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 · NCT07542496 · Observational (researchers observe without assigning treatment) · Lead sponsor: Société Algérienne de Formation et Recherche en Oncologie
View the official record on ClinicalTrials.gov →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.
Who can take part
Age range
19 Years and older
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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.
Where it is running
2 locations listed.
- CAC BLIDA, Algiers, Algeria 16000 - Algiers, Algeria
- CHU Béni Messous, Algiers, Algeria 16000 - Algiers, Algeria