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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

Recruitingn/aAges 19 Years - anyFemaleSociété Algérienne de Formation et Recherche en O…
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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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What it tests

  • Not listed
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Where

2 sites
CAC BLIDA, Algiers, Algeria 16000
Algiers, Algeria
CHU Béni Messous, Algiers, Algeria 16000
Algiers, Algeria
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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