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
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
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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