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.
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.
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.
Hoffmann-La Roche
Lead sponsor