A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
A Randomized, Open-label, Multicenter, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus TCbHP in Neoadjuvant Treatment of Breast Cancer With Positive HER2 Expression
1 other identifier
interventional
544
1 country
78
Brief Summary
This is a randomized, open, positive drug control, multi center phase III study. Through the evaluation of tpCR, bpCR, ORR, EFS, IDFS, OS , AEs and other indicators, it proves the effectiveness and safety of TQB2102 for injection versus TCbHP in the neoadjuvant treatment of HER2 positive breast cancer patients.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Sep 2025
Typical duration for phase_3
78 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 20, 2025
CompletedFirst Posted
Study publicly available on registry
June 29, 2025
CompletedStudy Start
First participant enrolled
September 15, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
September 1, 2029
March 27, 2026
August 1, 2025
2 years
June 20, 2025
March 26, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC)
Rate of subjects with no residual invasive cancer in the primary breast lesion and negative regional lymph nodes upon microscopic examination after primary tumor resection, as assessed by IRC.
Up to 26 months after study start
Secondary Outcomes (8)
Rate of total physiological complete response (tpCR) evaluated by the investigator
Up to 24 months after study start
Breast pathological complete response (bpCR) evaluated by IRC and the investigator
Up to 26 months after study start
Objective response rate (ORR)
Up to 22 months after study start
There year Event-free survival (EFS)
Up to 50 months after study start
There year Invasive Disease-free survival (IDFS)
Up to 50 months after study start
- +3 more secondary outcomes
Study Arms (2)
TQB2102 for injection
EXPERIMENTAL6mg/kg TQB2102 for injection, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 8 cycles.
Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
ACTIVE COMPARATORTrastuzumab injection (The first dose is 8mg/kg, followed by 6mg/kg), Pertuzumab Injection (The first dose is 840, followed by 420mg), Docetaxel Injection (75mg/m2 ) combined with Carboplatin Injection (AUC-6, 800 mg max), Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 6 cycles.
Interventions
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
TCbHP is a commonly used chemotherapy scheme for HER2 positive breast cancer. H represents Trastuzumab injection, P represents Pertuzumab Injection, T represents Docetaxel injection and C represents Carboplatin injection.
Eligibility Criteria
You may qualify if:
- Voluntarily participate in this study, sign the informed consent form, and have good compliance;
- Eastern Cooperative Oncology Group performance status (ECOG PS) score: 0-1; expected survival \>6 months;
- Histologically or cytologically confirmed HER2-positive invasive breast cancer;
- Hormone receptor (HR) status confirmed;
- Clinical stage at diagnosis: T2-4 with any N, M0, or any T with N1-3, M0;
- Agree to undergo breast cancer resection if meeting surgical criteria after neoadjuvant therapy;
- Major organ function is adequate, meeting specific criteria;
- Must agree to use contraception during the study and for 6 months after study completion; female patients must have a negative serum pregnancy test within 7 days before enrollment and must not be lactating; male subjects must agree to use contraception during the study and for 6 months after study completion
You may not qualify if:
- Stage IV metastatic breast cancer or other cases judged by the investigator as unsuitable for radical surgical resection after neoadjuvant therapy;
- Bilateral breast cancer 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, surgery, etc.;
- Comorbidities and medical history:
- Other malignancies within 5 years or currently;
- Adverse reactions from prior treatment not recovered to CTCAE v5.0 grade ≤1;
- Major surgery, significant traumatic injury within 4 weeks before first dose, or anticipated major surgery during the study, or unhealed wounds/fractures;
- Conditions affecting intravenous injection or blood sampling;
- Congenital bleeding or coagulation disorders, or bleeding/coagulation disorders within 28 days before study treatment, or use of aspirin \>325 mg/day (maximum antiplatelet dose), dipyridamole, ticlopidine, clopidogrel, or cilostazol within 7 days before study treatment;
- Arterial/deep venous thrombotic events within 6 months before first dose, e.g., cerebrovascular accident, deep vein thrombosis, pulmonary embolism;
- Poorly controlled blood pressure (systolic ≥150 mmHg or diastolic ≥100 mmHg);
- Significant cardiovascular disease, including；
- Uncontrolled ≥CTCAE grade 2 infection within 14 days before study treatment;
- History of interstitial lung disease/pneumonitis (non-infectious) requiring steroid treatment, current interstitial lung disease/pneumonitis, or suspected interstitial lung disease/pneumonitis on screening imaging that cannot be ruled out;
- +11 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (78)
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000, China
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000, China
The First Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, 241000, China
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005, China
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142, China
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010, China
The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center
Chongqing, Chongqing Municipality, 400030, China
The First Hospital Affiliated to Army Medical University
Chongqing, Chongqing Municipality, 400038, China
Quanzhou First Hospital
Quanzhou, Fujian, 362000, China
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000, China
Zhongshan Hospital Xiamen university
Xiamen, Fujian, 361006, China
ZhangZhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363099, China
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000, China
Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050, China
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 730000, China
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000, China
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000, China
Meizhou People's Hospital
Meizhou, Guangdong, 514000, China
Shantou Central Hospital
Shantou, Guangdong, 515031, China
Guigang City People's Hospital
Guigang, Guangxi, 537300, China
Guangxi Cancer Institutu (Guangxi Cancer Hospital, Guangxi Medical University Cancer Hospital, Guangxi Cancer Center)
Nanning, Guangxi, 530021, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530022, China
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001, China
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002, China
Cangzhou Central Hospital
Cangzhou, Hebei, 061012, China
First Hospital of QinHuangDao
Qinhuangdao, Hebei, 066099, China
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050035, China
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, 154002, China
Harbin Medical University Cancer Hospital
Harbin, Heilongjinag, 150081, China
Anyang Tumor Hospital
Anyang, Henan, 455001, China
The People's Hospital of Anyang City
Anyang, Henan, 455099, China
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000, China
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100, China
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 453000, China
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000, China
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000, China
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011, China
Xiangya Hospital Central South University
Changsha, Hunan, 410028, China
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421200, China
Xiangya Hospital ZhuZhou Central South University
Zhuzhou, Hunan, 412007, China
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24000, China
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029, China
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210031, China
NanChang People's Hospital
Nanchang, Jiangxi, 330009, China
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029, China
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000, China
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012, China
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110000, China
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002, China
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 111000, China
The First Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
Xi'an, Shaanxi, 710005, China
The Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
Xi'an, Shaanxi, 710038, China
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061, China
Cancer Hospital of Shandong First Medical University, Shandong Cancer Institute, Shandong Cancer Hospital
Jinan, Shandong, 250117, China
Linyi Cancer Hospital
Linyi, Shandong, 276034, China
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, 271000, China
WeiFang People's Hospital
Weifang, Shandong, 261000, China
Weihai Municipal Hospital
Weihai, Shandong, 264299, China
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000, China
Zibo Central Hospital
Zibo, Shandong, China
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030, China
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200052, China
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000, China
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001, China
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099, China
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610031, China
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000, China
The Second People's Hospital of YiBin
Yibin, Sichuan, 644000, China
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300060, China
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060, China
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, 830000, China
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, 830000, China
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000, China
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000, China
Shaoxing People's Hospital
Shaoxing, Zhejiang, 212300, China
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000, China
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000, China
MeSH Terms
Interventions
Intervention Hierarchy (Ancestors)
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 20, 2025
First Posted
June 29, 2025
Study Start
September 15, 2025
Primary Completion (Estimated)
September 1, 2027
Study Completion (Estimated)
September 1, 2029
Last Updated
March 27, 2026
Record last verified: 2025-08