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 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: WO460692025-524498-17-00
• Study Type: interventional
• Target: 650
• Locations: 22 countries
• Sites: 147

Brief 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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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)).

  Approximately 35 months

Secondary Outcomes (20)

• Progression-free Survival in Participants with Central Nervous System Metastases (PFS-CNS) by BICR

  Approximately 35 months

• Overall Survival in Full Analysis Set (OS-FAS)

  Approximately 53 months

• Objective Response Rate (ORR) by BICR

  Approximately 35 months

• Duration of Response (DOR) as per BICR

  Approximately 35 months

• Clinical Benefit Rate (CBR) as per BICR

  Approximately 35 months

Study Arms (3)

Arm A - RO7771950 Dose Type 1

EXPERIMENTAL

Drug: RO7771950; Drug: Trastuzumab; Drug: Capecitabine

Arm B - RO7771950 Dose Type 2

EXPERIMENTAL

Drug: RO7771950; Drug: Trastuzumab; Drug: Capecitabine

Arm C - Tucatinib

ACTIVE COMPARATOR

Drug: Tucatinib; Drug: Trastuzumab; Drug: Capecitabine

Interventions

RO7771950 DRUG

Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID).

Also known as: ZN-A-1041, RG6596

Arm A - RO7771950 Dose Type 1; Arm B - RO7771950 Dose Type 2

Tucatinib DRUG

Participants will receive a dose of tucatinib PO BID.

Arm C - Tucatinib

Capecitabine DRUG

Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.

Arm A - RO7771950 Dose Type 1; Arm B - RO7771950 Dose Type 2; Arm C - Tucatinib

Trastuzumab DRUG

Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC).

Arm A - RO7771950 Dose Type 1; Arm B - RO7771950 Dose Type 2; Arm C - Tucatinib

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (152)

The West Clinic, PC dba West Cancer Center

Germantown, Tennessee, 38138, United States

RECRUITING

Centro Médico Fleischer

Buenos Aires, C1414DRK, Argentina

RECRUITING

Investigaciones Clínicas Moleculares

Buenos Aires, C1425BGH, Argentina

RECRUITING

Instituto Alexander Fleming

Buenos Aires, C1426ANZ, Argentina

RECRUITING

Fundación Respirar

CABA, C1426AAL, Argentina

RECRUITING

Hospital Provincial del Centenario

Rosario, S2002KDS, Argentina

RECRUITING

Centro Oncológico de Excelencia

San Juan, J5402BGA, Argentina

RECRUITING

Macquarie University Hospital

Macquarie Park, New South Wales, 2113, Australia

RECRUITING

Monash Health

Clayton, Victoria, 3168, Australia

RECRUITING

Barwon Health

Geelong, Victoria, 3220, Australia

RECRUITING

Peter MacCallum Cancer Centre

Melbourne, Victoria, 3000, Australia

RECRUITING

Sunshine Hospital

St Albans, Victoria, 3021, Australia

RECRUITING

Lkh-Univ. Klinikum Graz

Graz, 8036, Austria

RECRUITING

Ordensklinikum Linz Barmherzige Schwestern

Linz, 4010, Austria

RECRUITING

Lkh Salzburg - Univ. Klinikum Salzburg

Salzburg, 5020, Austria

RECRUITING

Cliniques Universitaires St-Luc

Brussels, 1200, Belgium

RECRUITING

Jessa Zkh (Campus Virga Jesse)

Hasselt, 3500, Belgium

RECRUITING

AZ Groeninge

Kortrijk, 8500, Belgium

RECRUITING

UZ Leuven Gasthuisberg

Leuven, 3000, Belgium

RECRUITING

AZ St Maarten Campus Leopoldstr

Mechelen, 2800, Belgium

RECRUITING

Clinique Ste-Elisabeth

Namur, 5000, Belgium

RECRUITING

ZAS Sint Augustinus Wilrijk

Wilrijk, 2610, Belgium

RECRUITING

Sunnybrook Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Princess Margaret Cancer Center

