This study involves patients with HER2-positive breast cancer that has spread to other parts of the body or has advanced locally. HER2-positive means that cancer cells have too much of a certain protein called HER2 on their surface, which makes the cancer grow faster. The study is testing two medications given together: trastuzumab deruxtecan, also known as T-DXd or DS-8201, and pertuzumab. Both medications are given through a vein as an infusion. The study also uses two digital health tools called CANKADO PRO-React Onco and RESILIENCE MD, which are smartphone applications that help monitor symptoms and side effects. These digital tools allow patients to report how they are feeling and provide educational information about managing side effects related to the treatment.
The purpose of this study is to see how well the combination of trastuzumab deruxtecan and pertuzumab works as a first treatment for this type of breast cancer when using digital tools to actively manage side effects, and to understand how this treatment affects quality of life. During the study, patients will receive the study medications every three weeks through infusion. They will use a smartphone application to regularly track their symptoms, medication intake, and overall well-being. The digital platform can send alerts to doctors if symptoms become severe or worsen, allowing the medical team to adjust care quickly. Some patients may also have access to optional support programs through the app, such as help with fatigue, physical activity guidance, and meditation, depending on their country. Patients will need to have a smartphone with internet access that meets specific technical requirements to use these digital tools.
The study will measure several things, including how long it takes before patients need to start a different cancer treatment, and how long it takes for physical functioning to worsen based on quality of life questionnaires. Doctors will also track side effects, how often doses need to be adjusted, how well patients can continue treatment, and how often patients need emergency visits or hospitalizations. The study will look at how the cancer responds to treatment, including whether tumors shrink or disappear, and how long any response lasts. Quality of life will be measured using questionnaires that ask about physical symptoms, daily functioning, and overall health status. The study will also track how well patients use the digital health tools and how satisfied they are with the monitoring system and the care they receive.



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