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 (BREnnA)
September 2, 2026 updated by: Hoffmann-La Roche
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
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
650
Phase
- Phase 2
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry
Study Contact Backup
- Name: Reference Study ID Number: WO46069 https://forpatients.roche.com/ No attachments to email below.
- Phone Number: 888-662-6728 (U.S. only)
- Email: global-roche-genentech-trials@gene.com
Study Locations
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Buenos Aires, Argentina, C1426ANZ
- Recruiting
- Instituto Alexander Fleming
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Buenos Aires, Argentina, C1414DRK
- Recruiting
- Centro Médico Fleischer
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Buenos Aires, Argentina, C1425BGH
- Recruiting
- Investigaciones Clínicas Moleculares
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CABA, Argentina, C1426AAL
- Recruiting
- Fundacion Respirar
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Rosario, Argentina, S2002KDS
- Recruiting
- Hospital Provincial del Centenario
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San Juan, Argentina, J5402BGA
- Recruiting
- Centro Oncológico de Excelencia
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New South Wales
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Macquarie Park, New South Wales, Australia, 2113
- Recruiting
- Macquarie University Hospital
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Victoria
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Clayton, Victoria, Australia, 3168
- Recruiting
- Monash Health
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Geelong, Victoria, Australia, 3220
- Recruiting
- Barwon Health
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Melbourne, Victoria, Australia, 3000
- Recruiting
- Peter MacCallum Cancer Centre
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St Albans, Victoria, Australia, 3021
- Recruiting
- Sunshine Hospital
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Graz, Austria, 8036
- Recruiting
- Lkh-Univ. Klinikum Graz
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Linz, Austria, 4010
- Recruiting
- Ordensklinikum Linz Barmherzige Schwestern
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Salzburg, Austria, 5020
- Recruiting
- Lkh Salzburg - Univ. Klinikum Salzburg
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Brussels, Belgium, 1200
- Recruiting
- Cliniques Universitaires St-Luc
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Hasselt, Belgium, 3500
- Recruiting
- Jessa Zkh (Campus Virga Jesse)
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Kortrijk, Belgium, 8500
- Recruiting
- AZ Groeninge
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Leuven, Belgium, 3000
- Recruiting
- UZ Leuven Gasthuisberg
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Mechelen, Belgium, 2800
- Recruiting
- AZ St Maarten Campus Leopoldstr
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Namur, Belgium, 5000
- Recruiting
- Clinique Ste-Elisabeth
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Wilrijk, Belgium, 2610
- Recruiting
- ZAS Sint Augustinus Wilrijk
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Espírito Santo
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Vitória, Espírito Santo, Brazil, 29043-260
- Recruiting
- Hospital Santa Rita de Cassia Vitoria
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Federal District
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Brasília, Federal District, Brazil, 71.635-610
- Recruiting
- Hospital Brasilia
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Pernambuco
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Recife, Pernambuco, Brazil, 50040-000
- Recruiting
- Hospital do Cancer de Pernambuco - HCP
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Rio Grande do Sul
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Porto Alegre, Rio Grande do Sul, Brazil, 90050-170
- Recruiting
- Santa Casa de Misericordia de Porto Alegre
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São Paulo
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São Carlos, São Paulo, Brazil, 13561-130
- Recruiting
- Advanze Pesquisa - Oncologia Sao Carlos
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São Paulo, São Paulo, Brazil, 01323-903
- Recruiting
- Hospital Alemao Oswaldo Cruz
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São Paulo, São Paulo, Brazil, 05652-900
- Recruiting
- Hospital Israelita Albert Einstein
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Ontario
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Ottawa, Ontario, Canada, K1H 8L6
- Recruiting
- Ottawa General Hospital
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Toronto, Ontario, Canada, M5G 2M9
- Recruiting
- Princess Margaret Cancer Center
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Toronto, Ontario, Canada, M4N 3M5
- Recruiting
- Sunnybrook Odette Cancer Centre
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Quebec
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Greenfield Park, Quebec, Canada, J4V 2H1
- Recruiting
- Hopital Charles Le Moyne
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Montreal, Quebec, Canada, H1T 2M4
- Recruiting
- Hopital Maisonneuve-Rosemont
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Montreal, Quebec, Canada, H4A 3J1
- Recruiting
- McGill University Health Centre - Glen Site
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Montreal, Quebec, Canada, H2L 4M1
- Recruiting
- CHUM
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Québec, Quebec, Canada, G1S 4L8
- Recruiting
- Hospital Du Saint-Sacrement
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Iquique, Chile, 1111442
- Recruiting
- Centro Oncología Precisión Iquique
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Las Condes, Chile, 7560908
- Recruiting
- Medicina de Precisión - Celerity
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Providencia, Chile, 7500994
- Recruiting
- Oncovida
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Santiago, Chile, 8330034
- Recruiting
- Centro de Investigación Clínica UC-CICUC
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Santiago, Chile, 7510187
- Recruiting
- Icegclinic
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Región Bio Bio
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Concepción, Región Bio Bio, Chile, Alto Horno 777
- Recruiting
- Hospital las Higueras
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Beijing, China, 100044
- Recruiting
- Peking University People's Hospital
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Beijing, China, 100021
- Recruiting
- Cancer Hospital Chinese Academy of Medical Sciences.
