A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

Summary

This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis.

Conditions

• Breast Cancer

Interventions

DRUG

RC48-ADC

RC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks

DRUG

Paclitaxel Injection

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Docetaxel Injection

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Vinorelbine Tartrate Injection

Administered according to label, as one option for Physician's Choice (determined before randomization)

DRUG

Capecitabine Tablets

Administered according to label, as one option for Physician's Choice (determined before randomization)

Sponsors & Collaborators

• RemeGen Co., Ltd.

  lead INDUSTRY

Principal Investigators

• Binghe Xu · Oncology Hospital, Chinese Academy of Medical Sciences

• Tao Sun · Liaoning Cancer Hospital & Institute

• Wei Li · Jilin University First Hospital

• Yuee Teng · First Affiliated Hospital of China Medical University

• Shu Wang · Peking University People's Hospital

• Xiaojia Wang · Zhejiang Cancer Hospital

• Min Yan · Henan Cancer Hospital

• Jifeng Feng · Jiangsu Cancer Institute & Hospital

• Ying Cheng · Jilin Provincial Tumor Hospital

• Ying Wang · Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

• Ying Wang · Sun Yat-sen University Cancer Prevention and Control Center

• Ning Liao · Guangdong Provincial People's Hospital

• Haibo Wang · Qingdao University Hospital

• Quchang Ouyang · Hunan Cancer Hospital

• Yueyin Pan · Anhui Provincial Hospital

• Yingying Du · The First Affiliated Hospital of Anhui Medical University

• Changlu Hu · Anhui Provincial Cancer Hospital

• Zhongsheng Tong · Tianjin Cancer Hospital

• Jin Yang · The First Affiliated Hospital of Xi'an Jiaotong University School of Medicine

• Lihua Song · Shandong Cancer Hospital and Institute

• Xiuwen Wang · Qilu Hospital of Shandong University

• Yu Jiang · West China Hospital

• Yunjiang Liu · Hebei Medical University Fourth Hospital

• Jing Cheng · Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

• Huihua Xiong · Tongji Hospital

• Xinhong Wu · Hubei Cancer Hospital

• Peng Shen · Zhejiang University

• Weimin Xie · Cancer Hospital Affiliated to Guangxi Medical University

• Xin Zhou · Chongqing University Cancer Hospital

• Li Ran · Cancer Hospital of Guizhou Province

• Yu Wang · Shanxi Province Cancer Hospital

• Jinnan Gao · Bethune Hospital of Shanxi Province

• Jingfen Wang · Linyi Cancer Hospital

• Liangming Zhang · Yantai Yuhuangding Hospital

• Xianhe Xie · First Affiliated Hospital of Fujian Medical University

• Ru Zeng · The First Affiliated Hospital of Xiamen University

• Airong Wang · Weihai Municipal Hospital

• Zhengqiu Zhu · The Affiliated Hospital of Xuzhou Medical University

• Sanyuan Sun · Xuzhou Central Hospital

• Qingshan Li · Affiliated Hospital of Chengde Medical College

• Aimin Zang · Affiliated Hospital of Hebei University

• Liuzhong Yang · The First Affiliated Hospital of Xinxiang Medical College

• Meili Sun · Jinan Central Hospital

• Liang Li · Zibo Central Hospital

• Guohua Yu · Weifang People's Hospital

• Xujuan Wang · Neijiang Second People's Hospital

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-09-29

Primary Completion

2024-06-30

Completion

2024-12-30

Countries

• China

Study Locations