Actively Recruiting
A Randomized, Open-label Phase III Trial Comparing TQB2102 Injection Versus TCbHP Chemotherapy for Neoadjuvant Treatment of HER2-positive Breast Cancer
Led by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. · Updated on 2026-03-27
544
Participants Needed
78
Research Sites
104 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of TQB2102 for injection compared to a standard chemotherapy regimen called TCbHP in patients with HER2-positive breast cancer. This phase III, randomized, open-label, multi-center study focuses on neoadjuvant treatment, which is therapy given before surgery. The study aims to measure the total pathological complete response and other outcomes such as event-free survival and overall survival. Participants receive either TQB2102 for injection at 6 mg/kg by intravenous infusion every 3 weeks for 8 cycles or a combination of Trastuzumab, Pertuzumab, Docetaxel, and Carboplatin given intravenously every 3 weeks for 6 cycles. The study monitors participants throughout the treatment period and collects data on tumor response and side effects. During the study, participants will undergo assessments including tumor response evaluations by independent review and investigators, safety monitoring for adverse events, and laboratory tests. Follow-up will continue for up to 50 months after the start of the study to observe long-term outcomes. Participants are expected to comply with contraceptive use requirements and attend all scheduled visits for treatment and evaluations.
CONDITIONS
Brief Title
A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Voluntarily agree to join and sign informed consent with good compliance
- ECOG performance status score of 0 or 1 with expected survival over 6 months
- Confirmed HER2-positive invasive breast cancer by histology or cytology
- Hormone receptor status confirmed
- Clinical stage T2-4 with any N, M0 or any T with N1-3, M0
- Agree to breast cancer surgery after neoadjuvant therapy if criteria are met
- Adequate major organ function as specified
- Agree to use contraception during study and for 6 months after completion; females with negative pregnancy test within 7 days before enrollment and not breastfeeding; males agreeing to contraception during study and for 6 months after
You will not qualify if you...
- Stage IV metastatic breast cancer or unsuitable for surgery after neoadjuvant therapy
- Bilateral or inflammatory breast cancer
- History of invasive breast cancer or ductal carcinoma in situ
- Prior anti-tumor therapy for breast cancer including chemotherapy, endocrine therapy, targeted therapy, radiotherapy, or surgery
- Other malignancies within 5 years or current malignancies
- Unrecovered adverse reactions from prior treatments above CTCAE grade 1
- Major surgery or significant injury within 4 weeks before first dose, unhealed wounds or fractures
- Conditions affecting intravenous injection or blood sampling
- Bleeding or coagulation disorders or use of certain blood-thinning medications before study
- Arterial or deep venous thrombotic events within 6 months before first dose
- Poorly controlled high blood pressure
- Significant cardiovascular disease
- Uncontrolled infection grade 2 or higher within 14 days before treatment
- History or presence of interstitial lung disease or pneumonitis requiring steroids or suspected on screening
- Prior biopsy or surgery of primary tumor or lymph nodes before study treatment
- Treatment with chemotherapy, radiotherapy, or other anti-tumor therapy within 3 weeks before study
- Prior taxane or carboplatin therapy for any cancer
- Use of traditional Chinese medicine with anti-tumor indications within 2 weeks before study
- Severe allergy to monoclonal antibodies or any study drug components
- Uncontrolled autoimmune disease within 2 weeks before treatment
- Live vaccination within 28 days before treatment
- Any condition that may risk safety or study completion as judged by investigator
AI-Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 18 to 24 weeks depending on assigned treatment
Participants receive either TQB2102 injection or a combination chemotherapy regimen as neoadjuvant treatment for HER2-positive breast cancer.
6 to 8 intravenous infusion visits every 3 weeks
Duration - Up to 50 months after study start
Participants are monitored for treatment response and adverse events after completing neoadjuvant therapy and surgery.
