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RECRUITING
NCT07673029
PHASE3

A Trial Comparing GQ1005 and T-DM1 in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer

Sponsor: GeneQuantum Healthcare (Suzhou) Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is designed to compare efficacy and safety of GQ1005 versus T-DM1 in HER2-positive, unresectable and/or metastatic breast cancer patients previously treated with trastuzumab and taxane.

Official title: A Phase III, Multicenter, Open-label, Randomized Controlled Study Comparing GQ1005 and Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and a Taxane

Key Details

Gender

All

Age Range

18 Years - 75 Years

Study Type

INTERVENTIONAL

Enrollment

228

Start Date

2025-01-10

Completion Date

2028-01-09

Last Updated

2026-06-29

Healthy Volunteers

No

Interventions

DRUG

GQ1005

Administered I.V.

DRUG

T-DM1

Administered I.V.

Locations (70)

The First Affiliated Hospital of Bengbu Medical University

Bengbu, Anhui, China

The Affiliated Fuyang Hospital of Anhui Medical University

Fuyang, Anhui, China

The First Affiliated Hospital of Anhui Medical University

Hefei, Anhui, China

Anhui Cancer Hospital

Hefei, Anhui, China

The Fifth Medical Center of the Chinese People's Liberation Army General Hospital

Beijing, Beijing Municipality, China

Chongqing University Cancer Hospital

Chongqing, Chongqing Municipality, China

Fujian Cancer Hospital

Fuzhou, Fujian, China

The Second Affiliated Hospital of Fujian Medical University

Quanzhou, Fujian, China

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, China

Sun Yat-sen Memorial Hospital, Sun Yat-sen University

Guangzhou, Guangdong, China

Meizhou People's Hospital

Meizhou, Guangdong, China

Shantou Central Hospital

Shantou, Guangdong, China

Guangxi Medical University Cancer Hospital

Nanning, Guangxi, China

Guizhou Provincial People's Hospital

Guiyang, Guizhou, China

Guizhou Medical University Cancer Hospital

Guiyang, Guizhou, China

The Affiliated Hospital of Hebei University

Baoding, Hebei, China

The Affiliated Hospital of Hebei University of Engineering

Handan, Hebei, China

The Fourth Hospital of Hebei Medical University

Shijiazhuang, Hebei, China

Xingtai People's Hospital

Xingtai, Hebei, China

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Anyang Cancer Hospital

Anyang, Henan, China

Luoyang Central Hospital

Luoyang, Henan, China

The First Affiliated Hospital of Henan University of Science and Technology

Luoyang, Henan, China

The First Affiliated Hospital of Henan Medical University

Xinxiang, Henan, China

Xuchang Central Hospital

Xuchang, Henan, China

Henan Cancer Hospital

Zhengzhou, Henan, China

The First Affiliated Hospital of Zhengzhou University

Zhengzhou, Henan, China

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology

Wuhan, Hubei, China

Renmin Hospital of Wuhan University

Wuhan, Hubei, China

Zhongnan Hospital of Wuhan University

Wuhan, Hubei, China

Hubei Cancer Hospital

Wuhan, Hubei, China

Hunan Cancer Hospital

Changsha, Hunan, China

Yongzhou Central Hospital

Yongzhou, Hunan, China

Xuzhou Central Hospital

Xuzhou, Jiangsu, China

Ganzhou Cancer Hospital

Ganzhou, Jiangxi, China

Nanchang People's Hospital

Nanchang, Jiangxi, China

The First Hospital of Jilin University

Changchun, Jilin, China

The Second Affiliated Hospital of Dalian Medical University

Dalian, Liaoning, China

The First Affiliated Hospital of Jinzhou Medical University

Jinzhou, Liaoning, China

The First Affiliated Hospital of China Medical University

Shenyang, Liaoning, China

Liaoning Cancer Hospital

Shenyang, Liaoning, China

The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

The First Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, China

Shandong Cancer Hospital

Jinan, Shandong, China

The Second People's Hospital of Liaocheng City

Linqing, Shandong, China

Linyi Cancer Hospital

Linyi, Shandong, China

Linyi Central Hospital

Linyi, Shandong, China

The Affiliated Hospital of Qingdao University

Qingdao, Shandong, China

Yidu Central Hospital of Weifang City

Qingzhou, Shandong, China

Weifang People's Hospital

Weifang, Shandong, China

Yantai Yuhuangding Hospital

Yantai, Shandong, China

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, China

Renji Hospital, School of Medicine, Shanghai Jiao Tong University

Shanghai, Shanghai Municipality, China

Shanghai Gaobo Cancer Hospital

Shanghai, Shanghai Municipality, China

Shanxi Cancer Hospital

Taiyuan, Shanxi, China

The Third People's Hospital of Chengdu City

Chengdu, Sichuan, China

West China Hospital of Sichuan University

Chengdu, Sichuan, China

Deyang People's Hospital

Deyang, Sichuan, China

The Second People's Hospital of Neijiang City

Neijiang, Sichuan, China

Suining Central Hospital

Suining, Sichuan, China

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, China

Yunnan Cancer Hospital

Kunming, Yunnan, China

The First People's Hospital of Hangzhou City

Hangzhou, Zhejiang, China

Women's Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Zhejiang Cancer Hospital

Hangzhou, Zhejiang, China

The First People's Hospital of Xiaoshan District, Hangzhou City

Hangzhou, Zhejiang, China

The Affiliated People's Hospital of Ningbo University

Ningbo, Zhejiang, China