New drug targets breast cancer in the brain
NCT ID NCT07413939
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 6 times
Summary
This study tests a new drug, RO7771950, designed to reach the brain, for people with HER2-positive breast cancer that has spread to the brain or other organs. About 650 participants will receive either the new drug or an existing drug (tucatinib), both combined with standard therapies. The goal is to see if the new drug can better delay cancer growth or improve survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- RO7771950 (also called ZN-A-1041)
- What this could lead to
- If it works, this could offer a new treatment option for HER2-positive breast cancer that has spread to the brain, potentially improving how long people live without their cancer growing.
- What could go wrong
- This is an early-to-mid stage trial, so the new drug may not work better than the existing treatment. Side effects are possible, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 650 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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May 2026
- Expected to finish
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Sep 2032
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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.
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HER2-positive breast cancer are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
186 sites in 25 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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A.O. Universitaria Di Parma
RECRUITINGParma, Emilia-Romagna, 43100, Italy
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AZ Groeninge
RECRUITINGKortrijk, 8500, Belgium
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AZ St Maarten Campus Leopoldstr
RECRUITINGMechelen, 2800, Belgium
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Abdurrahman Yurtarslan Onkoloji Training and Research Hospital
RECRUITINGAnkara, 06200, Turkey (Türkiye)
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Acibadem Izmir Kent Hospital
RECRUITINGIzmir, 35630, Turkey (Türkiye)
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Advanze Pesquisa - Oncologia Sao Carlos
RECRUITINGSão Carlos, São Paulo, 13561-130, Brazil
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Ajou University Medical Center
RECRUITINGGyeonggi-do, 16499, South Korea
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Akdeniz University Medical Faculty
RECRUITINGAntalya, 07058, Turkey (Türkiye)
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Anhui Provincial Hospital
RECRUITINGHefei, 230001, China
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Ankara Bilkent City Hospital
RECRUITINGAnkara, 06490, Turkey (Türkiye)
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Asan Medical Center
RECRUITINGSeoul, 05505, South Korea
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Asst Degli Spedali Civili Di Brescia
RECRUITINGBrescia, Lombardy, 25123, Italy
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Asst Grande Ospedale Metropolitano Niguarda
RECRUITINGMilan, Lombardy, 20162, Italy
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Asst Papa Giovanni XXIII
RECRUITINGBergamo, Lombardy, 24127, Italy
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Assuta Medical Centre
RECRUITINGTel Aviv, DUMMY_VALUE, Israel
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Astera Cancer Care East Brunswick
RECRUITINGEast Brunswick, New Jersey, 08816, United States
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Auckland City Hospital, Cancer and Blood Research
RECRUITINGAuckland, 1023, New Zealand
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Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji
RECRUITINGBakirkoy / Istanbul, 34147, Turkey (Türkiye)
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Bangkok Metropolitan Administration Medical College and Vajira Hospital
RECRUITINGWachira Phayaban, 10300, Thailand
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Barts Health NHS Trust
RECRUITINGLondon, EC1A 7BE, United Kingdom
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Barwon Health
RECRUITINGGeelong, Victoria, 3220, Australia
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Beijing Cancer Hospital
RECRUITINGBeijing, 100021, China
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Bács-Kiskun Vármegyei Oktatókórház
RECRUITINGKecskemét, 6000, Hungary
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CHU de Grenoble - Hôpital Nord
RECRUITINGGrenoble, 38043, France
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CHUM
RECRUITINGMontreal, Quebec, H2L 4M1, Canada
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CHVNG/E_Unidade 1
RECRUITINGVila Nova de Gaia, 4434-502, Portugal
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Cancer Hospital Chinese Academy of Medical Sciences.
