Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
NCT ID: NCT03433313
Last Updated: 2023-01-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
807 participants
INTERVENTIONAL
2018-10-16
2022-01-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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EG12014
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.
EG12014
EG12014 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
Herceptin
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.
Herceptin
Herceptin 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
Interventions
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EG12014
EG12014 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
Herceptin
Herceptin 6mg/kg is ongoing to be administered after 8mg/kg loading dose.
Eligibility Criteria
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Exclusion Criteria
2. Pregnancy or lactation or considering becoming pregnant.
3. Metastases, other than sentinel/axillary lymph nodes.
4. Previous treatment (chemotherapy, biologic therapy, radiation, or surgery) for invasive malignant disease or other concomitant malignancy, other than basal cell carcinoma of the skin. Previous treatment for carcinoma in situ of the cervix is allowed.
5. Previous treatment with Herceptin.
6. Angina pectoris or arrhythmia requiring medication; poorly controlled hypertension; history of myocardial infarction or cardiac failure, New York Heart Association (NYHA) class II or higher; clinically significant cardiac valvular disease; hemodynamic effective pericardial effusion; other cardiomyopathies; LVEF of \<55%.
7. Any investigational treatment less than 30 days prior to study entry, or within a time interval less than at least 5 half-lives of the investigational medicinal product, whichever is longer.
8. Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
9. History of hypersensitivity to drugs with similar chemical structures to trastuzumab.
10. History of, or known current problems with, drug or alcohol abuse.
11. Other serious illness, medical disorder or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.
18 Years
65 Years
FEMALE
No
Sponsors
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EirGenix, Inc.
INDUSTRY
Responsible Party
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Locations
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Detroit Clinical Research Center
Farmington Hills, Michigan, United States
Aultman Hospital, Cancer Center
Canton, Ohio, United States
Brest Regional Oncology Center
Brest, , Belarus
Gomel Regional Clinical Oncology Center
Homyel, , Belarus
N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center
Lesnoy, , Belarus
Minsk City Clinical Oncology Center
Minsk, , Belarus
Mogilev Regional Oncology Center
Mogilev, , Belarus
Vitebsk Regional Clinical Oncology Center
Vitebsk, , Belarus
Medical Research Limited Society
Temuco, , Chile
Oncocentro Apys
Viña del Mar, , Chile
Clinic Life Foundation
Medellín, , Colombia
Rodrigo Botero SAS
Medellín, , Colombia
LTD High-Tech Hospital MedCenter
Batumi, , Georgia
JSC "Evex Hospitals
Kutaisi, , Georgia
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine
Tbilisi, , Georgia
LTD Aversi Clinic
Tbilisi, , Georgia
LTD Cancer Research Centre
Tbilisi, , Georgia
LTD Health House
Tbilisi, , Georgia
LTD Institute of Clinical Oncology
Tbilisi, , Georgia
LTD S.Khechinashvili University Hospital
Tbilisi, , Georgia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
Tbilisi, , Georgia
Cytecare Cancer Hospitals
Bengaluru, , India
King George's Medical University, Department of Endocrine surgery, Shatabdi Phase II
Lucknow, , India
Tata Memorial Centre
Mumbai, , India
HCG NCHRI Cancer Centre
Nagpur, , India
Christian Medical College, Department of Medical Oncology
Vellore, , India
Arkhangelsk Clinical Oncology Center
Arkhangelsk, , Russia
Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center
Chelyabinsk, , Russia
Evimed, LLC
Chelyabinsk, , Russia
Ivanovo Regional Oncology Center
Ivanovo, , Russia
Republican Clinical Oncology Center
Kazan', , Russia
Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
