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RECRUITING
NCT07413939
PHASE2/PHASE3

RO7771950 Versus Tucatinib in Combination With Trastuzumab and Capecitabine in People With Locally Advanced or Metastatic Breast Cancer That is Human Epidermal Growth Factor Receptor 2 (HER2)-Positive

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

The purpose of this study is to assess the efficacy and safety of RO7771950 in combination with trastuzumab and capecitabine, compared to tucatinib in combination with trastuzumab and capecitabine.

Official title: A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

650

Start Date

2026-05-21

Completion Date

2032-09-29

Last Updated

2026-10-06

Healthy Volunteers

No

Interventions

DRUG

RO7771950

Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).

DRUG

Tucatinib

Participants will receive a dose of tucatinib PO BID.

DRUG

Trastuzumab

Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).

DRUG

Capecitabine

Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.

Locations (206)

Clearview Cancer Institute

Huntsville, Alabama, United States

Banner Health MD Anderson AZ

Gilbert, Arizona, United States

UCSF Helen Diller Family CCC

San Francisco, California, United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut, United States

Astera Cancer Care East Brunswick

East Brunswick, New Jersey, United States

New York Oncology Hematology, P.C.

Albany, New York, United States

New York Cancer and Blood Specialists

Shirley, New York, United States

Stony Brook Univ Cancer Ctr

Stony Brook, New York, United States

Montefiore Einstein Cancer Center

The Bronx, New York, United States

The West Clinic, PC dba West Cancer Center

Germantown, Tennessee, United States

Sarah Cannon Research Institute

Nashville, Tennessee, United States

Tennessee Oncology Elliston Place Plaza

Nashville, Tennessee, United States

Texas Oncology Cancer Center

Austin, Texas, United States

The Center for Cancer and Blood Disorders - Fort Worth

Fort Worth, Texas, United States

Centro Médico Fleischer

Buenos Aires, Argentina

Investigaciones Clínicas Moleculares

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Fundación Respirar

CABA, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Centro Oncológico de Excelencia

San Juan, Argentina

Blacktown Hospital

Blacktown, New South Wales, Australia

Macquarie University Hospital

Macquarie Park, New South Wales, Australia

Monash Health

Clayton, Victoria, Australia

Barwon Health

Geelong, Victoria, Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria, Australia

Sunshine Hospital

St Albans, Victoria, Australia

Sir Charles Gairdner Hospital

Perth, Western Australia, Australia

Lkh-Univ. Klinikum Graz

Graz, Austria

Ordensklinikum Linz Barmherzige Schwestern

Linz, Austria

Lkh Salzburg - Univ. Klinikum Salzburg

Salzburg, Austria

Medizinische Universität Wien

Vienna, Austria

Cliniques Universitaires St-Luc

Brussels, Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, Belgium

AZ Groeninge

Kortrijk, Belgium

UZ Leuven Gasthuisberg

Leuven, Belgium

AZ St Maarten Campus Leopoldstr

Mechelen, Belgium

Clinique Ste-Elisabeth

Namur, Belgium

ZAS Sint Augustinus Wilrijk

Wilrijk, Belgium

Hospital Santa Rita de Cassia Vitoria

Vitória, Espírito Santo, Brazil

Hospital Brasilia

Brasília, Federal District, Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco, Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul, Brazil

Advanze Pesquisa - Oncologia Sao Carlos

São Carlos, São Paulo, Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo, Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo, Brazil

Instituto D'Or Pesquisa e Ensino

São Paulo, Brazil

Ottawa General Hospital

Ottawa, Ontario, Canada

Sunnybrook Odette Cancer Centre

Toronto, Ontario, Canada

Princess Margaret Cancer Center

Toronto, Ontario, Canada

Hopital Charles Le Moyne

Greenfield Park, Quebec, Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec, Canada

CHUM

Montreal, Quebec, Canada

McGill University Health Centre - Glen Site

Montreal, Quebec, Canada

Hospital Du Saint-Sacrement

Québec, Quebec, Canada

Hospital las Higueras

Concepción, Región Bio Bio, Chile

Centro Oncología Precisión Iquique

Iquique, Chile

Medicina de Precisión - Celerity

Las Condes, Chile

Oncovida

Providencia, Chile

Icegclinic

Santiago, Chile

Centro de Investigación Clínica UC-CICUC

Santiago, Chile

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu, China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality, China

Beijing Cancer Hospital

Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, China

Peking University People's Hospital

Beijing, China

the First Affiliated Hospital of Bengbu Medical College

Bengbu, China

West China Hospital, Sichuan University

Chengdu, China

Fujian Medical University Union Hospital

Fuzhou, China

Sun yat-sen University Cancer Center

Guangzhou, China

Sun Yat-sen Memorial Hospital

Guangzhou, China

The Second Affiliated Hospital of Zhejiang University College

HangzhouZhejiang, China

Anhui Provincial Hospital

Hefei, China

Jiangmen Central Hospital

Jiangmen, China

Shandong Cancer Hospital

Jinan, China

Yunnan Cancer Hospital

Kunming, China

Nanchang People?s Hospital

Nanchang, China

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, China

Fudan University Shanghai Cancer Center

Shanghai, China

Tumor Hospital of the affiliated medical college of Shantou University

Shantou, China

Shantou Center Hospital

Shantou, China

Tianjin Cancer Hospital

Tianjin, China

Xinjiang Medical University Cancer Hospital

Ürümqi, China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, China

Hubei Cancer Hospital

Wuhan, China

The Second Affiliated Hospital of Xi?an Jiaotong University, College of Medicine

Xi'an, China

Masaryk?v onkologický ústav

Brno, Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia

Nemocnice AGEL Novy Jicin a.s.

Nový Jičín, Czechia

Fakultni nemocnice v Motole

Prague, Czechia

CHU de Grenoble - Hôpital Nord

Grenoble, France

Centre Leon Berard

Lyon, France

Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

Nice, France

Centre Eugene Marquis;Service d'oncologie

Rennes, France

Institut Universitaire de Cancer de Toulouse Oncopole

Toulouse, France

KEM - Evang. Huyssens-Stiftung Essen-Huttrop

Essen, North Rhine-Westphalia, Germany

Städtisches Klinikum Dessau

Dessau, Germany

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, Germany

Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

Hanover, Germany

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, Germany

InVO - Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, Germany

And 106 more locations on ClinicalTrials.gov