Actively Recruiting
Randomized, Open-label Phase III Study of TQB2930 Plus Chemotherapy Versus Trastuzumab Plus Chemotherapy for HER2-Positive Advanced Breast Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2026-06-03
416
Participants Needed
75
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating treatments for HER2-positive advanced breast cancer in patients who have already received at least two prior anti-HER2 therapies. This Phase III clinical trial compares the effects and safety of TQB2930, a HER2 bispecific antibody drug, combined with chemotherapy, against trastuzumab combined with chemotherapy. The study aims to evaluate which treatment approach may better manage advanced breast cancer that has progressed despite prior therapies. Participants are randomly assigned to one of two groups. One group receives TQB2930 injection at 30 mg/kg every three weeks along with a chemotherapy agent chosen by the investigator, with each treatment cycle lasting 21 days. The other group receives trastuzumab starting with an 8 mg/kg dose followed by 6 mg/kg every three weeks, combined with investigator-selected chemotherapy, also given in 21-day cycles. Chemotherapy options include drugs like Capecitabine, Gemcitabine, Vinorelbine, or Eribulin. Throughout the study, participants undergo regular assessments to monitor disease progression and treatment response, including scans and evaluations lasting about one to two years. The main outcome measured is progression-free survival as assessed by an independent review committee. Additional outcomes include overall survival, duration of response, tumor response rates, and safety monitoring for adverse events. Blood samples are collected at specific cycles to measure drug levels and immune responses. The study includes safety follow-up for 90 days after the last dose or until another anticancer treatment begins.
CONDITIONS
Brief Title
TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to participate and sign informed consent
- Age between 18 and 75 years at consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy greater than 3 months
- Confirmed HER2-positive recurrent or metastatic breast cancer
- Received at least two prior lines of anti-HER2 targeted therapy for advanced disease
- At least one measurable lesion per RECIST 1.1 criteria (excluding brain lesions)
- Willing to receive investigator-selected chemotherapy regimen
- Adequate organ function
- Female participants of childbearing potential must agree to effective contraception during the study and for 6 months after
You will not qualify if you...
- Other malignancies within 5 years or concurrent cancers except certain treated skin or cervical cancers
- Uncontrolled toxicities greater than Grade 1 from prior therapies (except hair loss)
- Major surgery, open biopsy, or significant injury within 28 days before randomization
- Non-healing wounds or fractures
- Arterial or venous thromboembolic events within 6 months
- History of drug abuse or psychiatric disorders affecting compliance
- Poorly controlled hypertension (SBP >160 mmHg despite treatment)
- Grade 2 or higher myocardial ischemia, arrhythmias, or heart failure (NYHA Class II or above)
- Active or uncontrolled severe infections (Grade 2 or higher)
- Known chronic hepatitis B
- Active syphilis infection
- Renal failure requiring dialysis
- Immunodeficiency disorders such as HIV
- Poorly controlled diabetes
- Significant proteinuria
- Epilepsy requiring medication
- Recent chemotherapy, radiotherapy, or immunotherapy within 4 weeks
- Use of Chinese herbal medicines with antitumor indications within 2 weeks
- Severe bone lesions from metastases
- Untreated brain metastases or leptomeningeal disease
- Prior HER2 therapy-related significant heart function decline
- Uncontrolled or symptomatic hypertension requiring bisphosphonates
- Uncontrolled cancer-related pain
- Lymphangitis carcinomatosa or uncontrolled effusions
- Use of immunosuppressants or corticosteroids above specified doses within 2 weeks
- Severe hypersensitivity to monoclonal antibodies
- Participation in other investigational antitumor trials within 4 weeks
- Any condition that risks safety or study completion
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Repeated 21-day cycles until disease progression or discontinuation
Participants receive TQB2930 or trastuzumab injections in combination with chemotherapy drugs every 3 weeks in repeated 21-day cycles.
Visits every 3 weeks for treatment dosing and assessments
Duration - Up to approximately 90 days after the last dose and up to 2 years for survival monitoring
Participants are monitored for safety and survival after completing treatment.
