HER2-positive Breast CancerPhase 2/3BREnnANCT07413939
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
A Phase 2/3 study testing RO7771950, Tucatinib and Trastuzumab in people with HER2-positive Breast Cancer, run by Hoffmann-La Roche at 206 sites in 25 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- RO7771950, Tucatinib and Trastuzumab
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 650 participants
- Where
- 206 sitesin 25 countries
- Study dates
- 21 May 2026to 29 Sep 2032
- Phase
- Phase 2/3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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%.
Who cannot join
- 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.
Trial locations and contacts
206 sites in 25 countries. Contact the study team or a site near you to ask about taking part.
Reference Study ID Number: WO46069 https://forpatients.roche.com/ No attachments to email below. contact
Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry contact
206 sites in 25 countries
China25 sites, 25 recruiting
- Recruiting
Beijing Cancer Hospital
Beijing, 100021
- Recruiting
Cancer Hospital Chinese Academy of Medical Sciences.
Beijing, 100021
- Recruiting
Peking University People's Hospital
Beijing, 100044
- Recruiting
the First Affiliated Hospital of Bengbu Medical College
Bengbu, 233000
- Recruiting
West China Hospital, Sichuan University
Chengdu, 610041
- Recruiting
Fujian Medical University Union Hospital
Fuzhou, 350001
- Recruiting
Sun yat-sen University Cancer Center
Guangzhou, 510060
- Recruiting
Sun Yat-sen Memorial Hospital
Guangzhou, 510120
- Recruiting
The Second Affiliated Hospital of Zhejiang University College
HangzhouZhejiang, 310009
- Recruiting
Anhui Provincial Hospital
Hefei, 230001
- Recruiting
Jiangmen Central Hospital
Jiangmen, 529030
- Recruiting
Shandong Cancer Hospital
Jinan, 250117
- Recruiting
Yunnan Cancer Hospital
Kunming, 650118
- Recruiting
Nanchang People?s Hospital
Nanchang, 330025
- Recruiting
Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210031
- Recruiting
Guangxi Cancer Hospital of Guangxi Medical University
Nanning, 530201
- Recruiting
Ruijin Hospital Shanghai Jiaotong University School of Medicine
Shanghai, Shanghai Municipality, 200025
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, 200032
- Recruiting
Tumor Hospital of the affiliated medical college of Shantou University
Shantou, 515000
- Recruiting
Shantou Center Hospital
Shantou, 515031
- Recruiting
Tianjin Cancer Hospital
Tianjin, 300000
- Recruiting
Xinjiang Medical University Cancer Hospital
Ürümqi, 830011
- Recruiting
Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
Wuhan, 430030
- Recruiting
Hubei Cancer Hospital
Wuhan, 430079
- Recruiting
The Second Affiliated Hospital of Xi?an Jiaotong University, College of Medicine
Xi'an, 710004
Italy15 sites, 15 recruiting
- Recruiting
Irccs Centro Di Riferimento Oncologico (CRO)
Aviano, Friuli Venezia Giulia, 33081
- Recruiting
Asst Papa Giovanni XXIII
Bergamo, Lombardy, 24127
- Recruiting
Asst Degli Spedali Civili Di Brescia
Brescia, Lombardy, 25123
- Recruiting
IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
Meldola, Emilia-Romagna, 47014
- Recruiting
Ospedale San Raffaele
Milan, Lombardy, 20132
- Recruiting
Irccs Istituto Nazionale Dei Tumori (Int)
Milan, Lombardy, 20133
- Recruiting
IEO Istituto Europeo di Oncologia
Milan, Lombardy, 20141
- Recruiting
Asst Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, 20162
- Recruiting
Humanitas Centro Catanese Di Oncologia
Misterbianco (CT), Sicily, 95045
- Recruiting
Istituto Nazionale Tumori Irccs Fondazione g. PASCALE
Naples, Campania, 80131
- Recruiting
IOV - Istituto Oncologico Veneto - IRCCS
Padova, Veneto, 35128
- Recruiting
A.O. Universitaria Di Parma
Parma, Emilia-Romagna, 43100
- Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, 00168
- Recruiting
Università Campus Bio-Medico di Roma
Rome, Lazio, 128
- Recruiting
Istituto Clinico Humanitas
Rozzano, Lombardy, 20089
United States14 sites, 14 recruiting
- Recruiting
New York Oncology Hematology, P.C.
