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Clinical Trials in the UK / NCT07413939
Recruiting Phase 2/3

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 · tracked via the Priya Life Science UK tracker
Sponsor
Hoffmann-La Roche
Phase
Phase 2/3
Started
2026-05-21
Last updated
2026-09-03

Condition(s) studied

HER2-positive Breast Cancer

Investigational drug(s) / intervention(s)

RO7771950TucatinibTrastuzumabCapecitabine

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

Tucatinib: Participants will receive a dose of tucatinib PO BID.

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

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

Study 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

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (186)

FacilityCityRegionStatus
Astera Cancer Care East Brunswick East Brunswick New Jersey Recruiting
New York Oncology Hematology, P.C. Albany New York Recruiting
New York Cancer and Blood Specialists Shirley New York Recruiting
The West Clinic, PC dba West Cancer Center Germantown Tennessee Recruiting
Centro Médico Fleischer Buenos Aires Argentina Recruiting
Investigaciones Clínicas Moleculares Buenos Aires Argentina Recruiting
Instituto Alexander Fleming Buenos Aires Argentina Recruiting
Fundación Respirar CABA Argentina Recruiting
Hospital Provincial del Centenario Rosario Argentina Recruiting
Centro Oncológico de Excelencia San Juan Argentina Recruiting
Macquarie University Hospital Macquarie Park New South Wales Recruiting
Monash Health Clayton Victoria Recruiting
Barwon Health Geelong Victoria Recruiting
Peter MacCallum Cancer Centre Melbourne Victoria Recruiting
Sunshine Hospital St Albans Victoria Recruiting
Lkh-Univ. Klinikum Graz Graz Austria Recruiting
Ordensklinikum Linz Barmherzige Schwestern Linz Austria Recruiting
Lkh Salzburg - Univ. Klinikum Salzburg Salzburg Austria Recruiting
Cliniques Universitaires St-Luc Brussels Belgium Recruiting
Jessa Zkh (Campus Virga Jesse) Hasselt Belgium Recruiting
AZ Groeninge Kortrijk Belgium Recruiting
UZ Leuven Gasthuisberg Leuven Belgium Recruiting
AZ St Maarten Campus Leopoldstr Mechelen Belgium Recruiting
Clinique Ste-Elisabeth Namur Belgium Recruiting
ZAS Sint Augustinus Wilrijk Wilrijk Belgium Recruiting
Hospital Santa Rita de Cassia Vitoria Vitória Espírito Santo Recruiting
Hospital Brasilia Brasília Federal District Recruiting
Hospital do Cancer de Pernambuco - HCP Recife Pernambuco Recruiting
Santa Casa de Misericordia de Porto Alegre Porto Alegre Rio Grande do Sul Recruiting
Advanze Pesquisa - Oncologia Sao Carlos São Carlos São Paulo Recruiting
Hospital Alemao Oswaldo Cruz São Paulo São Paulo Recruiting
Hospital Israelita Albert Einstein São Paulo São Paulo Recruiting
Ottawa General Hospital Ottawa Ontario Recruiting
Sunnybrook Odette Cancer Centre Toronto Ontario Recruiting
Princess Margaret Cancer Center Toronto Ontario Recruiting
Hopital Charles Le Moyne Greenfield Park Quebec Recruiting
Hopital Maisonneuve-Rosemont Montreal Quebec Recruiting
CHUM Montreal Quebec Recruiting
McGill University Health Centre - Glen Site Montreal Quebec Recruiting
Hospital Du Saint-Sacrement Québec Quebec Recruiting

+ 146 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07413939 on ClinicalTrials.gov ↗ ← All trials in the UK