MedTrace Logo

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

NCT03433313 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 807

Last updated 2023-01-20

No results posted yet for this study

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.

Conditions

Interventions

DRUG

EG12014

EG12014 6mg/kg is ongoing to be administered after 8mg/kg loading dose.

DRUG

Herceptin

Herceptin 6mg/kg is ongoing to be administered after 8mg/kg 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
65 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-10-16
Primary Completion
2022-01-20
Completion
2022-01-20
FDA Drug
Yes

Countries

  • United States
  • Belarus
  • Chile
  • Colombia
  • Georgia
  • India
  • Russia
  • South Africa
  • South Korea
  • Taiwan
  • Ukraine

Study Locations

More Related Trials

Entities

Drugs
Diseases

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 NCT03433313 on ClinicalTrials.gov