HER2-positive Advanced Breast CancerPhase 3NCT07047365

TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer

A Phase 3 study testing TQB2930+ chemotherapy and Trastuzumab+ chemotherapy in people with HER2-positive Advanced Breast Cancer, run by Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd. at 75 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

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Trial summary

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… Read more about this study

Who is it for?: Ages 18 to 75 years
Conditions the study is for: HER2-positive Advanced Breast Cancer
What is being tested?: TQB2930+ chemotherapy and Trastuzumab+ chemotherapy
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 416 participants
Where: 75 sitesChina
Study dates: 25 Jul 2025to Dec 2028
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

Subjects voluntarily participate in this study and sign the informed consent form;
Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy >3 months;
Cytologically or histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive recurrent or metastatic breast cancer;
Received ≥2 prior lines of anti-HER2 targeted therapy in the advanced setting;
At least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria (excluding brain lesions);
Willing to receive one of the investigator-selected chemotherapy regimens;
Adequate organ function;
Female subjects of childbearing potential must agree to use effective contraception (e.g., Intrauterine Device (IUD), oral contraceptives, or condoms) during the study and for 6 months after study completion.

Who cannot join

Concurrent Diseases and Medical History:
Other malignancies within 5 years before randomization or concurrent malignancies (except adequately treated non-melanoma skin cancer, in situ cervical cancer, or other cancers with curative treatment and no recurrence for ≥3 years);
Uncontrolled toxicities (>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/venous thromboembolic events within 6 months before randomization;

Show all 30Show fewer

History of drug abuse or psychiatric disorders that may affect compliance;
Poorly controlled hypertension (e.g., Systolic Blood Pressure (SBP) >160 mmHg despite treatment);
≥Grade 2 myocardial ischemia/infarction, arrhythmias, or congestive heart failure (New York Heart Association （NYHA）Class ≥II);
Active or uncontrolled severe infections (≥CTCAE Grade 2);
Known chronic hepatitis B;
Active syphilis infection;
Renal failure requiring hemodialysis/peritoneal dialysis;
Immunodeficiency disorders (e.g., Human Immunodeficiency Virus (HIV) ;
Poorly controlled diabetes;
Urine protein ≥++ on dipstick with 24-hour urine protein >1.0 g;
Epilepsy requiring medication.
Tumor-Related Conditions and Treatments:
Chemotherapy, radiotherapy, or immunotherapy within 4 weeks before randomization (or within 5 half-lives of prior drugs, whichever is shorter);
Chinese herbal medicines with approved antitumor indications (per National Medical Products Administration (NMPA) labeling) within 2 weeks;
Severe Bone Lesions from bone metastases;
Untreated brain metastases, Leptomeningeal metastases, or carcinomatous meningitis;
Prior HER2-targeted therapy-induced Left Ventricular Ejection Fraction (LVEF) decline to <50% or absolute reduction >15%;
Uncontrolled or symptomatic Hypertension requiring ongoing bisphosphonates;
Uncontrolled cancer-related pain;
Existed Lymphangitis Carcinomatosa or uncontrolled effusions;
Use of Immunosuppressant or systemic corticosteroids (≥10 mg/day prednisone equivalent) within 2 weeks.
Severe hypersensitivity to monoclonal antibodies;
Participation in other antitumor clinical trials with investigational drugs within 4 weeks before randomization;
Any condition deemed by the investigator to jeopardize subject safety or study completion.

Trial locations and contacts

75 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Qingyuan Zhang, Doctor contact

