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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TQB2930+ chemotherapy | Experimental | 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. |
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| Trastuzumab+ chemotherapy | Active Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| TQB2930+ chemotherapy | Drug | TQB2930 injection is a HER2 bispecific antibody drug; Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free survival (PFS) | Independent Imaging Review Committee (IRC)-assessed PFS | Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| PFS assessed by Investigator | PFS assessed by Investigator | Baseline up to Investigator-Assessed investigator, approximately 1 years |
| Overall survival (OS) | From randomization to the time of death from any cause. |
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Inclusion Criteria:
Exclusion Criteria:
Concurrent Diseases and Medical History:
Tumor-Related Conditions and Treatments:
Severe hypersensitivity to monoclonal antibodies;
Participation in other antitumor clinical trials with investigational drugs within 4 weeks before randomization;
Any condition deemed by the investigator to jeopardize subject safety or study completion.
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Qingyuan Zhang, Doctor | Contact | 13313612989 | ns86298333@163.com | |
| Jinming Yu, Doctor | Contact | 13806406293 | sdyujinming@126.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Not yet recruiting | Bengbu | Anhui | 233060 | China |
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| Trastuzumab+ chemotherapy | Drug | Trastuzumab is a HER2-specific targeted drug; Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs. |
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| From date of the first dose until the date of death from any cause, up to approximately 2 years |
| Duration of Response (DOR) | Subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 criteria. | From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 2 years |
| Proportion of subjects achieving partial response (PR) | Subjects with partial response (PR) per RECIST 1.1 criteria. | From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years |
| Objective Response Rate (ORR) | Percentage of subjects achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria. | From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years |
| Clinical Benefit Rate (CBR) | Proportion of subjects with best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) lasting ≥24 weeks per RECIST 1.1 criteria. | From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first) , up to approximately 1 years |
| Adverse event rate | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). | From baseline until 90 days after the last dose or initiation of new antitumor therapy, whichever occurs first |
| Plasma concentration of TQB2930 | Serum concentrations of TQB2930 in subjects after administration in the treatment group. | Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 30 minutes after dosing on Cycle 4 Day 1 and Cycle 7 Day 1, each cycle is 21 days |
| Anti-Drug Antibody (ADA) Positivity Rate | Anti-drug antibody (ADA) positivity in post-dose blood samples from subjects in the treatment group. | Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days |
| Anti-Drug Antibody (ADA) Positivity Rate | Neutralizing antibody (NAb) testing performed when anti-drug antibodies (ADAs) were detected in post-dose blood samples from the treatment group. | Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 , and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days |
| Anhui Provincial Hospital( The First Affiliated Hospital of USTC) | Not yet recruiting | Hefei | Anhui | 230001 | China |
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| The Second Affiliated Hospital of Anhui Medical University | Not yet recruiting | Hefei | Anhui | 230001 | China |
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| The Fifth Medical Center of Chinese People's Liberation Army General Hospital | Not yet recruiting | Beijing | Beijing Municipality | 100071 | China |
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| Chong Qing University Cancer Hospital | Not yet recruiting | Chongqing | Chongqing Municipality | 400030 | China |
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| Fuzhou First Generel Hospital Affiliated with Fujian Medical University | Not yet recruiting | Fuzhou | Fujian | 350009 | China |
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| The First Hospital of Lanzhou University | Not yet recruiting | Lanzhou | Gansu | 730000 | China |
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| Gansu Cancer Hospital | Not yet recruiting | Lanzhou | Gansu | 730050 | China |
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| Sun Yat - sen University Cancer Center | Not yet recruiting | Guangzhou | Guangdong | 510060 | China |
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| Peking University Shenzhen Hospital | Not yet recruiting | Shenzhen | Guangdong | 518000 | China |
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| The Second Affiliated Hospital of Guangxi University of Science and Technology | Not yet recruiting | Liuzhou | Guangxi | 545006 | China |
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| Liuzhou People's Hospital | Not yet recruiting | Liuzhou | Guangxi | 545200 | China |
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| Affiliated Cancer Hospital of Guangxi Medical Universit | Not yet recruiting | Nanning | Guangxi | 530028 | China |
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| The Affiiated Cancer Hospital of Guizhou Medical University | Not yet recruiting | Guiyang | Guizhou | 550000 | China |
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| Guizhou Provincial People's Hospital | Not yet recruiting | Guiyang | Guizhou | 550002 | China |
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| Hainan General Hospital | Not yet recruiting | Haikou | Hainan | 570311 | China |
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| The First Hospital of Qinhuangdao | Not yet recruiting | Qinhuangdao | Hebei | 066000 | China |
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| The Fourth Hospital of Hebei Medical University | Not yet recruiting | Shijiazhuang | Hebei | 050035 | China |
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| Tangshan People's Hospital | Not yet recruiting | Tangshan | Hebei | 063001 | China |
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| Harbin Medical University Cancer Hospital | Recruiting | Harbin | Heilongjiang | 150000 | China |
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| The First Affiliated Hospital of Harbin Medical University | Not yet recruiting | Harbin | Heilongjiang | 150000 | China |
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| Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital) | Not yet recruiting | Jiamusi | Heilongjiang | 154007 | China |
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| Mudanjiang Cancer Hospital | Not yet recruiting | Mudanjiang | Heilongjiang | 157009 | China |
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| AnYang Tumor Hospital | Not yet recruiting | Anyang | Henan | 455001 | China |
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| The First Affiliated Hospital of Henan University of Science & Technology | Not yet recruiting | Luoyang | Henan | 471000 | China |
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| Nanyang Second General Hospital | Not yet recruiting | Nanyang | Henan | 47300 | China |
