HER2-positive Breast CancerPhase 3NCT07043725
A Clinical Study of Neoadjuvant Treatment With TQB2102 for Injection for Human Epidermal Growth Factor Receptor 2 (HER2) Positive Breast Cancer
A Phase 3 study testing TQB2102 for injection and Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection in people with HER2-positive Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 77 sites in China.
Trial 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 Active Comparator in the neoadjuvant treatment of HER2 positive breast cancer… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- HER2-positive Breast Cancer
- What is being tested?
- TQB2102 for injection and Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 544 participants
- Where
- 77 sitesChina
- Study dates
- 15 Sep 2025to Sep 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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;
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- 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;
- Tumor-related symptoms and treatment:
- Prior excisional biopsy of primary tumor and/or axillary lymph nodes or sentinel lymph node biopsy before study treatment;
- Surgery, chemotherapy, radiotherapy, or other anti-tumor therapy within 3 weeks before study treatment (washout period calculated from last treatment);
- Prior taxane or carboplatin therapy for any malignancy;
- Treatment with National Medical Products Administration-approved traditional Chinese medicine with clear anti-tumor indications within 2 weeks before study treatment.
- Study treatment-related:
- Severe hypersensitivity to monoclonal antibodies;
- Uncontrolled active autoimmune disease within 2 weeks before study treatment;
- Allergy to any study drug or its components/excipients;
- Live vaccination within 28 days before study treatment, including measles, mumps, rubella, varicella, yellow fever, seasonal flu, Influenza A virus subtype (H1N1) flu, rabies, Bacille Calmette-Guerin vaccine (BCG), and typhoid vaccines.
- Any condition judged by the investigator to jeopardize subject safety or study completion.
Trial locations and contacts
77 sites in 1 country. Contact the study team or a site near you to ask about taking part.
77 sites in 1 country
China77 sites, 77 recruiting
- Not yet recruiting
Anyang Tumor Hospital
Anyang, Henan, 455001
Haiqvan Jia, Master, 15037238358, jiahaiquan666@126.com
- Not yet recruiting
The People's Hospital of Anyang City
Anyang, Henan, 455099
Yong Zhang, Doctor, 16637230379, zy13700726935@163.com
- Not yet recruiting
Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100005
Yidong Zhou, Doctor, 1350107228, zhouyd@pumch.cn
- Not yet recruiting
Beijing Cancer Hospital
Beijing, Beijing Municipality, 100142
Zhaoqing Fan, Doctor, 13601052226, zhqfan@sina.com
- Not yet recruiting
The First Affiliated Hospital of Bengbu Medical University
Bengbu, Anhui, 233000
Gongsheng Jin, Doctor, 13095520028, jgs2007@qq.com
- Not yet recruiting
Cangzhou Central Hospital
Cangzhou, Hebei, 061012
Guozhong Cui, Master, 13315777876, 916291826@qq.com
- Not yet recruiting
The First Bethune Hospital of Jilin University
Changchun, Jilin, 130000
Dong Song, Doctor, 13943189777, songdong117@126.com
- Not yet recruiting
The Second Xiangya Hospital of Central South University
Changsha, Hunan, 410011
Wenjun Yi, Master, 18608403318, xiaoyun199@126.com
- Not yet recruiting
Xiangya Hospital Central South University
Changsha, Hunan, 410028
Zhi Xiao, Doctor, 18975138230, zhixiao@csu.edu.cn
- Not yet recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610031
Jing Luo, Doctor, 18981838521, jingluopi@163.com
- Not yet recruiting
Chifeng Municipal Hospital
Chifeng, Inner Mongolia, 24000
Yingqi Wu, Bachelor, 18047660376, cfwyq2008@163.com
Yashun Qiao, Master, 18047664999, 42033732@qq.com
- Not yet recruiting
