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.
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);
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.
Adult women with HER2-positive breast cancer receiving a pertuzumab biosimilar in the neoadjuvant setting or as first-line treatment in the metastatic setting.
Cohort
Other
Not listed
Treatment Regimen Utilization
Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen.
Line of Therapy
Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting.
Treatment Duration
Median duration of treatment (in months) with pertuzumab biosimilar.
Prescribing Context
Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting.
Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)
Proportion of patients achieving pathological complete response (pCR) based on local histopathological assessment.
Disease-Free Survival (DFS) (Neoadjuvant Cohort)
Time from surgery to disease recurrence or death from any cause.
Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)
Proportion of patients alive without disease progression at 24 months.
Progression-Free Survival (PFS) (Metastatic Cohort)
Time from treatment initiation to disease progression or death from any cause.
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).
Click on the lead sponsor to view all of their trials.
Société Algérienne de Formation et Recherche en Oncologie
Lead sponsor
ES Clinical Research
Collaborator
AlgenPharm
Collaborator