adjuvant endocrine therapy (ET), which is defined as having relapsed with prior standard adjuvant ET, on-treatment after \>/=12 months or off-treatment within 12 months of completion. Prior use of adjuvant CDK4/6i is allowed (if relapse occurred \>/=12 months since completion).
* No prior systemic anti-cancer therapy for advanced disease
* Measurable disease as defined per RECIST v.1.1 or non-measurable (including bone-only) disease
* Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1
* For pre/perimenopausal women and for men: willing to undergo and maintain treatment with approved LHRH agonist therapy (as per local guidelines) for the duration of study treatment

Exclusion Criteria

* Prior systemic therapy (e.g., prior chemotherapy, immunotherapy, or biologic therapy) for locally advanced unresectable or metastatic breast cancer
* Prior treatment with another SERD (e.g., fulvestrant, oral SERDs) or novel ER-targeting agents
* Advanced, symptomatic, visceral spread that is at risk of life-threatening complications in the short term
* Active cardiac disease or history of cardiac dysfunction
* Clinically significant history of liver disease
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hoffmann-La Roche

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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Southern Cancer Center

Daphne, Alabama, United States

Site Status RECRUITING

Sutter Auburn Faith Hospital

Auburn, California, United States

Site Status WITHDRAWN

La Hematology Oncology Medical Group

Glendale, California, United States

Site Status RECRUITING

Marin Cancer Care Inc

Greenbrae, California, United States

Site Status RECRUITING

Kaiser Permanente - Harbor City

Harbor City, California, United States

Site Status RECRUITING

USC Norris Comprehensive Cancer Center

Los Angeles, California, United States

Site Status RECRUITING

USC Norris Cancer Center

Newport Beach, California, United States

Site Status RECRUITING

Sutter Medical Group, Roseville Clinic

Roseville, California, United States

Site Status WITHDRAWN

Sutter Health Medical Center

Sacramento, California, United States

Site Status WITHDRAWN

The Lundquist Institute for BioMedical Innovation at Harbor-UCLA Medical Cente

Torrance, California, United States

Site Status RECRUITING

Rocky Mountain Cancer Centers

Littleton, Colorado, United States

Site Status RECRUITING

Georgetown University Medical Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

MedStar Washington Hosp Center

Washington D.C., District of Columbia, United States

Site Status RECRUITING

AdventHealth Altamonte

Altamonte Springs, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists - Broadway

Fort Myers, Florida, United States

Site Status RECRUITING

Cancer Specialists of North Florida

Jacksonville, Florida, United States

Site Status RECRUITING

Comprehensive Hematology Oncology

St. Petersburg, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists - Tampa

Tampa, Florida, United States

Site Status RECRUITING

Florida Cancer Specialists - EAST - SCRI - PPDS

West Palm Beach, Florida, United States

Site Status RECRUITING

Grady Health System

Atlanta, Georgia, United States

Site Status RECRUITING

Winship Cancer Institute of Emory University

Atlanta, Georgia, United States

Site Status RECRUITING

Advocate Lutheran General Hospital

Park Ridge, Illinois, United States

Site Status RECRUITING

Springfield Clinic

Springfield, Illinois, United States

Site Status RECRUITING

Mission Cancer + Blood - IMMC

Des Moines, Iowa, United States

Site Status RECRUITING

Baptist Health Lexington

Lexington, Kentucky, United States

Site Status RECRUITING

Baptist Health Hamburg

Lexington, Kentucky, United States

Site Status RECRUITING

Baptist Health Louisville

Louisville, Kentucky, United States

Site Status RECRUITING

New England Cancer Specialists

Scarborough, Maine, United States

Site Status RECRUITING

Maryland Oncology Hematology

Annapolis, Maryland, United States

Site Status RECRUITING

Frederick Health Hospital

Frederick, Maryland, United States

Site Status WITHDRAWN

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status RECRUITING

Henry Ford Hospital

Detroit, Michigan, United States

Site Status RECRUITING

HCA Midwest Division

Kansas City, Missouri, United States

Site Status RECRUITING

Cancer Care Center of O'Fallon

O'Fallon, Missouri, United States

Site Status RECRUITING

Oncology Hematology West - Grand Island

Grand Island, Nebraska, United States

Site Status RECRUITING

Oncology Hematology West - Legacy

Omaha, Nebraska, United States

Site Status RECRUITING

Astera Cancer Care East Brunswick

East Brunswick, New Jersey, United States

Site Status RECRUITING

Capital Health Regional Medical Center

Pennington, New Jersey, United States

Site Status WITHDRAWN

Queens Hospital Cancer Center

Jamaica, New York, United States

Site Status RECRUITING

Duke Women Cancer Care

Raleigh, North Carolina, United States

Site Status RECRUITING

Oncology Hematology Care

Cincinnati, Ohio, United States

Site Status WITHDRAWN

Asante Rogue Regional Medical Center

Medford, Oregon, United States

Site Status RECRUITING

Alliance Cancer Specialists

Bensalem, Pennsylvania, United States

Site Status RECRUITING

Ann B. Barshinger Cancer Institute

Lancaster, Pennsylvania, United States

Site Status RECRUITING

Abramson Cancer Center; Univ of Pennsylvania; Clinical Research Unit

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

WellSpan Oncology Research

York, Pennsylvania, United States

Site Status RECRUITING

Brown University Health

Providence, Rhode Island, United States

Site Status RECRUITING

Medical University of South Carolina

Charleston, South Carolina, United States

Site Status RECRUITING

Avera Cancer Institute - Aberdeen

Aberdeen, South Dakota, United States

Site Status RECRUITING

Avera Cancer Institute

Sioux Falls, South Dakota, United States

Site Status RECRUITING

West Cancer Center

Germantown, Tennessee, United States

Site Status RECRUITING

SCRI Oncology Partners

Nashville, Tennessee, United States

Site Status RECRUITING

Texas Oncology Cancer Center

Austin, Texas, United States

Site Status RECRUITING

JPS Oncology & Infusion Center

Fort Worth, Texas, United States

Site Status RECRUITING

Texas Oncology - DFW

Irving, Texas, United States

Site Status RECRUITING

Virginia Cancer Specialists, PC

Fairfax, Virginia, United States

Site Status RECRUITING

Virginia Commonwealth University - Massey Cancer Center

Richmond, Virginia, United States

Site Status RECRUITING

Northwest Medical Specialties

Tacoma, Washington, United States

Site Status RECRUITING

West Virginia University Hospitals Inc

Morgantown, West Virginia, United States

Site Status RECRUITING

Aurora BayCare Medical Center

Green Bay, Wisconsin, United States

Site Status RECRUITING

Aurora St Lukes Medical Center

Milwaukee, Wisconsin, United States

Site Status RECRUITING

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

Buenos Aires, , Argentina

Site Status RECRUITING

Inst. de Oncologia Angel H. Roffo

Buenos Aires, , Argentina

Site Status RECRUITING

Centro Oncologico Korben

Ciudad Autonoma Buenos Aires, , Argentina

Site Status RECRUITING

Sanatorio Allende

Córdoba, , Argentina

Site Status RECRUITING

Centro Oncologico Riojano Integral (CORI)

La Rioja, , Argentina

Site Status RECRUITING

Hospital Alemán

Recoleta, , Argentina

Site Status RECRUITING

Instituto de Oncología de Rosario

Rosario, , Argentina

Site Status RECRUITING

Sanatorio Parque S.A.

Rosario, , Argentina

Site Status RECRUITING

Hospital Provincial del Centenario

Rosario, , Argentina

Site Status RECRUITING

Centro Oncológico de Excelencia

San Juan, , Argentina

Site Status RECRUITING

Northern Beaches Hospital

Frenchs Forest, New South Wales, Australia

Site Status RECRUITING

Nepean Hospital

Kingswood, New South Wales, Australia

Site Status RECRUITING

Mater Hospital

North Sydney, New South Wales, Australia

Site Status RECRUITING

University of the Sunshine Coast

Sippy Downs, Queensland, Australia

Site Status RECRUITING

Mater Misericordiae Limited

South Brisbane, Queensland, Australia

Site Status RECRUITING

Cancer Research SA

Adelaide, South Australia, Australia

Site Status RECRUITING

Barwon Health

Geelong, Victoria, Australia

Site Status RECRUITING

Sunshine Hospital

St Albans, Victoria, Australia

Site Status RECRUITING

South West Healthcare

Warrnambool, Victoria, Australia

Site Status WITHDRAWN

Lkh-Univ. Klinikum Graz

Graz, , Austria

Site Status RECRUITING

Medical University Innsbruck

Innsbruck, , Austria

Site Status WITHDRAWN

Ordensklinikum Linz Barmherzige Schwestern

Linz, , Austria

Site Status RECRUITING

Oö. Gesundheits- und Spitals-AG/LKH Steyr

Steyr, , Austria

Site Status RECRUITING

Medizinische Universität Wien

Vienna, , Austria

Site Status WITHDRAWN

Cliniques Universitaires St-Luc

Brussels, , Belgium

Site Status RECRUITING

GHdC Site Les Viviers

Charleroi, , Belgium

Site Status RECRUITING

UZ Gent

Ghent, , Belgium

Site Status RECRUITING

UZ Leuven Gasthuisberg

Leuven, , Belgium

Site Status RECRUITING

CHU de Liège (Sart Tilman)