The First Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Qiao Cheng, Doctor, 13098794661, Chengqiaocyfy@163.com
- Not yet recruiting
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, 400010
Guobing Yin, Doctor, 15823267119, 285243608@qq.com
- Not yet recruiting
The Cancer Hospital Affiliated to Chongqing University, Chongqing Cancer Hospital, Chongqing Cancer Research Institute, and Chongqing Cancer Center
Chongqing, Chongqing Municipality, 400030
Xiaoyu Liu, Master, 13883276180, xiaoyuliu1219@163.com
- Not yet recruiting
The First Hospital Affiliated to Army Medical University
Chongqing, Chongqing Municipality, 400038
Yi Zhang, Doctor, 13983701489, zhangyi1489@sina.com
- Not yet recruiting
Sun Yat-sen Memorial Hospital, Sun Yat-sen University
Guangzhou, Guangdong, 510000
Ying Wang, Doctor, 13925038181, yingwang1101@126.com
Jianli Zhao, Doctor, 15920589334, zhaojli5@mail.sysu@edu.cn
- Not yet recruiting
The Second Affiliated Hospital of Guangzhou Medical University
Guangzhou, Guangdong, 510000
Xinxin Chen, Master, 13922295490, Janechew@163.com
- Not yet recruiting
Guigang City People's Hospital
Guigang, Guangxi, 537300
Shunchong Xiao, Master, 13978584740, 263092840@qq.com
- Not yet recruiting
The Affiliated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550001
Zhihong Wang, Bachelor, 13595159308, wzh1968626@sina.com
- Not yet recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Yuzhe Gao, Bachelor, 15985183677, gyzhe2004@126.com
- Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjinag, 150081
Tong Liu, Doctor, 15945953777, tomtomtomliu@126.com
- Not yet recruiting
Anhui Provincial Cancer Hospital
Hefei, Anhui, 230000
Shikai Hong, Doctor, 18963789035, shikhong@163.com
- Not yet recruiting
The First Affiliated Hospital of University of South China
Hengyang, Hunan, 421200
Zecheng Hu, Doctor, 13875710120, 22069496@qq.com
- Recruiting
Jiamusi Cancer Hospital
Jiamusi, Heilongjiang, 154002
Hongmei Sun, Bachelor, 15344540000, shm1357@163.com
- Recruiting
Cancer Hospital of Shandong First Medical University, Shandong Cancer Institute, Shandong Cancer Hospital
Jinan, Shandong, 250117
Pengfei Qiu, Doctor, 18615205204, qiupengfei2002@aliyun.com
- Not yet recruiting
The First Affiliated Hospital of Jinzhou Medical University
Jinzhou, Liaoning, 121012
Wei Tao, Doctor, 13840625077, tw198122@sina.com
- Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoling Ling, Master, 18693265668, lingxiaolingedu@163.com
- Not yet recruiting
Gansu Provincial Academic Institute for Medical Research, Gansu Provincial Cancer Hospital
Lanzhou, Gansu, 730050
Xiaorong Bai, Bachelor, 13893217378, 13893217378@163.com
Yanxiang Guo, Bachelor, 13919409550, 35956138@qq.com
- Not yet recruiting
Linyi Cancer Hospital
Linyi, Shandong, 276034
Jingfen Wang, Bachelor, 15963976026, 2298641960@qq.com
- Not yet recruiting
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471000
Limin Wei, Bachelor, 13783100995, 13783100995@163.com
Miao Deng, Bachelor, 13938895644, fuqizhi33@126.com
- Not yet recruiting
The Affiliated Hospital of Southwest Medical University
Luzhou, Sichuan, 646000
Lijia He, Bachelor, 13619042857, 908380148@qq.com
- Not yet recruiting
Meizhou People's Hospital
Meizhou, Guangdong, 514000
Jingna Wu, Bachelor, 13431819838, 547511952@qq.com
- Not yet recruiting
NanChang People's Hospital
Nanchang, Jiangxi, 330009
Xiaobo Wu, Doctor, 13870070885, syywxb@163.com
- Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Zhengkui Sun, 13907000210, sunzhengkui616@163.com
- Not yet recruiting
Jiangsu Province Hospital
Nanjing, Jiangsu, 210029
Xiaoan Liu, Doctor, 13805170249, liuxiaoan@126.com
- Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210031
Yongzhong Yao, Doctor, 13505158227, loyal1006@hotmail.com
- Not yet recruiting
Guangxi Cancer Institutu (Guangxi Cancer Hospital, Guangxi Medical University Cancer Hospital, Guangxi Cancer Center)
