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Recruiting Phase 3

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

NCT07047365 · tracked via the Priya Life Science China tracker
Phase
Phase 3
Started
2025-07-25
Last updated
2026-06-03

Condition(s) studied

HER2-positive Advanced Breast Cancer

Investigational drug(s) / intervention(s)

TQB2930+ chemotherapy →Trastuzumab+ chemotherapy →

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

Study 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 prior lines of anti-HER2 therapy in the advanced station.

Eligibility

Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

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

Trial sites (75)

FacilityCityRegionStatus
The First Affiliated Hospital of Bengbu Medical College Bengbu Anhui Not Yet Recruiting
Anhui Provincial Hospital( The First Affiliated Hospital of USTC) Hefei Anhui Not Yet Recruiting
The Second Affiliated Hospital of Anhui Medical University Hefei Anhui Not Yet Recruiting
The Fifth Medical Center of Chinese People's Liberation Army General Hospital Beijing Beijing Municipality Not Yet Recruiting
Chong Qing University Cancer Hospital Chongqing Chongqing Municipality Not Yet Recruiting
Fuzhou First Generel Hospital Affiliated with Fujian Medical University Fuzhou Fujian Not Yet Recruiting
The First Hospital of Lanzhou University Lanzhou Gansu Not Yet Recruiting
Gansu Cancer Hospital Lanzhou Gansu Not Yet Recruiting
Sun Yat - sen University Cancer Center Guangzhou Guangdong Not Yet Recruiting
Peking University Shenzhen Hospital Shenzhen Guangdong Not Yet Recruiting
The Second Affiliated Hospital of Guangxi University of Science and Technology Liuzhou Guangxi Not Yet Recruiting
Liuzhou People's Hospital Liuzhou Guangxi Not Yet Recruiting
Affiliated Cancer Hospital of Guangxi Medical Universit Nanning Guangxi Not Yet Recruiting
The Affiiated Cancer Hospital of Guizhou Medical University Guiyang Guizhou Not Yet Recruiting
Guizhou Provincial People's Hospital Guiyang Guizhou Not Yet Recruiting
Hainan General Hospital Haikou Hainan Not Yet Recruiting
The First Hospital of Qinhuangdao Qinhuangdao Hebei Not Yet Recruiting
The Fourth Hospital of Hebei Medical University Shijiazhuang Hebei Not Yet Recruiting
Tangshan People's Hospital Tangshan Hebei Not Yet Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting
The First Affiliated Hospital of Harbin Medical University Harbin Heilongjiang Not Yet Recruiting
Jiamusi Tuberculosis Hospital (Jiamusi Tumor Hospital) Jiamusi Heilongjiang Not Yet Recruiting
Mudanjiang Cancer Hospital Mudanjiang Heilongjiang Not Yet Recruiting
AnYang Tumor Hospital Anyang Henan Not Yet Recruiting
The First Affiliated Hospital of Henan University of Science & Technology Luoyang Henan Not Yet Recruiting
Nanyang Second General Hospital Nanyang Henan Not Yet Recruiting
The First Affiliated Hospital of Xinxiang Medical University Xinxiang Henan Not Yet Recruiting
Henan Cancer Hospital Zhengzhou Henan Not Yet Recruiting
The First Affiliated Hospital of Zhengzhou University Zhengzhou Henan Not Yet Recruiting
Jingmen People's Hospital Jingmen Hubei Not Yet Recruiting
Xiangyang Central Hospital Xiangyang Hubei Not Yet Recruiting
The First People's Hospital of Changde City Changde Hunan Not Yet Recruiting
Hunan Cancer Hospital Changsha Hunan Not Yet Recruiting
People's Hospital of Hunan Province Changsha Hunan Not Yet Recruiting
Xiangya Hospital of Central South University Changsha Hunan Not Yet Recruiting
The Central Hospital of Yongzhou Yongzhou Hunan Not Yet Recruiting
Zhangjiajie People's Hospital Zhangjiajie Hunan Not Yet Recruiting
JiangSu Cancer Hosipital Nanjing Jiangsu Not Yet Recruiting
The Affiliated Sir Run Run Hospital of Nanjing Medical University Nanjing Jiangsu Not Yet Recruiting
Nanjing Drum Tower Hospital Nanjing Jiangsu Not Yet Recruiting

+ 35 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07047365 on ClinicalTrials.gov ↗ ← All trials in China