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Monoclonal Antibodies

EG12014 for Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by EirGenix, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from time of informed consent to end of study (up to approximately 25 months or death)
Awards & highlights

Study Summary

This trial is comparing the effectiveness of two different drugs to see which is better at treating breast cancer.

Eligible Conditions
  • Breast Cancer

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from time of informed consent to end of study (up to approximately 25 months or death)
This trial's timeline: 3 weeks for screening, Varies for treatment, and from time of informed consent to end of study (up to approximately 25 months or death) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Determination of pathologic complete response (pCR) at time of surgery
Secondary outcome measures
Evaluation of Immunogenicity of EG12014 and Herceptin
Event-free survival (EFS) up to end of study (EOS)
Incidence of AEs
+4 more

Side effects data

From 2014 Phase 4 trial • 32 Patients • NCT01301729
59%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: EG12014Experimental Treatment1 Intervention
Epirubicin and cyclophosphamide followed by EG12014 plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
Group II: HerceptinActive Control1 Intervention
Epirubicin and cyclophosphamide followed by Herceptin plus paclitaxel. All patients will be scheduled for surgery (breast and axillary lymph nodes) at 3 to 6 weeks after completion of neoadjuvant chemotherapy.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
EG12014
2016
Completed Phase 3
~900

Find a Location

Who is running the clinical trial?

EirGenix, Inc.Lead Sponsor
2 Previous Clinical Trials
219 Total Patients Enrolled
1 Trials studying Breast Cancer
135 Patients Enrolled for Breast Cancer

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
2018. "Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03433313.
~124 spots leftby Apr 2025
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