Albany, New York, 12206
- Recruiting
Texas Oncology Cancer Center
Austin, Texas, 78731
- Recruiting
Astera Cancer Care East Brunswick
East Brunswick, New Jersey, 08816
- Recruiting
The Center for Cancer and Blood Disorders - Fort Worth
Fort Worth, Texas, 76104
- Recruiting
The West Clinic, PC dba West Cancer Center
Germantown, Tennessee, 38138
- Recruiting
Banner Health MD Anderson AZ
Gilbert, Arizona, 85234
- Recruiting
Clearview Cancer Institute
Huntsville, Alabama, 35805
- Recruiting
Sarah Cannon Research Institute
Nashville, Tennessee, 37203-1632
- Recruiting
Tennessee Oncology Elliston Place Plaza
Nashville, Tennessee, 37203
- Recruiting
Eastern Connecticut Hematology and Oncology Associates
Norwich, Connecticut, 06360
- Recruiting
UCSF Helen Diller Family CCC
San Francisco, California, 94158
- Recruiting
New York Cancer and Blood Specialists
Shirley, New York, 11967
- Recruiting
Stony Brook Univ Cancer Ctr
Stony Brook, New York, 11794
- Recruiting
Montefiore Einstein Cancer Center
The Bronx, New York, 10461
Spain14 sites, 14 recruiting
- Recruiting
Hospital Universitari Dexeus - Grupo Quironsalud
Barcelona, 08028
- Recruiting
Vall d'Hebron Institute of Oncology (VHIO), Barcelona
Barcelona, 08035
- Recruiting
Hospital Clinic Provincial
Barcelona, 08036
- Recruiting
Hospital Universitario Basurto
Bilbao, Vizcaya, 48013
- Recruiting
Hospital Universitario Virgen de La Arrixaca
EL Palmar (EL Palmar), Murcia, 30120
- Recruiting
Hospital Universitario San Cecilio
Granada, 18016
- Recruiting
Complejo Hospitalario de Jaen
Jaén, 23007
- Recruiting
IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica
Madrid, 28007
- Recruiting
Hospital General Universitario Gregorio Marañon
Madrid, 28009
- Recruiting
Hospital Ramon y Cajal
Madrid, 28034
- Recruiting
Hospital Universitario 12 De Octubre
Madrid, 28041
- Recruiting
Hospital Clinico Universitario Virgen de la Victoria
Málaga, 29010
- Recruiting
Hospital Universitario de Canarias
San Cristóbal de La Laguna, Tenerife, 38320
- Recruiting
Hospital Universitario Virgen del Rocio
Seville, 41013
Turkey (Türkiye)12 sites, 12 recruiting
- Recruiting
Hacettepe University Medical Faculty
Altındağ, 06230
- Recruiting
Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
Ankara, 06200
- Recruiting
Ankara Bilkent City Hospital
Ankara, 06490
- Recruiting
Akdeniz University Medical Faculty
Antalya, 07058
- Recruiting
Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
Bakirkoy / Istanbul, 34147
- Recruiting
Ege University Medical Faculty
Bornova, Izmir, 35100
- Recruiting
Trakya University Medical Faculty
Erdine, 22030
- Recruiting
Istinye University Liv Hospital Topkapi
Istanbul, 34010
- Recruiting
Marmara University Pendik Research and Training Hospital
Istanbul, 34722
- Recruiting
Acibadem Izmir Kent Hospital
Izmir, 35630
- Recruiting
Mersin City Education and Research Hospital
Mersin, 33240
- Recruiting
Medikal Park Samsun
Samsun, 55200
Germany11 sites, 11 recruiting
- Recruiting
Städtisches Klinikum Dessau
Dessau, 06847
- Recruiting
KEM - Evang. Huyssens-Stiftung Essen-Huttrop
Essen, North Rhine-Westphalia, 45136
- Recruiting
Universitätsklinikum Hamburg-Eppendorf (UKE)
Hamburg, 20246
- Recruiting
Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie
Hanover, 30625
- Recruiting
Nationales Centrum für Tumorerkrankungen (NCT)
Heidelberg, 69120
- Recruiting
InVO - Institut für Versorgungsforschung in der Onkologie GbR
Koblenz, 56068
- Recruiting
Dres. Andreas Köhler und Roswitha Fuchs
Langen, 63225
- Recruiting
Rotkreuzklinikum München
München, 80637
- Recruiting
St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
Paderborn, 33098
- Recruiting
Marien-Hospital Witten
Witten, 58452
- Recruiting
Helios Klinik Wuppertal
Wuppertal, 42283
South Korea10 sites, 10 recruiting
- Recruiting
Kyungpook National University Chilgok Hospital
Daegu, 41404
- Recruiting
National Cancer Center
Goyang-si, 10408
- Recruiting
Ajou University Medical Center
Gyeonggi-do, 16499
- Recruiting
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggido, 13620
- Recruiting
Seoul National University Hospital
Seoul, 03080
- Recruiting
Severance Hospital, Yonsei University Health System
Seoul, 03722
- Recruiting
Asan Medical Center
Seoul, 05505
- Recruiting
Gangnam Severance Hospital
Seoul, 06273
- Recruiting
Samsung Medical Center
Seoul, 06351
- Recruiting
Seoul St Mary's Hospital
Seoul, 06591
Poland9 sites, 9 recruiting
- Recruiting
Instytut "Centrum Zdrowia Matki Polki"
?ód?, 93-338
- Recruiting
Uniwersyteckie Centrum Kliniczne im. K. Gibinskiego SUM
Katowice, 40-514
- Recruiting
Szpital Uniwersytecki w Krakowie
Krakow, 31202
- Recruiting
Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie
Olsztyn, 10-228
- Recruiting
Opolskie Centrum Onkologii
Opole, 45-061
- Recruiting
Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
Opole, 45-061
- Recruiting
Uniwersytecki Szpital Kliniczny w Poznaniu
Późna, 60569
- Recruiting
NU-MED Centrum Diagnostyki i Terapii Onkologicznej
Tomaszów Mazowiecki, 97-200
- Recruiting
Dolno?l?skie Centrum Onkologii
Wroc?aw, 53-413
Brazil8 sites, 8 recruiting
- Recruiting
Hospital Brasilia
Brasília, Federal District, 71.635-610
- Recruiting
Santa Casa de Misericordia de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90050-170
- Recruiting
Hospital do Cancer de Pernambuco - HCP
Recife, Pernambuco, 50040-000
- Recruiting
Advanze Pesquisa - Oncologia Sao Carlos
São Carlos, São Paulo, 13561-130
- Recruiting
Hospital Alemao Oswaldo Cruz
São Paulo, São Paulo, 01323-903
- Recruiting
Hospital Israelita Albert Einstein
São Paulo, São Paulo, 05652-900
- Recruiting
Instituto D'Or Pesquisa e Ensino
São Paulo, 04543-000
- Recruiting
Hospital Santa Rita de Cassia Vitoria
Vitória, Espírito Santo, 29043-260
Canada8 sites, 8 recruiting
- Recruiting
Hopital Charles Le Moyne
Greenfield Park, Quebec, J4V 2H1
- Recruiting
Hopital Maisonneuve-Rosemont
Montreal, Quebec, H1T 2M4
- Recruiting
CHUM
Montreal, Quebec, H2L 4M1
- Recruiting
McGill University Health Centre - Glen Site
Montreal, Quebec, H4A 3J1
- Recruiting
Ottawa General Hospital
Ottawa, Ontario, K1H 8L6
- Recruiting
Hospital Du Saint-Sacrement
Québec, Quebec, G1S 4L8
- Recruiting
Sunnybrook Odette Cancer Centre
Toronto, Ontario, M4N 3M5
- Recruiting
Princess Margaret Cancer Center
Toronto, Ontario, M5G 2M9
Portugal8 sites, 8 recruiting
- Recruiting
Hospital Professor Doutor Fernando Fonseca, E.P.E.
