drugset / Trial / NCT06884254

Efficacy and Safety Study of EG1206A (EirGenix' Pertuzumab) Compared With EU-sourced Perjeta® (Pertuzumab) in Patients With HER2-positive Hormone Receptor Negative Early Breast Cancer.

NCT06884254

Phase 3 Withdrawn EirGenix, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The purpose of this research study is to compare the efficacy and safety of EG1206A with Perjeta in combination with trastuzumab and chemotherapy as neoadjuvant treatment for 18 weeks, followed by surgery and subsequent EG1206A or Perjeta in combination with trastuzumab, as adjuvant treatment for 36 weeks.

Timeline

Start
2025-05
Primary completion
2026-11
Completion
2027-12

Drugs

EvaluationDrugModalityDoseRoute
Subject EG1206A Unknown 420 mg
Comparator Pertuzumab Monoclonal antibody 420 mg

Indications