Using a pertuzumab biosimilar for HER2-positive breast cancer before surgery and as first-line treatment for metastatic disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, multicenter, non-interventional bicohort study enrolling about 1,000 patients in Algeria, with roughly 500 in a neoadjuvant cohort and 500 in a first-line metastatic cohort. Patients are treated with a pertuzumab biosimilar as part of routine clinical care and followed to record treatment patterns, clinical outcomes, and safety. Key outcomes include pathological complete response (pCR) and disease-free survival (DFS) in the neoadjuvant cohort, progression-free survival (PFS) in the metastatic cohort, overall survival (OS), treatment response, and adverse events graded by CTCAE. Data will be collected from participating centers to describe real-world effectiveness and tolerability of the biosimilar.

Why it matters

Who can join: the full rules

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's running

• CAC BLIDA, Algiers, Algeria 16000
  Algiers, Algeria Recruiting
• CHU Béni Messous, Algiers, Algeria 16000
  Algiers, Algeria Recruiting

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.