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 (PERTUREAL)

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Her 2 Positive Breast Cancer

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.

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

Study Locations

• Algeria
  • Algiers, Algeria
    • Recruiting
    • CAC BLIDA, Algiers, Algeria 16000
    • Contact: BOUNEDJAR Adda, Professor; Phone Number: +213 25 20 90 72; Email: contact@esclinicalresearch.com
  • Algiers, Algeria
    • Recruiting
    • CHU Béni Messous, Algiers, Algeria 16000
    • Contact: Oukkal Mohammed, Professor; Phone Number: +213 219 311 90; Email: contact@esclinicalresearch.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult women with HER2-positive breast cancer receiving a pertuzumab biosimilar in the neoadjuvant setting or as first-line treatment in the metastatic setting.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Cohort 1; Patients treated with a pertuzumab biosimilar in the neoadjuvant setting for HER2-positive breast cancer.
Cohort 2; Patients treated with a pertuzumab biosimilar as first-line therapy in the metastatic setting for HER2-positive metastatic breast cancer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Treatment Regimen Utilization	Percentage (%) of patients receiving each pertuzumab biosimilar-containing treatment regimen.	Up to 36 months
Line of Therapy	Percentage (%) of patients receiving pertuzumab biosimilar as neoadjuvant therapy or first-line treatment in metastatic setting.	Up to 36 months
Treatment Duration	Median duration of treatment (in months) with pertuzumab biosimilar.	Up to 36 months
Prescribing Context	Percentage (%) of prescriptions initiated in neoadjuvant versus metastatic setting.	Up to 36 months
Methods of Response Assessment	Percentage (%) of patients assessed using clinical, radiological, and/or pathological methods.	Up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)	Proportion of patients achieving pathological complete response (pCR) based on local histopathological assessment.	Up to 12 months
Disease-Free Survival (DFS) (Neoadjuvant Cohort)	Time from surgery to disease recurrence or death from any cause.	Up to 24 months
Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)	Proportion of patients alive without disease progression at 24 months.	24 months
Progression-Free Survival (PFS) (Metastatic Cohort)	Time from treatment initiation to disease progression or death from any cause.	Up to 24 months
Treatment Response (Both Cohorts)	Clinical, radiological, and/or pathological response assessed according to routine clinical practice.	Up to 24 months
Overall Survival (OS) (Both Cohorts)	Time from treatment initiation to death from any cause.	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).	Up to 24 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Up to 24 months

Collaborators and Investigators

• Sponsor: Société Algérienne de Formation et Recherche en Oncologie
• Collaborators: ES Clinical Research; AlgenPharm

Study record dates

Study Major Dates

• Study Start (Actual): January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027

Study Registration Dates

• First Submitted: April 2, 2026
• First Submitted That Met QC Criteria: April 14, 2026
• First Posted (Actual): April 21, 2026

Study Record Updates

• Last Update Posted (Actual): April 21, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: Breast Cancer; Cancer; Observational Study; Neoadjuvant Therapy; Pertuzumab; Cohort Study; Biosimilar; Real-world data; Non-Interventional Study; HER2-Positive Breast Cancer; Algeria; Algerian Study; HER2-Targeted Therapy; Breast cancer in Algerian patients; Anti-HER2 Therapy
• Additional Relevant MeSH Terms: Neoplasms by Site; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Neoplasms; Breast Neoplasms
• Other Study ID Numbers: SAFRO 0304

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No