RECRUITINGBeijing, 100021, China
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Centre Antoine Lacassagne Centre Régional de Lutte Contre Le Cancer
RECRUITINGNice, 06100, France
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Centre Eugene Marquis;Service d'oncologie
RECRUITINGRennes, 35042, France
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Centre Leon Berard
RECRUITINGLyon, 69008, France
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Centro Médico Fleischer
RECRUITINGBuenos Aires, C1414DRK, Argentina
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Centro Oncología Precisión Iquique
RECRUITINGIquique, 1111442, Chile
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Centro Oncológico de Excelencia
RECRUITINGSan Juan, J5402BGA, Argentina
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Centro de Investigación Clínica UC-CICUC
RECRUITINGSantiago, 8330034, Chile
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Chaim Sheba Medical Center
RECRUITINGRamat Gan, 5262000, Israel
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Chang Gung Memorial Hospital - Linkou
RECRUITINGTaoyuan City, 333, Taiwan
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Chris Hani Baragwanath Clinical Trial Site
RECRUITINGSoweto, 2013, South Africa
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Christie Hospital Nhs Trust
RECRUITINGManchester, M20 4GJ, United Kingdom
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Chulabhorn Hospital
RECRUITINGLak Si, 10210, Thailand
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Clinique Ste-Elisabeth
RECRUITINGNamur, 5000, Belgium
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Cliniques Universitaires St-Luc
RECRUITINGBrussels, 1200, Belgium
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Complejo Hospitalario de Jaen
RECRUITINGJaén, 23007, Spain
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Debreceni Egyetem Klinikai Kozpont
RECRUITINGDebrecen, 4032, Hungary
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Dolno?l?skie Centrum Onkologii
RECRUITINGWroc?aw, 53-413, Poland
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Dres. Andreas Köhler und Roswitha Fuchs
RECRUITINGLangen, 63225, Germany
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Ege University Medical Faculty
RECRUITINGBornova, Izmir, 35100, Turkey (Türkiye)
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Faculty of Med. Siriraj Hosp.
RECRUITINGBangkok, 10700, Thailand
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Fakultni Nemocnice Hradec Kralove
RECRUITINGHradec Králové, 500 05, Czechia
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Fakultni nemocnice v Motole
RECRUITINGPrague, 150 06, Czechia
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Fondazione Policlinico Universitario Agostino Gemelli IRCCS
RECRUITINGRome, Lazio, 00168, Italy
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Fudan University Shanghai Cancer Center
RECRUITINGShanghai, 200032, China
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Fujian Medical University Union Hospital
RECRUITINGFuzhou, 350001, China
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Fundación Respirar
RECRUITINGCABA, C1426AAL, Argentina
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Gangnam Severance Hospital
RECRUITINGSeoul, 06273, South Korea
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Guangxi Cancer Hospital of Guangxi Medical University
RECRUITINGNanning, 530201, China
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Hacettepe University Medical Faculty
RECRUITINGAltındağ, 06230, Turkey (Türkiye)
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Hadassah University Hospital - Ein Kerem
RECRUITINGJerusalem, 9112001, Israel
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Helios Klinik Wuppertal
RECRUITINGWuppertal, 42283, Germany
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Hopital Charles Le Moyne
RECRUITINGGreenfield Park, Quebec, J4V 2H1, Canada
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Hopital Maisonneuve-Rosemont
RECRUITINGMontreal, Quebec, H1T 2M4, Canada
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Hospital Alemao Oswaldo Cruz
RECRUITINGSão Paulo, São Paulo, 01323-903, Brazil
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Hospital Beatriz Angelo
RECRUITINGLoures, 2674-514, Portugal
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Hospital Brasilia
RECRUITINGBrasília, Federal District, 71.635-610, Brazil
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Hospital Clinic Provincial
RECRUITINGBarcelona, 08036, Spain
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Hospital Clinico Universitario Virgen de la Victoria
RECRUITINGMálaga, 29010, Spain
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Hospital Du Saint-Sacrement
RECRUITINGQuébec, Quebec, G1S 4L8, Canada
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Hospital General Universitario Gregorio Marañon
RECRUITINGMadrid, 28009, Spain
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Hospital Israelita Albert Einstein
RECRUITINGSão Paulo, São Paulo, 05652-900, Brazil
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Hospital Pedro Hispano
RECRUITINGMatosinhos Municipality, 4454-509, Portugal
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Hospital Professor Doutor Fernando Fonseca, E.P.E.
