An observational study in Breast Cancer and Her 2 Positive Breast Cancer, sponsored by Société Algérienne de Formation et Recherche en Oncologie. Recruiting at 2 sites in Algeria. Open to female participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2026-04-21.
Sponsored by Société Algérienne de Formation et Recherche en Oncologie · Observational
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.
Adult women with HER2-positive breast cancer receiving a pertuzumab biosimilar in the neoadjuvant setting or as first-line treatment in the metastatic setting.
Exclusion Criteria:
Patients treated with a pertuzumab biosimilar in the neoadjuvant setting for HER2-positive breast cancer.
Patients treated with a pertuzumab biosimilar as first-line therapy in the metastatic setting for HER2-positive metastatic breast cancer.
Treatment 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
Correlation Between Clinical and Biological Factors and Treatment Response
Assessment of correlation between treatment response (based on clinical, radiological, or pathological evaluation) and clinical and biological factors including age, tumor grade, hormonal receptor status, Ki-67, menopausal status, comorbidities, and treatment characteristics, using regression analysis. Results will be reported as odds ratios (OR) with 95% confidence intervals (CI).
Time frame: Up to 24 months
Plan to share: No
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Société Algérienne de Formation et Recherche en Oncologie