Liège, , Belgium

Site Status RECRUITING

AZ St Maarten Campus Leopoldstr

Mechelen, , Belgium

Site Status RECRUITING

Clinique Ste-Elisabeth

Namur, , Belgium

Site Status RECRUITING

ZAS Sint Augustinus Wilrijk

Wilrijk, , Belgium

Site Status RECRUITING

Crio - Centro Regional Integrado de Oncologia

Fortaleza, Ceará, Brazil

Site Status RECRUITING

CEDOES - Diagnóstico e Pesquisa

Vitória, Espírito Santo, Brazil

Site Status RECRUITING

Obras Sociais Irma Dulce - Osid

Salvador, Estado de Bahia, Brazil

Site Status RECRUITING

Hospital Sírio-Libanês

Brasília, Federal District, Brazil

Site Status RECRUITING

Hospital Araujo Jorge

Goiânia, Goiás, Brazil

Site Status RECRUITING

Hospital Sao Domingos

São Luís, Maranhão, Brazil

Site Status RECRUITING

Hospital do Câncer de Londrina

Londrina, Paraná, Brazil

Site Status RECRUITING

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, Brazil

Site Status RECRUITING

Vencer Oncoclínica - Centro de Pesquisa do Piauí

Teresina, Piauí, Brazil

Site Status RECRUITING

Oncosite - Centro de Pesquisa Clinica Em Oncologia Ltda

Ijuí, Rio Grande do Sul, Brazil

Site Status RECRUITING

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital Sao Lucas - PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital Nossa Senhora da Conceicao

Porto Alegre, Rio Grande do Sul, Brazil

Site Status RECRUITING

Hospital de Cancer de Barretos

Barretos, São Paulo, Brazil

Site Status RECRUITING

Hospital Amaral Carvalho

Jaú, São Paulo, Brazil

Site Status RECRUITING

Hospital Sírio-Libanês

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Clinica de Pesquisa e Centro de Estudos em Oncologia Ginecologica e Mamaria Ltda

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Hospital A. C. Camargo

São Paulo, São Paulo, Brazil

Site Status RECRUITING

Instituto D'Or de Pesquisa e Ensino

Rio de Janeiro, , Brazil

Site Status RECRUITING

Cross Cancer Institute

Edmonton, Alberta, Canada

Site Status RECRUITING

Royal Victoria Regional Health Centre

Barrie, Ontario, Canada

Site Status RECRUITING

Credit Valley Hospital/Carlo Fidani Peel Regional Cancer Centre

Mississauga, Ontario, Canada

Site Status RECRUITING

Lakeridge Health Oshawa

Oshawa, Ontario, Canada

Site Status RECRUITING

Thunder Bay Regional Health Sciences Centre

Thunder Bay, Ontario, Canada

Site Status RECRUITING

North York General Hospital

Toronto, Ontario, Canada

Site Status RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Site Status RECRUITING

CIUSSS du Saguenay Lac-Saint-Jean, Chicoutimi Hospital

Chicoutimi, Quebec, Canada

Site Status RECRUITING

CISSS Chaudière-Appalaches

Lévis, Quebec, Canada

Site Status RECRUITING

Centre Hospitalier de l'Universite de Montreal (CHUM)

