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
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Breast Cancer, Her 2 Positive Breast Cancer. Basic parameters: from 19 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Algeria
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Detailed description
This is a non-interventional, prospective, multicenter, bicohort observational study conducted in a real-world setting. It aims to describe the clinical and therapeutic characteristics of patients treated with a pertuzumab biosimilar and to evaluate outcomes in both neoadjuvant and metastatic settings. Approximately 1,000 patients will be included, with 500 patients per cohort. Cohort 1 includes patients receiving a pertuzumab biosimilar in the neoadjuvant treatment of HER2-positive breast cancer, while Cohort 2 includes patients treated in the first-line metastatic setting for HER2-positive metastatic breast cancer.
Primary outcome measures
- Treatment Regimen Utilization [Time frame: Up to 36 months]
- Line of Therapy [Time frame: Up to 36 months]
- Treatment Duration [Time frame: Up to 36 months]
- Prescribing Context [Time frame: Up to 36 months]
- Methods of Response Assessment [Time frame: Up to 36 months]
Secondary outcome measures (7)
- Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort) [Time frame: Up to 12 months]
- Disease-Free Survival (DFS) (Neoadjuvant Cohort) [Time frame: Up to 24 months]
- Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort) [Time frame: 24 months]
- Progression-Free Survival (PFS) (Metastatic Cohort) [Time frame: Up to 24 months]
- Treatment Response (Both Cohorts) [Time frame: Up to 24 months]
- Overall Survival (OS) (Both Cohorts) [Time frame: Up to 24 months]
- Incidence and Severity of Adverse Events [Time frame: Up to 24 months]
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Algeria · 2 centers
- CAC BLIDA, Algiers, Algeria 16000 — Algiers
- CHU Béni Messous, Algiers, Algeria 16000 — Algiers
Identifiers
NCT: NCT07542496 · SAFRO 0304