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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
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
Conditions
Interventions
RO7771950
Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
Tucatinib
Participants will receive a dose of tucatinib PO BID.
Trastuzumab
Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
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