Montreal, Quebec, Canada

Site Status RECRUITING

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada

Site Status WITHDRAWN

CHU de Québec - Hôpital du Saint-Sacrement

Québec, Quebec, Canada

Site Status RECRUITING

Hopital regional de saint jerome

Saint-Jérôme, Quebec, Canada

Site Status RECRUITING

Centre hospitalier regional de Trois-Rivieres

Trois-Rivières, Quebec, Canada

Site Status RECRUITING

Allan Blair Cancer Centre

Regina, Saskatchewan, Canada

Site Status RECRUITING

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, Canada

Site Status RECRUITING

Hospital las Higueras

Concepción, Región Bio Bio, Chile

Site Status RECRUITING

Centro de Oncología de Precisión

Las Condes, , Chile

Site Status RECRUITING

Clínica Puerto Montt

Port Montt, , Chile

Site Status RECRUITING

Oncovida

Providencia, , Chile

Site Status RECRUITING

Centro De Cancer Universidad Catolica

Santiago, , Chile

Site Status RECRUITING

Instituto Nacional del Cancer

Santiago, , Chile

Site Status RECRUITING

Icegclinic

Santiago, , Chile

Site Status RECRUITING

Beijing Cancer Hospital

Beijing, , China

Site Status RECRUITING

the First Hospital of Jilin University

Changchun, , China

Site Status RECRUITING

Hunan Cancer Hospital

Changsha, , China

Site Status RECRUITING

West China Hospital of Sichuan University

Chengdu, , China

Site Status RECRUITING

Sichuan Provincial People's Hospital

Chengdu, , China

Site Status RECRUITING

The First Affiliated Hospital, Chongqing Medical University

Chongqing, , China

Site Status RECRUITING

Fujian Medical University Union Hospital

Fuzhou, , China

Site Status RECRUITING

No. 900 Hospital (Fuzhou General Hospital)

Fuzhou, , China

Site Status RECRUITING

Cancer Center, Sun Yat-sen University of Medical Sciences

Guangzhou, , China

Site Status RECRUITING

The Second Affiliated Hospital of Zhejiang University College

Hangzhou, , China

Site Status RECRUITING

Harbin Medical University Cancer Hospital

Harbin, , China

Site Status RECRUITING

Jinan Central Hospital

Jinan, , China

Site Status RECRUITING

Shandong Cancer Hospital

Jinan, , China

Site Status RECRUITING

The First People's Hospital of Yunnan Province

Kunming, , China

Site Status RECRUITING

The First Affiliated Hospital to Henan University of Science and Technology

Luoyang, , China

Site Status RECRUITING

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, , China

Site Status RECRUITING

Zhongshan Hospital Fudan University

Shanghai, , China

Site Status RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, , China

Site Status RECRUITING

Shanxi Province Cancer Hospital

Taiyuan, , China

Site Status RECRUITING

Taizhou Hospital of Zhejiang Province

Taizhou, , China

Site Status WITHDRAWN

Tianjin Cancer Hospital

Tianjin, , China

Site Status RECRUITING

The Tumor Hospital of Xinjiang Medical University

Ürümqi, , China

Site Status RECRUITING

Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, , China

Site Status RECRUITING

Hubei Cancer Hospital

Wuhan, , China

Site Status RECRUITING

The Second Affiliated Hospital of Xi'an Jiao Tong University

Xi'an, , China

Site Status RECRUITING

Xi'an International Medical Center Hospital

Xi'an, , China

Site Status RECRUITING

The Affiliated Hospital of Xuzhou Medical University

Xuzhou, , China

Site Status RECRUITING

Zhejiang Cancer Hospital

Zhejiang, , China

Site Status RECRUITING

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, , China

Site Status RECRUITING

Fundación CTIC - Centro de Tratamiento e Investigación sobre Cáncer Luis Carlos Sarmiento Angulo

Bogota, D.C., , Colombia

Site Status RECRUITING

Clinica Colsanitas S.A. sede Clinica Universitaria Colombia

Bogotá D.C., , Colombia

Site Status RECRUITING

IPS Salud SURA Chipichape Cali

Cali, , Colombia

Site Status RECRUITING

Oncomedica S.A.

