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

Launched by CHIA TAI TIANQING PHARMACEUTICAL GROUP NANJING SHUNXIN PHARMACEUTICAL CO., LTD. · Jun 24, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a new drug called TQB2930, combined with chemotherapy, to treat advanced breast cancer that tests positive for a protein called HER2. The study will compare this new treatment to the current standard treatment, which is trastuzumab combined with chemotherapy. The goal is to see if TQB2930 works better and is safe for patients who have already tried at least two other HER2-targeted treatments for their advanced cancer.

People eligible for this study are adults between 18 and 75 years old who have HER2-positive breast cancer that has come back or spread, and who have measurable tumors. They must have previously received at least two HER2 treatments for their advanced cancer and be in good overall health with an expected life expectancy of more than three months. Participants will receive either the new drug plus chemotherapy or the standard treatment with chemotherapy, and they will be closely monitored for how well the treatment works and any side effects. Women who can become pregnant will need to use effective birth control during the study and for six months afterward. The study is not yet open for enrollment.

Gender

ALL

Eligibility criteria

• 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.