RECRUITINGAmadora-Lisbon, 2610-276, Portugal
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Hospital Provincial del Centenario
RECRUITINGRosario, S2002KDS, Argentina
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Hospital Ramon y Cajal
RECRUITINGMadrid, 28034, Spain
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Hospital Santa Rita de Cassia Vitoria
RECRUITINGVitória, Espírito Santo, 29043-260, Brazil
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Hospital Universitario 12 De Octubre
RECRUITINGMadrid, 28041, Spain
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Hospital Universitario Basurto
RECRUITINGBilbao, Vizcaya, 48013, Spain
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Hospital Universitario San Cecilio
RECRUITINGGranada, 18016, Spain
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Hospital Universitario Virgen de La Arrixaca
RECRUITINGEL Palmar (EL Palmar), Murcia, 30120, Spain
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Hospital Universitario Virgen del Rocio
RECRUITINGSeville, 41013, Spain
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Hospital Universitario de Canarias
RECRUITINGSan Cristóbal de La Laguna, Tenerife, 38320, Spain
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Hospital da Luz
RECRUITINGLisbon, 1500-650, Portugal
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Hospital de Santa Maria
RECRUITINGLisbon, 1649-035, Portugal
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Hospital do Cancer de Pernambuco - HCP
RECRUITINGRecife, Pernambuco, 50040-000, Brazil
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Hospital las Higueras
RECRUITINGConcepción, Región Bio Bio, Alto Horno 777, Chile
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Hubei Cancer Hospital
RECRUITINGWuhan, 430079, China
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Humanitas Centro Catanese Di Oncologia
RECRUITINGMisterbianco (CT), Sicily, 95045, Italy
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IEO Istituto Europeo di Oncologia
RECRUITINGMilan, Lombardy, 20141, Italy
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IOB Madrid Institute of Oncology Hospital Beata Maria Ana de Jesus;Unidad Central de Oncología Médica y de Investigación Oncológica
RECRUITINGMadrid, 28007, Spain
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IOV - Istituto Oncologico Veneto - IRCCS
RECRUITINGPadova, Veneto, 35128, Italy
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IPO de Lisboa
RECRUITINGLisbon, 1099-023, Portugal
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IPO do Porto
RECRUITINGPorto, 4200-072, Portugal
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IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola
RECRUITINGMeldola, Emilia-Romagna, 47014, Italy
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Icegclinic
RECRUITINGSantiago, 7510187, Chile
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InVO - Institut für Versorgungsforschung in der Onkologie GbR
RECRUITINGKoblenz, 56068, Germany
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Instituto Alexander Fleming
RECRUITINGBuenos Aires, C1426ANZ, Argentina
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Instytut "Centrum Zdrowia Matki Polki"
RECRUITING?ód?, 93-338, Poland
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Investigaciones Clínicas Moleculares
RECRUITINGBuenos Aires, C1425BGH, Argentina
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Irccs Centro Di Riferimento Oncologico (CRO)
RECRUITINGAviano, Friuli Venezia Giulia, 33081, Italy
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Irccs Istituto Nazionale Dei Tumori (Int)
RECRUITINGMilan, Lombardy, 20133, Italy
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Istinye University Liv Hospital Topkapi
RECRUITINGIstanbul, 34010, Turkey (Türkiye)
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Istituto Clinico Humanitas
RECRUITINGRozzano, Lombardy, 20089, Italy
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Jessa Zkh (Campus Virga Jesse)
RECRUITINGHasselt, 3500, Belgium
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Jiangmen Central Hospital
RECRUITINGJiangmen, 529030, China
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KEM - Evang. Huyssens-Stiftung Essen-Huttrop
RECRUITINGEssen, North Rhine-Westphalia, 45136, Germany
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Kyungpook National University Chilgok Hospital
RECRUITINGDaegu, 41404, South Korea
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Leicester Royal Infirmary
RECRUITINGLeicester, LE2 7LG, United Kingdom
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Lkh Salzburg - Univ. Klinikum Salzburg
RECRUITINGSalzburg, 5020, Austria
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Lkh-Univ. Klinikum Graz
RECRUITINGGraz, 8036, Austria
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Macquarie University Hospital
RECRUITINGMacquarie Park, New South Wales, 2113, Australia
