Comparing RO7771950 with a drug combination of tucatinib, trastuzumab, and capecitabine in patients with HER2-positive metastatic or locally advanced breast cancer
This study involves patients with HER2-positive breast cancer, a type of cancer where cells have too much of a certain protein that helps them grow. The cancer being studied may be locally advanced, meaning it has spread to nearby tissues, or metastatic, meaning it has spread to other parts of the body. Some patients may also have central nervous system metastases, which refers to cancer that has spread to the brain or spinal cord. The purpose of the study is to compare the effectiveness of a new drug called RO7771950 against a drug named tucatinib.
Participants in the study will receive a combination of medications. One group will take RO7771950 along with trastuzumab and capecitabine. The other group will receive tucatinib combined with trastuzumab and capecitabine. The trastuzumab may be given through an IV infusion, which is a liquid medicine delivered directly into a vein, or as a subcutaneous injection, which is administered just under the skin. The other medications are taken as an oral tablet by mouth.
During the study, medical professionals will monitor how the treatments affect the cancer and how the body responds over time. The research will look at how long the cancer stays stable without growing, a measure known as progression-free survival. Other aspects of the study include monitoring overall survival, how much the tumors shrink, and any side effects experienced during the treatment period.
Who Can Join the Study?
You must have a confirmed diagnosis of breast cancer that is either locally advanced (meaning the cancer has grown into nearby tissues and cannot be removed by surgery) or metastatic (meaning the cancer has spread to other parts of the body).
Your cancer must be HER2-positive, which means a laboratory test has confirmed that your cancer cells have too much of a specific protein called human epidermal growth factor receptor 2.
The HER2 status must be confirmed by a central laboratory using a specific tissue sample called formalin-fixed, paraffin-embedded (FFPE), which is a standard way of preserving tissue for testing.
The cancer must be measurable, meaning the tumors can be clearly seen and tracked using medical imaging such as a CT scan, MRI, or X-ray.
If you have bone lesions (areas of damage in the bone caused by cancer), they must be lytic or mixed lytic, which describes how the cancer is affecting the bone structure, and they must be visible on scans.
You must have already received at least one previous treatment designed to target the HER2 protein.
You must have previously used an antibody-drug conjugate (ADC), which is a type of targeted therapy that uses an antibody to deliver a drug directly to cancer cells.
If you have previously taken a tyrosine kinase inhibitor (TKI)—a type of drug that blocks signals that help cancer cells grow—it must have been used as a preventive treatment (neoadjuvant or adjuvant) at least 12 months before your cancer was found to be advanced or spread.
You cannot have previously used a tyrosine kinase inhibitor (TKI) specifically to treat metastatic or locally advanced breast cancer.
Who Cannot Join the Study?
Taking an experimental drug or a new treatment being tested in other studies within the last 28 days.
Receiving other anti-cancer treatments at the same time, though certain hormone treatments for non-cancer issues or specific bone medicines are allowed.
Having brain metastases (cancer that has spread to the brain) that cause worsening nerve problems or increased intracranial pressure (pressure inside the skull) leading to symptoms like vomiting, headaches, or vision changes.
Having brain cancer spots that need immediate local therapy (treatment focused on a specific area, such as surgery or radiation).
Needing a high daily dose of systemic corticosteroids (strong medicines used to reduce inflammation) to manage brain-related symptoms.
Needing anti-epileptic medication (drugs used to prevent seizures) to control seizures, unless the person is on a stable dose of a specific medicine called levetiracetam.
Having congestive heart failure (a condition where the heart does not pump blood as well as it should) that is moderate or severe.
Having significant peripheral arterial disease (narrowed or blocked blood vessels) or issues with the heart muscle, such as hypertrophic cardiomyopathy (thickening of the heart muscle).
Showing abnormal results on an ECG (a test that records the electrical activity of the heart), such as heart blocks (interruptions in the heart’s electrical signals) or a prolonged PR interval (a delay in the electrical signal moving through the heart).
Having an arrhythmia (an irregular heartbeat) that requires medical treatment or intervention.
Having unstable angina (chest pain that happens unpredictably or while resting) or having had a myocardial infarction (a heart attack) within the last 6 months.
Having undergone coronary artery bypass graft (surgery to improve blood flow to the heart) or stenting (placing a small tube to keep an artery open) within the last 6 months.
Having a prolonged QT interval (a measurement of the time it takes for the heart’s electrical system to recharge) or a history of Torsade de Pointes (a specific type of dangerous irregular heartbeat).
Having poorly controlled hypertension (high blood pressure) where the top number is above 180 or the bottom number is above 100.
Having a history of ventricular dysrhythmias (irregular heartbeats starting in the lower chambers of the heart) or structural heart disease (physical changes to the heart’s shape or size).
Having coronary heart disease (damage to the heart’s blood vessels) that causes symptoms or shows signs of low oxygen to the heart.
Having significant electrolyte abnormalities (unhealthy levels of essential minerals like potassium, magnesium, or calcium in the blood).
Having active or untreated hepatitis B or hepatitis C (viral infections that affect the liver) or any chronic liver disease (long-term liver damage).
Trastuzumab is a targeted therapy used to treat certain types of breast cancer by blocking a specific protein that helps cancer cells grow.
Tucatinib is a medication taken by mouth that targets and inhibits a specific enzyme involved in the growth of cancer cells.
RO7771950 is an experimental medication taken as a tablet that is being studied for its ability to cross the blood-brain barrier to treat cancer cells.
Capecitabine is a type of chemotherapy pill used to stop the growth of cancer cells throughout the body.
HER2-Positive Breast Cancer – This is a type of cancer where cells in the breast grow abnormally due to an excess of a specific protein called human epidermal growth factor receptor 2. The disease can be locally advanced, meaning it has grown into nearby tissues, or metastatic, meaning it has spread to distant parts of the body. In some cases, the cancer cells may also spread to the central nervous system, such as the brain. The condition progresses as these abnormal cells multiply and move through the body. This specific form of cancer is characterized by the presence of the HER2 protein on the surface of the cancer cells.
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