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Beijing, China, 100021
- Recruiting
- Beijing Cancer Hospital
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Bengbu, China, 233000
- Recruiting
- The First Affiliated Hospital of Bengbu Medical College
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Chengdu, China, 610041
- Recruiting
- West China Hospital, Sichuan University
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Fuzhou, China, 350001
- Recruiting
- Fujian Medical University Union Hospital
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Guangzhou, China, 510060
- Recruiting
- Sun Yat-Sen University Cancer Center
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Guangzhou, China, 510120
- Recruiting
- Sun Yat-sen Memorial Hospital
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HangzhouZhejiang, China, 310009
- Recruiting
- The Second Affiliated Hospital of Zhejiang University College
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Hefei, China, 230001
- Recruiting
- Anhui Provincial Hospital
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Jiangmen, China, 529030
- Recruiting
- Jiangmen Central Hospital
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Jinan, China, 250117
- Recruiting
- Shandong Cancer Hospital
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Kunming, China, 650118
- Recruiting
- Yunnan Cancer Hospital
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Nanchang, China, 330025
- Recruiting
- Nanchang People?s Hospital
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Nanning, China, 530201
- Recruiting
- Guangxi Cancer Hospital of Guangxi Medical University
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Shanghai, China, 200032
- Recruiting
- Fudan University Shanghai Cancer Center
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Shantou, China, 515031
- Recruiting
- Shantou Center Hospital
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Shantou, China, 515000
- Recruiting
- Tumor Hospital of the affiliated medical college of Shantou University
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Tianjin, China, 300000
- Recruiting
- Tianjin Cancer Hospital
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Wuhan, China, 430079
- Recruiting
- Hubei Cancer Hospital
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Wuhan, China, 430030
- Recruiting
- Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
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Xi'an, China, 710004
- Recruiting
- The Second Affiliated Hospital of Xi?an Jiaotong University, College of Medicine
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Jiangsu
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Nanjing, Jiangsu, China, 210031
- Recruiting
- Nanjing Drum Tower Hospital, The Affiliated Hospital of Nanjing University Medical School
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Shanghai Municipality
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Shanghai, Shanghai Municipality, China, 200025
- Recruiting
- Ruijin Hospital Shanghai Jiaotong University School of Medicine
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Brno, Czechia, 656 53
- Recruiting
- Masaryk?v onkologický ústav
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Hradec Králové, Czechia, 500 05
- Recruiting
- Fakultni nemocnice Hradec Kralove
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Nový Jičín, Czechia, 741 01
- Recruiting
- Nemocnice AGEL Novy Jicin a.s.
