OncRef

Clinical Trial: NCT03433313

Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:EirGenix, Inc.
Information Provided By:EirGenix, Inc.
Last Update Posted:2023-01-20

Study Overview

Brief Summary

The purpose of this research study is to compare the efficacy and safety of EG12014 with Herceptin as neoadjuvant treatment for 12 weeks, followed by surgery and subsequent EG12014 or Herceptin adjuvant treatment for up to 12 months.

Official Title

A Phase III, Randomized, Multicenter, Double-blind Study to Compare Efficacy and Safety of EG12014 With Herceptin as Neoadjuvant Treatment in Combination With Anthracycline/Paclitaxel Systemic Therapy in HER2-Positive Early Breast Cancer

Conditions

Breast Cancer

Intervention / Treatment

  • Drug: EG12014
  • Drug: Herceptin

Other Study ID Numbers

  • EGC002
  • 2017-003973-33
  • 2017

Start Date (Actual)

2018-10-16

Primary Completion Date (Actual)

2022-01-20

Study Completion Date (Actual)

2022-01-20

Enrollment (Actual)

807

Study Type

Interventional

Phase

Phase 3