Actively Recruiting
TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2026-02-02
416
Participants Needed
69
Research Sites
175 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 time of consent
- Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
- Estimated life expectancy greater than 3 months
- Cytologically or histologically confirmed HER2-positive recurrent or metastatic breast cancer
- Received at least 2 prior lines of anti-HER2 targeted therapy in the advanced setting
- Have at least one measurable lesion per RECIST 1.1 criteria (excluding brain lesions)
- Willing to receive one of the investigator-selected chemotherapy regimens
- Adequate organ function
- Female participants of childbearing potential agree to use effective contraception during the study and for 6 months after completion
You will not qualify if you...
- Other malignancies within 5 years before randomization except treated non-melanoma skin cancer, in situ cervical cancer, or other cancers with curative treatment and no recurrence for 3 years
- Uncontrolled toxicities greater than 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 or venous thromboembolic events within 6 months before randomization
- History of drug abuse or psychiatric disorders affecting compliance
- Poorly controlled hypertension (e.g., systolic blood pressure over 160 mmHg despite treatment)
- Grade 2 or higher myocardial ischemia/infarction, arrhythmias, or congestive heart failure NYHA Class II or above
- Active or uncontrolled severe infections (CTCAE Grade 2 or above)
- Known chronic hepatitis B infection
- Active syphilis infection
- Renal failure requiring dialysis
- Immunodeficiency disorders such as HIV
- Poorly controlled diabetes
- Urine protein 2+ or higher with 24-hour urine protein over 1.0 g
- Epilepsy requiring medication
- Chemotherapy, radiotherapy, or immunotherapy within 4 weeks before randomization
- Use of Chinese herbal medicines with approved antitumor indications within 2 weeks
- Severe bone lesions from metastases
- Untreated brain metastases, leptomeningeal metastases, or carcinomatous meningitis
- Prior HER2-targeted therapy causing left ventricular ejection fraction decline below 50% or reduction over 15%
- Uncontrolled or symptomatic hypertension requiring ongoing bisphosphonates
- Uncontrolled cancer-related pain
- Existing lymphangitis carcinomatosa or uncontrolled effusions
- Use of immunosuppressants or systemic corticosteroids (prednisone equivalent 10 mg/day or more) within 2 weeks
- Severe hypersensitivity to monoclonal antibodies
- Participation in other antitumor clinical trials with investigational drugs within 4 weeks before randomization
- Any condition that may jeopardize safety or study completion as judged by the investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 69 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
Chong Qing University Cancer Hospital
Chongqing, Chongqing Municipality, China, 400030
Not Yet Recruiting
5
Fuzhou First Generel Hospital Affiliated with Fujian Medical University
Fuzhou, Fujian, China, 350009
Not Yet Recruiting
6
Gansu Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
7
Sun Yat - sen University Cancer Center
Guangzhou, Guangdong, China, 510060
Not Yet Recruiting
8
Peking University Shenzhen Hospital
Shenzhen, Guangdong, China, 518000
Not Yet Recruiting
9
Liuzhou People's Hospital
Liuzhou, Guangxi, China, 545200
Not Yet Recruiting
10
Affiliated Cancer Hospital of Guangxi Medical Universit
Nanning, Guangxi, China, 530028
Not Yet Recruiting
11
The Affiiated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550000
Not Yet Recruiting
12
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Not Yet Recruiting
13
Hainan General Hospital
Haikou, Hainan, China, 570311
Not Yet Recruiting
14
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, China, 066000
Not Yet Recruiting
15
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050035
Not Yet Recruiting
16
Tangshan People's Hospital
Tangshan, Hebei, China, 063001
Not Yet Recruiting
17
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, China, 150000
Actively Recruiting
18
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, China, 150000
Not Yet Recruiting
19
Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)
Jiamusi, Heilongjiang, China, 154007