13313612989

ns86298333@163.com

Jinming Yu, Doctor contact

13806406293

sdyujinming@126.com

City, postcode or hospital

Sites recruiting now only

75 sites in 1 country

China75 sites, 75 recruiting

AnYang Tumor Hospital
Anyang, Henan, 455001
Jing Sun, Master, 13939995116, sunjingshengrui@126.com
Not yet recruiting
Bao Ji Central Hospital
Baoji, Shaanxi, 721008
Qing She, Master, 13689175365, sheqing01@163.com
Not yet recruiting
The Fifth Medical Center of Chinese People's Liberation Army General Hospital
Beijing, Beijing Municipality, 100071
Tao Wang, Doctor, 13910928773, wangtaodoc@163.com
Not yet recruiting
The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, 233060
Mingliang Zhang, Master, 13855269689, 19257387@qq.com
Not yet recruiting
Jilin Cancer Hospital
Changchun, Jilin, 130000
Fei Chen, Master, 18604430968, flyrchenfei@sina.com
Not yet recruiting
The first hospital of Jilin University
Changchun, Jilin, 130400
Zheng Lv, Doctor, 15804301705, 28861541@qq.com
Not yet recruiting
The First People's Hospital of Changde City
Changde, Hunan, 415000
Tao Wu, Doctor, 15873644000, 20689452@qq.com
Not yet recruiting
Hunan Cancer Hospital
Changsha, Hunan, 410000
Quchang Ouyang, Doctor, 13973135318, ouyangquchang@hnca.org.cn
Not yet recruiting
People's Hospital of Hunan Province
Changsha, Hunan, 410005
Huaxin Duan, Doctor, 13347315509, 317102912@qq.com
Not yet recruiting
Xiangya Hospital of Central South University
Changsha, Hunan, 410008
Jun Huang, Doctor, 18229944886, 404369@csu.edu.cn
Not yet recruiting
Sichuan Academy of Medical Sciences & Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Jing Luo, Doctor, 18981838521, jingluopi@163.com
Not yet recruiting
Chong Qing University Cancer Hospital
Chongqing, Chongqing Municipality, 400030
Xianjun Tang, Master, 13629798351, tangxianjun000017@163.com
Not yet recruiting
Affiliated Zhongshan Hospital Of Dalian University
Dalian, Liaoning, 116001
Xiang Li, Doctor, 18018931093, 94207842@qq.com
Not yet recruiting
Fuzhou First Generel Hospital Affiliated with Fujian Medical University
Fuzhou, Fujian, 350009
Fangwei Xie, Doctor, 135 0935 6590, 9714497@qq.com
Not yet recruiting
Ganzhou Cancer Hospital
Ganzhou, Jiangxi, 341000
Yongqiang Ye, Master, 13970791192, yyq362@163.com
Not yet recruiting
Ganzhou People's Hospital
Ganzhou, Jiangxi, 341001
Chen Wang, Master, 13807078925, goestbaby@163.com
Not yet recruiting
Sun Yat - sen University Cancer Center
Guangzhou, Guangdong, 510060
Fei Xu, Doctor, 13711277870, Xufei@sysucc.org.cn
Not yet recruiting
The Affiiated Cancer Hospital of Guizhou Medical University
Guiyang, Guizhou, 550000
Jianying Chang, Bachelor, 13984407392, 1534085548@qq.com
Not yet recruiting
Guizhou Provincial People's Hospital
Guiyang, Guizhou, 550002
Yong Li, Doctor, 13628566285, liyong7229771@163.com
Not yet recruiting
Hainan General Hospital
Haikou, Hainan, 570311
Haixia Wang, Bachelor, 13876965218, wanghaixia74@163.com
Not yet recruiting
3201 Hospital
Hanzhong, Shaanxi, 723000
Shan Tian, Bachelor, 15591600553, 296255281@qq.com
Not yet recruiting
Harbin Medical University Cancer Hospital
Harbin, Heilongjiang, 150000
Qingyuan Zhang, Doctor, 13313612989, ns86298333@163.com
Recruiting
The First Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang, 150000
Xuesong Chen, Doctor, 15804500816, cxs1978@163.com
Not yet recruiting
Anhui Provincial Hospital( The First Affiliated Hospital of USTC)
Hefei, Anhui, 230001
Nannan Lu, Doctor, 18130056850, lnn279@ustc.edu.cn