Montería, , Colombia

Site Status RECRUITING

Sociedad de Oncología y hematología del Cesar Ltda

Valledupar, , Colombia

Site Status RECRUITING

Clinica CIMCA

San José, , Costa Rica

Site Status RECRUITING

ICIMED Instituto de Investigación en Ciencias Médicas

San José, , Costa Rica

Site Status RECRUITING

Proclinical Pharma

San José, , Costa Rica

Site Status WITHDRAWN

Kuopio Uni Hospital

Kuopio, , Finland

Site Status RECRUITING

Tampere University Hospital

Tampere, , Finland

Site Status RECRUITING

ICO Paul Papin

Angers, , France

Site Status RECRUITING

Institut Sainte Catherine

Avignon, , France

Site Status RECRUITING

Hopital Jean Minjoz

Besançon, , France

Site Status RECRUITING

Centre Francois Baclesse

Caen, , France

Site Status RECRUITING

Centre Jean Perrin

Clermont-Ferrand, , France

Site Status RECRUITING

Centre Hospitalier Saint Louis

La Rochelle, , France

Site Status RECRUITING

Centre Oscar Lambret

Lille, , France

Site Status RECRUITING

Centre Leon Berard

Lyon, , France

Site Status RECRUITING

Centre Cancerologie Grand Montpellier

Montpellier, , France

Site Status RECRUITING

Institut Jean Godinot

Reims, , France

Site Status RECRUITING

Centre Eugene Marquis

Rennes, , France

Site Status RECRUITING

IUCT Oncopole

Toulouse, , France

Site Status RECRUITING

Gustave Roussy

Villejuif, , France

Site Status RECRUITING

Sozialstiftung Bamberg, Klinikum am Bruderwald, Gynäkologie

Bamberg, , Germany

Site Status RECRUITING

St. Elisabeth Krankenhaus Köln GmbH

Cologne, , Germany

Site Status RECRUITING

DONAU ISAR Klinikum Deggendorf

Deggendorf, , Germany

Site Status WITHDRAWN

Gynonco Düsseldorf, MVZ Medical Center GmbH

Düsseldorf, , Germany

Site Status RECRUITING

Universitätsklinikum Erlangen

Erlangen, , Germany

Site Status RECRUITING

Kliniken Essen-Mitte

Essen, , Germany

Site Status RECRUITING

Praxis für Interdisziplinäre Onkologie und Hämatologie GbR

Freiburg im Breisgau, , Germany

Site Status RECRUITING

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, , Germany

Site Status RECRUITING

Universitätsklinikum des Saarlandes

Homburg/Saar, , Germany

Site Status RECRUITING

Brustzentrum Rhein-Ruhr Servicegesellschaft mbH

Mönchengladbach, , Germany

Site Status RECRUITING

Rotkreuzklinikum München

München, , Germany

Site Status RECRUITING

Anticancer Hospital Ag. Savas

Athens, , Greece

Site Status RECRUITING

Aretaieio Hospital of Athens

Athens, , Greece

Site Status RECRUITING

University Hospital of Larissa

Larissa, , Greece

Site Status RECRUITING

University Hospital of Patras Medical Oncology

Pátrai, , Greece

Site Status RECRUITING

European Interbalkan Medical Center

Thessaloniki, , Greece

Site Status RECRUITING

Oncomedica

Guatemala City, , Guatemala

Site Status RECRUITING

Celan S.A.

Guatemala City, , Guatemala

Site Status RECRUITING

INTEGRA Cancer Institute

Guatemala City, , Guatemala

Site Status RECRUITING

Onco Go, S.A.

Guatemala City, , Guatemala

Site Status RECRUITING

Grupo Angeles

Guatemala City, , Guatemala

Site Status RECRUITING

Medi-k

Guatemala City, , Guatemala

Site Status RECRUITING

Centro Medico Integral de Cancerologia CEMIC

Salcajá, , Guatemala

Site Status RECRUITING

Pamela Youde Nethersole Eastern Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Queen Mary Hospital

Hong Kong, , Hong Kong

Site Status RECRUITING

Orszagos Onkologiai Intezet

Budapest, , Hungary

Site Status RECRUITING

Bács-Kiskun Vármegyei Oktatókórház

Kecskemét, , Hungary

Site Status RECRUITING

B-A-Z Vármegyei Központi Kórház és Egyetemi Oktatókórház

Miskolc, , Hungary

Site Status RECRUITING

Nograd Varmegyei Szent Lazar Korhaz

Salgótarján, , Hungary

Site Status RECRUITING

HealthCare Global Enterprises Limited

Banglore, Karnataka, India

Site Status RECRUITING

MVR Cancer Centre and Research Institute

Kozhikode, Kerala, India

Site Status RECRUITING

Regional Cancer Centre

Trivandrum, Kerala, India

Site Status RECRUITING

Sir H. N. Reliance Foundation Hospital and Research Centre

Mumbai, Maharashtra, India

Site Status RECRUITING

Grant Medical Foundation, Ruby Hall Clinic

Pune, Maharashtra, India

Site Status RECRUITING

Sahyadri Speciality Hospital

Pune, Maharashtra, India

Site Status RECRUITING

Sunact Cancer Institute

Thane, Maharashtra, India

Site Status RECRUITING

Max Super Speciality Hospital

New Delhi, National Capital Territory of Delhi, India

Site Status WITHDRAWN

Hadassah Ein Karem Hospital

Jerusalem, , Israel

Site Status RECRUITING

Rabin Medical Center

Petah Tikva, , Israel

Site Status RECRUITING

Sheba MC

Ramat Gan, , Israel

Site Status RECRUITING

Sourasky Medical Center

Tel Aviv, , Israel

Site Status RECRUITING

Presidio Ospedaliero di Summa-Perrino

Brindisi, Apulia, Italy

Site Status RECRUITING

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

Avellino, Campania, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Federico II

