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Brief Title: Efficacy and Safety Study of EG12014 Compared With Herceptin in Subjects With HER2 Positive Early Breast Cancer
Official Title: 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
Study ID: NCT03433313
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:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
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, Gomel, , 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
Keimyung University - Dongsan Medical Center, Daegu, , Korea, Republic of
Arkhangelsk Clinical Oncology Center, Arkhangel'sk, , Russian Federation
Chelyabinsk Regional Clinical Oncology and Nuclear Medicine Center, Chelyabinsk, , Russian Federation
Evimed, LLC, Chelyabinsk, , Russian Federation
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
N.N. Blokhin National Medical Oncology Research Center, Moscow, , Russian Federation
National Medical Research Center for Radiology, Moscow, , Russian Federation
Vitamed" LLC, Moscow, , Russian Federation
A.F.Tsyb Medical Radiology Research Center, Obninsk, , Russian Federation
Clinical Oncology Center, Omsk, , Russian Federation
Pyatigorsk Interdistrict Oncology Center, Pyatigorsk, , Russian Federation
Rostov Oncology Research Institute, Rostov-on-Don, , Russian Federation
Regional Clinical Oncology Center, Ryazan', , Russian Federation
AV Medical Group, Saint Petersburg, , Russian Federation
City Clinical Oncology Center, Saint Petersburg, , Russian Federation
Clinic "Mart", Saint Petersburg, , Russian Federation
I.I. Mechnikov North-Western State Medical University, Saint Petersburg, , Russian Federation
Leningrad Regional Oncology Center (Outpatient Department), Saint Petersburg, , Russian Federation
Leningrad Regional Oncology Center (Surgery Department), 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
Private Medical Institution "EVROMEDSERVIS", Department of Oncology, Saint Petersburg, , Russian Federation
St. Petersburg Clinical Research and Practical Center for Specialized Types of Medical Care (Oncology), Saint Petersburg, , Russian Federation
Republican Oncology Center, Saransk, , Russian Federation
Oncology Center #2, Sochi, , Russian Federation
Tomsk National Research Medical Center, Tomsk, , Russian Federation
Regional Clinical Oncology Center, Veliky Novgorod, , Russian Federation
Volgograd Regional Clinical Oncology Center, Volgograd, , Russian Federation
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
Kaohsiung Medical University Chung-Ho Memorial Hospital, Kaohsiung, , 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, , 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, Luts'k, , 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