Not yet recruiting
The Second Affiliated Hospital of Anhui Medical University
Hefei, Anhui, 230001
Fanfan Li, Doctor, 13855137365, 693671174@qq.com
Not yet recruiting
Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital)
Jiamusi, Heilongjiang, 154007
Hongmei Sun, Master, 15344540000, SHM1357@163.com
Not yet recruiting
Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital）
Jinan, Shandong, 250021
Rui Jiang, Doctor, 15168889393, jiangruizh@163.com
Not yet recruiting
Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital)
Jinan, Shandong, 250117
Jinming Yu, Doctor, 13806406293, sdyujinming@126.com
Not yet recruiting
Jingmen People's Hospital
Jingmen, Hubei, 448000
Jingjing Li, Doctor, 19986599090, Lijj0505@126.com
Not yet recruiting
Yunnan Cancer Hospital
Kunming, Yunnan, 650000
Guojun Zhang, Doctor, 18850064298, edu.cngjzhang@xah.xmu.edu.cn
Not yet recruiting
The First Hospital of Lanzhou University
Lanzhou, Gansu, 730000
Xiaoling Ling, Master, 18693165668, lingxiaolingedu@163.com
Not yet recruiting
Gansu Cancer Hospital
Lanzhou, Gansu, 730050
Yingxia Tian, Bachelor, 13919451841, Tianyxlz@163.com
Not yet recruiting
Linyi cancer Hospital
Linyi, Shandong, 276000
Jingfen Wang, Bachelor, 15963976026, 2298641960@qq.com
Not yet recruiting
The Second Affiliated Hospital of Guangxi University of Science and Technology
Liuzhou, Guangxi, 545006
Chaoting Chen, Master, 13014883599, 490870758@qq.com
Not yet recruiting
Liuzhou People's Hospital
Liuzhou, Guangxi, 545200
Cheng Lin, Master, 13707826711, 14116332@qq.com
Not yet recruiting
The First Affiliated Hospital of Henan University of Science & Technology
Luoyang, Henan, 471000
Xinshuai Wang, Doctor, 13837986128, xshuaiw@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
Mudanjiang Cancer Hospital
Mudanjiang, Heilongjiang, 157009
Song Wang, Bachelor, 18645758197, 28860719@qq.com
Not yet recruiting
Jiangxi Cancer Hospital
Nanchang, Jiangxi, 330029
Zhengkui Sun, Doctor, 13907000210, sunzhengkui616@163.com
Not yet recruiting
Affiliated Hospital of North Sichuan Medical College
Nanchong, Sichuan, 637000
Yan Gui, Master, 15882618827, 15882618827@163.com
Not yet recruiting
JiangSu Cancer Hosipital
Nanjing, Jiangsu, 210000
Yuan Yuan, Doctor, 13851588800, yuanyuan208ky@163.com
Not yet recruiting
The Affiliated Sir Run Run Hospital of Nanjing Medical University
Nanjing, Jiangsu, 210000
Xiaoxiang Guan, Doctor, 18852059888, xguan@njmu.edu.cn
Not yet recruiting
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210031
Li Xie, Doctor, 13605169652, sherry01130@163.com
Not yet recruiting
Affiliated Cancer Hospital of Guangxi Medical Universit
Nanning, Guangxi, 530028
Yan Liu, Doctor, 15877129696, liuyansunny@163.com
Not yet recruiting
Nanyang Second General Hospital
Nanyang, Henan, 47300
Lina Liu, Master, 13838793362, liulina1996@163.com
Not yet recruiting
Ningbo Medical Center Lihuili Hospital
Ningbo, Zhejiang, 315000
Jinhua Ding, Master, 13957498690, cookie800128@sina.com
Not yet recruiting
Ningbono.2Hospitai
Ningbo, Zhejiang, 315000
Xujun Li, Bachelor, 13957801861, Hxyang2004@163.com
Not yet recruiting
The First Affiliated Hospial of Ningbo University
Ningbo, Zhejiang, 315000
Yu Guo, Bachelor, 13646663641, guoyu308@163.com
Not yet recruiting
The First Hospital of Qinhuangdao
Qinhuangdao, Hebei, 066000
Meng Han, Doctor, 13333335237, meng68527@163.com
Not yet recruiting
Shengjing Hospital of China Medical University
Shenyang, Liaoning, 110021
