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

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.

NCT Number	NCT07542496
Lead Sponsor	Société Algérienne de Formation et Recherche en Oncologie Collaborators: ES Clinical Research, AlgenPharm
Conditions	Breast Cancer, Her 2 Positive Breast Cancer
Enrollment	1,000 participants
Start Date	2026-01-15
Primary Completion	2027-01-15 (estimated)
Study Completion	2027-01-15 (estimated)
Updated on ClinicalTrials.gov	2026-04-21