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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NCT06884254 · Status: WITHDRAWN · Phase: PHASE3 · Type: INTERVENTIONAL

Last updated 2025-10-14

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • EirGenix, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-31
Primary Completion
2026-11-30
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs

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 NCT06884254 on ClinicalTrials.gov