TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer
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
1 other identifier
interventional
416
1 country
69
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Jul 2025
Typical duration for phase_3
69 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 24, 2025
CompletedFirst Posted
Study publicly available on registry
July 2, 2025
CompletedStudy Start
First participant enrolled
July 25, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2028
February 2, 2026
May 1, 2025
2.9 years
June 24, 2025
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Progression-free survival (PFS)
Independent Imaging Review Committee (IRC)-assessed PFS
Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years
Secondary Outcomes (10)
PFS assessed by Investigator
Baseline up to Investigator-Assessed investigator, approximately 1 years
Overall survival (OS)
From date of the first dose until the date of death from any cause, up to approximately 2 years
Duration of Response (DOR)
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)
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)
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
- +5 more secondary outcomes
Study Arms (2)
TQB2930+ chemotherapy
EXPERIMENTALSubjects 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.
Trastuzumab+ chemotherapy
ACTIVE COMPARATORSubjects 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.
Interventions
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.
Trastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Concurrent Diseases and Medical History:
- Other malignancies within 5 years before randomization or concurrent malignancies (except adequately treated non-melanoma skin cancer, in situ cervical cancer, or other cancers with curative treatment and no recurrence for ≥3 years);
- Uncontrolled toxicities (\>CTCAE Grade 1) from prior therapies (excluding alopecia);
- Major surgery, open biopsy, or significant traumatic injury within 28 days before randomization;
- Non-healing wounds or fractures;
- Arterial/venous thromboembolic events within 6 months before randomization;
- History of drug abuse or psychiatric disorders that may affect compliance;
- Poorly controlled hypertension (e.g., Systolic Blood Pressure (SBP) \>160 mmHg despite treatment);
- ≥Grade 2 myocardial ischemia/infarction, arrhythmias, or congestive heart failure (New York Heart Association （NYHA）Class ≥II);
- Active or uncontrolled severe infections (≥CTCAE Grade 2);
- Known chronic hepatitis B;
- Active syphilis infection;
- Renal failure requiring hemodialysis/peritoneal dialysis;
- Immunodeficiency disorders (e.g., Human Immunodeficiency Virus (HIV) ;
- Poorly controlled diabetes;
- +15 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (69)
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233060, China
Anhui Provincial Hospital( The First Affiliated Hospital of USTC)
Hefei, Anhui, 230001, China
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001, China
Chong Qing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030, China
Fuzhou First Generel Hospital Affiliated with Fujian Medical University
Fuzhou, Fujian, 350009, China
Gansu Cancer Hospital
Lanzhou, Gansu, 730050, China
Sun Yat - sen University Cancer Center
Guangzhou, Guangdong, 510060, China
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000, China
Liuzhou People's Hospital
Liuchow, Guangxi, 545200, China
Affiliated Cancer Hospital of Guangxi Medical Universit
Nanning, Guangxi, 530028, China
The Affiiated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Hainan General Hospital
Haikou, Hainan, 570311, China
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050035, China
Tangshan People's Hospital
Tangshan, Hebei, 063001, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000, China
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000, China
Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)
Jiamusi, Heilongjiang, 154007, China
Mudanjiang Cancer Hospital
Mudanjiang, Heilongjiang, 157009, China
AnYang Tumor Hospital
Anyang, Henan, 455001, China
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000, China
Nanyang Second General Hospital
Nanyang, Henan, 47300, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100, China
Henan Cancer Hospital
Zhengzhou, Henan, 450000, China
Jingmen People's Hospital
Jingmen, Hubei, 448000, China
Xiangyang Central Hospital
Xiangyang, Hubei, 441021, China
The First People's Hospital of Changde City
Changde, Hunan, 415000, China
Hunan Cancer Hospital
Changsha, Hunan, 410000, China
People's Hospital of Hunan Province
Changsha, Hunan, 410005, China
Xiangya Hospital of Central South University
Changsha, Hunan, 410008, China
The Central Hospital of Yongzhou
Yongzhou, Hunan, 425002, China
Zhangjiajie People's Hospital
Zhangjiajie, Hunan, 427000, China
JiangSu Cancer Hosipital
Nanjing, Jiangsu, 210000, China
The Affiliated Sir Run Run Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210031, China
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, 215600, China
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009, China
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, 341000, China
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341001, China
Jilin Cancer Hospital
Changchun, Jilin, 130000, China
The first hospital of Jilin University
Changchun, Jilin, 130400, China
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, 116001, China
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110021, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110043, China
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750000, China
Qinghai University Affiliated Hospital
Xining, Qinghai, 810001, China
Bao Ji Central Hospital
Baoji, Shaanxi, 721008, China
3201 Hospital
Hanzhong, Shaanxi, 723000, China
The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
Xi'an, Shaanxi, 710004, China
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032, China
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, 250117, China
Linyi cancer Hospital
Linyi, Shandong, 276000, China
Weifang People'S Hospital
Weifang, Shandong, 261000, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000, China
Suining Central Hospital
Suining, Sichuan, 629099, China
The Second People's Hospital of Yibin City
Yibin, Sichuan, 644000, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308, China
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, 830000, China
Yunnan Cancer Hospital
Kunming, Yunnan, 650000, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000, China
Ningbono.2Hospitai
Ningbo, Zhejiang, 315000, China
The First Affiliated Hospial of Ningbo University
Ningbo, Zhejiang, 315000, China
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 24, 2025
First Posted
July 2, 2025
Study Start
July 25, 2025
Primary Completion (Estimated)
June 1, 2028
Study Completion (Estimated)
December 1, 2028
Last Updated
February 2, 2026
Record last verified: 2025-05