Caigang Liu, Doctor, 18940254967, zlzxlcsy@163.com
Not yet recruiting
Liaoning Cancer Hospital & Institute
Shenyang, Liaoning, 110043
Bin Liu, Doctor, 18900917676, liubin1980@163.com
Not yet recruiting
Peking University Shenzhen Hospital
Shenzhen, Guangdong, 518000
Shubin Wang, Doctor, 13823394076, wangshubin2020@126.com
Not yet recruiting
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050035
Li Ma, Doctor, 13932116886, mali1021@126.com
Not yet recruiting
Suining Central Hospital
Suining, Sichuan, 629099
Hongwei Yang, Master, 18008258079, snsyhw@163.com
Not yet recruiting
Zhangjiagang First People's Hospital
Suzhou, Jiangsu, 215600
Zhixiang Zhuang, Master, 13951106391, 13951106391@139.com
Not yet recruiting
Shanxi Cancer Hospital
Taiyuan, Shanxi, 030000
Guohui Han, Master, 13754858188, 13754858188@163.com
Not yet recruiting
Tangshan People's Hospital
Tangshan, Hebei, 063001
Haifeng Cai, Doctor, 13303050005, 13303050005@163.com
Not yet recruiting
Tianjin Medical University Cancer Institute & Hospital
Tianjin, Tianjin Municipality, 300060
Yehui Shi, Doctor, 18622221183, shiyehui@tjmuch.com
Not yet recruiting
Tianjin Cancer Hospital Airport Hospital
Tianjin, Tianjin Municipality, 300308
Chunfang Hao, Doctor, 13602031629, haochf@163.com
Not yet recruiting
Xinjiang Medical University Affiliated Tumor Hospital
Ürümqi, Xinjiang, 830000
Bing Zhao, Doctor, 13899908184, 819502412@qq.com
Not yet recruiting
Weifang People'S Hospital
Weifang, Shandong, 261000
Wenhui Wang, Master, 18605368857, wwh8857@163.com
Not yet recruiting
The Second Affiliated Hospital of Wenzhou Medical University
Wenzhou, Zhejiang, 325000
Yaxin Zhao, Doctor, 13857747779, zyx@wmu.edu.cn
Not yet recruiting
The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital)
Xi'an, Shaanxi, 710004
Shuqun Zhang, Doctor, 13891841249, zhangshuqunc1118@126.com
Not yet recruiting
Xijing Hospital of Air Force Military Medical University
Xi'an, Shaanxi, 710032
Nanlin Li, Doctor, 13709113279, nanlin-74@163.com
Not yet recruiting
Xiangyang Central Hospital
Xiangyang, Hubei, 441021
Yuehua Wang, Master, 13995777482, 510839835@qq.com
Not yet recruiting
Qinghai University Affiliated Hospital
Xining, Qinghai, 810001
Miaozhou Wang, Master, 18609780037, wangmiaozhou@163.com
Not yet recruiting
The First Affiliated Hospital of Xinxiang Medical University
Xinxiang, Henan, 453100
Liuzhong Yang, Master, 13639638824, 56236053@qq.com
Not yet recruiting
Xuzhou Central Hospital
Xuzhou, Jiangsu, 221009
Yanhua Liu, Doctor, 18952171926, liuyanhua71926@163.com
Not yet recruiting
The Second People's Hospital of Yibin City
Yibin, Sichuan, 644000
Xin Chen, Master, 13990923371, 13990923371@139.com
Not yet recruiting
People's Hospital of Ningxia Hui Autonomous Region
Yinchuan, Ningxia, 750000
Xinlan Liu, Master, 13709577339, nxliuxinlan@163.com
Not yet recruiting
The Central Hospital of Yongzhou
Yongzhou, Hunan, 425002
Sijuan Ding, Master, 13574624257, 874663807@qq.com
Not yet recruiting
Yuncheng Central Hospital
Yuncheng, Shanxi, 044099
Xiaoke Hou, Master, 17703591026, hxk13720980018@163.com
Not yet recruiting
Zhangjiajie People's Hospital
Zhangjiajie, Hunan, 427000
Juan Yu, Master, 13707442614, 39597792@qq.com
Not yet recruiting
Henan Cancer Hospital
Zhengzhou, Henan, 450000
Min Yan, Doctor, 15713857388, ym200678@126.com
Not yet recruiting
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
Xinhong Pei, Doctor, 13303849018, peixh18@163.com
Not yet recruiting

