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NCT07413939PHASE2, PHASE3Recruiting

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

Hoffmann-La Roche

Start Date

5/21/2026

Completion Date

9/29/2032

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.

Eligibility Criteria

Age Range: 18 years to No maximum

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.

Interventions

DRUG

RO7771950

DRUG

Tucatinib

DRUG

Trastuzumab

DRUG

Capecitabine

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Conditions

HER2-positive Breast Cancer

Locations

Clearview Cancer Institute

Huntsville, Alabama 35805

United States

Banner Health MD Anderson AZ

Gilbert, Arizona 85234

United States

UCSF Helen Diller Family CCC

San Francisco, California 94158

United States

Eastern Connecticut Hematology and Oncology Associates

Norwich, Connecticut 06360

United States

Astera Cancer Care East Brunswick

East Brunswick, New Jersey 08816

United States

New York Oncology Hematology, P.C.

Albany, New York 12206

United States

New York Cancer and Blood Specialists

Shirley, New York 11967

United States

Stony Brook Univ Cancer Ctr

Stony Brook, New York 11794

United States

Montefiore Einstein Cancer Center

The Bronx, New York 10461

United States

The West Clinic, PC dba West Cancer Center

Germantown, Tennessee 38138

United States

Sarah Cannon Research Institute

Nashville, Tennessee 37203-1632

United States

Tennessee Oncology Elliston Place Plaza

Nashville, Tennessee 37203

United States

Texas Oncology Cancer Center

Austin, Texas 78731

United States

The Center for Cancer and Blood Disorders - Fort Worth

Fort Worth, Texas 76104

United States

Centro Médico Fleischer

Buenos Aires, C1414DRK

Argentina

Investigaciones Clínicas Moleculares

Buenos Aires, C1425BGH

Argentina

Instituto Alexander Fleming

Buenos Aires, C1426ANZ

Argentina

Fundación Respirar

CABA, C1426AAL

Argentina

Hospital Provincial del Centenario

Rosario, S2002KDS

Argentina

Centro Oncológico de Excelencia

San Juan, J5402BGA

Argentina

Blacktown Hospital

Blacktown, New South Wales NSW 2148

Australia

Macquarie University Hospital

Macquarie Park, New South Wales 2109

Australia

Monash Health

Clayton, Victoria 3168

Australia

Barwon Health

Geelong, Victoria 3220

Australia

Peter MacCallum Cancer Centre

Melbourne, Victoria 3000

Australia

Sunshine Hospital

St Albans, Victoria 3021

Australia

Sir Charles Gairdner Hospital

Perth, Western Australia 6009

Australia

Lkh-Univ. Klinikum Graz

Graz, 8036

Austria

Ordensklinikum Linz Barmherzige Schwestern

Linz, 4010

Austria

Lkh Salzburg - Univ. Klinikum Salzburg

Salzburg, 5020

Austria

Medizinische Universität Wien

Vienna, 1090

Austria

Cliniques Universitaires St-Luc

Brussels, 1200

Belgium

Jessa Zkh (Campus Virga Jesse)