Amadora-Lisbon, 2610-276
- Recruiting
IPO de Lisboa
Lisbon, 1099-023
- Recruiting
Hospital da Luz
Lisbon, 1500-650
- Recruiting
Hospital de Santa Maria
Lisbon, 1649-035
- Recruiting
Hospital Beatriz Angelo
Loures, 2674-514
- Recruiting
Hospital Pedro Hispano
Matosinhos Municipality, 4454-509
- Recruiting
IPO do Porto
Porto, 4200-072
- Recruiting
CHVNG/E_Unidade 1
Vila Nova de Gaia, 4434-502
United Kingdom8 sites, 8 recruiting
- Recruiting
Leicester Royal Infirmary
Leicester, LE2 7LG
- Recruiting
The Clatterbridge Cancer Centre NHS Foundation Trust
Liverpool, L7 8YA
- Recruiting
Barts Health NHS Trust
London, EC1A 7BE
- Recruiting
Royal Marsden Hospital - Sutton
London, SW3 6JJ
- Recruiting
Royal Marsden Hospital
London, SW3 6JJ
- Recruiting
UCLH
London, WC1E 6AG
- Recruiting
Christie Hospital Nhs Trust
Manchester, M20 4GJ
- Recruiting
Musgrove Park Hospital
Montacute, TA1 5DA
Australia7 sites, 7 recruiting
- Recruiting
Blacktown Hospital
Blacktown, New South Wales, NSW 2148
- Recruiting
Monash Health
Clayton, Victoria, 3168
- Recruiting
Barwon Health
Geelong, Victoria, 3220
- Recruiting
Macquarie University Hospital
Macquarie Park, New South Wales, 2109
- Recruiting
Peter MacCallum Cancer Centre
Melbourne, Victoria, 3000
- Recruiting
Sir Charles Gairdner Hospital
Perth, Western Australia, 6009
- Recruiting
Sunshine Hospital
St Albans, Victoria, 3021
Belgium7 sites, 7 recruiting
- Recruiting
Cliniques Universitaires St-Luc
Brussels, 1200
- Recruiting
Jessa Zkh (Campus Virga Jesse)
Hasselt, 3500
- Recruiting
AZ Groeninge
Kortrijk, 8500
- Recruiting
UZ Leuven Gasthuisberg
Leuven, 3000
- Recruiting
AZ St Maarten Campus Leopoldstr
Mechelen, 2800
- Recruiting
Clinique Ste-Elisabeth
Namur, 5000
- Recruiting
ZAS Sint Augustinus Wilrijk
Wilrijk, 2610
Israel7 sites, 7 recruiting
- Recruiting
Rambam Health Care Campus
Haifa, 3109601
- Recruiting
Shaare Zedek Medical Center
Jerusalem, 9103102
- Recruiting
Hadassah University Hospital - Ein Kerem
Jerusalem, 9112001
- Recruiting
Rabin MC
Petah Tikva, 4910000
- Recruiting
Chaim Sheba Medical Center
Ramat Gan, 5262000
- Recruiting
Sourasky / Ichilov Hospital
Tel Aviv, 6423906
- Recruiting
Assuta Medical Centre
Tel Aviv
Argentina6 sites, 6 recruiting
- Recruiting
Centro Médico Fleischer
Buenos Aires, C1414DRK
- Recruiting
Investigaciones Clínicas Moleculares
Buenos Aires, C1425BGH
- Recruiting
Instituto Alexander Fleming
Buenos Aires, C1426ANZ
- Recruiting
Fundación Respirar
CABA, C1426AAL
- Recruiting
Hospital Provincial del Centenario
Rosario, S2002KDS
- Recruiting
Centro Oncológico de Excelencia
San Juan, J5402BGA
Chile6 sites, 6 recruiting
- Recruiting
Hospital las Higueras
Concepción, Región Bio Bio, Alto Horno 777
- Recruiting
Centro Oncología Precisión Iquique
Iquique, 1111442
- Recruiting
Medicina de Precisión - Celerity
Las Condes, 7560908
- Recruiting
Oncovida
Providencia, 7500994
- Recruiting
Icegclinic
Santiago, 7510187
- Recruiting
Centro de Investigación Clínica UC-CICUC
Santiago, 8330034
Thailand6 sites, 6 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok, 10400
- Recruiting
Faculty of Med. Siriraj Hosp.
