Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
- Registration Number
- NCT03433313
- Lead Sponsor
- EirGenix, Inc.
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 807
Not provided
- Bilateral breast cancer.
- Pregnancy or lactation or considering becoming pregnant.
- Metastases, other than sentinel/axillary lymph nodes.
- 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.
- Previous treatment with Herceptin.
- 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%.
- 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.
- Positive diagnostic test for hepatitis B virus (HBV), hepatitis C virus (HCV), or human immunodeficiency virus (HIV).
- History of hypersensitivity to drugs with similar chemical structures to trastuzumab.
- History of, or known current problems with, drug or alcohol abuse.
- Other serious illness, medical disorder or condition that, in the opinion of the Investigator, would make the patient unsuitable for participation in the study.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Herceptin 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. EG12014 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.
- Primary Outcome Measures
Name Time Method Determination of pathologic complete response (pCR) at time of surgery At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy) 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
- Secondary Outcome Measures
Name Time Method Incidence of AEs From time of informed consent to end of study (up to approximately 25 months or death) Incidence of AEs (including severity, seriousness, and relationship to study drug) and laboratory abnormalities
Measure serum trastuzumab concentration Prior to 1st infusion of study drug, during neoadjuvant treatment after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment Measure serum trastuzumab concentration for EG12014 and Herceptin arms
pCR at the time of surgery At the time of surgery (3-6 weeks after completion of neoadjuvant chemotherapy) pCR is defined as the absence of invasive cancer in breast tissue only (ypT0/is) as assessed by central laboratory
Overall survival (OS) up to End of Study (EOS) Randomization to end of study (up to approximately 24 months or death) OS up to EOS is defined as time from the date of initial randomization to the date of death
Evaluation of Immunogenicity of EG12014 and Herceptin Prior to 1st infusion of study drug, during neoadjuvant treatment, after the last dose of neoadjuvant treatment, during adjuvant treatment, and End of Treatment Titer of anti-drug antibodies (ADA)
Event-free survival (EFS) up to end of study (EOS) Randomization to date of progression or end of study (up to approximately 24 months or death) EFS is defined as time from initial randomization to the date when disease recurrence or progression (local, regional, distant or contralateral) is diagnosed according to institutional standard, or date of death of any cause, whichever is earlier
Overall response (OR) prior to surgery At screening and prior to surgery (3-6 weeks after completion of neoadjuvant chemotherapy) Objective response is defined as partial response (PR) or complete response (CR) according to RECIST v1.1
Trial Locations
- Locations (89)
Clinic Life Foundation
🇨🇴Medellín, Colombia
LTD High-Tech Hospital MedCenter
🇬🇪Batumi, Georgia
LTD Institute of Clinical Oncology
🇬🇪Tbilisi, Georgia
Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center
🇷🇺Chelyabinsk, Russian Federation
Regional Clinical Oncology Center
🇷🇺Veliky Novgorod, Russian Federation
Communal Non-profit enterprise "Regional Center of Oncology"
🇺🇦Kharkiv, Ukraine
Volyn Regional Oncology Center, Department of Chemotherapy
🇺🇦Luts'k, Ukraine
Odesa Regional Oncology Center
🇺🇦Odesa, Ukraine
Taipei Veterans General Hospital
🇨🇳Taipei, Taiwan
Rodrigo Botero SAS
🇨🇴Medellín, Colombia
Malkhaz Katsiashvili Multiprofile Emergency Medicine Center
🇬🇪Tbilisi, Georgia
King George's Medical University, Department of Endocrine surgery, Shatabdi Phase II
🇮🇳Lucknow, India
Tata Memorial Centre
🇮🇳Mumbai, India
Ivanovo Regional Oncology Center
🇷🇺Ivanovo, Russian Federation
Republican Clinical Oncology Center
🇷🇺Kazan, Russian Federation
Krasnoyarsk A.I. Kryzhanovsky Regional Oncology Center
🇷🇺Krasnoyarsk, Russian Federation
Kursk Regional Clinical Oncology Center
🇷🇺Kursk, Russian Federation
JSC "Evex Hospitals
🇬🇪Kutaisi, Georgia
LTD Health House
🇬🇪Tbilisi, Georgia
LTD S.Khechinashvili University Hospital
🇬🇪Tbilisi, Georgia
Cytecare Cancer Hospitals
🇮🇳Bengaluru, India
Christian Medical College, Department of Medical Oncology
🇮🇳Vellore, India
Rostov Oncology Research Institute