Nanning, Guangxi, 530021
Wei Wei, Doctor, 17307711162, 605347565@qq.com
- Not yet recruiting
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, 530022
Yang Li, Bachelor, 18807730356, young88818@163.com
- Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000
Jinhua Ding, Master, 13957498690, cookie800128@sina.com
- Not yet recruiting
The First Affiliated Hospital of Ningbo University
Ningbo, Zhejiang, 315000
Yu Guo, Bachelor, 13646663641, guoyu308@163.com
- Not yet recruiting
First Hospital of QinHuangDao
Qinhuangdao, Hebei, 066099
Meng Han, Doctor, 13333335237, meng68527@163.com
- Not yet recruiting
Quanzhou First Hospital
Quanzhou, Fujian, 362000
Xiaofeng Li, Doctor, 18965658239, 18965658239@189.cn
- Not yet recruiting
The Second Affiliated Hospital of Fujian Medical University
Quanzhou, Fujian, 362000
JianQing Lin, Master, 13905977336, ljq13905977336@163.com
- Recruiting
Fudan University Shanghai Cancer Center
Shanghai, Shanghai Municipality, 200030
Zhimin Shao, Doctor, 13524514617, szm@163.com
- Not yet recruiting
Huashan Hospital Fudan University
Shanghai, Shanghai Municipality, 200052
Yiting Jin, Doctor, 13818070274, jinyiting@huashan.org.cn
- Not yet recruiting
Shantou Central Hospital
Shantou, Guangdong, 515031
Zhiyong Wu, Doctor, 13502953050, stwuzy@163.com
- Not yet recruiting
Shaoxing People's Hospital
Shaoxing, Zhejiang, 212300
Liwei Meng, Master, 13625853445, sxmlw73@163.com
- Not yet recruiting
Shengjing Hospital Of China Medical University
Shenyang, Liaoning, 110000
Caigang Liu, Doctor, 18940256668, zlzxlcsy@163.com
- Not yet recruiting
The First Affiliated Hospital of China Medical University
Shenyang, Liaoning, 110002
Fan Yao, Doctor, 13998373748, yaofancmu@sina.com
- Not yet recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 111000
Xinfeng Zhang, Doctor, 18900918821, winter_zhang1982@126.com
- Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050035
Yunjiang Liu, Doctor, 13703297890, lyj818326@126.com
- Not yet recruiting
The Second Affiliated Hospital of Shandong First Medical University
Taian, Shandong, 271000
Xiangqi Li, Doctor, 18505386835, drlixqi@163.com
- Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
Guohui Han, Master, 13754858188, 13754858188@163.com
- Not yet recruiting
First Hospital of Shanxi Medical University
Taiyuan, Shanxi, 030001
Hongyan Jia, Doctor, 13700515784, swallow_jhy@163.com
- Not yet recruiting
Taizhou Hospital of Zhejiang Province
Taizhou, Zhejiang, 317000
Zhansheng Ma, Master, 15957608835, mzs@enzemed.com
- Not yet recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300060
Chunfang Hao, Doctor, 13602031629, haochf@163.com
- Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Jin Zhang, Doctor, 19622221173, zhangjintjmuch1@163.com
- Not yet recruiting
Xinjiang Medical University Cancer Hospital
Ürümqi, Xinjiang, 830000
Hongtao Li, Doctor, 13209994656, lht4656@163.com
- Not yet recruiting
WeiFang People's Hospital
Weifang, Shandong, 261000
Wenhui Wang, Master, 18605368857, wwh8857@163.com
- Not yet recruiting
Weihai Municipal Hospital
Weihai, Shandong, 264299
Chunxin Qin, Master, 18863165616, qcxwh001@163.com
- Not yet recruiting
The First Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Ouchen Wang, Doctor, 13957706099, woc099@163.com
- Not yet recruiting
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Chunping Liu, Doctor, 13871041729, lcp191@163.com
- Not yet recruiting
Zhongnan Hospital of Wuhan University
Wuhan, Hubei, 430000
Jinxuan Hou, Doctor, 13971431260, jhou@whu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Wannan Medical University
Wuhu, Anhui, 241000
Yabing Wang, Master, 13637135553, wangeb3@sina.com
- Not yet recruiting
Gansu Wuwei Tumour Hospital
Wuwei, Gansu, 730000
Wenlin Liu, Master, 13884568149, wuweilwl@163.com
- Not yet recruiting
The First Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