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Marien-Hospital Witten
RECRUITINGWitten, 58452, Germany
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Marmara University Pendik Research and Training Hospital
RECRUITINGIstanbul, 34722, Turkey (Türkiye)
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Masaryk?v onkologický ústav
RECRUITINGBrno, 656 53, Czechia
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McGill University Health Centre - Glen Site
RECRUITINGMontreal, Quebec, H4A 3J1, Canada
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Medical Oncology Centre of Rosebank
RECRUITINGCity of Johannesburg, 2196, South Africa
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Medicina de Precisión - Celerity
RECRUITINGLas Condes, 7560908, Chile
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Medikal Park Samsun
RECRUITINGSamsun, 55200, Turkey (Türkiye)
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Mersin City Education and Research Hospital
RECRUITINGMersin, 33240, Turkey (Türkiye)
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Monash Health
RECRUITINGClayton, Victoria, 3168, Australia
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Musgrove Park Hospital
RECRUITINGMontacute, TA1 5DA, United Kingdom
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NU-MED Centrum Diagnostyki i Terapii Onkologicznej
RECRUITINGTomaszów Mazowiecki, 97-200, Poland
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Nanchang People?s Hospital
RECRUITINGNanchang, 330025, China
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Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School
RECRUITINGNanjing, Jiangsu, 210031, China
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National Cancer Center
RECRUITINGGoyang-si, 10408, South Korea
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National Cheng Kung University Hospital
RECRUITINGTainan, 00704, Taiwan
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National Taiwan Uni Hospital
RECRUITINGTaipei, 10041, Taiwan
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Nationales Centrum für Tumorerkrankungen (NCT)
RECRUITINGHeidelberg, 69120, Germany
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Nemocnice AGEL Novy Jicin a.s.
RECRUITINGNový Jičín, 741 01, Czechia
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New York Cancer and Blood Specialists
RECRUITINGShirley, New York, 11967, United States
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New York Oncology Hematology, P.C.
RECRUITINGAlbany, New York, 12206, United States
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Oncovida
RECRUITINGProvidencia, 7500994, Chile
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Opolskie Centrum Onkologii
RECRUITINGOpole, 45-061, Poland
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Ordensklinikum Linz Barmherzige Schwestern
RECRUITINGLinz, 4010, Austria
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Ospedale San Raffaele
RECRUITINGMilan, Lombardy, 20132, Italy
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Ottawa General Hospital
RECRUITINGOttawa, Ontario, K1H 8L6, Canada
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Peking University People's Hospital
RECRUITINGBeijing, 100044, China
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Peter MacCallum Cancer Centre
RECRUITINGMelbourne, Victoria, 3000, Australia
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Princess Margaret Cancer Center
RECRUITINGToronto, Ontario, M5G 2M9, Canada
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Rabin MC
RECRUITINGPetah Tikva, 4910000, Israel
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Ramathibodi Hospital
RECRUITINGBangkok, 10400, Thailand
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Rambam Health Care Campus
RECRUITINGHaifa, 3109601, Israel
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Rotkreuzklinikum München
RECRUITINGMünchen, 80637, Germany
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Royal Marsden Hospital
RECRUITINGLondon, SW3 6JJ, United Kingdom
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Royal Marsden Hospital - Sutton
RECRUITINGLondon, SW3 6JJ, United Kingdom
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Ruijin Hospital Shanghai Jiaotong University School of Medicine
RECRUITINGShanghai, Shanghai Municipality, 200025, China
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Samsung Medical Center
RECRUITINGSeoul, 06351, South Korea
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Santa Casa de Misericordia de Porto Alegre
RECRUITINGPorto Alegre, Rio Grande do Sul, 90050-170, Brazil
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Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika)
RECRUITINGBudapest, 1082, Hungary
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Seoul National University Bundang Hospital
RECRUITINGSeongnam-si, Gyeonggido, 13620, South Korea
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Seoul National University Hospital