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Prague, Czechia, 150 06
- Recruiting
- Fakultni nemocnice v Motole
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Grenoble, France, 38043
- Recruiting
- CHU de Grenoble - Hôpital Nord
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Lyon, France, 69008
- Recruiting
- Centre Leon Berard
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Nice, France, 06100
- Recruiting
- Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer
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Rennes, France, 35042
- Recruiting
- Centre Eugene Marquis;Service d'oncologie
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Dessau, Germany, 06847
- Recruiting
- Städtisches Klinikum Dessau
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Hamburg, Germany, 20246
- Recruiting
- Universitätsklinikum Hamburg-Eppendorf (UKE)
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Heidelberg, Germany, 69120
- Recruiting
- Nationales Centrum für Tumorerkrankungen (NCT)
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Koblenz, Germany, 56068
- Recruiting
- InVO - Institut für Versorgungsforschung in der Onkologie GbR
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Langen, Germany, 63225
- Recruiting
- Dres. Andreas Köhler und Roswitha Fuchs
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München, Germany, 80637
- Recruiting
- Rotkreuzklinikum München
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Paderborn, Germany, 33098
- Recruiting
- St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
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Witten, Germany, 58452
- Recruiting
- Marien-Hospital Witten
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Wuppertal, Germany, 42283
- Recruiting
- Helios Klinik Wuppertal
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North Rhine-Westphalia
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Essen, North Rhine-Westphalia, Germany, 45136
- Recruiting
- KEM - Evang. Huyssens-Stiftung Essen-Huttrop
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Budapest, Hungary, 1082
- Recruiting
- Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
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Debrecen, Hungary, 4032
- Recruiting
- Debreceni Egyetem Klinikai Kozpont
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Kecskemét, Hungary, 6000
- Recruiting
- Bács-Kiskun Vármegyei Oktatókórház
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Haifa, Israel, 3109601
- Recruiting
- Rambam Health Care Campus
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Jerusalem, Israel, 9103102
- Recruiting
- Shaare Zedek Medical Center
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Jerusalem, Israel, 9112001
- Recruiting
- Hadassah University Hospital - Ein Kerem
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Petah Tikva, Israel, 4910000
- Recruiting
- Rabin MC
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Ramat Gan, Israel, 5262000
- Recruiting
- Chaim Sheba Medical Center
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Tel Aviv, Israel, 6423906
- Recruiting
- Sourasky / Ichilov Hospital
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Tel Aviv, Israel, DUMMY_VALUE
- Recruiting
- Assuta Medical Centre
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Emilia-Romagna
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Meldola, Emilia-Romagna, Italy, 47014
- Recruiting
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
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Parma, Emilia-Romagna, Italy, 43100
- Recruiting
- A.O. Universitaria Di Parma
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Friuli Venezia Giulia
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Aviano, Friuli Venezia Giulia, Italy, 33081
- Recruiting
- Irccs Centro Di Riferimento Oncologico (CRO)
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Lazio
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Rome, Lazio, Italy, 00168
- Recruiting
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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Rome, Lazio, Italy, 128
- Recruiting
- Università Campus Bio-Medico di Roma
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Lombardy
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Bergamo, Lombardy, Italy, 24127
- Recruiting
- ASST Papa Giovanni XXIII
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Brescia, Lombardy, Italy, 25123
- Recruiting
- Asst Degli Spedali Civili Di Brescia
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Milan, Lombardy, Italy, 20132
- Recruiting
- Ospedale San Raffaele
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Milan, Lombardy, Italy, 20133
- Recruiting
- Irccs Istituto Nazionale Dei Tumori (Int)
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Milan, Lombardy, Italy, 20162
- Recruiting
- ASST Grande Ospedale Metropolitano Niguarda
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Milan, Lombardy, Italy, 20141
- Recruiting
- IEO Istituto Europeo di Oncologia
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Rozzano, Lombardy, Italy, 20089
- Recruiting
- Istituto Clinico Humanitas
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Sicily
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Misterbianco (CT), Sicily, Italy, 95045
- Recruiting
- Humanitas Centro Catanese Di Oncologia
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Veneto
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Padova, Veneto, Italy, 35128
- Recruiting
- IOV - Istituto Oncologico Veneto - IRCCS
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Auckland, New Zealand, 1023
- Recruiting
- Auckland City Hospital, Cancer and Blood Research
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Tauranga, New Zealand, 3112
- Recruiting
- Tauranga Hospital, Clinical Trials Unit
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?ód?, Poland, 93-338
- Recruiting
- Instytut "Centrum Zdrowia Matki Polki"
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Katowice, Poland, 40-514
- Recruiting
- Uniwersyteckie Centrum Kliniczne im. K. Gibinskiego SUM
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Krakow, Poland, 31202
- Recruiting
- Szpital Uniwersytecki w Krakowie
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Olsztyn, Poland, 10-228
- Recruiting
- Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie
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Opole, Poland, 45-061
- Recruiting
- Opolskie Centrum Onkologii
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Opole, Poland, 45-061
- Recruiting
- Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
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Późna, Poland, 60569
- Recruiting
- Uniwersytecki Szpital Kliniczny w Poznaniu
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Tomaszów Mazowiecki, Poland, 97-200
- Recruiting
- NU-MED Centrum Diagnostyki i Terapii Onkologicznej
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Wroc?aw, Poland, 53-413
- Recruiting
- Dolno?l?skie Centrum Onkologii
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Amadora-Lisbon, Portugal, 2610-276
- Recruiting
- Hospital Professor Doutor Fernando Fonseca, E.P.E.
