HER2-positive Advanced Breast Cancer
Conditions
Brief 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.
Interventions
DRUGTQB2930+ 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.
DRUGTrastuzumab+ chemotherapy
Trastuzumab is a HER2-specific targeted drug； Capecitabine Tablets, Gemcitabine Hydrochloride for Injection, Vinorelbine Tartrate Injection and Eribulin Mesylate Injection are Chemotherapy Drugs.
Sponsors
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Progression-free survival (PFS) | Baseline up to IRC-assessed Disease Progression(PD), approximately 1 years | Independent Imaging Review Committee (IRC)-assessed PFS |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PFS assessed by Investigator | Baseline up to Investigator-Assessed investigator, approximately 1 years | PFS assessed by Investigator |
| Overall survival (OS) | From date of the first dose until the date of death from any cause, up to approximately 2 years | From randomization to the time of death from any cause. |
| Duration of Response (DOR) | 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 | Subjects with best overall response of complete response (CR) or partial response (PR) per RECIST 1.1 criteria. |
| Proportion of subjects achieving partial response (PR) | 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 | Subjects with partial response (PR) per RECIST 1.1 criteria. |
| Objective Response Rate (ORR) | 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 | Percentage of subjects achieving complete response (CR) or partial response (PR) per RECIST 1.1 criteria. |
| Clinical Benefit Rate (CBR) | 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 | 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. |
| Adverse event rate | From baseline until 90 days after the last dose or initiation of new antitumor therapy, whichever occurs first | The occurrence of all adverse events (AEs), serious adverse events (SAEs) and treatment-related adverse events (TEAEs). |
| Plasma concentration of TQB2930 | 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 | Serum concentrations of TQB2930 in subjects after administration in the treatment group. |
| Anti-Drug Antibody (ADA) Positivity Rate | 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 in post-dose blood samples from subjects in the treatment group. |
Countries
China
Contacts
CONTACTQingyuan Zhang, Doctor
CONTACTJinming Yu, Doctor
Outcome results
None listed