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 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 1000

Last updated 2026-04-21

No results posted yet for this study

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

Sponsors & Collaborators

  • ES Clinical Research

    collaborator UNKNOWN
  • AlgenPharm

    collaborator UNKNOWN
  • Société Algérienne de Formation et Recherche en Oncologie

    lead OTHER

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-15
Primary Completion
2027-01-15
Completion
2027-01-15

Countries

  • Algeria

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07542496 on ClinicalTrials.gov