Xi'an, Shaanxi, 710005
Nanlin Li, Doctor, 13709113279, nanlin-74@163.com
- Not yet recruiting
The Second Affiliated Hospital of the Air Force Medical University of the People's Liberation Army
Xi'an, Shaanxi, 710038
Huadong Zhao, Doctor, 13991318177, zhaolujy@fmmu.edu.cn
- Not yet recruiting
The First Affiliated Hospital of Xi'an Jiaotong University
Xi'an, Shaanxi, 710061
Wei Zhang, Doctor, 13936608299, renyyyyy@126.com
- Not yet recruiting
Zhongshan Hospital Xiamen university
Xiamen, Fujian, 361006
Minjun Meng, Master, 133 1385 2305, 31455216@qq.com
- Not yet recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
Shuang Qin, Master, 13503805916, dashanren@126.com
- Not yet recruiting
Yantai Yuhuangding Hospital
Yantai, Shandong, 264000
Guangdong Qiao, Master, 13361368867, qiaogddxy@163.com
- Not yet recruiting
The Second People's Hospital of YiBin
Yibin, Sichuan, 644000
Ke Zheng, Bachelor, 13568577403, scybzk@yeah.net
- Not yet recruiting
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099
Xiaoke Hou, Master, 17703591026, hxk13720980018@163.com
- Not yet recruiting
ZhangZhou Municipal Hospital of Fujian Province
Zhangzhou, Fujian, 363099
Xiong Wu, Bachelor, 13960094771, 378361374@qq.com
- Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 453000
Jingruo Li, Doctor, 13939021305, yanruqin@163.com
- Not yet recruiting
Xiangya Hospital ZhuZhou Central South University
Zhuzhou, Hunan, 412007
Wei Zhou, Master, 19973337856, 1142496746@qq.com
- Not yet recruiting
Zibo Central Hospital
Zibo, Shandong
Yu Ding, Master, 18678185965, dingyu924@sina.com
About this study
Official title: 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
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 Active Comparator in the neoadjuvant treatment of HER2 positive breast cancer patients.
About 544 HER2 positive early or locally advanced breast cancer patients will be randomly assigned to TQB2102 treatment group (test group) or Docetaxel combined with Carboplatin, Trastuzumab, and Pertuzumab (TCbHP) (Active Comparator) in a 1:1 ratio.
The subjects in the test group will receive 8 cycles of study drug treatment, and the subjects in the control group will receive 6 cycles of study drug treatment, followed by surgery for breast cancer, and disease recurrence visit and survival visit after surgery.
- Conditions
- HER2-positive Breast Cancer
- Being tested
- TQB2102 for injection, Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TQB2102 for injectionDrug
TQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC)
Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin InjectionDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| TQB2102 for injection | Experimental | 6mg/kg TQB2102 for injection, Intravenous infusion, administered every 3 weeks, 21 days as a treatment cycle, 8 cycles. Receives: Drug: TQB2102 for injection |
| Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection | Active comparator | Trastuzumab 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. Receives: Drug: Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to 26 months after study start
Secondary outcomes (8)
Rate of total physiological complete response (tpCR) evaluated by the investigator
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 the investigator.
Measured: Up to 24 months after study start
Breast pathological complete response (bpCR) evaluated by IRC and the investigator
Percentage of subjects with no residual invasive cancer in the primary breast lesion upon microscopic examination after primary tumor resection, as assessed by IRC and the investigator.
Measured: Up to 26 months after study start
Objective response rate (ORR)
The percentage of subjects achieving complete response (CR) or partial response (PR) as assessed by the investigator based on the Response Evaluation Criteria In Solid Tumors (RECIST 1.1) .
