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NCT03433313 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
A Phase 3 study of Breast Cancer, sponsored by EirGenix.
- Completed
- Registry status
- Phase 3
- Development phase
- 807
- Enrollment target
- 20
- Study locations
NCT03433313: Completed Phase 3 study of Breast Cancer, sponsored by EirGenix.
NCT03433313 is a Phase 3 study of Breast Cancer that has completed, run by EirGenix. The registered enrollment target is 807 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (71% lower). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03433313, a Phase 3 study of Breast Cancer, has completed, sponsored by EirGenix.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 807 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
pCR is defined as the absence of residual invasive cancer on hematoxylin and eosin evaluation of the complete resected breast specimen and all sampled sentinel and/or axillary lymph nodes
Conditions Studied
Interventions
- DRUG EG12014
- DRUG Herceptin
Study Locations (20)
Other
- Brest Regional Oncology Center - Brest
- Gomel Regional Clinical Oncology Center - Homyel
- N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center - Lesnoy
- Minsk City Clinical Oncology Center - Minsk
- Mogilev Regional Oncology Center - Mogilev
- Vitebsk Regional Clinical Oncology Center - Vitebsk
- Medical Research Limited Society - Temuco
- Oncocentro Apys - Viña del Mar
- Clinic Life Foundation - Medellín
- Rodrigo Botero SAS - Medellín
- LTD High-Tech Hospital MedCenter - Batumi
- JSC "Evex Hospitals - Kutaisi
- LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine - Tbilisi
- LTD Aversi Clinic - Tbilisi
- LTD Cancer Research Centre - Tbilisi
- LTD Health House - Tbilisi
- LTD Institute of Clinical Oncology - Tbilisi
- LTD S.Khechinashvili University Hospital - Tbilisi
Michigan
- Detroit Clinical Research Center - Farmington Hills
Ohio
- Aultman Hospital, Cancer Center - Canton
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 807 participants |
| Start Date | 2018-10-16 |
| Est. Completion | 2022-01-20 |
| Phase | Phase 3 |
What the finished NCT03433313 record still lists
NCT03433313 is an interventional study that assigns participants to a tested intervention. The registered 807 participants enrollment target is mid-sized for trials with a published cap, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (71% lower).
The record links to 1 condition, with Breast Cancer appearing as the primary indexed condition, and to 2 interventions - of which EG12014 is the first listed.
NCT03433313 names 20 study sites across 3 states, led by Other, Michigan, Ohio.
Frequently Asked Questions
What is clinical trial NCT03433313 about?
NCT03433313 is a clinical study titled "Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer". 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.
What is the current status of trial NCT03433313?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 807 participants. The study started on 2018-10-16. Estimated completion is 2022-01-20.
What conditions does trial NCT03433313 study?
This clinical trial studies the following conditions: Breast Cancer.
What interventions are being tested in trial NCT03433313?
The interventions under investigation include: EG12014 (DRUG), Herceptin (DRUG).
Who is sponsoring clinical trial NCT03433313?
This trial is sponsored by EirGenix, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03433313 being conducted?
This trial has 20 study locations across Michigan, Ohio. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03433313's enrollment target sits among peer trials
807 143rd of 1224 higher than 1,082 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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