Recruiting NCT07413939
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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: RO7771950, Tucatinib, Trastuzumab, Capecitabine.
- Who it may be relevant to
- Registry conditions: HER2-positive Breast Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States, Argentina, Australia, Austria, Belgium +18
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
A Two-part, Seamless, Multicenter, Randomized, Open-label, Adaptive Phase II/III Study of the Blood-brain Barrier Penetrant RO7771950 Versus Tucatinib, Both in Combination With Trastuzumab and Capecitabine, in Patients With Pretreated Unresectable Locally Advanced or Metastatic HER2-Positive Breast Cancer, With or Without Central Nervous System Metastases
Overview
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.
Interventions
- Drug RO7771950
Participants will receive one of two doses of RO7771950 orally (PO) twice a day (BID). - Drug Tucatinib
Participants will receive a dose of tucatinib PO BID. - Drug Trastuzumab
Participants will receive trastuzumab in accordance with local prescribing information, either through intravenous (IV) or subcutaneously (SC). - Drug Capecitabine
Participants will receive capecitabine according to local prescribing information. Capecitabine will be administered PO BID.
Primary outcome measures
- Progression-free Survival (PFS) as Determined by Blinded Independent Central Review (BICR) [Time frame: Approximately 35 months]
Secondary outcome measures (12)
- Progression-free Survival in Participants with Central Nervous System Metastases (PFS-CNS) by BICR [Time frame: Approximately 35 months]
- Overall Survival in Full Analysis Set (OS-FAS) [Time frame: Approximately 53 months]
- Objective Response Rate (ORR) by BICR [Time frame: Approximately 35 months]
- Duration of Response (DOR) as per BICR [Time frame: Approximately 35 months]
- Clinical Benefit Rate (CBR) as per BICR [Time frame: Approximately 35 months]
- ORR in Participants with CNS Metastases (ORR-CNS) [Time frame: Approximately 35 months]
- DOR in Participants with CNS Metastases (DOR-CNS) [Time frame: Approximately 35 months]
- CBR in Participants with CNS Metastases (CBR-CNS) [Time frame: Approximately 35 months]
- Changes from Baseline in Symptoms Burden in Participants With Brain Tumors [Time frame: Approximately 35 months]
- Changes from Baseline in Function and Health-related Quality of Life (HRQoL) [Time frame: Approximately 35 months]
- Incidence of Adverse Events (AEs) [Time frame: Approximately 35 months]
- Severity of AEs [Time frame: Approximately 35 months]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 18 centers
- Nanjing Drum Tower Hospital, the Affiliated Hospital of Nanjing University Medical School — Nanjing
- Beijing Cancer Hospital — Beijing
- Cancer Hospital Chinese Academy of Medical Sciences. — Beijing
- Peking University People's Hospital — Beijing
- the First Affiliated Hospital of Bengbu Medical College — Bengbu
- West China Hospital, Sichuan University — Chengdu
- Fujian Medical University Union Hospital — Fuzhou
- Sun yat-sen University Cancer Center — Guangzhou
- … and 10 more centers
Italy · 13 centers
- IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola — Meldola
- A.O. Universitaria Di Parma — Parma
- Irccs Centro Di Riferimento Oncologico (CRO) — Aviano
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS — Rome
- Università Campus Bio-Medico di Roma — Rome
- Asst Papa Giovanni XXIII — Bergamo
- Asst Degli Spedali Civili Di Brescia — Brescia
- Ospedale San Raffaele — Milan
- … and 5 more centers
Spain · 13 centers
Center list to be confirmed — check the primary protocol.
Turkey (Türkiye) · 12 centers
Center list to be confirmed — check the primary protocol.
Poland · 9 centers
Center list to be confirmed — check the primary protocol.
Portugal · 8 centers
Center list to be confirmed — check the primary protocol.
Belgium · 7 centers
- Cliniques Universitaires St-Luc — Brussels
- Jessa Zkh (Campus Virga Jesse) — Hasselt
- AZ Groeninge — Kortrijk
- UZ Leuven Gasthuisberg — Leuven
- AZ St Maarten Campus Leopoldstr — Mechelen
- Clinique Ste-Elisabeth — Namur
- ZAS Sint Augustinus Wilrijk — Wilrijk
South Korea · 7 centers
Center list to be confirmed — check the primary protocol.
Argentina · 6 centers
- Centro Médico Fleischer — Buenos Aires
- Investigaciones Clínicas Moleculares — Buenos Aires
- Instituto Alexander Fleming — Buenos Aires
- Fundación Respirar — CABA
- Hospital Provincial del Centenario — Rosario
- Centro Oncológico de Excelencia — San Juan
Canada · 6 centers
- Sunnybrook Odette Cancer Centre — Toronto
- Princess Margaret Cancer Center — Toronto
- Hopital Maisonneuve-Rosemont — Montreal
- CHUM — Montreal
- McGill University Health Centre - Glen Site — Montreal
- Hopital du Saint Sacrement — Québec
Chile · 6 centers
- Hospital las Higueras — Concepción
- Centro Oncología Precisión Iquique — Iquique
- Medicina de Precisión - Celerity — Las Condes
- Oncovida — Providencia
- Centro de Investigación Clínica UC-CICUC — Santiago
- Icegclinic — Santiago
Germany · 6 centers
- Städtisches Klinikum Dessau — Dessau
- InVO - Institut für Versorgungsforschung in der Onkologie GbR — Koblenz
- Dres. Andreas Köhler und Roswitha Fuchs — Langen
- Rotkreuzklinikum München — München
- St. Vincenz-Krankenhaus GmbH Paderborn Frauen- und Kinderklinik St. Louise — Paderborn
- Marien-Hospital Witten — Witten
Israel · 6 centers
- Rambam Health Care Campus — Haifa
- Shaare Zedek Medical Center — Jerusalem
- Rabin Medical Center — Petah Tikva
- Chaim Sheba Medical Center — Ramat Gan
- Ichilov Sourasky Medical Center — Tel Aviv
- Assula Medical Center — Tel Aviv
Thailand · 6 centers
Center list to be confirmed — check the primary protocol.
Australia · 5 centers
- Macquarie University Hospital — Macquarie Park
- Monash Health — Clayton
- Barwon Health — Geelong
- Peter MacCallum Cancer Centre — Melbourne
- Sunshine Hospital — St Albans
Taiwan · 5 centers
Center list to be confirmed — check the primary protocol.
United Kingdom · 5 centers
Center list to be confirmed — check the primary protocol.
Austria · 3 centers
- Lkh-Univ. Klinikum Graz — Graz
- Ordensklinikum Linz Barmherzige Schwestern — Linz
- Lkh Salzburg - Univ. Klinikum Salzburg — Salzburg
Czechia · 3 centers
- Masaryk?v onkologický ústav — Brno
- Fakultni Nemocnice Hradec Kralove — Hradec Králové
- Fakultni nemocnice v Motole — Prague
Hungary · 3 centers
- Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika) — Budapest
- Debreceni Egyetem Klinikai Kozpont — Debrecen
- Bács-Kiskun Vármegyei Oktatókórház — Kecskemét
New Zealand · 2 centers
Center list to be confirmed — check the primary protocol.
South Africa · 2 centers
Center list to be confirmed — check the primary protocol.
United States · 1 center
- The West Clinic, PC dba West Cancer Center — Germantown
Identifiers
NCT: NCT07413939 · WO46069 · 2025-524498-17-00