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

Hopital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

RECRUITING

CHUM

Montreal, Quebec, H2L 4M1, Canada

RECRUITING

McGill University Health Centre - Glen Site

Montreal, Quebec, H4A 3J1, Canada

RECRUITING

Hopital du Saint Sacrement

Québec, Quebec, G1S 4L8, Canada

RECRUITING

Hospital las Higueras

Concepción, Región Bio Bio, Alto Horno 777, Chile

RECRUITING

Centro Oncología Precisión Iquique

Iquique, 1111442, Chile

RECRUITING

Medicina de Precisión - Celerity

Las Condes, 7560908, Chile

RECRUITING

Oncovida

Providencia, 7500994, Chile

RECRUITING

Centro de Investigación Clínica UC-CICUC

Santiago, 8330034, Chile

RECRUITING

Icegclinic

Santiago, Chile

RECRUITING

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

Nanjing, Jiangsu, 210031, China

RECRUITING

Beijing Cancer Hospital

Beijing, 100021, China

RECRUITING

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, 100021, China

RECRUITING

Peking University People's Hospital

Beijing, 100044, China

RECRUITING

the First Affiliated Hospital of Bengbu Medical College

Bengbu, 233000, China

RECRUITING

West China Hospital, Sichuan University

Chengdu, 610041, China

RECRUITING

Fujian Medical University Union Hospital

Fuzhou, 350001, China

RECRUITING

Sun yat-sen University Cancer Center

Guangzhou, 510060, China

RECRUITING

The Second Affiliated Hospital of Zhejiang University College

HangzhouZhejiang, 310009, China

RECRUITING

Anhui Provincial Hospital

Hefei, 230001, China

RECRUITING

Jiangmen Central Hospital

Jiangmen, 529030, China

RECRUITING

Shandong Cancer Hospital

Jinan, 250117, China

RECRUITING

Yunnan Cancer Hospital

Kunming, 650118, China

RECRUITING

Nanchang People?s Hospital

Nanchang, 330025, China

RECRUITING

Guangxi Cancer Hospital of Guangxi Medical University

Nanning, 530201, China

RECRUITING

Tumor Hospital of the affiliated medical college of Shantou University

Shantou, 515000, China

RECRUITING

Shantou Center Hospital

Shantou, 515031, China

RECRUITING

Hubei Cancer Hospital

Wuhan, 430079, China

RECRUITING

Masaryk?v onkologický ústav

Brno, 656 53, Czechia

RECRUITING

Fakultni Nemocnice Hradec Kralove

Hradec Králové, 500 05, Czechia

RECRUITING

Fakultni nemocnice v Motole

Prague, 150 06, Czechia

RECRUITING

Städtisches Klinikum Dessau

Dessau, 06847, Germany

RECRUITING

InVO - Institut für Versorgungsforschung in der Onkologie GbR

Koblenz, 56068, Germany

RECRUITING

Dres. Andreas Köhler und Roswitha Fuchs

Langen, 63225, Germany

RECRUITING

Rotkreuzklinikum München

München, 80637, Germany

RECRUITING

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

Paderborn, 33098, Germany

RECRUITING

Marien-Hospital Witten

Witten, 58452, Germany

RECRUITING

Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)

Budapest, 1082, Hungary

RECRUITING

Debreceni Egyetem Klinikai Kozpont

Debrecen, 4032, Hungary

RECRUITING

Bács-Kiskun Vármegyei Oktatókórház

Kecskemét, 6000, Hungary

RECRUITING

Rambam Health Care Campus

Haifa, 3109601, Israel

RECRUITING

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

RECRUITING

Rabin Medical Center

Petah Tikva, 4910000, Israel

RECRUITING

Chaim Sheba Medical Center

Ramat Gan, 5262000, Israel

RECRUITING

Ichilov Sourasky Medical Center

Tel Aviv, 6423906, Israel

RECRUITING

Assula Medical Center

Tel Aviv, 6971028, Israel

RECRUITING

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

Meldola, Emilia-Romagna, 47014, Italy

RECRUITING

A.O. Universitaria Di Parma

Parma, Emilia-Romagna, 43100, Italy

RECRUITING

Irccs Centro Di Riferimento Oncologico (CRO)