Visits scheduled periodically for up to 50 months
Trial Site Locations
Total: 78 locations
1
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, China, 233000
Not Yet Recruiting
2
Anhui Provincial Cancer Hospital
Hefei, Anhui, China, 230000
Not Yet Recruiting
3
The First Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, China, 241000
Not Yet Recruiting
4
Peking Union Medical College Hospital
Beijing, Beijing Municipality, China, 100005
Not Yet Recruiting
5
Beijing Cancer Hospital
Beijing, Beijing Municipality, China, 100142
Not Yet Recruiting
6
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
7
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China, 400010
Not Yet Recruiting
8
The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center
Chongqing, Chongqing Municipality, China, 400030
Not Yet Recruiting
9
The First Hospital Affiliated to Army Medical University
Chongqing, Chongqing Municipality, China, 400038
Not Yet Recruiting
10
Quanzhou First Hospital
Quanzhou, Fujian, China, 362000
Not Yet Recruiting
11
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, China, 362000
Not Yet Recruiting
12
Zhongshan Hospital Xiamen university
Xiamen, Fujian, China, 361006
Not Yet Recruiting
13
ZhangZhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, China, 363099
Not Yet Recruiting
14
The First Hospital of Lanzhou University
Lanzhou, Gansu, China, 730000
Not Yet Recruiting
15
Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital
Lanzhou, Gansu, China, 730050
Not Yet Recruiting
16
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, China, 730000
Not Yet Recruiting
17
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
18
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, China, 510000
Not Yet Recruiting
19
Meizhou People's Hospital
Meizhou, Guangdong, China, 514000
Not Yet Recruiting
20
Shantou Central Hospital
Shantou, Guangdong, China, 515031
Not Yet Recruiting
21
Guigang City People's Hospital
Guigang, Guangxi, China, 537300
Not Yet Recruiting
22
Guangxi Cancer Institutu (Guangxi Cancer Hospital, Guangxi Medical University Cancer Hospital, Guangxi Cancer Center)
Nanning, Guangxi, China, 530021
Not Yet Recruiting
23
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China, 530022
Not Yet Recruiting
24
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, China, 550001
Not Yet Recruiting
25
Guizhou Provincial People's Hospital
Guiyang, Guizhou, China, 550002
Not Yet Recruiting
26
Cangzhou Central Hospital
Cangzhou, Hebei, China, 061012
Not Yet Recruiting
27
First Hospital of QinHuangDao
Qinhuangdao, Hebei, China, 066099
Not Yet Recruiting
28
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, China, 050035
Not Yet Recruiting
29
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, China, 154002
Actively Recruiting
30
Harbin Medical University Cancer Hospital
Harbin, Heilongjinag, China, 150081
Not Yet Recruiting
31
Anyang Tumor Hospital
Anyang, Henan, China, 455001
Not Yet Recruiting
32
The People's Hospital of Anyang City
Anyang, Henan, China, 455099
Not Yet Recruiting
33
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China, 471000
Not Yet Recruiting
34
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, China, 453100
Not Yet Recruiting
35
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China, 453000
Not Yet Recruiting
36
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, China, 430000
Not Yet Recruiting
37
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, China, 430000
Not Yet Recruiting
38
The Second Xiangya Hospital of Central South University
Changsha, Hunan, China, 410011
Not Yet Recruiting
39
Xiangya Hospital Central South University
Changsha, Hunan, China, 410028
Not Yet Recruiting
40
The First Affiliated Hospital of University of South China
Hengyang, Hunan, China, 421200
Not Yet Recruiting
41
Xiangya Hospital ZhuZhou Central South University
Zhuzhou, Hunan, China, 412007
Not Yet Recruiting
42
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, China, 24000
Not Yet Recruiting
43
Jiangsu Province Hospital
Nanjing, Jiangsu, China, 210029
Not Yet Recruiting
44
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, China, 210031
Not Yet Recruiting
45
NanChang People's Hospital
Nanchang, Jiangxi, China, 330009
Not Yet Recruiting
46
Jiangxi Cancer Hospital
Nanchang, Jiangxi, China, 330029
Not Yet Recruiting
47
The First Bethune Hospital of Jilin University
Changchun, Jilin, China, 130000
Not Yet Recruiting
48
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, China, 121012
Not Yet Recruiting
49
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, China, 110000
Not Yet Recruiting
50
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, China, 110002
Not Yet Recruiting
51
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, China, 111000
Not Yet Recruiting
52
The First Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
Xi'an, Shaanxi, China, 710005
Not Yet Recruiting
53
The Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
Xi'an, Shaanxi, China, 710038
Not Yet Recruiting
54
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, China, 710061
Not Yet Recruiting
55
Cancer Hospital of Shandong First Medical University, Shandong Cancer Institute, Shandong Cancer Hospital
Jinan, Shandong, China, 250117
Actively Recruiting
56
Linyi Cancer Hospital
Linyi, Shandong, China, 276034
Not Yet Recruiting
57
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, China, 271000
Not Yet Recruiting
58
WeiFang People's Hospital
Weifang, Shandong, China, 261000
Not Yet Recruiting
59
Weihai Municipal Hospital
Weihai, Shandong, China, 264299
Not Yet Recruiting
60
Yantai Yuhuangding Hospital
Yantai, Shandong, China, 264000
Not Yet Recruiting
61
Zibo Central Hospital
Zibo, Shandong, China
Not Yet Recruiting
62
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, China, 200030
Actively Recruiting
63
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, China, 200052
Not Yet Recruiting
64
Shanxi Cancer Hospital
Taiyuan, Shanxi, China, 030000
Not Yet Recruiting
65
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, China, 030001
Not Yet Recruiting
66
Yuncheng Central Hospital
Yuncheng, Shanxi, China, 044099
Not Yet Recruiting
67
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, China, 610031
Not Yet Recruiting
68
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, China, 646000
Not Yet Recruiting
69
The Second People's Hospital of YiBin
Yibin, Sichuan, China, 644000
Not Yet Recruiting
70
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
71
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, China, 300060
Not Yet Recruiting
72
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
73
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, China, 830000
Not Yet Recruiting
74
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
75
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, China, 315000
Not Yet Recruiting
76
Shaoxing People's Hospital
Shaoxing, Zhejiang, China, 212300
Not Yet Recruiting
77
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, China, 317000
Not Yet Recruiting
78
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, China, 325000
Not Yet Recruiting
Research Team
Z
Zhimin Shao, Doctor
C
Caigang Liu, 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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