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
Recruiting · NCT07413939 · Interventional (participants receive a specific treatment) · Lead sponsor: Hoffmann-La Roche
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 2, Phase 3
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
60 locations listed across 3 US states.
- Astera Cancer Care East Brunswick - East Brunswick, New Jersey, United States
- New York Oncology Hematology, P.C. - Albany, New York, United States
- New York Cancer and Blood Specialists - Shirley, New York, United States
- The West Clinic, PC dba West Cancer Center - Germantown, Tennessee, United States
- Instytut "Centrum Zdrowia Matki Polki" - ?ód?, Poland
- Hacettepe University Medical Faculty - Altındağ, Turkey (Türkiye)
- Hospital Professor Doutor Fernando Fonseca, E.P.E. - Amadora-Lisbon, Portugal
- Abdurrahman Yurtarslan Onkoloji Training and Research Hospital - Ankara, Turkey (Türkiye)
- Ankara Bilkent City Hospital - Ankara, Turkey (Türkiye)
- Akdeniz University Medical Faculty - Antalya, Turkey (Türkiye)
- Auckland City Hospital, Cancer and Blood Research - Auckland, New Zealand
- Bakirkoy Dr. Sadi Konuk Egitim ve Arastirma Hastanesi, Tibbi Onkoloji - Bakirkoy / Istanbul, Turkey (Türkiye)
- Ramathibodi Hospital - Bangkok, Thailand
- Faculty of Med. Siriraj Hosp. - Bangkok, Thailand
- Vall d'Hebron Institute of Oncology (VHIO), Barcelona - Barcelona, Spain
- Hospital Clinic Provincial - Barcelona, Spain
- 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
- Ege University Medical Faculty - Bornova, Izmir, Turkey (Türkiye)
- Masaryk?v onkologický ústav - Brno, Czechia
- Cliniques Universitaires St-Luc - Brussels, Belgium
- Semmelweis Egyetem;Onkológiai Profil (Belgyógyászati és Onkológiai Klinika) - Budapest, Hungary
- Centro Médico Fleischer - Buenos Aires, Argentina
- Investigaciones Clínicas Moleculares - Buenos Aires, Argentina
- Instituto Alexander Fleming - Buenos Aires, Argentina
- Fundación Respirar - CABA, Argentina
- West China Hospital, Sichuan University - Chengdu, China
- Medical Oncology Centre of Rosebank - City of Johannesburg, South Africa
- Kyungpook National University Chilgok Hospital - Daegu, South Korea
- Debreceni Egyetem Klinikai Kozpont - Debrecen, Hungary
- Städtisches Klinikum Dessau - Dessau, Germany
- Trakya University Medical Faculty - Erdine, Turkey (Türkiye)
- Fujian Medical University Union Hospital - Fuzhou, China
- National Cancer Center - Goyang-si, South Korea
- Hospital Universitario San Cecilio - Granada, Spain
- Lkh-Univ. Klinikum Graz - Graz, Austria
- CHU de Grenoble - Hôpital Nord - Grenoble, France
- Sun yat-sen University Cancer Center - Guangzhou, China
- Sun Yat-sen Memorial Hospital - Guangzhou, China
- Ajou University Medical Center - Gyeonggi-do, South Korea
- Rambam Health Care Campus - Haifa, Israel
- Universitätsklinikum Hamburg-Eppendorf (UKE) - Hamburg, Germany
- The Second Affiliated Hospital of Zhejiang University College - HangzhouZhejiang, China
- Jessa Zkh (Campus Virga Jesse) - Hasselt, Belgium
- Anhui Provincial Hospital - Hefei, China
- Nationales Centrum für Tumorerkrankungen (NCT) - Heidelberg, Germany
- Fakultni Nemocnice Hradec Kralove - Hradec Králové, Czechia
- Centro Oncología Precisión Iquique - Iquique, Chile
- 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)
- Complejo Hospitalario de Jaen - Jaén, Spain
- Shaare Zedek Medical Center - Jerusalem, Israel
- Hadassah University Hospital - Ein Kerem - Jerusalem, Israel
- Jiangmen Central Hospital - Jiangmen, China
- Shandong Cancer Hospital - Jinan, China
- Uniwersyteckie Centrum Kliniczne im. K. Gibinskiego SUM - Katowice, Poland
- Bács-Kiskun Vármegyei Oktatókórház - Kecskemét, Hungary
Showing 60 of 186 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →