Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer

PHASE3CompletedINTERVENTIONAL
Enrollment

652

Participants

Timeline

Start Date

November 30, 2016

Primary Completion Date

November 23, 2018

Study Completion Date

September 28, 2021

Conditions
Breast Cancer
Interventions
BIOLOGICAL

HLX02

8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles.

BIOLOGICAL

Herceptin®

8 mg/kg administered intravenously over 90 minutes as a loading dose on Day 1, Cycle 1 then 6 mg/kg every 3 weeks for subsequent cycles

DRUG

docetaxel

75 mg/m2 will be administered on Day 2, Cycle 1.then be given every 3 weeks on Day 1 of each subsequent cycle

Trial Locations (88)

1000

Manila Doctors Hospital, Manila

1502

Cardinal Santos Medical Center, San Juan City

1605

The Medical City, Pasig

6000

Cebu Doctors University Hospital, Cebu City

8000

Metro Davao Medical and Research Center, Inc., Davao City

14029

CTPI Chernihiv Regional Oncological Dispensary, Chernihiv

21029

Podilskyi Regional Oncological Center, Vinnytsia

25006

Treatment-Diagnostic Center of Private Enterprise of PPC Atsynus, Kropyvnytskyi

29000

Khmelnytskyi Regional Oncological Dispensary, Khmelnytskyi

36011

Poltava Reg Cl Onc Dispensary of PRC Chemotherapy Dept HSEI of Ukr UMSA, Poltava

40022

RCI Sumy Regional Clinical Oncological Dispensary Dept of of Chemotherapy Sumy SU, Sumy

43018

Communal Enterprise Volyn Regional Medical Center of Oncology of Volyn Regional Council, Lutsk

49102

"CNECity Clin Hosp#4of Dnipro City Council Dept of Chemotherapy SI Dnipropetrovsk MA of MOHU", Dnipro

50048

CI Kryvyi Rih Oncological Dispensary of DRC, Kryvyi Rih

58013

CI Chernivtsi RC Oncological Dispensary, Chernivtsi

61070

Communal Non-profit Enterprise Regional Center of Oncology, Kharkiv

65025

CI Odesa Regional Clinical Hospital, Odesa

65055

Odesa Regional Oncologic Dispensary, Odesa

69040

CI Zaporizhzhia RC Onc Dispensary of ZRC Dept of Breast Pathology SI Zaporizhzhia MA of PGE of MoHU, Zaporizhzhia

CI Zaporizhzhia Regional Clinical Oncological Dispensary of ZRC, Zaporizhzhia

73000

CI of Kherson Reg Council Kherson Regional Oncologic Dispensary, Kherson

76018

CI Carpathian Clinical Oncological Center, Ivano-Frankivsk

79031

CI of LRC Lviv Oncological Regional Treatment and Diagnostic Center, Lviv

88000

CNE CCCH of Uzh CC Oncological Center, Ther Dept, SHEI UNU, Uzhhorod

88014

Transcarpathian Regional Clinical Oncological Dispensary, Uzhhorod

Unknown

The First Affiliated Hospital of Anhui Medical University, Hefei

The Second Hospital of Anhui Medical University, Hefei

Beijing Friendship Hospital, Capital Medical University, Beijing

Chongqing University Cancer Hospital, Chongqing

Fujian Cancer Hospital, Fuzhou

Fujian Medical University Union Hospital, Fuzhou

The First Affiliated Hospital of Xiamen University, Xiamen

Affiliated Cancer Hospital and Institute of Guangzhou Medical University, Guangzhou

First Affiliated Hospital of Guangzhou University of TMC, Guangzhou

Sun Yat-Sen Memorial Hospital, Sun Yat-Sen University, Guangzhou

Sun Yat-sen University, Cancer Center, Guanzhou

The University of Hong Kong-Shenzhen Hospital, Shenzhen

Affiliated Hospital of Guangdong Medical University, Zhanjiang

Liuzhou General Hospital, Liuzhou

Affiliated Hospital of Hebei University, Baoding

Hebei Cangzhou Central Hospital, Cangzhou

The Fourth Hospital of Hebei Medical University, Shijiazhuang

Harbin Medical University Cancer Hospital, Harbin

Henan Cancer Hospital, Zhengzhou

The 2nd Xiangya Hospital of Central South University, Changsha

Hubei Cancer Hospital, Wuhan

Tongji Hospital, Tongji Medical College, Huazhong University of Science & Technology, Wuhan

The Third Xiangya Hospital of Central South University, Changsha

Jiangsu Cancer Hospital, Nanjing

Jiangsu Province Hospital, Nanjing

Nanjing Bayi Hospital, Nanjing

The Affiliated Drum Tower Hospital of Nanjing University, Nanjing

Nantong Tumor Hospital, Nantong

Wuxi 4th People's Hospital, Wuxi

Xuzhou Central Hospital, Xuzhou

Northern Jiangsu People's Hospital, Yangzhou

The Second Affiliated Hospital of Nanchang University, Nanchang

Jilin Cancer Hospital, Changchun

Jilin Province People's Hospital, Changchun

The First Hospital of Jilin University, Changchun

The Second Hospital of Dalian Medical University, Dalian

General Hospital of the Northern Theater of the Chinese People's Liberation Army, Shenyang

Liaoning Cancer Hospital & Institute, Shenyang

The First Hospital of China Medical University, Shenyang

Affiliated Hospital of Qinghai University, Xining

Affiliated Hospital of Jining Medical University, Jining

Jinan Central Hospital, Jinan

Yantai Yuhuangding Hospital, Yantai

Fudan University Shanghai Cancer Center, Shanghai

Ruijin Hospital of Shanghai Jiaotong University School of Medicine, Shanghai

Shannxi Provincial Tumor Hospital, Xi'an

The 2nd Hospital of Xi'An Jiaotong University, Xi’an

The First Affiliated Hospital of Xi'an Jiaotong University, Xi’an

West China Hospital, Sichuan University, Chengdu

Nanchong Central Hospital, Nanchong

Tianjin Medical University Cancer Institute & Hospital, Tianjing

Yunnan Cancer Hospital, Kunming

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine, Hangzhou

The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou

The Second Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou

Zhejiang Cancer Hospital, Hangzhou

Beijing Cancer Hospital, Beijing

Cancer Hospital, Chinese Academy of Medical Sciences, Beijing

Chinese PLA General Hospital, Beijing

Peking Union Medical College Hospital, Beijing

03022

National Institute of Cancer, Kyiv

03115

CNE Kyiv City Clin Oncological Center of Ex Body of Kyiv CC(KCSA), Kyiv

Kyiv Сity Clinical Oncological Center, Kyiv

All Listed Sponsors
lead

Shanghai Henlius Biotech

INDUSTRY

NCT03084237 - Compare Efficacy, Safety and Immunogenicity of HLX02 and Herceptin in Previously Untreated HER2 +Overexpressing Metastatic Breast Cancer | Biotech Hunter | Biotech Hunter