Hasselt, 3500

Belgium

AZ Groeninge

Kortrijk, 8500

Belgium

UZ Leuven Gasthuisberg

Leuven, 3000

Belgium

AZ St Maarten Campus Leopoldstr

Mechelen, 2800

Belgium

Clinique Ste-Elisabeth

Namur, 5000

Belgium

ZAS Sint Augustinus Wilrijk

Wilrijk, 2610

Belgium

Hospital Santa Rita de Cassia Vitoria

Vitória, Espírito Santo 29043-260

Brazil

Hospital Brasilia

Brasília, Federal District 71.635-610

Brazil

Hospital do Cancer de Pernambuco - HCP

Recife, Pernambuco 50040-000

Brazil

Santa Casa de Misericordia de Porto Alegre

Porto Alegre, Rio Grande do Sul 90050-170

Brazil

Advanze Pesquisa - Oncologia Sao Carlos

São Carlos, São Paulo 13561-130

Brazil

Hospital Alemao Oswaldo Cruz

São Paulo, São Paulo 01323-903

Brazil

Hospital Israelita Albert Einstein

São Paulo, São Paulo 05652-900

Brazil

Instituto D'Or Pesquisa e Ensino

São Paulo, 04543-000

Brazil

Ottawa General Hospital

Ottawa, Ontario K1H 8L6

Canada

Sunnybrook Odette Cancer Centre

Toronto, Ontario M4N 3M5

Canada

Princess Margaret Cancer Center

Toronto, Ontario M5G 2M9

Canada

Hopital Charles Le Moyne

Greenfield Park, Quebec J4V 2H1

Canada

Hopital Maisonneuve-Rosemont

Montreal, Quebec H1T 2M4

Canada

CHUM

Montreal, Quebec H2L 4M1

Canada

McGill University Health Centre - Glen Site

Montreal, Quebec H4A 3J1

Canada

Hospital Du Saint-Sacrement

Québec, Quebec G1S 4L8

Canada

Hospital las Higueras

Concepción, Región Bio Bio Alto Horno 777

Chile

Centro Oncología Precisión Iquique

Iquique, 1111442

Chile

Medicina de Precisión - Celerity

Las Condes, 7560908

Chile

Oncovida

Providencia, 7500994

Chile

Icegclinic

Santiago, 7510187

Chile

Centro de Investigación Clínica UC-CICUC

Santiago, 8330034

Chile

Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School

Nanjing, Jiangsu 210031

China

Ruijin Hospital Shanghai Jiaotong University School of Medicine

Shanghai, Shanghai Municipality 200025

China

Beijing Cancer Hospital

Beijing, 100021

China

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, 100021

China

Peking University People's Hospital

Beijing, 100044

China

the First Affiliated Hospital of Bengbu Medical College

Bengbu, 233000

China

West China Hospital, Sichuan University

Chengdu, 610041

China

Fujian Medical University Union Hospital

Fuzhou, 350001

China

Sun yat-sen University Cancer Center

Guangzhou, 510060

China

Sun Yat-sen Memorial Hospital

Guangzhou, 510120

China

The Second Affiliated Hospital of Zhejiang University College

HangzhouZhejiang, 310009

China

Anhui Provincial Hospital

Hefei, 230001

China

Jiangmen Central Hospital

Jiangmen, 529030

China

Shandong Cancer Hospital

Jinan, 250117

China

Yunnan Cancer Hospital

Kunming, 650118

China

Nanchang People?s Hospital

Nanchang, 330025

China

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, 530201

China

Fudan University Shanghai Cancer Center

Shanghai, 200032

China

Tumor Hospital of the affiliated medical college of Shantou University

Shantou, 515000

China

Shantou Center Hospital

Shantou, 515031

China

Tianjin Cancer Hospital

Tianjin, 300000

China

Xinjiang Medical University Cancer Hospital

Ürümqi, 830011

China

Tongji Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, 430030

China

Hubei Cancer Hospital

Wuhan, 430079

China

The Second Affiliated Hospital of Xi?an Jiaotong University, College of Medicine

Xi'an, 710004

China

Masaryk?v onkologický ústav

Brno, 656 53

Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 05

Czechia

Nemocnice AGEL Novy Jicin a.s.

Nový Jičín, 741 01

Czechia

Fakultni nemocnice v Motole

Prague, 150 06

Czechia

CHU de Grenoble - Hôpital Nord

Grenoble, 38043

France

Centre Leon Berard

Lyon, 69008

France

Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer

Nice, 06100

France

Centre Eugene Marquis;Service d'oncologie

Rennes, 35042

France

Institut Universitaire de Cancer de Toulouse Oncopole

Toulouse, 31100

France

KEM - Evang. Huyssens-Stiftung Essen-Huttrop

Essen, North Rhine-Westphalia 45136

Germany

Städtisches Klinikum Dessau

Dessau, 06847

Germany

Universitätsklinikum Hamburg-Eppendorf (UKE)

Hamburg, 20246

Germany

Medizinische Hochschule Zentrum Frauenheilkunde Abt.Gynäkologische Onkologie

Hanover, 30625

Germany

Nationales Centrum für Tumorerkrankungen (NCT)

