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.
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.
Study Type
OBSERVATIONAL
Enrollment
1,000
CAC BLIDA, Algiers, Algeria 16000
Algiers, Algeria
RECRUITINGCHU Béni Messous, Algiers, Algeria 16000
Algiers, Algeria
RECRUITINGTreatment Regimen Utilization
Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen.
Time frame: Up to 36 months
Line of Therapy
Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting.
Time frame: Up to 36 months
Treatment Duration
Median duration of treatment (in months) with pertuzumab biosimilar.
Time frame: Up to 36 months
Prescribing Context
Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting.
Time frame: Up to 36 months
Methods of Response Assessment
Percentage (%) of patients assessed using clinical, radiological, and/or pathological methods.
Time frame: Up to 36 months
Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)
Proportion of patients achieving pathological complete response (pCR) based on local histopathological assessment.
Time frame: Up to 12 months
Disease-Free Survival (DFS) (Neoadjuvant Cohort)
Time from surgery to disease recurrence or death from any cause.
Time frame: Up to 24 months
Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)
Proportion of patients alive without disease progression at 24 months.
Time frame: 24 months
Progression-Free Survival (PFS) (Metastatic Cohort)
Time from treatment initiation to disease progression or death from any cause.
Time frame: Up to 24 months
Treatment Response (Both Cohorts)
Clinical, radiological, and/or pathological response assessed according to routine clinical practice.
Time frame: Up to 24 months
Overall Survival (OS) (Both Cohorts)
Time from treatment initiation to death from any cause.
Time frame: Up to 24 months
Incidence and Severity of Adverse Events
Incidence (%) and severity of adverse events (AEs), graded according to Common Terminology Criteria for Adverse Events (CTCAE).
Time frame: Up to 24 months
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