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Lisbon, Portugal, 1500-650
- Recruiting
- Hospital da Luz
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Lisbon, Portugal, 1649-035
- Recruiting
- Hospital de Santa Maria
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Lisbon, Portugal, 1099-023
- Recruiting
- IPO de Lisboa
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Loures, Portugal, 2674-514
- Recruiting
- Hospital Beatriz Angelo
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Matosinhos Municipality, Portugal, 4454-509
- Recruiting
- Hospital Pedro Hispano
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Porto, Portugal, 4200-072
- Recruiting
- IPO do Porto
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Vila Nova de Gaia, Portugal, 4434-502
- Recruiting
- CHVNG/E_Unidade 1
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City of Johannesburg, South Africa, 2196
- Recruiting
- Medical Oncology Centre of Rosebank
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Soweto, South Africa, 2013
- Recruiting
- Chris Hani Baragwanath Clinical Trial Site
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Daegu, South Korea, 41404
- Recruiting
- Kyungpook National University Chilgok Hospital
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Goyang-si, South Korea, 10408
- Recruiting
- National Cancer Center
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Gyeonggi-do, South Korea, 16499
- Recruiting
- Ajou University Medical Center
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Seoul, South Korea, 05505
- Recruiting
- Asan Medical Center
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Seoul, South Korea, 03080
- Recruiting
- Seoul National University Hospital
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Seoul, South Korea, 03722
- Recruiting
- Severance Hospital, Yonsei University Health System
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Seoul, South Korea, 06351
- Recruiting
- Samsung Medical Center
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Seoul, South Korea, 06273
- Recruiting
- Gangnam Severance Hospital
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Seoul, South Korea, 06591
- Recruiting
- Seoul St Mary's Hospital
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Gyeonggido
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Seongnam-si, Gyeonggido, South Korea, 13620
- Recruiting
- Seoul National University Bundang Hospital
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Barcelona, Spain, 08035
- Recruiting
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona
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Barcelona, Spain, 08036
- Recruiting
- Hospital Clinic Provincial
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Granada, Spain, 18016
- Recruiting
- Hospital Universitario San Cecilio
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Jaén, Spain, 23007
- Recruiting
- Complejo Hospitalario de Jaen
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Madrid, Spain, 28041
- Recruiting
- Hospital Universitario 12 de Octubre
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Madrid, Spain, 28034
- Recruiting
- Hospital Ramon y Cajal
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Madrid, Spain, 28009
- Recruiting
- Hospital General Universitario Gregorio Maranon
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Madrid, Spain, 28007
- Recruiting
- IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica
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Málaga, Spain, 29010
- Recruiting
- Hospital Clinico Universitario Virgen de la Victoria
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Seville, Spain, 41013
- Recruiting
- Hospital Universitario Virgen del Rocio
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Murcia
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EL Palmar (EL Palmar), Murcia, Spain, 30120
- Recruiting
- Hospital Universitario Virgen de La Arrixaca
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Tenerife
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San Cristóbal de La Laguna, Tenerife, Spain, 38320
- Recruiting
- Hospital Universitario de Canarias
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Vizcaya
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Bilbao, Vizcaya, Spain, 48013
- Recruiting
- Hospital Universitario Basurto
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Taichung, Taiwan, 407219
- Recruiting
- Taichung Veterans General Hospital
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Tainan, Taiwan, 00704
- Recruiting
- National Cheng Kung University Hospital
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Taipei, Taiwan, 112201
- Recruiting
- Taipei Veterans General Hospital
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Taipei, Taiwan, 10041
- Recruiting
- National Taiwan Uni Hospital
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Taoyuan City, Taiwan, 333
- Recruiting
- Chang Gung Memorial Hospital - Linkou
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Bangkok, Thailand, 10400
- Recruiting
- Ramathibodi Hospital
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Bangkok, Thailand, 10700
- Recruiting
- Faculty of Med. Siriraj Hosp.