Krasnoyarsk, , Russia
Kursk Regional Clinical Oncology Center
Kursk, , Russia
N.N. Blokhin National Medical Oncology Research Center
Moscow, , Russia
National Medical Research Center for Radiology
Moscow, , Russia
Vitamed" LLC
Moscow, , Russia
A.F.Tsyb Medical Radiology Research Center
Obninsk, , Russia
Clinical Oncology Center
Omsk, , Russia
Pyatigorsk Interdistrict Oncology Center
Pyatigorsk, , Russia
Rostov Oncology Research Institute
Rostov-on-Don, , Russia
Regional Clinical Oncology Center
Ryazan, , Russia
AV Medical Group
Saint Petersburg, , Russia
City Clinical Oncology Center
Saint Petersburg, , Russia
Clinic "Mart"
Saint Petersburg, , Russia
I.I. Mechnikov North-Western State Medical University
Saint Petersburg, , Russia
Leningrad Regional Oncology Center (Outpatient Department)
Saint Petersburg, , Russia
Leningrad Regional Oncology Center (Surgery Department)
Saint Petersburg, , Russia
N.N. Petrov National Medical Research Center of Oncology
Saint Petersburg, , Russia
Oncology Center of Moskovskiy District
Saint Petersburg, , Russia
Private Medical Institution "EVROMEDSERVIS", Department of Oncology
Saint Petersburg, , Russia
St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care (Oncology)
Saint Petersburg, , Russia
Republican Oncology Center
Saransk, , Russia
Oncology Center #2
Sochi, , Russia
Tomsk National Research Medical Center
Tomsk, , Russia
Regional Clinical Oncology Center
Veliky Novgorod, , Russia
Volgograd Regional Clinical Oncology Center
Volgograd, , Russia
GVI Oncology, Cape Gate Oncology Centre
Cape Town, , South Africa
The Oncology Centre
Durban, , South Africa
Medical Oncology Centre of Rosebank
Johannesburg, , South Africa
Little Company of Mary Medical Center, Department of Oncology
Pretoria, , South Africa
University of Pretoria, Department of Medical Oncology
Pretoria, , South Africa
Keimyung University - Dongsan Medical Center
Daegu, , South Korea
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung City, , Taiwan
China Medical University Hospital
Taichung, , Taiwan
National Taiwan University Hospital
Taipei, , Taiwan
Taipei Veterans General Hospital
Taipei, , Taiwan
Tri-Service General Hospital
Taipei, , Taiwan
Linkou Chang Gung Memorial Hospital
Taoyuan District, , Taiwan
Chernihiv Regional Oncology Center
Chernihiv, , Ukraine
Chernivtsi Regional Clinical Oncology Center
Chernivtsi, , Ukraine
Clinical Oncology Center
Dnipro, , Ukraine
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy
Dnipro, , Ukraine
Prikarpattia Clinical Oncology Center
Ivano-Frankivsk, , Ukraine
Communal Non-profit enterprise "Regional Center of Oncology"
Kharkiv, , Ukraine
State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences, Department of Clinical Oncology and Hematology
Kharkiv, , Ukraine
Khmelnytskyi Regional Oncology Center
Khmelnytskyi, , Ukraine
Kryvyi Rih Oncology Center, Department of Chemotherapy
Kryvyi Rih, , Ukraine
Kyiv City clinical Hospital #2
Kyiv, , Ukraine
Kyiv Regional Oncology Center, Department of Mastology
Kyiv, , Ukraine
Medical Center "Verum"
Kyiv, , Ukraine
Medical Center of First Private Clinic
Kyiv, , Ukraine
Volyn Regional Oncology Center, Department of Chemotherapy
Lutsk, , Ukraine
Public Institution under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy
Lviv, , Ukraine
Mariupol Oncology Center
Mariupol, , Ukraine
Odesa Regional Clinical Hospital, Center for Mastology, Department of Thoracic Surgery
Odesa, , Ukraine
Odesa Regional Oncology Center
Odesa, , Ukraine
Ternopil Regional Clinical Oncology Center, Department of Chemotherapy
Ternopil, , Ukraine
Central City Clinical Hospital, Department of Oncology and Radiology
Uzhhorod, , Ukraine
Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy
Uzhhorod, , Ukraine
Podillia Regional Oncology Center
Vinnytsia, , Ukraine
Zhytomyr Regional Oncology Center
Zhytomyr, , Ukraine
Countries
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Other Identifiers
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2017-003973-33
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
EGC002
Identifier Type: -
Identifier Source: org_study_id
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