Aviano, Friuli Venezia Giulia, 33081, Italy

RECRUITING

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, 00168, Italy

RECRUITING

Università Campus Bio-Medico di Roma

Rome, Lazio, 128, Italy

RECRUITING

Asst Papa Giovanni XXIII

Bergamo, Lombardy, 24127, Italy

RECRUITING

Asst Degli Spedali Civili Di Brescia

Brescia, Lombardy, 25123, Italy

RECRUITING

Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

RECRUITING

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Lombardy, 20133, Italy

RECRUITING

IEO Istituto Europeo di Oncologia

Milan, Lombardy, 20141, Italy

RECRUITING

Asst Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, 20162, Italy

RECRUITING

Istituto Clinico Humanitas

Rozzano, Lombardy, 20089, Italy

RECRUITING

Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), Sicily, 95045, Italy

RECRUITING

Auckland City Hospital, Cancer and Blood Research

Auckland, 1023, New Zealand

RECRUITING

Tauranga Hospital, Clinical Trials Unit

Tauranga, 3112, New Zealand

RECRUITING

Instytut "Centrum Zdrowia Matki Polki"

?ód?, 93-338, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne im. K. Gibinskiego SUM

Katowice, 40-514, Poland

RECRUITING

Szpital Uniwersytecki w Krakowie

Krakow, 31202, Poland

RECRUITING

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

Olsztyn, 10-228, Poland

RECRUITING

Opolskie Centrum Onkologii

Opole, 45-061, Poland

RECRUITING

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

Opole, 45-061, Poland

RECRUITING

Uniwersytecki Szpital Kliniczny w Poznaniu

Późna, 60569, Poland

RECRUITING

NU-MED Centrum Diagnostyki i Terapii Onkologicznej

Tomaszów Mazowiecki, 97-200, Poland

RECRUITING

Dolno?l?skie Centrum Onkologii

Wroc?aw, 53-413, Poland

RECRUITING

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

Amadora-Lisbon, 2610-276, Portugal

RECRUITING

IPO de Lisboa

Lisbon, 1099-023, Portugal

RECRUITING

Hospital da Luz

Lisbon, 1500-650, Portugal

RECRUITING

Hospital de Santa Maria

Lisbon, 1649-035, Portugal

RECRUITING

Hospital Beatriz Angelo

Loures, 2674-514, Portugal

RECRUITING

Hospital Pedro Hispano

Matosinhos Municipality, 4454-509, Portugal

RECRUITING

IPO do Porto

Porto, 4200-072, Portugal

RECRUITING

CHVNG/E_Unidade 1

Vila Nova de Gaia, 4434-502, Portugal

RECRUITING

Medical Oncology Centre of Rosebank

City of Johannesburg, 2196, South Africa

RECRUITING

Chris Hani Baragwanath Clinical Trial Site

Soweto, 2013, South Africa

RECRUITING

National Cancer Center

Goyang-si, 10408, South Korea

RECRUITING

Ajou University Medical Center

Gyeonggi-do, 16499, South Korea

RECRUITING

Seoul National University Hospital

Seoul, 03080, South Korea

RECRUITING

Severance Hospital, Yonsei University Health System

Seoul, 03722, South Korea

RECRUITING

Asan Medical Center

Seoul, 05505, South Korea

RECRUITING

Samsung Medical Center

Seoul, 06351, South Korea

RECRUITING

Seoul St Mary's Hospital

Seoul, 06591, South Korea

RECRUITING

Hospital Universitario Virgen de La Arrixaca

EL Palmar (EL Palmar), Murcia, 30120, Spain

RECRUITING

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Tenerife, 38320, Spain

RECRUITING

Hospital Universitario Basurto

Bilbao, Vizcaya, 48013, Spain

RECRUITING

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

Barcelona, 08035, Spain

RECRUITING

Hospital Clinic Provincial

Barcelona, 08036, Spain

RECRUITING

Hospital Universitario San Cecilio

Granada, 18016, Spain

RECRUITING

Complejo Hospitalario de Jaen

Jaén, 23007, Spain

RECRUITING

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

