A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

PHASE2/PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

301

Participants

Timeline

Start Date

April 24, 2018

Primary Completion Date

July 31, 2024

Study Completion Date

December 31, 2024

Conditions
Breast NeoplasmsBreast DiseasesCapecitabineHER2-positive Breast CancerHER2 Positive Breast CarcinomaHER2-positive Advanced Breast With Liver Metastases
Interventions
DRUG

RC48-ADC

RC48-ADC 2.0 mg/kg IV every 14 days

DRUG

Lapatinib

Lapatinib 1250 mg orally once daily during each 21-day cycle.

DRUG

Capecitabine

Capecitabine 2000 mg/m\^2 orally daily on Days 1-14 of each 21-day treatment cycle.

Trial Locations (67)

100021

Cancer Hospital Chinese Academy of Medical Sciences, Beijing

Unknown

Liaoning Cancer Hospital & Institute, Shenyang

The First Hospital of China Medical University, Shenyang

An Yang Cancer Hospital, Anyang

Beijing Luhe Hospital, Beijing

Peking University People's Hospital, Beijing

The First Affiliated Hospital of Bengbu Medical College, Bengbu

Bin Zhou No.1 People's Hospital, Binzhou

Jilin Cancer Hospital, Changchun

The First Hospital Jilin University, Changchun

The First Hospital of Jilin University, Changchun

Hunan Cancer Hospital, Changsha

The Second Xiyang Hospital of Central South University, Changsha

Xiangya Hospital Central South University, Changsha

Heping Hospital Affiliated to Changzhi Medical College, Changzhi

Affiliated Hospital of Chengde Medical University, Chengde

West China Hospital,Sichuan University, Chengdu

Chongqing University Three gorges Hospital, Chongqing

The Southwest Hospital of AMU, Chongqing

The Second Hospital of Dalian Medical University, Dalian

Fujian Cancer Hospital, Fuzhou

Guangdong Provincial People's Hospital, Guangzhou

Sun Yat-Sen Memorial Hospital, Guangzhou

The Affiliated Tumor Hospital of Guangzhou Medical University, Guangzhou

Guizhou Cancer Hospital, Guiyang

The First Affiliated Hospital of Medical School of Zhejiang University, Hangzhou

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

Zhejiang Cancer Hospital, Hangzhou

Harbin Medical University Cancer Hospital, Ha’erbin

Anhui Cancer Hospital, Hefei

Anhui Province Hospital, Hefei

The First Affiliated Hospital of Anhui Medical University, Hefei

Qilu Hospital of Shandong University, Jinan

The First People's Hospital of Jining, Jining

Yunnan Cancer Hospital, Kunming

Linyi Cancer Hospital, Linyi

The First Affiliated Hospital of Henan University of Science & Technology, Luoyang

Jiangsu Cancer Hospital, Nanjing

The Affiliated Tumor Hospital of Guangxi Medical University, Nanning

The Second People's Hospital of Neijiang, Neijiang

Hospital of Qingdao University, Qingdao

Fudan University Shanghai Cancer Center, Shanghai

Shanghai Changhai Hospital, Shanghai

Shanghai Ruijin Hospital, Shanghai

Cancer Hospital of Shantou University Medical College, Shantou

Yue Bei People's Hospital, Shaoguan

The Fourth Hospital of Hebei Medical University, Shijiazhuang

Shanxi Bethune Hospital, Taiyuan

Shanxi Cancer Hospital, Taiyuan

Taizhou Enze Medical Center, Taizhou

Tai'an City Central Hospital, Tai’an

Tianjin Cancer Hospitial, Tianjin

Weihai Municipal Hospital, Weihai

Hubei Cancer Hospital, Wuhan

Tongji Medical College of HUST, Wuhan

Wuhan Union Hospital, Wuhan

The First Affiliated Hospital of the Fourth Military University of P.L.A., Xi'an

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

Xing Tai People's Hospital, Xingtai

The First Affiliated Hospital of Xinxiang Medical University, Xinxiang

The Affiliated Hospital of Xuzhou Medical University, Xuzhou

Xuzhou Central Hospital, Xuzhou

Yanbian University Hospital, Yanbian

Yantai Yuhuangding Hospital, Yantai

Yuncheng Central Hospital, Yuncheng

Henan Cancer Hospital, Zhengzhou

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

All Listed Sponsors
lead

RemeGen Co., Ltd.

INDUSTRY

NCT03500380 - A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases | Biotech Hunter | Biotech Hunter