Observational Study of a Pertuzumab Biosimilar for HER2-Positive Breast Cancer in Neoadjuvant and First-Line Metastatic Treatments

What this Trial Is About

Researchers are conducting an observational study to understand how a pertuzumab biosimilar is used and its clinical results in people with HER2-positive breast cancer. The study focuses on two groups patients receiving this treatment before surgery neoadjuvant setting and those receiving it as first-line therapy for metastatic breast cancer. The study aims to assess important outcomes including pathological complete response, disease-free survival, progression-free survival, overall survival, treatment response, and safety across both groups. This non-interventional study will include about 1,000 patients across multiple centers, with 500 patients in each group. Cohort 1 involves patients treated with the pertuzumab biosimilar before surgery for HER2-positive breast cancer, while Cohort 2 includes those treated in the first-line metastatic setting. All treatments are part of routine clinical care, not controlled by the study. No experimental interventions are assigned by the researchers. Participants will be followed for up to 36 months to observe treatment use, therapy lines, duration, and how response is assessed. Clinical outcomes such as pathological complete response in the neoadjuvant group, disease-free survival, progression-free survival, treatment response, overall survival, and adverse events will be monitored for up to 24 months. Data will be collected from medical records and routine care, with safety and tolerability evaluated according to standard criteria.

Real-world Bicohort Observational Study of a Pertuzumab Biosimilar in the Treatment of Breast Cancer: in the Neoadjuvant Setting and in First-line Metastatic Disease