Citta Metropolitana Di Napoli

Researchers are evaluating the safety and effectiveness of a combination therapy of tucatinib, trastuzumab, and capecitabine in women with HER2-positive metastatic breast cancer. This study focuses on patients who have progressed after at least two prior anti-HER2 treatments and aims to observe how this treatment performs in a real-world clinical setting following approved indications and dosing guidelines. Tucatinib is an oral, highly selective HER2 tyrosine kinase inhibitor that has received regulatory approval based on previous trials demonstrating improved progression-free and overall survival in this patient population, including those with brain metastases. Patients will receive tucatinib in combination with trastuzumab and capecitabine according to their treating clinician's usual practice without additional treatment procedures imposed by the study. The study is observational and non-interventional, enrolling about 300 women who meet the treatment criteria. Data collection includes baseline characteristics, safety monitoring, and performance status evaluations during the period of tucatinib-based treatment. The study continues with a follow-up period lasting 18 months after treatment ends to monitor responses, survival, and any subsequent therapies. During participation, patients will undergo assessments including symptomatic response and best response evaluations by their clinicians following local practice. Safety and treatment effectiveness will be monitored throughout treatment and during the extended follow-up. Radiological and clinical data will be collected, and prior or subsequent treatments will be recorded to help understand the real-world impact of this therapy. The total observation time spans the treatment duration plus 18 months of follow-up to ensure comprehensive safety and efficacy evaluation.