Not Yet Recruiting
20
Mudanjiang Cancer Hospital
Mudanjiang, Heilongjiang, China, 157009
Not Yet Recruiting
21
AnYang Tumor Hospital
Anyang, Henan, China, 455001
Not Yet Recruiting
22
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, China, 471000
Not Yet Recruiting
23
Nanyang Second General Hospital
Nanyang, Henan, China, 47300
Not Yet Recruiting
24
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
Not Yet Recruiting
25
Henan Cancer Hospital
Zhengzhou, Henan, China, 450000
Not Yet Recruiting
26
Jingmen People's Hospital
Jingmen, Hubei, China, 448000
Not Yet Recruiting
27
Xiangyang Central Hospital
Xiangyang, Hubei, China, 441021
Not Yet Recruiting
28
The First People's Hospital of Changde City
Changde, Hunan, China, 415000
Not Yet Recruiting
29
Hunan Cancer Hospital
Changsha, Hunan, China, 410000
Not Yet Recruiting
30
People's Hospital of Hunan Province
Changsha, Hunan, China, 410005
Not Yet Recruiting
31
Xiangya Hospital of Central South University
Changsha, Hunan, China, 410008
Not Yet Recruiting
32
The Central Hospital of Yongzhou
Yongzhou, Hunan, China, 425002
Not Yet Recruiting
33
Zhangjiajie People's Hospital
Zhangjiajie, Hunan, China, 427000
Not Yet Recruiting
34
JiangSu Cancer Hosipital
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
35
The Affiliated Sir Run Run Hospital of Nanjing Medical University
Nanjing, Jiangsu, China, 210000
Not Yet Recruiting
36
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210031
Not Yet Recruiting
37
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, China, 215600
Not Yet Recruiting
38
Xuzhou Central Hospital
Xuzhou, Jiangsu, China, 221009
Not Yet Recruiting
39
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, China, 341000
Not Yet Recruiting
40
Ganzhou People's Hospital
Ganzhou, Jiangxi, China, 341001
Not Yet Recruiting
41
Jilin Cancer Hospital
Changchun, Jilin, China, 130000
Not Yet Recruiting
42
The first hospital of Jilin University
Changchun, Jilin, China, 130400
Not Yet Recruiting
43
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, China, 116001
Not Yet Recruiting
44
Shengjing Hospital of China Medical University
Shenyang, Liaoning, China, 110021
Not Yet Recruiting
45
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 110043
Not Yet Recruiting
46
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, China, 750000
Not Yet Recruiting
47
Qinghai University Affiliated Hospital
Xining, Qinghai, China, 810001
Not Yet Recruiting
48
Bao Ji Central Hospital
Baoji, Shaanxi, China, 721008
Not Yet Recruiting
49
3201 Hospital
Hanzhong, Shaanxi, China, 723000
Not Yet Recruiting
50
The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
Xi'an, Shaanxi, China, 710004
Not Yet Recruiting
51
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, China, 710032
Not Yet Recruiting
52
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, China, 250117
Not Yet Recruiting
53
Linyi cancer Hospital
Linyi, Shandong, China, 276000
Not Yet Recruiting
54
Weifang People'S Hospital
Weifang, Shandong, China, 261000
Not Yet Recruiting
55
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
56
Yuncheng Central Hospital
Yuncheng, Shanxi, China, 044099
Not Yet Recruiting
57
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610072
Not Yet Recruiting
58
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Not Yet Recruiting
59
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, China, 637000
Not Yet Recruiting
60
Suining Central Hospital
Suining, Sichuan, China, 629099
Not Yet Recruiting
61
The Second People's Hospital of Yibin City
Yibin, Sichuan, China, 644000
Not Yet Recruiting
62
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
63
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300308
Not Yet Recruiting
64
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
65
Yunnan Cancer Hospital
Kunming, Yunnan, China, 650000
Not Yet Recruiting
66
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
67
Ningbono.2Hospitai
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
68
The First Affiliated Hospial of Ningbo University
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
69
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
Q
Qingyuan Zhang, Doctor
CONTACT
J
Jinming Yu, Doctor
CONTACT
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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