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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

NCT07413939 · Hoffmann-La Roche
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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
About this study
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.
Eligibility criteria
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 design
Enrollment target: 650 participants
Allocation: randomized
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2026-05-21
Estimated completion: 2032-09-29
Last updated: 2026-09-03
Interventions
Drug: RO7771950Drug: TucatinibDrug: TrastuzumabDrug: Capecitabine
Primary outcomes
  • Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) (Approximately 35 months)
Sponsor
Hoffmann-La Roche · industry
Contacts & investigators
ContactReference Study ID Number: WO46069 https://forpatients.roche.com/ No attachments to email below. · contact · global-roche-genentech-trials@gene.com · 888-662-6728 (U.S. only)
ContactFastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry · contact
InvestigatorClinical Trials · study_director, Hoffmann-La Roche
All locations (186)
Astera Cancer Care East BrunswickRecruiting
East Brunswick, New Jersey, United States
New York Oncology Hematology, P.C.Recruiting
Albany, New York, United States
New York Cancer and Blood SpecialistsRecruiting
Shirley, New York, United States
The West Clinic, PC dba West Cancer CenterRecruiting
Germantown, Tennessee, United States
Centro Médico FleischerRecruiting
Buenos Aires, Argentina
Investigaciones Clínicas MolecularesRecruiting
Buenos Aires, Argentina
Instituto Alexander FlemingRecruiting
Buenos Aires, Argentina
Fundación RespirarRecruiting
CABA, Argentina
Hospital Provincial del CentenarioRecruiting
Rosario, Argentina
Centro Oncológico de ExcelenciaRecruiting
San Juan, Argentina
Macquarie University HospitalRecruiting
Macquarie Park, New South Wales, Australia
Monash HealthRecruiting
Clayton, Victoria, Australia
Barwon HealthRecruiting
Geelong, Victoria, Australia
Peter MacCallum Cancer CentreRecruiting
Melbourne, Victoria, Australia
Sunshine HospitalRecruiting
St Albans, Victoria, Australia
Lkh-Univ. Klinikum GrazRecruiting
Graz, Austria
Ordensklinikum Linz Barmherzige SchwesternRecruiting
Linz, Austria
Lkh Salzburg - Univ. Klinikum SalzburgRecruiting
Salzburg, Austria
Cliniques Universitaires St-LucRecruiting
Brussels, Belgium
Jessa Zkh (Campus Virga Jesse)Recruiting
Hasselt, Belgium
AZ GroeningeRecruiting
Kortrijk, Belgium
UZ Leuven GasthuisbergRecruiting
Leuven, Belgium
AZ St Maarten Campus LeopoldstrRecruiting
Mechelen, Belgium
Clinique Ste-ElisabethRecruiting
Namur, Belgium
ZAS Sint Augustinus WilrijkRecruiting
Wilrijk, Belgium
Hospital Santa Rita de Cassia VitoriaRecruiting
Vitória, Espírito Santo, Brazil
Hospital BrasiliaRecruiting
Brasília, Federal District, Brazil
Hospital do Cancer de Pernambuco - HCPRecruiting
Recife, Pernambuco, Brazil
Santa Casa de Misericordia de Porto AlegreRecruiting
Porto Alegre, Rio Grande do Sul, Brazil
Advanze Pesquisa - Oncologia Sao CarlosRecruiting
São Carlos, São Paulo, Brazil
Hospital Alemao Oswaldo CruzRecruiting
São Paulo, São Paulo, Brazil
Hospital Israelita Albert EinsteinRecruiting
São Paulo, São Paulo, Brazil
Ottawa General HospitalRecruiting
Ottawa, Ontario, Canada
Sunnybrook Odette Cancer CentreRecruiting
Toronto, Ontario, Canada