Madrid, 28007, Spain

RECRUITING

Hospital General Universitario Gregorio Marañon

Madrid, 28009, Spain

RECRUITING

Hospital Ramon y Cajal

Madrid, 28034, Spain

RECRUITING

Hospital Universitario 12 De Octubre

Madrid, 28041, Spain

RECRUITING

Hospital Clinico Universitario Virgen de la Victoria

Málaga, 29010, Spain

RECRUITING

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

RECRUITING

Taichung Veterans General Hospital

Taichung, 407219, Taiwan

RECRUITING

National Cheng Kung University Hospital

Tainan, 00704, Taiwan

RECRUITING

National Taiwan Uni Hospital

Taipei, 10041, Taiwan

RECRUITING

Taipei Veterans General Hospital

Taipei, 112201, Taiwan

RECRUITING

Chang Gung Memorial Hospital - Linkou

Taoyuan City, 333, Taiwan

RECRUITING

Ramathibodi Hospital

Bangkok, 10400, Thailand

RECRUITING

Faculty of Med. Siriraj Hosp.

Bangkok, 10700, Thailand

RECRUITING

Srinagarind Hospital, Khon Kaen Uni

Khon Kaen, 40002, Thailand

RECRUITING

Chulabhorn Hospital

Lak Si, 10210, Thailand

RECRUITING

Songklanagarind Hospital

Songkhla, 90110, Thailand

RECRUITING

Bangkok Metropolitan Administration Medical College and Vajira Hospital

Wachira Phayaban, 10300, Thailand

RECRUITING

Hacettepe University Medical Faculty

Altındağ, 06230, Turkey (Türkiye)

RECRUITING

Abdurrahman Yurtarslan Onkoloji Training and Research Hospital

Ankara, 06200, Turkey (Türkiye)

RECRUITING

Ankara Bilkent City Hospital

Ankara, 06490, Turkey (Türkiye)

RECRUITING

Akdeniz University Medical Faculty

Antalya, 07058, Turkey (Türkiye)

RECRUITING

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

Bakirkoy / Istanbul, 34147, Turkey (Türkiye)

RECRUITING

Ege University Medical Faculty

Bornova, Izmir, 35100, Turkey (Türkiye)

RECRUITING

Trakya University Medical Faculty

Erdine, 22030, Turkey (Türkiye)

RECRUITING

Istinye University Liv Hospital Topkapi

Istanbul, 34010, Turkey (Türkiye)

RECRUITING

Marmara University Pendik Research and Training Hospital

Istanbul, 34722, Turkey (Türkiye)

RECRUITING

Acibadem Izmir Kent Hospital

Izmir, 35630, Turkey (Türkiye)

RECRUITING

Mersin City Education and Research Hospital

Mersin, 33240, Turkey (Türkiye)

RECRUITING

Medikal Park Samsun

Samsun, 55200, Turkey (Türkiye)

RECRUITING

Leicester Royal Infirmary

Leicester, LE2 7LG, United Kingdom

RECRUITING

Royal Marsden Hospital

London, SW3 6JJ, United Kingdom

RECRUITING

UCLH

London, WC1E 6AG, United Kingdom

RECRUITING

Christie Hospital Nhs Trust

Manchester, M20 4GJ, United Kingdom

RECRUITING

Royal Marsden Hospital - Sutton

Sutton, SM2 5PT, United Kingdom

RECRUITING

Related Links

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MeSH Terms

Interventions

tucatinib; Trastuzumab; Capecitabine

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Central Study Contacts

Reference Study ID Number: WO46069 https://forpatients.roche.com/ No attachments to email below.

CONTACT

888-662-6728 (U.S. only); global-roche-genentech-trials@gene.com

Fastest response: use the inquiry form. https://www.gene.com/contact-us/submit-medical-inquiry

CONTACT

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 10, 2026
• First Posted: February 17, 2026
• Study Start: May 21, 2026
• Primary Completion (Estimated): May 1, 2029
• Study Completion (Estimated): September 29, 2032
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share

Locations

CA (6); AR (6); CZ (3); CL (6); TW (5); HU (3); KR (7); NZ (2); US (1); IL (6); GB (5); BE (7); PT (8); AU (3); CN (18); PL (9); IT (13); ZA (2); ES (13); TH (6); TU (12); DE (6)