Periodic visits up to 2 years for survival and safety assessments
Trial Site Locations
Total: 75 locations
1
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China, 233060
Not Yet Recruiting
2
Anhui Provincial Hospital( The First Affiliated Hospital of USTC)
Hefei, Anhui, China, 230001
Not Yet Recruiting
3
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China, 230001
Not Yet Recruiting
4
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, China, 100071
Not Yet Recruiting
5
Chong Qing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Not Yet Recruiting
6
Fuzhou First Generel Hospital Affiliated with Fujian Medical University
Fuzhou, Fujian, China, 350009
Not Yet Recruiting
7
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
8
Gansu Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
9
Sun Yat - sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
10
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518000
Not Yet Recruiting
11
The Second Affiliated Hospital of Guangxi University of Science and Technology
Liuzhou, Guangxi, China, 545006
Not Yet Recruiting
12
Liuzhou People's Hospital
Liuzhou, Guangxi, China, 545200
Not Yet Recruiting
13
Affiliated Cancer Hospital of Guangxi Medical Universit
Nanning, Guangxi, China, 530028
Not Yet Recruiting
14
The Affiiated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550000
Not Yet Recruiting
15
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Not Yet Recruiting
16
Hainan General Hospital
Haikou, Hainan, China, 570311
Not Yet Recruiting
17
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, China, 066000
Not Yet Recruiting
18
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050035
Not Yet Recruiting
19
Tangshan People's Hospital
Tangshan, Hebei, China, 063001
Not Yet Recruiting
20
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
21
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
22
Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)
Jiamusi, Heilongjiang, China, 154007
Not Yet Recruiting
23
Mudanjiang Cancer Hospital
Mudanjiang, Heilongjiang, China, 157009
Not Yet Recruiting
24
AnYang Tumor Hospital
Anyang, Henan, China, 455001
Not Yet Recruiting
25
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 471000
Not Yet Recruiting
26
Nanyang Second General Hospital
Nanyang, Henan, China, 47300
Not Yet Recruiting
27
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
Not Yet Recruiting
28
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
29
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 450052
Not Yet Recruiting
30
Jingmen People's Hospital
Jingmen, Hubei, China, 448000
Not Yet Recruiting
31
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
Not Yet Recruiting
32
The First People's Hospital of Changde City
Changde, Hunan, China, 415000
Not Yet Recruiting
33
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
34
People's Hospital of Hunan Province
Changsha, Hunan, China, 410005
Not Yet Recruiting
35
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
36
The Central Hospital of Yongzhou
Yongzhou, Hunan, China, 425002
Not Yet Recruiting
37
Zhangjiajie People's Hospital
Zhangjiajie, Hunan, China, 427000
Not Yet Recruiting
38
JiangSu Cancer Hosipital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
39
The Affiliated Sir Run Run Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
40
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210031
Not Yet Recruiting
41
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, China, 215600
Not Yet Recruiting
42
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Not Yet Recruiting
43
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, China, 341000
Not Yet Recruiting
44
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 341001
Not Yet Recruiting
45
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
46
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Not Yet Recruiting
47
The first hospital of Jilin University
Changchun, Jilin, China, 130400
Not Yet Recruiting
48
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, China, 116001
Not Yet Recruiting
49
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110021
Not Yet Recruiting
50
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110043
Not Yet Recruiting
51
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China, 750000
Not Yet Recruiting
52
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810001
Not Yet Recruiting
53
Bao Ji Central Hospital
Baoji, Shaanxi, China, 721008
Not Yet Recruiting
54
3201 Hospital
Hanzhong, Shaanxi, China, 723000
Not Yet Recruiting
55
The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
Xi'an, Shaanxi, China, 710004
Not Yet Recruiting
56
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China, 710032
Not Yet Recruiting
57
Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital）
Jinan, Shandong, China, 250021
Not Yet Recruiting
58
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, China, 250117
Not Yet Recruiting
59
Linyi cancer Hospital
Linyi, Shandong, China, 276000
Not Yet Recruiting
60
Weifang People'S Hospital
Weifang, Shandong, China, 261000
Not Yet Recruiting
61
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
62
Yuncheng Central Hospital
Yuncheng, Shanxi, China, 044099
Not Yet Recruiting
63
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
64
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Not Yet Recruiting
65
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China, 637000
Not Yet Recruiting
66
Suining Central Hospital
Suining, Sichuan, China, 629099
Not Yet Recruiting
67
The Second People's Hospital of Yibin City
Yibin, Sichuan, China, 644000
Not Yet Recruiting
68
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
69
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300308
Not Yet Recruiting
70
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
71
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650000
Not Yet Recruiting
72
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
73
Ningbono.2Hospitai
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
74
The First Affiliated Hospial of Ningbo University
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
75
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
Q
Qingyuan Zhang, Doctor
J
Jinming Yu, Doctor
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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