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

ClinicalTrials.gov ID: NCT03433313

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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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID: NCT03433313
Recruitment status: Completed
Study type: Interventional
Phase: Phase 3
Lead sponsor: EirGenix, Inc.; Industry
Enrollment: 807 participants

Conditions and interventions

Conditions

Breast Cancer

Interventions

EG12014 Drug
Herceptin Drug

Drug

Eligibility (public fields only)

Age range: 18 Years to 65 Years
Sex: Female
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 16, 2018 (Actual)
Primary completion: Jan 20, 2022 (Actual)
Completion: Jan 20, 2022 (Actual)
Last update posted: Jan 20, 2023

2018 – 2022

United States locations

U.S. sites: 2
U.S. states: 2
U.S. cities: 2

Facility	City	State	ZIP	Site status
Detroit Clinical Research Center	Farmington Hills	Michigan	48334	—
Aultman Hospital, Cancer Center	Canton	Ohio	44718	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 89 non-U.S. sites.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT03433313, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Jan 20, 2023 · Synced Nov 15, 2026