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Khon Kaen, Thailand, 40002
- Recruiting
- Srinagarind Hospital, Khon Kaen Uni
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Lak Si, Thailand, 10210
- Recruiting
- Chulabhorn Hospital
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Songkhla, Thailand, 90110
- Recruiting
- Songklanagarind Hospital
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Wachira Phayaban, Thailand, 10300
- Recruiting
- Bangkok Metropolitan Administration Medical College and Vajira Hospital
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Altındağ, Turkey (Türkiye), 06230
- Recruiting
- Hacettepe University Medical Faculty
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Ankara, Turkey (Türkiye), 06490
- Recruiting
- Ankara Bilkent City Hospital
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Ankara, Turkey (Türkiye), 06200
- Recruiting
- Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
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Antalya, Turkey (Türkiye), 07058
- Recruiting
- Akdeniz University Medical Faculty
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Bakirkoy / Istanbul, Turkey (Türkiye), 34147
- Recruiting
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
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Bornova, Izmir, Turkey (Türkiye), 35100
- Recruiting
- Ege University Medical Faculty
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Erdine, Turkey (Türkiye), 22030
- Recruiting
- Trakya University Medical Faculty
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Istanbul, Turkey (Türkiye), 34010
- Recruiting
- Istinye University Liv Hospital Topkapi
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Istanbul, Turkey (Türkiye), 34722
- Recruiting
- Marmara University Pendik Research and Training Hospital
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Izmir, Turkey (Türkiye), 35630
- Recruiting
- Acibadem Izmir Kent Hospital
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Mersin, Turkey (Türkiye), 33240
- Recruiting
- Mersin City Education and Research Hospital
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Samsun, Turkey (Türkiye), 55200
- Recruiting
- Medikal Park Samsun
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Leicester, United Kingdom, LE2 7LG
- Recruiting
- Leicester Royal Infirmary
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London, United Kingdom, EC1A 7BE
- Recruiting
- Barts Health NHS Trust
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London, United Kingdom, SW3 6JJ
- Recruiting
- Royal Marsden Hospital
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London, United Kingdom, WC1E 6AG
- Recruiting
- UCLH
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London, United Kingdom, SW3 6JJ
- Recruiting
- Royal Marsden Hospital - Sutton
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Manchester, United Kingdom, M20 4GJ
- Recruiting
- Christie Hospital Nhs Trust
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Montacute, United Kingdom, TA1 5DA
- Recruiting
- Musgrove Park Hospital
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New Jersey
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East Brunswick, New Jersey, United States, 08816
- Recruiting
- Astera Cancer Care East Brunswick
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New York
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Albany, New York, United States, 12206
- Recruiting
- New York Oncology Hematology, P.C.
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Shirley, New York, United States, 11967
- Recruiting
- New York Cancer and Blood Specialists
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Tennessee
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Germantown, Tennessee, United States, 38138
- Recruiting
- The West Clinic, PC dba West Cancer Center
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Description
Inclusion Criteria:
- Pathologically documented locally advanced inoperable (LAI) or metastatic breast cancer (MBC) with confirmed HER2-positive status by central laboratory.
- Measurable disease as per by RECIST v1.1 in stage 1. Non-measurable disease allowed in stage 2.
- Previously treated (stable or progressive) or previously untreated CNS metastases, or leptomeningeal metastases.
- At least one prior line of anti-HER2-based therapy for LAI or metastatic disease.
- Prior anti-HER2 antibody-drug conjugate (ADC), such as trastuzumab-deruxtecan (T-DXd) or trastuzumab emtansine (T-DM1), in any treatment setting. Participants without prior ADC therapy may only be enrolled if approved standard-of-care (SOC) anti-HER2 ADC is not locally accessible at screening, or if there is a prospectively documented clinical contraindication.
- Prior tyrosine kinase inhibitor (TKI) in the (neo)adjuvant setting provided completion is > 12 months ahead of LAI occurrence. Prior treatment with TKIs for LAI/MBC is not permitted.
- Has protocol-defined adequate organ and bone marrow function.
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
- Baseline left ventricular ejection fraction (LVEF) ≥ 50%.
Exclusion Criteria:
- Concurrent anti-cancer treatment, or treatment with investigational therapy within 28 days prior to initiation of study treatment.
- Known active/untreated hepatitis B or C or chronic liver disease.
- Clinically significant cardiovascular disease or risk, including heart failure (New York Heart Association (NYHA) ≥ II), ischemic heart disease or recent coronary events/interventions, clinically significant arrhythmias or electrocardiogram (ECG) abnormalities, QT prolongation or risk of ventricular dysrhythmias, poorly controlled hypertension, peripheral arterial disease, dilated cardiomyopathy, or unstable angina.
- Clinically significant electrolyte abnormalities (e.g., hypokalemia, hypomagnesemia, hypocalcemia), or family history of sudden unexplained death or long QT syndrome.
- Concomitant use of any drug or herbal medicine known to strongly inhibit or induce CYP3A4 or CYP2C8 activity, oral coumarin-derivative anticoagulants.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Arm A - RO7771950 Dose Type 1
|
Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
Other Names:
Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
Participants will receive capecitabine according to local prescribing information.
Capecitabine will be administered PO BID.
|
|
Experimental: Arm B - RO7771950 Dose Type 2
|
Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
Other Names:
Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
Participants will receive capecitabine according to local prescribing information.
Capecitabine will be administered PO BID.
|
|
Active Comparator: Arm C - Tucatinib
|
Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
Participants will receive capecitabine according to local prescribing information.
Capecitabine will be administered PO BID.
Participants will receive a dose of tucatinib PO BID.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR)
Time Frame: Approximately 35 months
|
Time from randomization to disease progression or death, according to standard criteria (Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)).
|
Approximately 35 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Overall Survival in Full Analysis Set (OS-FAS)
Time Frame: Approximately 53 months
|
Time from randomization to death from any cause.
|
Approximately 53 months
|
|
ORR in Participants with CNS Metastases (ORR-CNS)
Time Frame: Approximately 35 months
|
Defined as ORR.
|
Approximately 35 months
|
|
DOR in Participants with CNS Metastases (DOR-CNS)
Time Frame: Approximately 35 months
|
Defined as DOR.
|
Approximately 35 months
|
|
CBR in Participants with CNS Metastases (CBR-CNS)
Time Frame: Approximately 35 months
|
Defined as CBR.
|
Approximately 35 months
|
|
Changes from Baseline in Symptoms Burden in Participants With Brain Tumors
Time Frame: Approximately 35 months
|
Measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasm module (EORTC QLQ-BN20).
|
Approximately 35 months
|
|
Changes from Baseline in Function and Health-related Quality of Life (HRQoL)
Time Frame: Approximately 35 months
|
Measured by the EORTC QLQ-Core 30 (C30).
|
Approximately 35 months
|
|
Incidence of Adverse Events (AEs)
Time Frame: Approximately 35 months
|
Approximately 35 months
|
|
|
Severity of AEs
Time Frame: Approximately 35 months
|
Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0).
