Actively Recruiting
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
Led by Société Algérienne de Formation et Recherche en Oncologie · Updated on 2026-04-21
1000
Participants Needed
2
Research Sites
52 weeks
Total Duration
On this page
Sponsors
S
Société Algérienne de Formation et Recherche en Oncologie
Lead Sponsor
E
ES Clinical Research
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
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
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 19 years or older at the time of inclusion
- Histologically confirmed HER2-positive invasive breast cancer (IHC 3+ or HER2 amplification by FISH/CISH/SISH)
- Decision to start pertuzumab biosimilar treatment in neoadjuvant or first-line metastatic setting
- Treatment given as part of routine clinical care, not a clinical trial
- Patient has provided written informed consent
You will not qualify if you...
- Receiving pertuzumab in other settings than neoadjuvant or first-line metastatic (e.g., adjuvant, late recurrence, maintenance therapy alone)
- Treatment is part of an interventional clinical trial
- History of severe allergy or known contraindication to pertuzumab
- Medical records unavailable or unable to ensure at least 6 months of follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 2 locations
1
CAC BLIDA, Algiers, Algeria 16000
Algiers, Algeria
Actively Recruiting
2
CHU Béni Messous, Algiers, Algeria 16000
Algiers, Algeria
Actively Recruiting
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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