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.

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

Outcome

Outcome not reported

Stopped: “Following SA from both the US FDA and the EMA, EirGenix, Inc. has decided to streamline the clinical-development program for EG1206A (biosimilar to Perjeta). EirGenix has concluded that the continuation of the study in no longer necessary.”

Drugs

Indications