Heidelberg, 69120

Germany

InVO - Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, 56068

Germany

Dres. Andreas Köhler und Roswitha Fuchs

Langen, 63225

Germany

Rotkreuzklinikum München

München, 80637

Germany

St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise

Paderborn, 33098

Germany

Marien-Hospital Witten

Witten, 58452

Germany

Helios Klinik Wuppertal

Wuppertal, 42283

Germany

Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)

Budapest, 1082

Hungary

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032

Hungary

Bács-Kiskun Vármegyei Oktatókórház

Kecskemét, 6000

Hungary

Rambam Health Care Campus

Haifa, 3109601

Israel

Shaare Zedek Medical Center

Jerusalem, 9103102

Israel

Hadassah University Hospital - Ein Kerem

Jerusalem, 9112001

Israel

Rabin MC

Petah Tikva, 4910000

Israel

Chaim Sheba Medical Center

Ramat Gan, 5262000

Israel

Sourasky / Ichilov Hospital

Tel Aviv, 6423906

Israel

Assuta Medical Centre

Tel Aviv,

Israel

Istituto Nazionale Tumori Irccs Fondazione g. PASCALE

Naples, Campania 80131

Italy

IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola

Meldola, Emilia-Romagna 47014

Italy

A.O. Universitaria Di Parma

Parma, Emilia-Romagna 43100

Italy

Irccs Centro Di Riferimento Oncologico (CRO)

Aviano, Friuli Venezia Giulia 33081

Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio 00168

Italy

Università Campus Bio-Medico di Roma

Rome, Lazio 128

Italy

Asst Papa Giovanni XXIII

Bergamo, Lombardy 24127

Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy 25123

Italy

Ospedale San Raffaele

Milan, Lombardy 20132

Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy 20133

Italy

IEO Istituto Europeo di Oncologia

Milan, Lombardy 20141

Italy

Asst Grande Ospedale Metropolitano Niguarda

Milan, Lombardy 20162

Italy

Istituto Clinico Humanitas

Rozzano, Lombardy 20089

Italy

Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), Sicily 95045

Italy

IOV - Istituto Oncologico Veneto - IRCCS

Padova, Veneto 35128

Italy

Auckland City Hospital, Cancer and Blood Research

Auckland, 1023

New Zealand

Tauranga Hospital, Clinical Trials Unit

Tauranga, 3112

New Zealand

Instytut "Centrum Zdrowia Matki Polki"

?ód?, 93-338

Poland

Uniwersyteckie Centrum Kliniczne im. K. Gibinskiego SUM

Katowice, 40-514

Poland

Szpital Uniwersytecki w Krakowie

Krakow, 31202

Poland

Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie

Olsztyn, 10-228

Poland

Opolskie Centrum Onkologii

Opole, 45-061

Poland

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Opole, 45-061

Poland

Uniwersytecki Szpital Kliniczny w Poznaniu

Późna, 60569

Poland

NU-MED Centrum Diagnostyki i Terapii Onkologicznej

Tomaszów Mazowiecki, 97-200

Poland

Dolno?l?skie Centrum Onkologii

Wroc?aw, 53-413

Poland

Hospital Professor Doutor Fernando Fonseca, E.P.E.

