The goal of this observational study is to describe the real-world utilization patterns of a pertuzumab biosimilar and to evaluate its clinical outcomes in patients with breast cancer in both neoadjuvant and metastatic settings. It also aims to assess pathological complete response (pCR), disease-free survival (DFS) in the neoadjuvant cohort, progression-free survival (PFS) in the metastatic cohort, overall survival (OS), treatment response, and safety and tolerability (adverse events according to CTCAE) across both cohorts.
Age ≥ 19 years at the time of inclusion;
Histologically confirmed diagnosis of HER2-positive invasive breast cancer (IHC 3+ score or HER2 amplification by FISH/CISH/SISH);
Decision to initiate treatment with a pertuzumab biosimilar in the neoadjuvant setting (neoadjuvant cohort) or as first-line therapy in the metastatic setting (metastatic cohort), in accordance with local indications;
Treatment prescribed as part of routine clinical care (outside of a clinical trial);
Treatment with pertuzumab in a therapeutic setting other than neoadjuvant or first-line metastatic (e.g., adjuvant, late recurrence beyond first-line, maintenance therapy alone, etc.);
Treatment administered as part of an interventional clinical trial;
History of severe allergy or known contraindication to pertuzumab;
Medical records unavailable or inability to ensure at least 6 months of minimal follow-up.
Société Algérienne de Formation et Recherche en Oncologie
Lead sponsor
ES Clinical Research
Collaborator
AlgenPharm
Collaborator