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

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

This project will look at how a pertuzumab biosimilar is used and how patients with HER2-positive breast cancer do when given it before surgery or as first-line treatment for metastatic disease.

Quick facts

• Study type: Observational
• Enrollment: 1000 (estimated)
• Ages: 19 Years and up
• Sex: Female
• Sponsor: Société Algérienne de Formation et Recherche en Oncologie (Academic / other)
• Drugs / interventions: pertuzumab
• Locations: 2 sites (Algiers and 1 other locations)
• Trial ID: NCT07542496 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 19 or older with histologically confirmed HER2-positive invasive breast cancer who are prescribed a pertuzumab biosimilar either as neoadjuvant therapy or as first-line treatment for metastatic disease and who can provide informed consent are ideal candidates.

Not a fit: Patients treated with pertuzumab outside the neoadjuvant or first-line metastatic settings, those enrolled in interventional trials, or those with known contraindications or severe allergy to pertuzumab are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, the results could support wider use of the pertuzumab biosimilar in routine care and help confirm its real-world effectiveness and safety for HER2-positive patients in Algeria.

How similar studies have performed: Randomized trials of the reference pertuzumab product have shown benefit in neoadjuvant and first-line metastatic HER2-positive disease, while biosimilar use is supported by regulatory extrapolation and growing but more limited real-world data.

Eligibility criteria

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 this trial is running

Algiers and 1 other locations

• CAC BLIDA, Algiers, Algeria 16000 — Algiers, Algeria (Recruiting)
• CHU Béni Messous, Algiers, Algeria 16000 — Algiers, Algeria (Recruiting)

Conditions Breast Cancer; Her 2 Positive Breast Cancer; Algerian Study; Real-world data; Algeria; Biosimilar; Pertuzumab; Cancer