The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer

PHASE3UnknownINTERVENTIONAL
Enrollment

410

Participants

Timeline

Start Date

July 1, 2018

Primary Completion Date

July 31, 2020

Study Completion Date

December 31, 2021

Conditions
HER2-positive Advanced Breast Cancer
Interventions
BIOLOGICAL

BAT8001 for injection

3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.

DRUG

Lapatinib

Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.

DRUG

Capecitabine

Capecitabine 1000 milligrams per square meter (mg/m\^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.

Trial Locations (51)

Unknown

The First Affiliated Hospital of Bengbu Medical College, Bengbu

Anhui Provincial Hospital, Hefei

Beijing Hospital, Beijing

Beijing Shijitan Hospital, Beijing

Chinese PLA General Hospital, Beijing

Peking union medical college hospital, Beijing

Chongqing Cancer Hospital, Chongqing

The First Affiliated Hospital of Xiamen University, Xiamen

Foshan City No. 1 People's Hospital, Foshan

Cancer Center of Guangzhou Medical University, Guangzhou

Sun Yat-sen Memorial Hospital. SYSU, Guangzhou

Sun Yat-sen University Cancer Center, Guangzhou

Peking University Shenzhen Hospital, Shenzhen

Shenzhen People's Hospital, Shenzhen

The First Affiliated Hospital of Guangdong Medical University, Zhanjiang

The Fifth Affiliated Hospital Sun Yat-sen University, Zhuhai

Liuzhou workers hospital, Liuzhou

The First Affiliated Hospital of Hainan Medical College, Haikou

Harbin Medical University Cancer Hospital, Harbin

The First Affiliated Hospital of Henan University of science and technology, Luoyang

The First Affiliated Hospital of Xixiang Medical College, Xinxiang

Hubei Cancer Hospital, Wuhan

Tongji Hospital of Tongji Medical College of HUST, Wuhan

Zhongnan Hospital of Wuhan University, Wuhan

Yichang Central Hospital, Yichang

Hunan Cancer Hospital, Changsha

Xiangya Hospital Central South University, Changsha

Jiangsu Cancer Hospital, Nanning

Affiliated Hospital of Jiangnan University, Wuxi

Yancheng City No. 1 People's Hospital, Yancheng

Jiangxi Cancer Hospital, Nanchang

The Third Hospital of Nanchang, Nanchang

Jilin Cancer Hospital, Changchun

The First Bethune Hospital of Jilin University, Changchun

Jinzhou Central Hospital, Jinzhou

Liaoning Cancer Hospital, Shenyang

General Hospital of Ningxia Medical University, Yinchuan

Shandong Cancer Hospital, Jinan

Linyi Cancer Hospital, Linyi

Weifang People's Hospital, Weifang

Fudan University Shanghai Cancer Hospital, Shanghai

Shanghai General Hospital, Shanghai

Shanghai Sixth People's Hospital, Shanghai

The Second Hospital of Anhui Medical University, Shanghai

Shanxi Cancer Hospital, Xi’an

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

West China Hospital of Sichuan University, Chengdu

Yunnan Cancer Hospital, Kunming

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

Zhejiang Cancer Hospital, Hangzhou

Taizhou Hispotal of Zhejiang Province, Taizhou

Sponsors
All Listed Sponsors
lead

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INDUSTRY