Princess Margaret Cancer CenterRecruiting
Toronto, Ontario, Canada
Hopital Charles Le MoyneRecruiting
Greenfield Park, Quebec, Canada
Hopital Maisonneuve-RosemontRecruiting
Montreal, Quebec, Canada
CHUMRecruiting
Montreal, Quebec, Canada
McGill University Health Centre - Glen SiteRecruiting
Montreal, Quebec, Canada
Hospital Du Saint-SacrementRecruiting
Québec, Quebec, Canada
Hospital las HiguerasRecruiting
Concepción, Región Bio Bio, Chile
Centro Oncología Precisión IquiqueRecruiting
Iquique, Chile
Medicina de Precisión - CelerityRecruiting
Las Condes, Chile
OncovidaRecruiting
Providencia, Chile
IcegclinicRecruiting
Santiago, Chile
Centro de Investigación Clínica UC-CICUCRecruiting
Santiago, Chile
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical SchoolRecruiting
Nanjing, Jiangsu, China
Ruijin Hospital Shanghai Jiaotong University School of MedicineRecruiting
Shanghai, Shanghai Municipality, China
Beijing Cancer HospitalRecruiting
Beijing, China
Cancer Hospital Chinese Academy of Medical Sciences.Recruiting
Beijing, China
Peking University People's HospitalRecruiting
Beijing, China
the First Affiliated Hospital of Bengbu Medical CollegeRecruiting
Bengbu, China
West China Hospital, Sichuan UniversityRecruiting
Chengdu, China
Fujian Medical University Union HospitalRecruiting
Fuzhou, China
Sun yat-sen University Cancer CenterRecruiting
Guangzhou, China
Sun Yat-sen Memorial HospitalRecruiting
Guangzhou, China
The Second Affiliated Hospital of Zhejiang University CollegeRecruiting
HangzhouZhejiang, China
Anhui Provincial HospitalRecruiting
Hefei, China
Jiangmen Central HospitalRecruiting
Jiangmen, China
Shandong Cancer HospitalRecruiting
Jinan, China
Yunnan Cancer HospitalRecruiting
Kunming, China
Nanchang People?s HospitalRecruiting
Nanchang, China
Guangxi Cancer Hospital of Guangxi Medical UniversityRecruiting
Nanning, China
Fudan University Shanghai Cancer CenterRecruiting
Shanghai, China
Tumor Hospital of the affiliated medical college of Shantou UniversityRecruiting
Shantou, China
Shantou Center HospitalRecruiting
Shantou, China
Tianjin Cancer HospitalRecruiting
Tianjin, China
Tongji Hospital Tongji Medical College Huazhong University of Science and TechnologyRecruiting
Wuhan, China
Hubei Cancer HospitalRecruiting
Wuhan, China
The Second Affiliated Hospital of Xi?an Jiaotong University, College of MedicineRecruiting
Xi'an, China
Masaryk?v onkologický ústavRecruiting
Brno, Czechia
Fakultni Nemocnice Hradec KraloveRecruiting
Hradec Králové, Czechia
Nemocnice AGEL Novy Jicin a.s.Recruiting
Nový Jičín, Czechia
Fakultni nemocnice v MotoleRecruiting
Prague, Czechia
CHU de Grenoble - Hôpital NordRecruiting
Grenoble, France
Centre Leon BerardRecruiting
Lyon, France
Centre Antoine Lacassagne Centre Régional de Lutte Contre Le CancerRecruiting
Nice, France
Centre Eugene Marquis;Service d'oncologieRecruiting
Rennes, France
KEM - Evang. Huyssens-Stiftung Essen-HuttropRecruiting
Essen, North Rhine-Westphalia, Germany
Städtisches Klinikum DessauRecruiting
Dessau, Germany
Universitätsklinikum Hamburg-Eppendorf (UKE)Recruiting
Hamburg, Germany
Nationales Centrum für Tumorerkrankungen (NCT)Recruiting
Heidelberg, Germany
InVO - Institut für Versorgungsforschung in der Onkologie GbRRecruiting
Koblenz, Germany
Dres. Andreas Köhler und Roswitha FuchsRecruiting
Langen, Germany
Rotkreuzklinikum MünchenRecruiting
München, Germany
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. LouiseRecruiting
Paderborn, Germany
Marien-Hospital WittenRecruiting
Witten, Germany
Helios Klinik WuppertalRecruiting
Wuppertal, Germany
Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)Recruiting
Budapest, Hungary
Debreceni Egyetem Klinikai KozpontRecruiting
Debrecen, Hungary
Bács-Kiskun Vármegyei OktatókórházRecruiting
Kecskemét, Hungary
Rambam Health Care CampusRecruiting
Haifa, Israel
Shaare Zedek Medical CenterRecruiting
Jerusalem, Israel
Hadassah University Hospital - Ein KeremRecruiting
Jerusalem, Israel
Rabin MCRecruiting
Petah Tikva, Israel
Chaim Sheba Medical CenterRecruiting
Ramat Gan, Israel
Sourasky / Ichilov HospitalRecruiting
Tel Aviv, Israel
Assuta Medical CentreRecruiting
Tel Aviv, Israel
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede MeldolaRecruiting
Meldola, Emilia-Romagna, Italy
A.O. Universitaria Di ParmaRecruiting
Parma, Emilia-Romagna, Italy
Irccs Centro Di Riferimento Oncologico (CRO)Recruiting
Aviano, Friuli Venezia Giulia, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCSRecruiting
Rome, Lazio, Italy
Università Campus Bio-Medico di RomaRecruiting
Rome, Lazio, Italy
Asst Papa Giovanni XXIIIRecruiting
Bergamo, Lombardy, Italy
Asst Degli Spedali Civili Di BresciaRecruiting
Brescia, Lombardy, Italy
Ospedale San RaffaeleRecruiting
Milan, Lombardy, Italy
Irccs Istituto Nazionale Dei Tumori (Int)Recruiting
Milan, Lombardy, Italy
IEO Istituto Europeo di OncologiaRecruiting
Milan, Lombardy, Italy
Asst Grande Ospedale Metropolitano NiguardaRecruiting
Milan, Lombardy, Italy
Istituto Clinico HumanitasRecruiting
Rozzano, Lombardy, Italy
Humanitas Centro Catanese Di OncologiaRecruiting
Misterbianco (CT), Sicily, Italy
IOV - Istituto Oncologico Veneto - IRCCSRecruiting
Padova, Veneto, Italy
Auckland City Hospital, Cancer and Blood ResearchRecruiting
Auckland, New Zealand
Tauranga Hospital, Clinical Trials UnitRecruiting
Tauranga, New Zealand
Instytut "Centrum Zdrowia Matki Polki"Recruiting
?ód?, Poland
Uniwersyteckie Centrum Kliniczne im. K. Gibinskiego SUMRecruiting
Katowice, Poland
Szpital Uniwersytecki w KrakowieRecruiting
Krakow, Poland
Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w OlsztynieRecruiting
Olsztyn, Poland
Opolskie Centrum OnkologiiRecruiting
Opole, Poland
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i RadioterapiiRecruiting
Opole, Poland
Uniwersytecki Szpital Kliniczny w PoznaniuRecruiting
Późna, Poland
NU-MED Centrum Diagnostyki i Terapii OnkologicznejRecruiting
Tomaszów Mazowiecki, Poland
Dolno?l?skie Centrum OnkologiiRecruiting
Wroc?aw, Poland
Hospital Professor Doutor Fernando Fonseca, E.P.E.Recruiting
Amadora-Lisbon, Portugal
IPO de LisboaRecruiting
Lisbon, Portugal
Hospital da LuzRecruiting
Lisbon, Portugal
Hospital de Santa MariaRecruiting
Lisbon, Portugal
Hospital Beatriz AngeloRecruiting
Loures, Portugal
Hospital Pedro HispanoRecruiting
Matosinhos Municipality, Portugal
IPO do PortoRecruiting
Porto, Portugal
CHVNG/E_Unidade 1Recruiting
Vila Nova de Gaia, Portugal
Medical Oncology Centre of RosebankRecruiting
City of Johannesburg, South Africa
Chris Hani Baragwanath Clinical Trial SiteRecruiting
Soweto, South Africa
Seoul National University Bundang HospitalRecruiting
Seongnam-si, Gyeonggido, South Korea
Kyungpook National University Chilgok HospitalRecruiting
Daegu, South Korea
National Cancer CenterRecruiting
Goyang-si, South Korea
