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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
2026-07-09
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 (109)
Hospital Provincial del Centenario
Rosario, Argentina
Monash Health
Clayton, Victoria, Australia
Barwon Health
Geelong, Victoria, Australia
Peter MacCallum Cancer Centre
Melbourne, Victoria, Australia
Lkh Salzburg - Univ. Klinikum Salzburg
Salzburg, 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
Princess Margaret Cancer Center
Toronto, Ontario, Canada
Hopital Maisonneuve-Rosemont
Montreal, Quebec, Canada
CHUM
Montreal, Quebec, Canada
McGill University Health Centre - Glen Site
Montreal, Quebec, Canada
Hopital du Saint Sacrement
Québec, Quebec, Canada
Centro Oncología Precisión Iquique
Iquique, Chile
Medicina de Precisión - Celerity
Las Condes, Chile
Centro de Investigación Clínica UC-CICUC
Santiago, Chile
Icegclinic
Santiago, Chile
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, China
Beijing Cancer Hospital
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, China
West China Hospital, Sichuan University
Chengdu, China
Sun yat-sen University Cancer Center
Guangzhou, China
The Second Affiliated Hospital of Zhejiang University College
HangzhouZhejiang, China
Anhui Provincial Hospital
Hefei, China
Jiangmen Central Hospital
Jiangmen, China
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, China
Tumor Hospital of the affiliated medical college of Shantou University
Shantou, China
Shantou Center Hospital
Shantou, China
Hubei Cancer Hospital
Wuhan, China
Fakultni Nemocnice Hradec Kralove
Hradec Králové, Czechia
Städtisches Klinikum Dessau
Dessau, Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, Germany
Dres. Andreas Köhler und Roswitha Fuchs
Langen, Germany
Rotkreuzklinikum München
München, Germany
Marien-Hospital Witten
Witten, Germany
Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
Budapest, Hungary
Debreceni Egyetem Klinikai Kozpont
Debrecen, Hungary
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, Hungary
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
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
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
Hospital da Luz
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 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
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)
Akdeniz University Medical Faculty
Antalya, 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)
Mersin City Education and Research Hospital
Mersin, Turkey (Türkiye)
Medikal Park Samsun
Samsun, Turkey (Türkiye)
Leicester Royal Infirmary
Leicester, United Kingdom
Royal Marsden Hospital
London, United Kingdom
Christie Hospital Nhs Trust
Manchester, United Kingdom
Royal Marsden Hospital - Sutton
Sutton, United Kingdom