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
Société Algérienne de Formation et Recherche en Oncologie
1,000 participants
Jan 15, 2026
OBSERVATIONAL
Conditions
Summary
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.
Eligibility
Inclusion Criteria5
- 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);
- Patient informed and having provided written informed consent.
Exclusion Criteria4
- 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.
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Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07542496