Napoli, Campania, Italy

Site Status RECRUITING

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

Napoli, Campania, Italy

Site Status RECRUITING

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, Italy

Site Status RECRUITING

I.R.S.T Srl IRCCS

Meldola, Emilia-Romagna, Italy

Site Status RECRUITING

A.O. Universitaria Di Parma

Parma, Emilia-Romagna, Italy

Site Status RECRUITING

RCCS - Centro di Riferimento

Aviano (PN), Friuli Venezia Giulia, Italy

Site Status RECRUITING

A.O. Universitaria S. Maria Della Misericordia Di Udine

Udine, Friuli Venezia Giulia, Italy

Site Status RECRUITING

Policlinico Universitario Agostino Gemelli

Rome, Lazio, Italy

Site Status RECRUITING

Università Campus Bio-Medico di Roma

Rome, Lazio, Italy

Site Status RECRUITING

Asst Papa Giovanni XXIII

Bergamo, Lombardy, Italy

Site Status RECRUITING

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, Italy

Site Status RECRUITING

Asst Di Cremona

Cremona, Lombardy, Italy

Site Status RECRUITING

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, Italy

Site Status RECRUITING

Istituto Clinico Humanitas

Rozzano, Lombardy, Italy

Site Status RECRUITING

A.O.U. Maggiore della Carità

Novara, Piedmont, Italy

Site Status RECRUITING

Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), Sicily, Italy

Site Status RECRUITING

Ospedale Di Macerata

Macerata, The Marches, Italy

Site Status RECRUITING

Azienda Ospedaliera Universitaria Careggi

Florence, Tuscany, Italy

Site Status RECRUITING

IOV - Istituto Oncologico Veneto - IRCCS

Padua, Veneto, Italy

Site Status RECRUITING

University of Nairobi - Institute of Tropical and Infectious Diseases

Nairobi, , Kenya

Site Status RECRUITING

Panamerican Clinical Research S.A de C.V.

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

RENATI INNOVATION S.A.P.I. de C.V

Guadalajara, Jalisco, Mexico

Site Status RECRUITING

Productos y Servicios Oncologicos Acacias SA de CV

Mexico City, Mexico CITY (federal District), Mexico

Site Status RECRUITING

Centro de Atencion Oncologica Viva S de RL de CV

Mexico City, Mexico CITY (federal District), Mexico

Site Status RECRUITING

Hospital Zambrano Hellion TecSalud

Monterrey, Nuevo León, Mexico

Site Status RECRUITING

Centro de Investigacion Clinica de Oaxaca

Oaxaca City, Oaxaca, Mexico

Site Status RECRUITING

PanAmerican Clinical Research, Querétaro

Queréaro, Querétaro, Mexico

Site Status RECRUITING

CENEIT Oncologicos

Mexico City, , Mexico

Site Status RECRUITING

Clinica Alivia sucursal Coyoacan

Mexico City, , Mexico

Site Status RECRUITING

Christchurch Hospital

Christchurch, , New Zealand

Site Status RECRUITING

Palmerston North Hospital

Palmerston North, , New Zealand

Site Status RECRUITING

Whangarei Hospital

Whangarei, , New Zealand

Site Status RECRUITING

Centro Medico Monte Carmelo

Arequipa, , Peru

Site Status RECRUITING

Hospital Goyeneche

Arequipa, , Peru

Site Status RECRUITING

Clínica Santa Beatriz

Lima, , Peru

Site Status RECRUITING

Hospital Nacional Arzobispo Loayza

Lima, , Peru

Site Status RECRUITING

Oncosalud Sac

Lima, , Peru

Site Status RECRUITING

Instituto Nacional de Enfermedades Neoplasicas

Lima, , Peru

Site Status RECRUITING

Clinica Internacional, Sede San Borja

Lima, , Peru

Site Status RECRUITING

Instituto Peruano de Oncología y Radioterapia

Lima, , Peru

Site Status RECRUITING

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

Trujillo, , Peru

Site Status RECRUITING

Clinica Peruana Americana

Trujillo, , Peru

Site Status WITHDRAWN

Instituto Regional de Enfermedades Neoplasicas - IREN Norte

Trujillo, , Peru

Site Status RECRUITING

Instytut "Centrum Zdrowia Matki Polki"