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| The First Affiliated Hospital of Xinxiang Medical University | Not yet recruiting | Xinxiang | Henan | 453100 | China |
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| Henan Cancer Hospital | Not yet recruiting | Zhengzhou | Henan | 450000 | China |
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| The First Affiliated Hospital of Zhengzhou University | Not yet recruiting | Zhengzhou | Henan | 450052 | China |
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| Jingmen People's Hospital | Not yet recruiting | Jingmen | Hubei | 448000 | China |
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| Xiangyang Central Hospital | Not yet recruiting | Xiangyang | Hubei | 441021 | China |
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| The First People's Hospital of Changde City | Not yet recruiting | Changde | Hunan | 415000 | China |
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| Hunan Cancer Hospital | Not yet recruiting | Changsha | Hunan | 410000 | China |
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| People's Hospital of Hunan Province | Not yet recruiting | Changsha | Hunan | 410005 | China |
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| Xiangya Hospital of Central South University | Not yet recruiting | Changsha | Hunan | 410008 | China |
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| The Central Hospital of Yongzhou | Not yet recruiting | Yongzhou | Hunan | 425002 | China |
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| Zhangjiajie People's Hospital | Not yet recruiting | Zhangjiajie | Hunan | 427000 | China |
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| JiangSu Cancer Hosipital | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| The Affiliated Sir Run Run Hospital of Nanjing Medical University | Not yet recruiting | Nanjing | Jiangsu | 210000 | China |
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| Nanjing Drum Tower Hospital | Not yet recruiting | Nanjing | Jiangsu | 210031 | China |
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| Zhangjiagang First People's Hospital | Not yet recruiting | Suzhou | Jiangsu | 215600 | China |
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| Xuzhou Central Hospital | Not yet recruiting | Xuzhou | Jiangsu | 221009 | China |
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| Ganzhou Cancer Hospital | Not yet recruiting | Ganzhou | Jiangxi | 341000 | China |
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| Ganzhou People's Hospital | Not yet recruiting | Ganzhou | Jiangxi | 341001 | China |
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| Jiangxi Cancer Hospital | Not yet recruiting | Nanchang | Jiangxi | 330029 | China |
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| Jilin Cancer Hospital | Not yet recruiting | Changchun | Jilin | 130000 | China |
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| The first hospital of Jilin University | Not yet recruiting | Changchun | Jilin | 130400 | China |
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| Affiliated Zhongshan Hospital Of Dalian University | Not yet recruiting | Dalian | Liaoning | 116001 | China |
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| Shengjing Hospital of China Medical University | Not yet recruiting | Shenyang | Liaoning | 110021 | China |
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| Liaoning Cancer Hospital & Institute | Not yet recruiting | Shenyang | Liaoning | 110043 | China |
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| People's Hospital of Ningxia Hui Autonomous Region | Not yet recruiting | Yinchuan | Ningxia | 750000 | China |
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| Qinghai University Affiliated Hospital | Not yet recruiting | Xining | Qinghai | 810001 | China |
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| Bao Ji Central Hospital | Not yet recruiting | Baoji | Shaanxi | 721008 | China |
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| 3201 Hospital | Not yet recruiting | Hanzhong | Shaanxi | 723000 | China |
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| The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital) | Not yet recruiting | Xi'an | Shaanxi | 710004 | China |
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| Xijing Hospital of Air Force Military Medical University | Not yet recruiting | Xi'an | Shaanxi | 710032 | China |
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| Shandong Provincial Hospital Affiliated to Shandong First Medical University(Shandong Provincial Hospital) | Not yet recruiting | Jinan | Shandong | 250021 | China |
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| Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital) | Not yet recruiting | Jinan | Shandong | 250117 | China |
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| Linyi cancer Hospital | Not yet recruiting | Linyi | Shandong | 276000 | China |
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| Weifang People'S Hospital | Not yet recruiting | Weifang | Shandong | 261000 | China |
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| Shanxi Cancer Hospital | Not yet recruiting | Taiyuan | Shanxi | 030000 | China |
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| Yuncheng Central Hospital | Not yet recruiting | Yuncheng | Shanxi | 044099 | China |
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| Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital | Not yet recruiting | Chengdu | Sichuan | 610072 | China |
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| The Affiliated Hospital of Southwest Medical University | Not yet recruiting | Luzhou | Sichuan | 646000 | China |
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| Affiliated Hospital of North Sichuan Medical College | Not yet recruiting | Nanchong | Sichuan | 637000 | China |
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| Suining Central Hospital | Not yet recruiting | Suining | Sichuan | 629099 | China |
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| The Second People's Hospital of Yibin City | Not yet recruiting | Yibin | Sichuan | 644000 | China |
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| Tianjin Medical University Cancer Institute & Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300060 | China |
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| Tianjin Cancer Hospital Airport Hospital | Not yet recruiting | Tianjin | Tianjin Municipality | 300308 | China |
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| Xinjiang Medical University Affiliated Tumor Hospital | Not yet recruiting | Ürümqi | Xinjiang | 830000 | China |
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| Yunnan Cancer Hospital | Not yet recruiting | Kunming | Yunnan | 650000 | China |
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| Ningbo Medical Center Lihuili Hospital | Not yet recruiting | Ningbo | Zhejiang | 315000 | China |
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| Ningbono.2Hospitai | Not yet recruiting | Ningbo | Zhejiang | 315000 | China |
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| The First Affiliated Hospial of Ningbo University | Not yet recruiting | Ningbo | Zhejiang | 315000 | China |
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| The Second Affiliated Hospital of Wenzhou Medical University | Not yet recruiting | Wenzhou | Zhejiang | 325000 | China |
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