Recruiting
TQB2930 Injection for the Treatment of HER2-positive Advanced Breast Cancer
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.
ClinicalTrials.gov IDNCT07047365
PhasePHASE3
Enrollment416
SponsorChia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Age18 Years – 75 Years
SexALL
About this study
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.
Interventions
- Drug: 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.
- Drug: 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.
Primary outcomes
- Progression-free survival (PFS) (Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years)
Eligibility information
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.
Study locations
- The First Affiliated Hospital of Bengbu Medical College, Bengbu, Anhui 233060 China
- Anhui Provincial Hospital( The First Affiliated Hospital of USTC), Hefei, Anhui 230001 China
- The Second Affiliated Hospital of Anhui Medical University, Hefei, Anhui 230001 China
- The Fifth Medical Center of Chinese People's Liberation Army General Hospital, Beijing, Beijing Municipality 100071 China
- Chong Qing University Cancer Hospital, Chongqing, Chongqing Municipality 400030 China
- Fuzhou First Generel Hospital Affiliated with Fujian Medical University, Fuzhou, Fujian 350009 China
- The First Hospital of Lanzhou University, Lanzhou, Gansu 730000 China
- Gansu Cancer Hospital, Lanzhou, Gansu 730050 China
- Sun Yat - sen University Cancer Center, Guangzhou, Guangdong 510060 China
- Peking University Shenzhen Hospital, Shenzhen, Guangdong 518000 China
Showing 10 of 75 reported sites. See the official listing for all locations.
Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.
Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-09.