?ód?, , Poland

Site Status RECRUITING

Centrum Onkologii im. Prof. Franciszka ?ukaszczyka

Bydgoszcz, , Poland

Site Status RECRUITING

Szpital Morski Im. Pck

Gdynia, , Poland

Site Status RECRUITING

Narodowy Instytut Onkologii Odzia? w Gliwicach

Gliwice, , Poland

Site Status RECRUITING

?wi?tokrzyskie Centrum Onkologii

Kielce, , Poland

Site Status RECRUITING

Przychodnia Lekarska KOMED, Roman Karaszewski

Konin, , Poland

Site Status RECRUITING

Szpital Wojewódzki im. Miko?aja Kopernika

Koszalin, , Poland

Site Status RECRUITING

Centrum Onkologii Ziemi Lubelskiej im. sw. Jana z Dukli

Lublin, , Poland

Site Status RECRUITING

Opolskie Centrum Onkologii

Opole, , Poland

Site Status WITHDRAWN

Mazowiecki Szpital Wojewódzki im. ?w. Jana Paw?a II

Siedlce, , Poland

Site Status RECRUITING

Zachodniopomorskie Centrum Onkologii

Szczecin, , Poland

Site Status RECRUITING

Narodowy Inst.Onkologii im.Sklodowskiej-Curie Panstw.Inst.Bad

Warsaw, , Poland

Site Status RECRUITING

IPO de Coimbra

Coimbra, , Portugal

Site Status RECRUITING

Hospital de S. Francisco Xavier

Lisbon, , Portugal

Site Status RECRUITING

Hospital da Luz

Lisbon, , Portugal

Site Status RECRUITING

IPO do Porto

Porto, , Portugal

Site Status RECRUITING

CHVNG/E_Unidade 1

Vila Nova de Gaia, , Portugal

Site Status RECRUITING

PanOncology Trials

San Juan, , Puerto Rico

Site Status RECRUITING

Spitalul Clinic Filantropia

Bucharest, , Romania

Site Status RECRUITING

Institutul Oncologic Prof. Dr. Alexandru Trestioreanu

Bucharest, , Romania

Site Status RECRUITING

Amethyst Cluj

Cluj County, , Romania

Site Status RECRUITING

Institutul Oncologic Prof. Dr. Ion Chiricuta Cluj Napoca

Cluj-Napoca, , Romania

Site Status RECRUITING

Centrul de Oncologie Sfantul Nectarie

Craiova, , Romania

Site Status RECRUITING

Institutul Regional de Oncologie Iasi

Iași, , Romania

Site Status RECRUITING

Centrul de Oncologie Oncohelp

Timișoara, , Romania

Site Status RECRUITING

National University Hospital

Singapore, , Singapore

Site Status RECRUITING

National Cancer Centre

Singapore, , Singapore

Site Status RECRUITING

Icon Cancer Centre Gleneagles

Singapore, , Singapore

Site Status RECRUITING

Institute of Oncology Ljubljana

Ljubljana, , Slovenia

Site Status RECRUITING

Cancercare Rondebosch Oncology

Cape Town, , South Africa

Site Status WITHDRAWN

Cancercare

Port Elizabeth, , South Africa

Site Status RECRUITING

Steve Biko Academic Hospital

Pretoria, , South Africa

Site Status RECRUITING

Kyungpook National University Chilgok Hospital

Daegu, , South Korea

Site Status RECRUITING

Seoul National University Bundang Hospital

Seongnam-si, , South Korea

Site Status RECRUITING

Korea University Anam Hospital

Seoul, , South Korea

Site Status RECRUITING

Seoul National University Hospital

Seoul, , South Korea

Site Status RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, , South Korea