Other trials in China

About this study

Official title: A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer

Conditions: HER2-positive Advanced Breast Cancer
Being tested: TQB2930+ chemotherapy, Trastuzumab+ chemotherapy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TQB2930+ chemotherapyDrug
TQB2930 injection is a HER2 bispecific antibody drug； Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.
Trastuzumab+ chemotherapyDrug
Trastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.

Study groups in NCT07047365
Study group	Role	What they receive
TQB2930+ chemotherapy	Experimental	Subjects will receive TQB2930 injection in combination with chemotherapy agents on Day 1 (D1) of each cycle. TQB2930 will be administered at a dose of 30 mg/kg every 3 weeks (Q3W), Each treatment cycle lasts 21 days. Receives: Drug: TQB2930+ chemotherapy
Trastuzumab+ chemotherapy	Active comparator	Subjects will receive trastuzumab in combination with chemotherapy agents on Day 1 (D1) of each cycle. The initial dose of trastuzumab is 8 mg/kg, followed by a maintenance dose of 6 mg/kg administered every 3 weeks (Q3W), Each treatment cycle lasts 21 days. Receives: Drug: Trastuzumab+ chemotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

Progression-free survival (PFS)
Independent Imaging Review Committee (IRC)-assessed PFS
Measured: Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years

Secondary outcomes (10)

PFS assessed by Investigator
PFS assessed by Investigator
Measured: Baseline up to Investigator-Assessed investigator, approximately 1 years
Overall survival (OS)
From randomization to the time of death from any cause.
Measured: From date of the first dose until the date of death from any cause, up to approximately 2 years
Duration of Response (DOR)
Subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 criteria.
Measured: From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 2 years
Proportion of subjects achieving partial response (PR)
Subjects with partial response (PR) per RECIST 1.1 criteria.
Measured: From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years
Objective Response Rate (ORR)
Percentage of subjects achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria.
Measured: From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years
Clinical Benefit Rate (CBR)
Proportion of subjects with best overall response (BOR) of complete response (CR), partial response (PR), or stable disease (SD) lasting ≥24 weeks per RECIST 1.1 criteria.
Measured: From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first) , up to approximately 1 years
Adverse event rate
The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs).
Measured: From baseline until 90 days after the last dose or initiation of new antitumor therapy, whichever occurs first
Plasma concentration of TQB2930
Serum concentrations of TQB2930 in subjects after administration in the treatment group.
Measured: Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 30 minutes after dosing on Cycle 4 Day 1 and Cycle 7 Day 1, each cycle is 21 days
Anti-Drug Antibody (ADA) Positivity Rate
Anti-drug antibody (ADA) positivity in post-dose blood samples from subjects in the treatment group.
Measured: Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days
Anti-Drug Antibody (ADA) Positivity Rate
Neutralizing antibody (NAb) testing performed when anti-drug antibodies (ADAs) were detected in post-dose blood samples from the treatment group.
Measured: Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 , and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

25 Jul 2025Dec 2028

First posted2 Jul 2025
Study start25 Jul 2025
Primary completionJun 2028 (estimated)
Study completionDec 2028 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for HER2-positive Advanced 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: 416 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07047365
Sponsor's protocol ID: TQB2930-III-01
Status last verified: May 2026
First submitted: 24 Jun 2025
Last updated: 3 Jun 2026
Results posted: No
FDA-regulated drug: No
FDA-regulated device: No

Interested in taking part?