|
Approximately 35 months
|
|
Change from Baseline in Echocardiogram (ECHO)/Multiple-gated Acquisition (MUGA)
Time Frame: Approximately 35 months
|
Approximately 35 months
|
|
|
Change from Baseline in the Columbia-suicide Severity Rating Scale (C-SSRS)
Time Frame: Approximately 35 months
|
Approximately 35 months
|
|
|
Number of Participants Reporting Presence, Frequency of Occurrence, Severity, and/or Degree of Interference With Daily Activities of Symptomatic Treatment Toxicities as Assessed Through Use of the Patient-reported Outcome (PRO)-CTCAE
Time Frame: Approximately 35 months
|
Activities can include PPE, Mouth/Throat Sores, Nausea, Vomiting, Diarrhea, Headache, Rash, Abdominal Pain, Decreased Appetite, and Fatigue.
|
Approximately 35 months
|
|
Proportion of Participants Reporting Each Response Option at Each Assessment Timepoint by Treatment Arm for Treatment Side-effect Bother Single-item Functional Assessment of Cancer Therapy (FACT-GP5)
Time Frame: Approximately 35 months
|
Approximately 35 months
|
|
|
Change from Baseline/Worsening in Symptomatic Treatment Toxicities as Assessed Through Use of the PRO-CTCAE
Time Frame: Approximately 35 months
|
Approximately 35 months
|
|
|
Change from Baseline/Worsening in Symptomatic Treatment Side-effect Bother FACT-GP5
Time Frame: Approximately 35 months
|
Approximately 35 months
|
|
|
Health Utility Scores of the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Time Frame: Approximately 35 months
|
Approximately 35 months
|
|
|
Plasma Concentration of RO7771950 and its Metabolite(s) at Specified Timepoints
Time Frame: Approximately 35 months
|
Approximately 35 months
|
|
|
Progression-free Survival in Participants with Central Nervous System Metastases (PFS-CNS) by BICR
Time Frame: Approximately 35 months
|
Time from randomization to disease progression or death, according to standard criteria (RECIST v1.1).
|
Approximately 35 months
|
|
Objective Response Rate (ORR) by BICR
Time Frame: Approximately 35 months
|
Proportion of participants with a complete response (CR), partial response (PR) according to standard criteria (RECIST v1.1).
|
Approximately 35 months
|
|
Duration of Response (DOR) as per BICR
Time Frame: Approximately 35 months
|
Time from the first occurrence of an objective response (CR or PR) to disease progression or death from any cause according to standard criteria (RECIST v1.1).
|
Approximately 35 months
|
|
Clinical Benefit Rate (CBR) as per BICR
Time Frame: Approximately 35 months
|
Proportion of participants with CR, PR, or stable disease (SD) according to standard criteria (RECIST v1.1).
|
Approximately 35 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Study Director: Clinical Trials, Hoffmann-La Roche
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 21, 2026
Primary Completion (Estimated)
May 1, 2029
Study Completion (Estimated)
September 29, 2032
Study Registration Dates
First Submitted
February 10, 2026
First Submitted That Met QC Criteria
February 10, 2026
First Posted (Actual)
February 17, 2026
Study Record Updates
Last Update Posted (Actual)
September 3, 2026
Last Update Submitted That Met QC Criteria
September 2, 2026
Last Verified
September 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Amino Acids, Peptides, and Proteins
- Proteins
- Heterocyclic Compounds, 1-Ring
- Heterocyclic Compounds
- Nucleic Acids, Nucleotides, and Nucleosides
- Antibodies, Monoclonal, Humanized
- Antibodies, Monoclonal
- Antibodies
- Immunoglobulins
- Immunoproteins
- Blood Proteins
- Serum Globulins
- Globulins
- Deoxycytidine
- Cytidine
- Pyrimidine Nucleosides
- Pyrimidines
- Nucleosides
- Uracil
- Pyrimidinones
- Deoxyribonucleosides
- Fluorouracil
- Trastuzumab
- Capecitabine
- tucatinib
Other Study ID Numbers
- WO46069
- 2025 (U.S. NIH Grant/Contract: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524498-17-00 (Ctis)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
YES
IPD Plan Description
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
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.