Breast Cancer, Her 2 Positive Breast Cancer
Conditions
Keywords
Algerian Study, Real-world data, Algeria, Biosimilar, Pertuzumab, Breast Cancer, Cancer, Breast cancer in Algerian patients, HER2-Positive Breast Cancer, Neoadjuvant Therapy, Anti-HER2 Therapy, Cohort Study, Non-Interventional Study, HER2-Targeted Therapy, Observational Study
Brief summary
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.
Interventions
None listed
Sponsors
Société Algérienne de Formation et Recherche en Oncologie
ES Clinical Research
AlgenPharm
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Treatment Regimen Utilization | Up to 36 months | Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen. |
| Line of Therapy | Up to 36 months | Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting. |
| Treatment Duration | Up to 36 months | Median duration of treatment (in months) with pertuzumab biosimilar. |
| Prescribing Context | Up to 36 months | Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting. |
| Methods of Response Assessment | Up to 36 months | Percentage (%) of patients assessed using clinical, radiological, and/or pathological methods. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort) | Up to 12 months | Proportion of patients achieving pathological complete response (pCR) based on local histopathological assessment. |
| Disease-Free Survival (DFS) (Neoadjuvant Cohort) | Up to 24 months | Time from surgery to disease recurrence or death from any cause. |
| Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort) | 24 months | Proportion of patients alive without disease progression at 24 months. |
| Progression-Free Survival (PFS) (Metastatic Cohort) | Up to 24 months | Time from treatment initiation to disease progression or death from any cause. |
| Treatment Response (Both Cohorts) | Up to 24 months | Clinical, radiological, and/or pathological response assessed according to routine clinical practice. |
| Overall Survival (OS) (Both Cohorts) | Up to 24 months | Time from treatment initiation to death from any cause. |
| Incidence and Severity of Adverse Events | Up to 24 months | Incidence (%) and severity of adverse events (AEs), graded according to Common Terminology Criteria for Adverse Events (CTCAE). |
Countries
Algeria
Outcome results
None listed