A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer

Status: Recruiting
Location: See all (66) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

TQB2930 is a HER2 bispecific antibody drug. This study aims to evaluate the efficacy and safety of TQB2930 combined with investigator's choice of chemotherapy versus trastuzumab combined with investigator's choice of chemotherapy in subjects with HER2-positive advanced breast cancer who have received at least two prior lines of anti-HER2 therapy in the advanced station.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• Subjects voluntarily participate in this study and sign the informed consent form;

• Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy \>3 months;

• Cytologically or histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive recurrent or metastatic breast cancer;

• Received ≥2 prior lines of anti-HER2 targeted therapy in the advanced setting;

• At least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria (excluding brain lesions);

• Willing to receive one of the investigator-selected chemotherapy regimens;

• Adequate organ function;

• Female subjects of childbearing potential must agree to use effective contraception (e.g., Intrauterine Device (IUD), oral contraceptives, or condoms) during the study and for 6 months after study completion.

Locations
Other Locations
China
AnYang Tumor Hospital
NOT_YET_RECRUITING
Anyang
Bao Ji Central Hospital
NOT_YET_RECRUITING
Baoji
The First Affiliated Hospital of Bengbu Medical College
NOT_YET_RECRUITING
Bengbu
Jilin Cancer Hospital
NOT_YET_RECRUITING
Changchun
The first hospital of Jilin University
NOT_YET_RECRUITING
Changchun
The First People's Hospital of Changde City
NOT_YET_RECRUITING
Changde
Hunan Cancer Hospital
NOT_YET_RECRUITING
Changsha
People's Hospital of Hunan Province
NOT_YET_RECRUITING
Changsha
Xiangya Hospital of Central South University
NOT_YET_RECRUITING
Changsha
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
NOT_YET_RECRUITING
Chengdu
Chong Qing University Cancer Hospital
NOT_YET_RECRUITING
Chongqing
Affiliated Zhongshan Hospital Of Dalian University
NOT_YET_RECRUITING
Dalian
Ganzhou Cancer Hospital
NOT_YET_RECRUITING
Ganzhou
Ganzhou People's Hospital
NOT_YET_RECRUITING
Ganzhou
Sun Yat - sen University Cancer Center
NOT_YET_RECRUITING
Guangzhou
Guizhou Provincial People's Hospital
NOT_YET_RECRUITING
Guiyang
The Affiiated Cancer Hospital of Guizhou Medical University
NOT_YET_RECRUITING
Guiyang
Hainan General Hospital
NOT_YET_RECRUITING
Haikou
3201 Hospital
NOT_YET_RECRUITING
Hanzhong
Harbin Medical University Cancer Hospital
RECRUITING
Harbin
The First Affiliated Hospital of Harbin Medical University
NOT_YET_RECRUITING
Harbin
Anhui Provincial Hospital( The First Affiliated Hospital of USTC)
NOT_YET_RECRUITING
Hefei
The Second Affiliated Hospital of Anhui Medical University
NOT_YET_RECRUITING
Hefei
Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)
NOT_YET_RECRUITING
Jiamusi
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
NOT_YET_RECRUITING
Jinan
Yunnan Cancer Hospital
NOT_YET_RECRUITING
Kunming
Gansu Cancer Hospital
NOT_YET_RECRUITING
Lanzhou
Linyi cancer Hospital
NOT_YET_RECRUITING
Linyi
Liuzhou People's Hospital
NOT_YET_RECRUITING
Liuzhou
The First Affiliated Hospital of Henan University of Science & Technology
NOT_YET_RECRUITING
Luoyang
The Affiliated Hospital of Southwest Medical University