Qingyuan Zhang, Doctor

13313612989

ns86298333@163.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All HER2-positive Advanced Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Open-label, Parallel-controlled, Multicenter Phase III Clinical Study Evaluating TQB2930 Combined With Investigator's Choice of Chemotherapy Versus Trastuzumab Combined With Investigator's Choice of Chemotherapy in the Treatment of HER2-Positive Advanced Breast Cancer
ClinicalTrials.gov ID: NCT07047365
Acronym / sponsor ID: TQB2930-III-01
Conditions: HER2-positive Advanced Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 416 participants (estimated)
Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
Study start: 25 Jul 2025 (actual)
Primary completion: Jun 2028 (estimated)
Study completion: Dec 2028 (estimated)
First posted: 2 Jul 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.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
TQB2930+ chemotherapy	Experimental	Drug: TQB2930+ chemotherapySubjects will receive TQB2930 injection in combination with chemotherapy agents on Day 1 (D1) of each cycle. TQB2930 will be administered at a dose of 30 mg/kg every 3 weeks (Q3W), Each treatment cycle lasts 21 days.
Trastuzumab+ chemotherapy	Active comparator	Drug: Trastuzumab+ chemotherapySubjects will receive trastuzumab in combination with chemotherapy agents on Day 1 (D1) of each cycle. The initial dose of trastuzumab is 8 mg/kg, followed by a maintenance dose of 6 mg/kg administered every 3 weeks (Q3W), Each treatment cycle lasts 21 days.

Who may qualify

Ages: 18 to 75 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Subjects voluntarily participate in this study and sign the informed consent form;
Age: 18-75 years (at time of signing Informed Consent Form (ICF); Eastern Cooperative Oncology Group (ECOG) performance status ≤1; estimated life expectancy >3 months;
Cytologically or histologically confirmed Human Epidermal Growth Factor Receptor 2 (HER2)-positive recurrent or metastatic breast cancer;
Received ≥2 prior lines of anti-HER2 targeted therapy in the advanced setting;
At least one measurable lesion meeting Response Evaluation Criteria in Solid Tumors, Version 1.1 (RECIST 1.1) criteria (excluding brain lesions);

Key exclusion criteria (30 listed)

Concurrent Diseases and Medical History:
Tumor-Related Conditions and Treatments:
Severe hypersensitivity to monoclonal antibodies;
Participation in other antitumor clinical trials with investigational drugs within 4 weeks before randomization;
Any condition deemed by the investigator to jeopardize subject safety or study completion.

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
TQB2930+ chemotherapyTQB2930 injection is a HER2 bispecific antibody drug； Chemotherapy: Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.	Drug	TQB2930+ chemotherapy
Trastuzumab+ chemotherapyTrastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.	Drug	Trastuzumab+ chemotherapy

Primary outcome

Progression-free survival (PFS)
Time frame: Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years
Independent Imaging Review Committee (IRC)-assessed PFS

10 secondary outcomes

PFS assessed by Investigator
Time frame: Baseline up to Investigator-Assessed investigator, approximately 1 years
Overall survival (OS)
Time frame: From date of the first dose until the date of death from any cause, up to approximately 2 years
Duration of Response (DOR)
Time frame: From date of the first dose until the date of first documented progression or date of death from any cause, up to approximately 2 years
Proportion of subjects achieving partial response (PR)
Time frame: From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years
Objective Response Rate (ORR)
Time frame: From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first), up to approximately 1 years
Clinical Benefit Rate (CBR)
Time frame: From the date of first documented tumor response to the date of first documented disease progression or death from any cause (whichever occurs first) , up to approximately 1 years
Adverse event rate
Time frame: From baseline until 90 days after the last dose or initiation of new antitumor therapy, whichever occurs first
Plasma concentration of TQB2930
Time frame: Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 30 minutes after dosing on Cycle 4 Day 1 and Cycle 7 Day 1, each cycle is 21 days
Anti-Drug Antibody (ADA) Positivity Rate
Time frame: Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1, and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days
Anti-Drug Antibody (ADA) Positivity Rate
Time frame: Within 60 minutes before dosing on Cycle 1 Day 1, Cycle 4 Day 1, Cycle 7 Day 1 , and Cycle 12 Day 1; and within 90 days after the last dose, each cycle is 21 days

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 3 Jun 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.

Qingyuan Zhang, Doctor contact

13313612989

ns86298333@163.com

Jinming Yu, Doctor contact

13806406293

sdyujinming@126.com

75 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 30 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 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 75 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 Qingyuan Zhang, Doctor (13313612989, ns86298333@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS) (time frame: Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07047365.

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 3 Jun 2026.