Bangkok, 10700
- Recruiting
Srinagarind Hospital, Khon Kaen Uni
Khon Kaen, 40002
- Recruiting
Chulabhorn Hospital
Lak Si, 10210
- Recruiting
Songklanagarind Hospital
Songkhla, 90110
- Recruiting
Bangkok Metropolitan Administration Medical College and Vajira Hospital
Wachira Phayaban, 10300
France5 sites, 5 recruiting
- Recruiting
CHU de Grenoble - Hôpital Nord
Grenoble, 38043
- Recruiting
Centre Leon Berard
Lyon, 69008
- Recruiting
Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer
Nice, 06100
- Recruiting
Centre Eugene Marquis;Service d'oncologie
Rennes, 35042
- Recruiting
Institut Universitaire de Cancer de Toulouse Oncopole
Toulouse, 31100
Taiwan5 sites, 5 recruiting
- Recruiting
Taichung Veterans General Hospital
Taichung, 407219
- Recruiting
National Cheng Kung University Hospital
Tainan, 00704
- Recruiting
National Taiwan Uni Hospital
Taipei, 10041
- Recruiting
Taipei Veterans General Hospital
Taipei, 112201
- Recruiting
Chang Gung Memorial Hospital - Linkou
Taoyuan City, 333
Austria4 sites, 4 recruiting
- Recruiting
Lkh-Univ. Klinikum Graz
Graz, 8036
- Recruiting
Ordensklinikum Linz Barmherzige Schwestern
Linz, 4010
- Recruiting
Lkh Salzburg - Univ. Klinikum Salzburg
Salzburg, 5020
- Recruiting
Medizinische Universität Wien
Vienna, 1090
Czechia4 sites, 4 recruiting
- Recruiting
Masaryk?v onkologický ústav
Brno, 656 53
- Recruiting
Fakultni Nemocnice Hradec Kralove
Hradec Králové, 500 05
- Recruiting
Nemocnice AGEL Novy Jicin a.s.
Nový Jičín, 741 01
- Recruiting
Fakultni nemocnice v Motole
Prague, 150 06
Hungary3 sites, 3 recruiting
- Recruiting
Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
Budapest, 1082
- Recruiting
Debreceni Egyetem Klinikai Kozpont
Debrecen, 4032
- Recruiting
Bács-Kiskun Vármegyei Oktatókórház
Kecskemét, 6000
New Zealand2 sites, 2 recruiting
- Recruiting
Auckland City Hospital, Cancer and Blood Research
Auckland, 1023
- Recruiting
Tauranga Hospital, Clinical Trials Unit
Tauranga, 3112
South Africa2 sites, 2 recruiting
- Recruiting
Medical Oncology Centre of Rosebank
City of Johannesburg, 2196
- Recruiting
Chris Hani Baragwanath Clinical Trial Site
Soweto, 2013
About this study
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
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.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- RO7771950, Tucatinib, Trastuzumab, Capecitabine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RO7771950Drug
Also called ZN-A-1041, RG6596
Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).