NOT_YET_RECRUITING
Luzhou
Mudanjiang Cancer Hospital
NOT_YET_RECRUITING
Mudanjiang
Affiliated Hospital of North Sichuan Medical College
NOT_YET_RECRUITING
Nanchong
JiangSu Cancer Hosipital
NOT_YET_RECRUITING
Nanjing
Nanjing Drum Tower Hospital
NOT_YET_RECRUITING
Nanjing
The Affiliated Sir Run Run Hospital of Nanjing Medical University
NOT_YET_RECRUITING
Nanjing
Affiliated Cancer Hospital of Guangxi Medical Universit
NOT_YET_RECRUITING
Nanning
Nanyang Second General Hospital
NOT_YET_RECRUITING
Nanyang
Ningbo Medical Center Lihuili Hospital
NOT_YET_RECRUITING
Ningbo
Ningbono.2Hospitai
NOT_YET_RECRUITING
Ningbo
The First Affiliated Hospial of Ningbo University
NOT_YET_RECRUITING
Ningbo
The First Hospital of Qinhuangdao
NOT_YET_RECRUITING
Qinhuangdao
Liaoning Cancer Hospital & Institute
NOT_YET_RECRUITING
Shenyang
Shengjing Hospital of China Medical University
NOT_YET_RECRUITING
Shenyang
Peking University Shenzhen Hospital
NOT_YET_RECRUITING
Shenzhen
The Fourth Hospital of Hebei Medical University
NOT_YET_RECRUITING
Shijiazhuang
Suining Central Hospital
NOT_YET_RECRUITING
Suining
Zhangjiagang First People's Hospital
NOT_YET_RECRUITING
Suzhou
Shanxi Cancer Hospital
NOT_YET_RECRUITING
Taiyuan
Tangshan People's Hospital
NOT_YET_RECRUITING
Tangshan
Tianjin Cancer Hospital Airport Hospital
NOT_YET_RECRUITING
Tianjin
Tianjin Medical University Cancer Institute & Hospital
NOT_YET_RECRUITING
Tianjin
Xinjiang Medical University Affiliated Tumor Hospital
NOT_YET_RECRUITING
Ürümqi
Weifang People'S Hospital
NOT_YET_RECRUITING
Weifang
The Second Affiliated Hospital of Wenzhou Medical University
NOT_YET_RECRUITING
Wenzhou
The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
NOT_YET_RECRUITING
Xi'an
Xijing Hospital of Air Force Military Medical University
NOT_YET_RECRUITING
Xi'an
Xiangyang Central Hospital
NOT_YET_RECRUITING
Xiangyang
Qinghai University Affiliated Hospital
NOT_YET_RECRUITING
Xining
The First Affiliated Hospital of Xinxiang Medical University
NOT_YET_RECRUITING
Xinxiang
Xuzhou Central Hospital
NOT_YET_RECRUITING
Xuzhou
The Second People's Hospital of Yibin City
NOT_YET_RECRUITING
Yibin
People's Hospital of Ningxia Hui Autonomous Region
NOT_YET_RECRUITING
Yinchuan
The Central Hospital of Yongzhou
NOT_YET_RECRUITING
Yongzhou
Yuncheng Central Hospital
NOT_YET_RECRUITING
Yuncheng
Henan Cancer Hospital
NOT_YET_RECRUITING
Zhengzhou
Contact Information
Primary
Qingyuan Zhang, Doctor
ns86298333@163.com
13313612989
Backup
Jinming Yu, Doctor
sdyujinming@126.com
13806406293
Time Frame
Start Date: 2025-07-25
Estimated Completion Date: 2028-12
Participants
Target number of participants: 416
Treatments
Experimental: TQB2930+ chemotherapy
Subjects will receive TQB2930 injection in combination with chemotherapy agents on Day 1 (D1) of each cycle. TQB2930 will be administered at a dose of 30 mg/kg every 3 weeks (Q3W), Each treatment cycle lasts 21 days.
Active_comparator: Trastuzumab+ chemotherapy
Subjects will receive trastuzumab in combination with chemotherapy agents on Day 1 (D1) of each cycle. The initial dose of trastuzumab is 8 mg/kg, followed by a maintenance dose of 6 mg/kg administered every 3 weeks (Q3W), Each treatment cycle lasts 21 days.
Related Therapeutic Areas
Sponsors
Leads: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.

This content was sourced from clinicaltrials.gov

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