Ajou University Medical CenterRecruiting
Gyeonggi-do, South Korea
Seoul National University HospitalRecruiting
Seoul, South Korea
Severance Hospital, Yonsei University Health SystemRecruiting
Seoul, South Korea
Asan Medical CenterRecruiting
Seoul, South Korea
Gangnam Severance HospitalRecruiting
Seoul, South Korea
Samsung Medical CenterRecruiting
Seoul, South Korea
Seoul St Mary's HospitalRecruiting
Seoul, South Korea
Hospital Universitario Virgen de La ArrixacaRecruiting
EL Palmar (EL Palmar), Murcia, Spain
Hospital Universitario de CanariasRecruiting
San Cristóbal de La Laguna, Tenerife, Spain
Hospital Universitario BasurtoRecruiting
Bilbao, Vizcaya, Spain
Vall d'Hebron Institute of Oncology (VHIO), BarcelonaRecruiting
Barcelona, Spain
Hospital Clinic ProvincialRecruiting
Barcelona, Spain
Hospital Universitario San CecilioRecruiting
Granada, Spain
Complejo Hospitalario de JaenRecruiting
Jaén, Spain
IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación OncológicaRecruiting
Madrid, Spain
Hospital General Universitario Gregorio MarañonRecruiting
Madrid, Spain
Hospital Ramon y CajalRecruiting
Madrid, Spain
Hospital Universitario 12 De OctubreRecruiting
Madrid, Spain
Hospital Clinico Universitario Virgen de la VictoriaRecruiting
Málaga, Spain
Hospital Universitario Virgen del RocioRecruiting
Seville, Spain
Taichung Veterans General HospitalRecruiting
Taichung, Taiwan
National Cheng Kung University HospitalRecruiting
Tainan, Taiwan
National Taiwan Uni HospitalRecruiting
Taipei, Taiwan
Taipei Veterans General HospitalRecruiting
Taipei, Taiwan
Chang Gung Memorial Hospital - LinkouRecruiting
Taoyuan City, Taiwan
Ramathibodi HospitalRecruiting
Bangkok, Thailand
Faculty of Med. Siriraj Hosp.Recruiting
Bangkok, Thailand
Srinagarind Hospital, Khon Kaen UniRecruiting
Khon Kaen, Thailand
Chulabhorn HospitalRecruiting
Lak Si, Thailand
Songklanagarind HospitalRecruiting
Songkhla, Thailand
Bangkok Metropolitan Administration Medical College and Vajira HospitalRecruiting
Wachira Phayaban, Thailand
Hacettepe University Medical FacultyRecruiting
Altındağ, Turkey (Türkiye)
Abdurrahman Yurtarslan Onkoloji Training and Research HospitalRecruiting
Ankara, Turkey (Türkiye)
Ankara Bilkent City HospitalRecruiting
Ankara, Turkey (Türkiye)
Akdeniz University Medical FacultyRecruiting
Antalya, Turkey (Türkiye)
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi OnkolojiRecruiting
Bakirkoy / Istanbul, Turkey (Türkiye)
Ege University Medical FacultyRecruiting
Bornova, Izmir, Turkey (Türkiye)
Trakya University Medical FacultyRecruiting
Erdine, Turkey (Türkiye)
Istinye University Liv Hospital TopkapiRecruiting
Istanbul, Turkey (Türkiye)
Marmara University Pendik Research and Training HospitalRecruiting
Istanbul, Turkey (Türkiye)
Acibadem Izmir Kent HospitalRecruiting
Izmir, Turkey (Türkiye)
Mersin City Education and Research HospitalRecruiting
Mersin, Turkey (Türkiye)
Medikal Park SamsunRecruiting
Samsun, Turkey (Türkiye)
Leicester Royal InfirmaryRecruiting
Leicester, United Kingdom
Barts Health NHS TrustRecruiting
London, United Kingdom
Royal Marsden Hospital - SuttonRecruiting
London, United Kingdom
Royal Marsden HospitalRecruiting
London, United Kingdom
UCLHRecruiting
London, United Kingdom
Christie Hospital Nhs TrustRecruiting
Manchester, United Kingdom
Musgrove Park HospitalRecruiting
Montacute, United Kingdom
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 · TrialPath