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.

A Phase 3, Randomized, Multicenter, Parallel-arm, Double-blind Study to Compare Efficacy and Safety of EG1206A (EirGenix' Pertuzumab) and Perjeta® (Pertuzumab) Sourced From EU as Neoadjuvant Treatment in Combination With Trastuzumab and Chemotherapy in Patients With HER2-positive Hormone Receptor-negative Early Breast Cancer

• Status: Withdrawn
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: EirGenix, Inc. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Early Breast Cancer

Interventions

Type	Name	Description
DRUG	EG1206A	EG1206A 420mg is ongoing to be administered after 840mg loading dose.
DRUG	Perjeta	Perjeta 420mg is ongoing to be administered after 840mg loading dose.

Timeline

• Start date: 2025-05-01
• Primary completion: 2026-11-01
• Completion: 2027-12-01
• First posted: 2025-03-19
• Last updated: 2025-10-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study