AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

โ† Trials
๐Ÿงช

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

RecruitingPhase 2, Phase 3Ages 18 Years - anyAllHoffmann-La Roche
๐Ÿ’ฌ

In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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) โ‰ฅ 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) โ‰ฅ 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.
๐Ÿ’Š

What it tests

  • RO7771950
  • Tucatinib
  • Trastuzumab
  • Capecitabine
๐Ÿ“

Where

206 sites
Clearview Cancer Institute
Huntsville, United States
Banner Health MD Anderson AZ
Gilbert, United States
UCSF Helen Diller Family CCC
San Francisco, United States
Eastern Connecticut Hematology and Oncology Associates
Norwich, United States
Astera Cancer Care East Brunswick
East Brunswick, United States
New York Oncology Hematology, P.C.
Albany, United States
New York Cancer and Blood Specialists
Shirley, United States
Stony Brook Univ Cancer Ctr
Stony Brook, United States

โ€ฆand 198 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
๐Ÿ›ก๏ธ

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it โ€” not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use ยท Privacy