Actively Recruiting
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
Led by Hoffmann-La Roche · Updated on 2026-05-11
650
Participants Needed
4
Research Sites
330 weeks
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pathologically confirmed locally advanced inoperable or metastatic HER2-positive breast cancer
- Measurable disease by RECIST v1.1 or RANO-BM in stage 1; non-measurable disease allowed in stage 2
- Previously treated or untreated central nervous system metastases or leptomeningeal metastases
- At least one prior line of anti-HER2 therapy for locally advanced or metastatic disease
- Prior anti-HER2 antibody-drug conjugate therapy or medically unfit for such treatment
- Prior tyrosine kinase inhibitor therapy in the (neo)adjuvant setting completed more than 12 months before locally advanced disease
- Adequate organ and bone marrow function as defined by protocol
- Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
- Baseline left ventricular ejection fraction (LVEF) of 50% or higher
You will not qualify if you...
- Receiving any other anti-cancer treatment or investigational therapy within 28 days before study treatment
- Known active or untreated hepatitis B or C or chronic liver disease
- Significant cardiovascular disease including heart failure NYHA class II or higher, ischemic heart disease, recent coronary events or interventions, significant arrhythmias, ECG abnormalities, QT prolongation or risk of ventricular dysrhythmias, uncontrolled hypertension, peripheral arterial disease, dilated cardiomyopathy, or unstable angina
- Significant electrolyte imbalances such as hypokalemia, hypomagnesemia, hypocalcemia, or family history of sudden unexplained death or long QT syndrome
- Use of drugs or herbal medicines that strongly inhibit or induce CYP3A4 or CYP2C8, or oral coumarin-derivative anticoagulants
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 4 locations
1
Hopital du Saint Sacrement
Québec, Quebec, Canada, G1S 4L8
Actively Recruiting
2
Taichung Veterans General Hospital
Taichung, Taiwan, 407219
Actively Recruiting
3
National Cheng Kung University Hospital
Tainan, Taiwan, 00704
Actively Recruiting
4
National Taiwan Uni Hospital
Taipei, Taiwan, 10041
Actively Recruiting
Research Team
R
Reference Study ID Number: WO46069 https://forpatients.roche.com/
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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