drugset / Trial / NCT03433313

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

NCT03433313

Phase 3 Completed 807 enrolled EirGenix, Inc.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2018-10-16
Primary completion
2022-01-20
Completion
2022-01-20

Drugs

EvaluationDrugModalityDoseRoute
Subject EG12014 Unknown 6 mg/kg
Comparator Trastuzumab Monoclonal antibody 6 mg/kg

Indications