Site Status RECRUITING

Asan Medical Center

Seoul, , South Korea

Site Status RECRUITING

Gangnam Severance Hospital

Seoul, , South Korea

Site Status RECRUITING

Ewha Womans University Mokdong Hospital

Seoul, , South Korea

Site Status RECRUITING

Samsung Medical Center

Seoul, , South Korea

Site Status RECRUITING

Ulsan University Hosiptal

Ulsan, , South Korea

Site Status RECRUITING

Institut Catala d?Oncologia Hospital Germans Trias i Pujol

Badalona, Barcelona, Spain

Site Status RECRUITING

Hospital de Jerez de la Frontera

Jerez de la Frontera, Cadiz, Spain

Site Status RECRUITING

Hospital Quiron de Madrid

Pozuelo de Alarcón, Madrid, Spain

Site Status RECRUITING

Hospital Universitario Virgen de La Arrixaca

EL Palmar (EL Palmar), Murcia, Spain

Site Status RECRUITING

Hospital Alvaro Cunqueiro

Vigo, Pontevedra, Spain

Site Status RECRUITING

Hospital Universitari Dexeus - Grupo Quironsalud

Barcelona, , Spain

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status RECRUITING

Hospital Juan Ramon Jimenez

Huelva, , Spain

Site Status RECRUITING

Complejo Hospitalario de Jaen-Hospital Universitario Medico Quirurgico

Jaén, , Spain

Site Status RECRUITING

Centro Oncologico MD Anderson Internacional

Madrid, , Spain

Site Status RECRUITING

Hospital de Madrid Norte Sanchinarro- Centro Integral Oncologico Clara Campal

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Virgen Macarena

Seville, , Spain

Site Status RECRUITING

Hospital Universitario Virgen del Rocio

Seville, , Spain

Site Status RECRUITING

Instituto Valenciano Oncologia

Valencia, , Spain

Site Status RECRUITING

Hospital Arnau de Vilanova (Valencia) Servicio de Oncologia

Valencia, , Spain

Site Status RECRUITING

Hsin-Chu Branch of National Taiwan University Hospital

Hsinchu, , Taiwan

Site Status RECRUITING

China Medical University Hospital

Taichung, , Taiwan

Site Status RECRUITING

Veterans General Hospital

Taipei, , Taiwan

Site Status RECRUITING

National Taiwan Uni Hospital

Taipei, , Taiwan

Site Status RECRUITING

Koo Foundation Sun Yat-Sen Cancer Center

Taipei, , Taiwan

Site Status RECRUITING

Veterans General Hospital - Taichung

Xitun Dist., , Taiwan

Site Status RECRUITING

Chulalongkorn Hospital

Bangkok, , Thailand

Site Status RECRUITING

National Cancer Institute

Bangkok, , Thailand

Site Status RECRUITING

Rajavithi Hospital

Bangkok, , Thailand

Site Status RECRUITING

Chulabhorn Hospital

Lak Si, , Thailand

Site Status RECRUITING

Maharaj Nakorn Chiang Mai Hospital;Depart of Radiology

Muang Chiang MAI Delivery Branch 3, , Thailand

Site Status RECRUITING

Songklanagarind Hospital

Songkhla, , Thailand

Site Status RECRUITING

Sakarya Training and Research Hospital

Adapazarı, , Turkey (Türkiye)

Site Status RECRUITING

Ankara City Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

Bakirkoy / Istanbul, , Turkey (Türkiye)

Site Status RECRUITING

Katip Celebi University Ataturk Training and Research Hospital

Izmir, , Turkey (Türkiye)

Site Status RECRUITING

Goztepe Prof.Dr. Suleyman Yalcin City Hospital

Kadiköy, , Turkey (Türkiye)

Site Status RECRUITING

Mersin City Education and Research Hospital

Mersin, , Turkey (Türkiye)

Site Status RECRUITING

Medikal Park Samsun

Samsun, , Turkey (Türkiye)

Site Status RECRUITING

Hacettepe Uni Medical Faculty Hospital

Sihhiye/Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Argentina Australia Austria Belgium Brazil Canada Chile China Colombia Costa Rica Finland France Germany Greece Guatemala Hong Kong Hungary India Israel Italy Kenya Mexico New Zealand Peru Poland Portugal Puerto Rico Romania Singapore Slovenia South Africa South Korea Spain Taiwan Thailand Turkey (Türkiye)

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Reference Study ID Number: CO44657 https://forpatients.roche.com/

Role: CONTACT

888-662-6728 (U.S. Only)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2022-502980-39-00

Identifier Type: REGISTRY

Identifier Source: secondary_id

CO44657

Identifier Type: -

Identifier Source: org_study_id

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