TucatinibDrug
Participants will receive a dose of tucatinib PO BID.
TrastuzumabDrug
Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).
CapecitabineDrug
Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.
| Study group | Role | What they receive |
|---|---|---|
| Arm A - RO7771950 Dose Type 1 | Experimental | Not described Receives: Drug: RO7771950; Drug: Trastuzumab; Drug: Capecitabine |
| Arm B - RO7771950 Dose Type 2 | Experimental | Not described Receives: Drug: RO7771950; Drug: Trastuzumab; Drug: Capecitabine |
| Arm C - Tucatinib | Active comparator | Not described Receives: Drug: Tucatinib; Drug: Trastuzumab; Drug: Capecitabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR)
Time from randomization to disease progression or death, according to standard criteria (Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1)).
Measured: Approximately 35 months
Secondary outcomes (20)
Progression-free Survival in Participants with Central Nervous System Metastases (PFS-CNS) by BICR
Time from randomization to disease progression or death, according to standard criteria (RECIST v1.1).
Measured: Approximately 35 months
Overall Survival in Full Analysis Set (OS-FAS)
Time from randomization to death from any cause.
Measured: Approximately 53 months
Objective Response Rate (ORR) by BICR
Proportion of participants with a complete response (CR), partial response (PR) according to standard criteria (RECIST v1.1).
Measured: Approximately 35 months
Duration of Response (DOR) as per BICR
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).
Measured: Approximately 35 months
Clinical Benefit Rate (CBR) as per BICR
Proportion of participants with CR, PR, or stable disease (SD) according to standard criteria (RECIST v1.1).
Measured: Approximately 35 months
ORR in Participants with CNS Metastases (ORR-CNS)
Defined as ORR.
Measured: Approximately 35 months
DOR in Participants with CNS Metastases (DOR-CNS)
Defined as DOR.
Measured: Approximately 35 months
CBR in Participants with CNS Metastases (CBR-CNS)
Defined as CBR.
Measured: Approximately 35 months
Changes from Baseline in Symptoms Burden in Participants With Brain Tumors
Measured by the European Organization for the Research and Treatment of Cancer Quality of Life Questionnaire - Brain Neoplasm module (EORTC QLQ-BN20).
Measured: Approximately 35 months
Changes from Baseline in Function and Health-related Quality of Life (HRQoL)
Measured by the EORTC QLQ-Core 30 (C30).
Measured: Approximately 35 months
Incidence of Adverse Events (AEs)
Measured: Approximately 35 months
Severity of AEs
Severity Determined According to National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0 (v5.0).
Measured: Approximately 35 months
Change from Baseline in Echocardiogram (ECHO)/Multiple-gated Acquisition (MUGA)
Measured: Approximately 35 months
Change from Baseline in the Columbia-suicide Severity Rating Scale (C-SSRS)
Measured: 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
Activities can include PPE, Mouth/Throat Sores, Nausea, Vomiting, Diarrhea, Headache, Rash, Abdominal Pain, Decreased Appetite, and Fatigue.
Measured: 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)
Measured: Approximately 35 months
Change from Baseline/Worsening in Symptomatic Treatment Toxicities as Assessed Through Use of the PRO-CTCAE
Measured: Approximately 35 months
Change from Baseline/Worsening in Symptomatic Treatment Side-effect Bother FACT-GP5
Measured: Approximately 35 months
Health Utility Scores of the European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L)
Measured: Approximately 35 months
Plasma Concentration of RO7771950 and its Metabolite(s) at Specified Timepoints
Measured: Approximately 35 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2026
- Study start21 May 2026
- Primary completion1 May 2029 (estimated)
- Study completion29 Sep 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 650 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07413939
- Sponsor's protocol ID
- WO46069
- Other IDs
- 2025-524498-17-00, 2025
- Acronym
- BREnnA
- Status last verified
- Oct 2026
- First submitted
- 10 Feb 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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