RECRUITINGSeoul, 03080, South Korea
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Seoul St Mary's Hospital
RECRUITINGSeoul, 06591, South Korea
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Severance Hospital, Yonsei University Health System
RECRUITINGSeoul, 03722, South Korea
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Shaare Zedek Medical Center
RECRUITINGJerusalem, 9103102, Israel
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Shandong Cancer Hospital
RECRUITINGJinan, 250117, China
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Shantou Center Hospital
RECRUITINGShantou, 515031, China
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Songklanagarind Hospital
RECRUITINGSongkhla, 90110, Thailand
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Sourasky / Ichilov Hospital
RECRUITINGTel Aviv, 6423906, Israel
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Srinagarind Hospital, Khon Kaen Uni
RECRUITINGKhon Kaen, 40002, Thailand
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St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise
RECRUITINGPaderborn, 33098, Germany
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Städtisches Klinikum Dessau
RECRUITINGDessau, 06847, Germany
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Sun Yat-sen Memorial Hospital
RECRUITINGGuangzhou, 510120, China
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Sun yat-sen University Cancer Center
RECRUITINGGuangzhou, 510060, China
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Sunnybrook Odette Cancer Centre
RECRUITINGToronto, Ontario, M4N 3M5, Canada
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Sunshine Hospital
RECRUITINGSt Albans, Victoria, 3021, Australia
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Szpital Kliniczny Ministerstwa Spraw Wewn?trznych i Administracji z Warmi?sko-Mazurskim Centrum Onkologii w Olsztynie
RECRUITINGOlsztyn, 10-228, Poland
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Szpital Uniwersytecki w Krakowie
RECRUITINGKrakow, 31202, Poland
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Taichung Veterans General Hospital
RECRUITINGTaichung, 407219, Taiwan
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Taipei Veterans General Hospital
RECRUITINGTaipei, 112201, Taiwan
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Tauranga Hospital, Clinical Trials Unit
RECRUITINGTauranga, 3112, New Zealand
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The Second Affiliated Hospital of Xi?an Jiaotong University, College of Medicine
RECRUITINGXi'an, 710004, China
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The Second Affiliated Hospital of Zhejiang University College
RECRUITINGHangzhouZhejiang, 310009, China
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The West Clinic, PC dba West Cancer Center
RECRUITINGGermantown, Tennessee, 38138, United States
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Tianjin Cancer Hospital
RECRUITINGTianjin, 300000, China
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Tongji Hospital Tongji Medical College Huazhong University of Science and Technology
RECRUITINGWuhan, 430030, China
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Trakya University Medical Faculty
RECRUITINGErdine, 22030, Turkey (Türkiye)
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Tumor Hospital of the affiliated medical college of Shantou University
RECRUITINGShantou, 515000, China
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UCLH
RECRUITINGLondon, WC1E 6AG, United Kingdom
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UZ Leuven Gasthuisberg
RECRUITINGLeuven, 3000, Belgium
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Università Campus Bio-Medico di Roma
RECRUITINGRome, Lazio, 128, Italy
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Universitätsklinikum Hamburg-Eppendorf (UKE)
RECRUITINGHamburg, 20246, Germany
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Uniwersytecki Szpital Kliniczny w Poznaniu
RECRUITINGPóźna, 60569, Poland
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Uniwersyteckie Centrum Kliniczne im. K. Gibinskiego SUM
RECRUITINGKatowice, 40-514, Poland
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Uniwersyteckie Centrum Kliniczne, Klinika Onkologii i Radioterapii
RECRUITINGOpole, 45-061, Poland
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Vall d'Hebron Institute of Oncology (VHIO), Barcelona
RECRUITINGBarcelona, 08035, Spain
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West China Hospital, Sichuan University
RECRUITINGChengdu, 610041, China
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Yunnan Cancer Hospital
RECRUITINGKunming, 650118, China
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ZAS Sint Augustinus Wilrijk
RECRUITINGWilrijk, 2610, Belgium
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the First Affiliated Hospital of Bengbu Medical College
RECRUITINGBengbu, 233000, China
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