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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
Dres. Andreas Köhler und Roswitha Fuchs
Langen, Germany
Rotkreuzklinikum München
München, Germany
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
Paderborn, Germany
Marien-Hospital Witten
Witten, Germany
Helios Klinik Wuppertal
Wuppertal, Germany
Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, Hungary
Rambam Health Care Campus
Haifa, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Hadassah University Hospital - Ein Kerem
Jerusalem, Israel
Rabin MC
Petah Tikva, Israel
Chaim Sheba Medical Center
Ramat Gan, Israel
Sourasky / Ichilov Hospital
Tel Aviv, Israel
Assuta Medical Centre
Tel Aviv, Israel
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
Naples, Campania, Italy
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, Italy
A.O. Universitaria Di Parma
Parma, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy
Università Campus Bio-Medico di Roma
Rome, Lazio, Italy
Asst Papa Giovanni XXIII
Bergamo, Lombardy, Italy
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, Italy
Ospedale San Raffaele
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, Italy
IEO Istituto Europeo di Oncologia
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy
Istituto Clinico Humanitas
Rozzano, Lombardy, Italy
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Sicily, Italy
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, Italy
Auckland City Hospital, Cancer and Blood Research
Auckland, New Zealand
Tauranga Hospital, Clinical Trials Unit
Tauranga, New Zealand
Instytut "Centrum Zdrowia Matki Polki"
?ód?, Poland
Uniwersyteckie Centrum Kliniczne im. K. Gibinskiego SUM
Katowice, Poland
Szpital Uniwersytecki w Krakowie
Krakow, Poland
Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, Poland
Opolskie Centrum Onkologii
Opole, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Opole, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, Poland
NU-MED Centrum Diagnostyki i Terapii Onkologicznej
Tomaszów Mazowiecki, Poland
Dolno?l?skie Centrum Onkologii
Wroc?aw, Poland
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora-Lisbon, Portugal
IPO de Lisboa
Lisbon, Portugal
Hospital da Luz
Lisbon, Portugal
Hospital de Santa Maria
Lisbon, Portugal
Hospital Beatriz Angelo
Loures, Portugal
Hospital Pedro Hispano
Matosinhos Municipality, Portugal
IPO do Porto
Porto, Portugal
CHVNG/E_Unidade 1
Vila Nova de Gaia, Portugal
Medical Oncology Centre of Rosebank
City of Johannesburg, South Africa
Chris Hani Baragwanath Clinical Trial Site
Soweto, South Africa
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, South Korea
Kyungpook National University Chilgok Hospital
Daegu, South Korea
National Cancer Center
Goyang-si, South Korea
Ajou University Medical Center
Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, South Korea
Severance Hospital, Yonsei University Health System
Seoul, South Korea
Asan Medical Center
Seoul, South Korea
Gangnam Severance Hospital
Seoul, South Korea
Samsung Medical Center
Seoul, South Korea
Seoul St Mary's Hospital
Seoul, South Korea
Hospital Universitario Virgen de La Arrixaca
EL Palmar (EL Palmar), Murcia, Spain
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Universitario Basurto
Bilbao, Vizcaya, Spain
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, Spain
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, Spain
Hospital Clinic Provincial
Barcelona, Spain
Hospital Universitario San Cecilio
Granada, Spain
Complejo Hospitalario de Jaen
Jaén, Spain
IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica
Madrid, Spain
Hospital General Universitario Gregorio Marañon
Madrid, Spain
Hospital Ramon y Cajal
Madrid, Spain
Hospital Universitario 12 De Octubre
Madrid, Spain
Hospital Clinico Universitario Virgen de la Victoria
Málaga, Spain
Hospital Universitario Virgen del Rocio
Seville, Spain
Taichung Veterans General Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan Uni Hospital
Taipei, Taiwan
Taipei Veterans General Hospital
Taipei, Taiwan
Chang Gung Memorial Hospital - Linkou
Taoyuan City, Taiwan
Ramathibodi Hospital
Bangkok, Thailand
Faculty of Med. Siriraj Hosp.
Bangkok, Thailand
Srinagarind Hospital, Khon Kaen Uni
Khon Kaen, Thailand
Chulabhorn Hospital
Lak Si, Thailand
Songklanagarind Hospital
Songkhla, Thailand
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Wachira Phayaban, Thailand
Hacettepe University Medical Faculty
Altındağ, Turkey (Türkiye)
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
Ankara, Turkey (Türkiye)
Ankara Bilkent City Hospital
Ankara, Turkey (Türkiye)
Akdeniz University Medical Faculty
Antalya, Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, Turkey (Türkiye)
Ege University Medical Faculty
Bornova, Izmir, Turkey (Türkiye)
Trakya University Medical Faculty
Erdine, Turkey (Türkiye)
Istinye University Liv Hospital Topkapi
Istanbul, Turkey (Türkiye)
Marmara University Pendik Research and Training Hospital
Istanbul, Turkey (Türkiye)
Acibadem Izmir Kent Hospital
Izmir, Turkey (Türkiye)
Mersin City Education and Research Hospital
Mersin, Turkey (Türkiye)
Medikal Park Samsun
Samsun, Turkey (Türkiye)
Leicester Royal Infirmary
Leicester, United Kingdom
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, United Kingdom
Barts Health NHS Trust
London, United Kingdom
Royal Marsden Hospital - Sutton
London, United Kingdom
Royal Marsden Hospital
London, United Kingdom
UCLH
London, United Kingdom
Christie Hospital Nhs Trust
Manchester, United Kingdom
Musgrove Park Hospital
Montacute, United Kingdom