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

NCT07542496 | Recruiting

• 1 other identifier: SAFRO 0304
• Study Type: observational
• Target: 1,000
• Locations: 1 country
• Sites: 2

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.

Conditions

Breast Cancer; Her 2 Positive Breast Cancer

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

Outcome Measures

Primary Outcomes (5)

• 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 Outcomes (7)

• Pathological Complete Response (pCR) Rate (Neoadjuvant Cohort)

  Up to 12 months

• Disease-Free Survival (DFS) (Neoadjuvant Cohort)

  Up to 24 months

• Progression-Free Survival Rate at 24 Months (PFSR) (Metastatic Cohort)

  24 months

• Progression-Free Survival (PFS) (Metastatic Cohort)

  Up to 24 months

• Treatment Response (Both Cohorts)

  Up to 24 months

Other Outcomes (1)

• Correlation Between Clinical and Biological Factors and Treatment Response

  Up to 24 months

Study Arms (2)

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.

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Société Algérienne de Formation et Recherche en Oncologie: lead
• ES Clinical Research: collaborator
• AlgenPharm: collaborator

Study Sites (2)

CAC BLIDA, Algiers, Algeria 16000

Algiers, Algeria

RECRUITING

CHU Béni Messous, Algiers, Algeria 16000

Algiers, Algeria

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms; Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 2, 2026
• First Posted: April 21, 2026
• Study Start: January 15, 2026
• Primary Completion (Estimated): January 15, 2027
• Study Completion (Estimated): January 15, 2027
• Last Updated: April 21, 2026

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

AL (2)