Trials / Completed
CompletedNCT03433313
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
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
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 807 (actual)
- Sponsor
- EirGenix, Inc. · Industry
- Sex
- Female
- Age
- 18 Years – 65 Years
- Healthy volunteers
- Not accepted
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
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2018-10-16
- Primary completion
- 2022-01-20
- Completion
- 2022-01-20
- First posted
- 2018-02-14
- Last updated
- 2023-01-20
Locations
91 sites across 11 countries: United States, Belarus, Chile, Colombia, Georgia, India, Russia, South Africa, South Korea, Taiwan, Ukraine
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03433313. Inclusion in this directory is not an endorsement.