Amadora-Lisbon, 2610-276

Portugal

IPO de Lisboa

Lisbon, 1099-023

Portugal

Hospital da Luz

Lisbon, 1500-650

Portugal

Hospital de Santa Maria

Lisbon, 1649-035

Portugal

Hospital Beatriz Angelo

Loures, 2674-514

Portugal

Hospital Pedro Hispano

Matosinhos Municipality, 4454-509

Portugal

IPO do Porto

Porto, 4200-072

Portugal

CHVNG/E_Unidade 1

Vila Nova de Gaia, 4434-502

Portugal

Medical Oncology Centre of Rosebank

City of Johannesburg, 2196

South Africa

Chris Hani Baragwanath Clinical Trial Site

Soweto, 2013

South Africa

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido 13620

South Korea

Kyungpook National University Chilgok Hospital

Daegu, 41404

South Korea

National Cancer Center

Goyang-si, 10408

South Korea

Ajou University Medical Center

Gyeonggi-do, 16499

South Korea

Seoul National University Hospital

Seoul, 03080

South Korea

Severance Hospital, Yonsei University Health System

Seoul, 03722

South Korea

Asan Medical Center

Seoul, 05505

South Korea

Gangnam Severance Hospital

Seoul, 06273

South Korea

Samsung Medical Center

Seoul, 06351

South Korea

Seoul St Mary's Hospital

Seoul, 06591

South Korea

Hospital Universitario Virgen de La Arrixaca

EL Palmar (EL Palmar), Murcia 30120

Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife 38320

Spain

Hospital Universitario Basurto

Bilbao, Vizcaya 48013

Spain

Hospital Universitari Dexeus - Grupo Quironsalud

Barcelona, 08028

Spain

Vall d'Hebron Institute of Oncology (VHIO), Barcelona

Barcelona, 08035

Spain

Hospital Clinic Provincial

Barcelona, 08036

Spain

Hospital Universitario San Cecilio

Granada, 18016

Spain

Complejo Hospitalario de Jaen

Jaén, 23007

Spain

IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica

Madrid, 28007

Spain

Hospital General Universitario Gregorio Marañon

Madrid, 28009

Spain

Hospital Ramon y Cajal

Madrid, 28034

Spain

Hospital Universitario 12 De Octubre

Madrid, 28041

Spain

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010

Spain

Hospital Universitario Virgen del Rocio

Seville, 41013

Spain

Taichung Veterans General Hospital

Taichung, 407219

Taiwan

National Cheng Kung University Hospital

Tainan, 00704

Taiwan

National Taiwan Uni Hospital

Taipei, 10041

Taiwan

Taipei Veterans General Hospital

Taipei, 112201

Taiwan

Chang Gung Memorial Hospital - Linkou

Taoyuan City, 333

Taiwan

Ramathibodi Hospital

Bangkok, 10400

Thailand

Faculty of Med. Siriraj Hosp.

Bangkok, 10700

Thailand

Srinagarind Hospital, Khon Kaen Uni

Khon Kaen, 40002

Thailand

Chulabhorn Hospital

Lak Si, 10210

Thailand

Songklanagarind Hospital

Songkhla, 90110

Thailand

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Wachira Phayaban, 10300

Thailand

Hacettepe University Medical Faculty

Altındağ, 06230

Turkey (Türkiye)

Abdurrahman Yurtarslan Onkoloji Training and Research Hospital

Ankara, 06200

Turkey (Türkiye)

Ankara Bilkent City Hospital

Ankara, 06490

Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, 07058

Turkey (Türkiye)

Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji

Bakirkoy / Istanbul, 34147

Turkey (Türkiye)

Ege University Medical Faculty

Bornova, Izmir, 35100

Turkey (Türkiye)

Trakya University Medical Faculty

Erdine, 22030

Turkey (Türkiye)

Istinye University Liv Hospital Topkapi

Istanbul, 34010

Turkey (Türkiye)

Marmara University Pendik Research and Training Hospital

Istanbul, 34722

Turkey (Türkiye)

Acibadem Izmir Kent Hospital

Izmir, 35630

Turkey (Türkiye)

Mersin City Education and Research Hospital

Mersin, 33240

Turkey (Türkiye)

Medikal Park Samsun

Samsun, 55200

Turkey (Türkiye)

Leicester Royal Infirmary

Leicester, LE2 7LG

United Kingdom

The Clatterbridge Cancer Centre NHS Foundation Trust

Liverpool, L7 8YA

United Kingdom

Barts Health NHS Trust

London, EC1A 7BE

United Kingdom

Royal Marsden Hospital - Sutton

London, SW3 6JJ

United Kingdom

Royal Marsden Hospital

London, SW3 6JJ

United Kingdom

UCLH

London, WC1E 6AG

United Kingdom

Christie Hospital Nhs Trust

Manchester, M20 4GJ

United Kingdom

Musgrove Park Hospital

Montacute, TA1 5DA

United Kingdom