TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer
Recruiting · NCT07047365 · Interventional (participants receive a specific treatment) · Lead sponsor: Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
View the official record on ClinicalTrials.gov →Interventions studied
TQB2930+ chemotherapyTrastuzumab+ chemotherapy
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.
Who can take part
Age range
18 Years to 75 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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.
Exclusion criteria
- 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;
- 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.
Where it is running
60 locations listed.
- The First Affiliated Hospital of Bengbu Medical College - Bengbu, Anhui, China
- Anhui Provincial Hospital( The First Affiliated Hospital of USTC) - Hefei, Anhui, China
- The Second Affiliated Hospital of Anhui Medical University - Hefei, Anhui, China
- The Fifth Medical Center of Chinese People's Liberation Army General Hospital - Beijing, Beijing Municipality, China
- Chong Qing University Cancer Hospital - Chongqing, Chongqing Municipality, China
- Fuzhou First Generel Hospital Affiliated with Fujian Medical University - Fuzhou, Fujian, China
- The First Hospital of Lanzhou University - Lanzhou, Gansu, China
- Gansu Cancer Hospital - Lanzhou, Gansu, China
- Sun Yat - sen University Cancer Center - Guangzhou, Guangdong, China
- Peking University Shenzhen Hospital - Shenzhen, Guangdong, China
- The Second Affiliated Hospital of Guangxi University of Science and Technology - Liuzhou, Guangxi, China
- Liuzhou People's Hospital - Liuzhou, Guangxi, China
- Affiliated Cancer Hospital of Guangxi Medical Universit - Nanning, Guangxi, China
- The Affiiated Cancer Hospital of Guizhou Medical University - Guiyang, Guizhou, China
- Guizhou Provincial People's Hospital - Guiyang, Guizhou, China
- Hainan General Hospital - Haikou, Hainan, China
- The First Hospital of Qinhuangdao - Qinhuangdao, Hebei, China
- The Fourth Hospital of Hebei Medical University - Shijiazhuang, Hebei, China
- Tangshan People's Hospital - Tangshan, Hebei, China
- Harbin Medical University Cancer Hospital - Harbin, Heilongjiang, China
- The First Affiliated Hospital of Harbin Medical University - Harbin, Heilongjiang, China
- Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital) - Jiamusi, Heilongjiang, China
- Mudanjiang Cancer Hospital - Mudanjiang, Heilongjiang, China
- AnYang Tumor Hospital - Anyang, Henan, China
- The First Affiliated Hospital of Henan University of Science & Technology - Luoyang, Henan, China
- Nanyang Second General Hospital - Nanyang, Henan, China
- The First Affiliated Hospital of Xinxiang Medical University - Xinxiang, Henan, China
- Henan Cancer Hospital - Zhengzhou, Henan, China
- The First Affiliated Hospital of Zhengzhou University - Zhengzhou, Henan, China
- Jingmen People's Hospital - Jingmen, Hubei, China
- Xiangyang Central Hospital - Xiangyang, Hubei, China
- The First People's Hospital of Changde City - Changde, Hunan, China
- Hunan Cancer Hospital - Changsha, Hunan, China
- People's Hospital of Hunan Province - Changsha, Hunan, China
- Xiangya Hospital of Central South University - Changsha, Hunan, China
- The Central Hospital of Yongzhou - Yongzhou, Hunan, China
- Zhangjiajie People's Hospital - Zhangjiajie, Hunan, China
- JiangSu Cancer Hosipital - Nanjing, Jiangsu, China
- The Affiliated Sir Run Run Hospital of Nanjing Medical University - Nanjing, Jiangsu, China
- Nanjing Drum Tower Hospital - Nanjing, Jiangsu, China
- Zhangjiagang First People's Hospital - Suzhou, Jiangsu, China
- Xuzhou Central Hospital - Xuzhou, Jiangsu, China
- Ganzhou Cancer Hospital - Ganzhou, Jiangxi, China
- Ganzhou People's Hospital - Ganzhou, Jiangxi, China
- Jiangxi Cancer Hospital - Nanchang, Jiangxi, China
- Jilin Cancer Hospital - Changchun, Jilin, China
- The first hospital of Jilin University - Changchun, Jilin, China
- Affiliated Zhongshan Hospital Of Dalian University - Dalian, Liaoning, China
- Shengjing Hospital of China Medical University - Shenyang, Liaoning, China
- Liaoning Cancer Hospital & Institute - Shenyang, Liaoning, China
- People's Hospital of Ningxia Hui Autonomous Region - Yinchuan, Ningxia, China
- Qinghai University Affiliated Hospital - Xining, Qinghai, China
- Bao Ji Central Hospital - Baoji, Shaanxi, China
- 3201 Hospital - Hanzhong, Shaanxi, China
- The Second Affiliated Hospital Of Xi'an Jiaotong University (Xibei Hospital) - Xi'an, Shaanxi, China
- Xijing Hospital of Air Force Military Medical University - Xi'an, Shaanxi, China
- Shandong Provincial Hospital Affiliated to Shandong First Medical University（Shandong Provincial Hospital） - Jinan, Shandong, China
- Cancer Hospital of Shandong First Medical University (Shandong Cancer Institute,Shandong Cancer Hospital) - Jinan, Shandong, China
- Linyi cancer Hospital - Linyi, Shandong, China
- Weifang People'S Hospital - Weifang, Shandong, China
Showing 60 of 75 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →