RecruitingPhase II/III🇵🇱 PolandEN originalBreast cancerHER2 positiveMetastatic / advanced

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

⚠️

This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.

About the trial

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.

Original English text from ClinicalTrials.gov

Who can (and can't) join

✓ Qualifies

  • Zaawansowany lub rozsiany rak piersi potwierdzony badaniem patologicznym, z dodatnim statusem HER2 potwierdzoną w laboratorium.
  • Mierzalne zmiany nowotworowe (lub niemierzalne w drugim etapie badania).
  • Przerzuty do mózgu lub opon mózgowych - wcześniej leczone lub nieleczone.
  • Co najmniej jedno poprzednie leczenie anty-HER2 dla raka zaawansowanego.
  • Poprzednie leczenie lekiem conjugowanym z przeciwciałem anty-HER2 (np. trastuzumab-deruxtecan lub trastuzumab emtansine).
  • Poprzednia terapia inhibitorem kinazy tyrozynowej w leczeniu adjuwantowym (zakończona ponad 12 miesięcy przed pojawieniem się raka zaawansowanego).
  • Prawidłowa funkcja narządów wewnętrznych i szpiku kostnego.
  • Ogólny stan zdrowia oceniany jako 0 lub 1 w skali ECOG oraz frakcja wyrzutowa lewej komory serca ≥50%.

✗ Disqualifies

  • Jednoczesne przyjmowanie innych leków przeciwnowotworowych lub leków eksperymentalnych w ciągu 28 dni przed badaniem.
  • Aktywne wirusowe zapalenie wątroby B lub C, lub przewlekła choroba wątroby.
  • Poważne problemy kardiologiczne: niewydolność serca, choroba niedokrwienna, zaburzenia rytmu serca, przedłużony QT, niekontrolowane nadciśnienie.
  • Nieprawidłowe stężenia elektrolitów lub rodzinna historia nagłych zgonów bądź długiego QT.
  • Jednoczesne stosowanie leków mocno hamujących lub stymulujących enzym CYP3A4/CYP2C8, lub leków z grupy kumarinowych.

Simplified criteria — AI translation

Trial details

Minimum age
18 Years
Last updated (source)
August 5, 2026
Sex
No restrictions

Therapies / drugs in trial

Locations (152)

The West Clinic, PC dba West Cancer Center

Germantown, United States

Centro Médico Fleischer

Buenos Aires, Argentina

Investigaciones Clínicas Moleculares

Buenos Aires, Argentina

Instituto Alexander Fleming

Buenos Aires, Argentina

Fundación Respirar

CABA, Argentina

Hospital Provincial del Centenario

Rosario, Argentina

Centro Oncológico de Excelencia

San Juan, Argentina

Macquarie University Hospital

Macquarie Park, Australia

Monash Health

Clayton, Australia

Barwon Health

Geelong, Australia

Peter MacCallum Cancer Centre

Melbourne, Australia

Sunshine Hospital

St Albans, Australia

Lkh-Univ. Klinikum Graz

Graz, Austria

Ordensklinikum Linz Barmherzige Schwestern

Linz, Austria

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

Sunnybrook Odette Cancer Centre

Toronto, Canada

Princess Margaret Cancer Center

Toronto, Canada

Hopital Maisonneuve-Rosemont

Montreal, Canada

CHUM

Montreal, Canada

McGill University Health Centre - Glen Site

Montreal, Canada

Hopital du Saint Sacrement

Québec, Canada

Hospital las Higueras

Concepción, Chile

Centro Oncología Precisión Iquique

Iquique, Chile

Medicina de Precisión - Celerity

Las Condes, Chile

Oncovida

Providencia, 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, China

Beijing Cancer Hospital

Beijing, China

Cancer Hospital Chinese Academy of Medical Sciences.

Beijing, China

Peking University People's Hospital

Beijing, China

the First Affiliated Hospital of Bengbu Medical College

Bengbu, China

West China Hospital, Sichuan University

Chengdu, China

Fujian Medical University Union Hospital

Fuzhou, 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

Shandong Cancer Hospital

Jinan, China

Yunnan Cancer Hospital

Kunming, China

Nanchang People?s Hospital

Nanchang, 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

Masaryk?v onkologický ústav

Brno, Czechia

Fakultni Nemocnice Hradec Kralove

Hradec Králové, Czechia

Fakultni nemocnice v Motole

Prague, 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

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

Paderborn, 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

Rambam Health Care Campus

Haifa, Israel

Shaare Zedek Medical Center

Jerusalem, Israel

Rabin Medical Center

Petah Tikva, Israel

Chaim Sheba Medical Center

Ramat Gan, Israel

Ichilov Sourasky Medical Center

Tel Aviv, Israel

Assula Medical Center

Tel Aviv, Israel

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

Meldola, Italy

A.O. Universitaria Di Parma

Parma, Italy

Irccs Centro Di Riferimento Oncologico (CRO)

Aviano, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Italy

Università Campus Bio-Medico di Roma

Rome, Italy

Asst Papa Giovanni XXIII

Bergamo, Italy

Asst Degli Spedali Civili Di Brescia

Brescia, Italy

Ospedale San Raffaele

Milan, Italy

Irccs Istituto Nazionale Dei Tumori (Int)

Milan, Italy

IEO Istituto Europeo di Oncologia

Milan, Italy

Asst Grande Ospedale Metropolitano Niguarda

Milan, Italy

Istituto Clinico Humanitas

Rozzano, Italy

Humanitas Centro Catanese Di Oncologia

Misterbianco (CT), 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

Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii

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

IPO de Lisboa

Lisbon, Portugal

Hospital da Luz

Lisbon, Portugal

Hospital de Santa Maria

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

National Cancer Center

Goyang-si, South Korea

Ajou University Medical Center

Gyeonggi-do, South Korea

Seoul National University Hospital

Seoul, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul St Mary's Hospital

Seoul, South Korea

Hospital Universitario Virgen de La Arrixaca

EL Palmar (EL Palmar), Spain

Hospital Universitario de Canarias

San Cristóbal de La Laguna, Spain

Hospital Universitario Basurto

Bilbao, 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)

Ankara Bilkent City Hospital

Ankara, Turkey (Türkiye)

Akdeniz University Medical Faculty

Antalya, Turkey (Türkiye)

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

Bakirkoy / Istanbul, Turkey (Türkiye)

Ege University Medical Faculty

Bornova, Izmir, 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)

Acibadem Izmir Kent Hospital

Izmir, 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

UCLH

London, United Kingdom

Christie Hospital Nhs Trust

Manchester, United Kingdom

Royal Marsden Hospital - Sutton

Sutton, United Kingdom

Trial contact

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

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

Contact information from ClinicalTrials.gov. Contact in English.

Share this trial

Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.

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