Measured: Up to 22 months after study start
There year Event-free survival (EFS)
Time from randomization to the first occurrence of any of the following events: ipsilateral or contralateral invasive breast cancer recurrence, regional or distant invasive breast cancer recurrence, or death from any cause.
Measured: Up to 50 months after study start
There year Invasive Disease-free survival (IDFS)
Time from randomization to the first occurrence of any of the following events: ipsilateral or contralateral invasive breast cancer recurrence, regional or distant invasive breast cancer recurrence, or death from any cause.
Measured: Up to 50 months after study start
Overall Survival (OS)
Time from randomization to death due to any cause.
Measured: Up to 50 months after study start
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests
To evaluate the safety of TQB2102 for Injection compared to TCbHP in the neoadjuvant treatment of HER2 positive early breast cancer, including: the incidence and severity of adverse events (AEs), abnormal laboratory test values, and serious adverse events (SAEs).
Measured: From the date of signing the informed consent to 40 days after the last dosing or radical mastectomy for breast cancer or a new anti-tumor treatment, whichever comes first.
Incidence of Anti-drug antibody (ADA) and neutralizing antibodies (NAb)
Incidence of ADA and Nab
Measured: Up to 22 months after study start
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2025
- Study start15 Sep 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 544 participants (estimated)
Sponsor and investigators
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07043725
- Sponsor's protocol ID
- TQB2102-III-05
- Status last verified
- Oct 2026
- First submitted
- 20 Jun 2025
- Last updated
- 2 Nov 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07043725
- Acronym / sponsor ID
- TQB2102-III-05
- Conditions
- HER2-positive Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 544 participants (estimated)
- Lead sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 15 Sep 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2029 (estimated)
- First posted
- 29 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 Active Comparator in the neoadjuvant treatment of HER2 positive breast cancer patients.
About 544 HER2 positive early or locally advanced breast cancer patients will be randomly assigned to TQB2102 treatment group (test group) or Docetaxel combined with Carboplatin, Trastuzumab, and Pertuzumab (TCbHP) (Active Comparator) in a 1:1 ratio.
The subjects in the test group will receive 8 cycles of study drug treatment, and the subjects in the control group will receive 6 cycles of study drug treatment, followed by surgery for breast cancer, and disease recurrence visit and survival visit after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TQB2102 for injection | Experimental | Drug: TQB2102 for injection6mg/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 comparator | Drug: Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin InjectionTrastuzumab 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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;
Key exclusion criteria (26 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TQB2102 for injectionTQB2102 for injection is a HER2 dual-antibody-drug Conjugate (ADC) | Drug | TQB2102 for injection |
| Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin InjectionTCbHP 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. | Drug | Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection |
Primary outcome
Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC)
Time frame: Up to 26 months after study start
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.
8 secondary outcomes
Rate of total physiological complete response (tpCR) evaluated by the investigator
Time frame: Up to 24 months after study start
Breast pathological complete response (bpCR) evaluated by IRC and the investigator
Time frame: Up to 26 months after study start
Objective response rate (ORR)
Time frame: Up to 22 months after study start
There year Event-free survival (EFS)
Time frame: Up to 50 months after study start
There year Invasive Disease-free survival (IDFS)
Time frame: Up to 50 months after study start
Overall Survival (OS)
Time frame: Up to 50 months after study start
Incidence and severity of adverse events (AEs) and serious adverse events (SAEs), and indicators of abnormal laboratory tests
Time frame: From the date of signing the informed consent to 40 days after the last dosing or radical mastectomy for breast cancer or a new anti-tumor treatment, whichever comes first.
Incidence of Anti-drug antibody (ADA) and neutralizing antibodies (NAb)
Time frame: Up to 22 months after study start
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
77 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing TQB2102 for injection and Trastuzumab injection and Pertuzumab Injection and Docetaxel Injection and Carboplatin Injection in people with HER2-positive Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 77 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhimin Shao, Doctor (13524514617, szm@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of total physiological complete response (tpCR) evaluated by Independent Review Committee (IRC) (time frame: Up to 26 months after study start). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.