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
Recruiting now
Conditions studied: Breast Cancer, Her 2 Positive Breast Cancer
In brief
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.
Key facts
- Study ID
- NCT07542496
- Run by
- Société Algérienne de Formation et Recherche en Oncologie
- People needed
- 1000
- Starts
- 2026-01-15
- Expected to finish
- 2027-01-15
- Last updated by the study team
- 2026-04-21
Who can join
Age: 19 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- CAC BLIDA, Algiers, Algeria 16000 — Algiers, Algeria (enrolling)
- CHU Béni Messous, Algiers, Algeria 16000 — Algiers, Algeria (enrolling)
Full record on ClinicalTrials.gov
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