🇷🇺Rostov-on-Don, Russian Federation
AV Medical Group
🇷🇺Saint Petersburg, Russian Federation
N.N. Blokhin National Medical Oncology Research Center
🇷🇺Moscow, Russian Federation
Evimed, LLC
🇷🇺Chelyabinsk, Russian Federation
Clinical Oncology Center
🇺🇦Dnipro, Ukraine
City Clinical Oncology Center
🇷🇺Saint Petersburg, Russian Federation
I.I. Mechnikov North-Western State Medical University
🇷🇺Saint Petersburg, Russian Federation
N.N. Petrov National Medical Research Center of Oncology
🇷🇺Saint Petersburg, Russian Federation
Oncology Center of Moskovskiy District
🇷🇺Saint Petersburg, Russian Federation
Kaohsiung Medical University Chung-Ho Memorial Hospital
🇨🇳Kaohsiung, Taiwan
LTD Acad. F. Todua Medical Center - LTD Research Institute of Clinical Medicine
🇬🇪Tbilisi, Georgia
A.F.Tsyb Medical Radiology Research Center
🇷🇺Obninsk, Russian Federation
Private Medical Institution "EVROMEDSERVIS", Department of Oncology
🇷🇺Saint Petersburg, Russian Federation
Ternopil Regional Clinical Oncology Center, Department of Chemotherapy
🇺🇦Ternopil', Ukraine
National Medical Research Center for Radiology
🇷🇺Moscow, Russian Federation
Vitamed" LLC
🇷🇺Moscow, Russian Federation
Clinic "Mart"
🇷🇺Saint Petersburg, Russian Federation
Volgograd Regional Clinical Oncology Center
🇷🇺Volgograd, Russian Federation
Public Institution under Lviv Regional Council: Lviv Regional Treatment and Diagnostics Oncology Center, Department of Chemotherapy
🇺🇦Lviv, Ukraine
Tri-Service General Hospital
🇨🇳Taipei, Taiwan
Leningrad Regional Oncology Center (Outpatient Department)
🇷🇺Saint Petersburg, Russian Federation
Prikarpattia Clinical Oncology Center
🇺🇦Ivano-Frankivsk, Ukraine
Minsk City Clinical Oncology Center
🇧🇾Minsk, Belarus
Vitebsk Regional Clinical Oncology Center
🇧🇾Vitebsk, Belarus
Keimyung University - Dongsan Medical Center
🇰🇷Daegu, Korea, Republic of
N.N. Aleksandrov Republican Research Oncology and Medical Radiology Center
🇧🇾Lesnoy, Belarus
Detroit Clinical Research Center
🇺🇸Farmington Hills, Michigan, United States
Medical Research Limited Society
🇨🇱Temuco, Chile
LTD Cancer Research Centre
🇬🇪Tbilisi, Georgia
Pyatigorsk Interdistrict Oncology Center
🇷🇺Pyatigorsk, Russian Federation
The Oncology Centre
🇿🇦Durban, South Africa
Oncocentro Apys
🇨🇱Viña Del Mar, Chile
Brest Regional Oncology Center
🇧🇾Brest, Belarus
HCG NCHRI Cancer Centre
🇮🇳Nagpur, India
University of Pretoria, Department of Medical Oncology
🇿🇦Pretoria, South Africa
Arkhangelsk Clinical Oncology Center
🇷🇺Arkhangel'sk, Russian Federation
Republican Oncology Center
🇷🇺Saransk, Russian Federation
St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care (Oncology)
🇷🇺Saint Petersburg, Russian Federation
Tomsk National Research Medical Center
🇷🇺Tomsk, Russian Federation
Linkou Chang Gung Memorial Hospital
🇨🇳Taoyuan, Taiwan
Chernihiv Regional Oncology Center
🇺🇦Chernihiv, Ukraine
Medical Oncology Centre of Rosebank
🇿🇦Johannesburg, South Africa
Little Company of Mary Medical Center, Department of Oncology
🇿🇦Pretoria, South Africa
Chernivtsi Regional Clinical Oncology Center
🇺🇦Chernivtsi, Ukraine
Dnipropetrovsk City Multispecialty Clinical Hospital #4, Department of Chemotherapy
🇺🇦Dnipro, Ukraine
National Taiwan University Hospital
🇨🇳Taipei, Taiwan
Kyiv City clinical Hospital #2
🇺🇦Kyiv, Ukraine
Kyiv Regional Oncology Center, Department of Mastology
🇺🇦Kyiv, Ukraine
Medical Center "Verum"
🇺🇦Kyiv, Ukraine
Mariupol Oncology Center
🇺🇦Mariupol, Ukraine
Zakarpattia Regional Clinical Oncology Center, Department of Chemotherapy
🇺🇦Uzhhorod, Ukraine
Khmelnytskyi Regional Oncology Center
🇺🇦Khmelnytskyi, Ukraine
Kryvyi Rih Oncology Center, Department of Chemotherapy
🇺🇦Kryvyi Rih, Ukraine
Podillia Regional Oncology Center
🇺🇦Vinnytsia, Ukraine
Medical Center of First Private Clinic
🇺🇦Kyiv, Ukraine
Central City Clinical Hospital, Department of Oncology and Radiology
🇺🇦Uzhhorod, Ukraine
Zhytomyr Regional Oncology Center
🇺🇦Zhytomyr, Ukraine
Gomel Regional Clinical Oncology Center
🇧🇾Gomel, Belarus
Mogilev Regional Oncology Center
🇧🇾Mogilev, Belarus
LTD Aversi Clinic
🇬🇪Tbilisi, Georgia
Leningrad Regional Oncology Center (Surgery Department)
🇷🇺Saint Petersburg, Russian Federation
Oncology Center #2
🇷🇺Sochi, Russian Federation
GVI Oncology, Cape Gate Oncology Centre
🇿🇦Cape Town, South Africa
China Medical University Hospital
🇨🇳Taichung, Taiwan
State Institution: S.P. Hryhoriev Institute of Medical Radiology under the Ukrainian Academy of Medical Sciences, Department of Clinical Oncology and Hematology
🇺🇦Kharkiv, Ukraine
Odesa Regional Clinical Hospital, Center for Mastology, Department of Thoracic Surgery
🇺🇦Odesa, Ukraine
Aultman Hospital, Cancer Center
🇺🇸Canton, Ohio, United States