This study adopted a randomized, open-label, positive drug-controlled, multi-center trial design. The primary endpoint was PFS evaluated by the Independent Review Committee (IRC). Eligible subjects were randomly assigned in a 1:1 ratio to receive either TQB2102 for injection or trastuzumab emtansine for injection.
The subjects voluntarily participated in this study, signed the informed consent form, and had good compliance;
Age: 18 - 75 years old (at the time of signing the informed consent form); Eastern Cooperative Oncology Group (ECOG )score ≤ 1; Expected survival period exceeds 3 months;
HER2-positive, unresectable, locally advanced or metastatic invasive breast cancer confirmed by histopathological or cytological examination;
According to the 2018 version of the American Society of Clinical Oncology (ASCO)/College of American Pathologists (CAP )HumanEpidermalGrowthFactorReceptor2 (HER2) testing guidelines, HER2 positive is defined as: immunohistochemical result of 3+ or Fluorescence In Situ Hybridization (FISH) dual probe positive;
Excluded are patients with known spinal cord compression or active central nervous system metastases .
Patients with only skin and/or intracranial lesions as target lesions.
Patients with adverse reactions from previous treatments that have not recovered to a CTCAE v5.0 grade score of ≤1.
Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
Parallel
TQB2102 Injection
DrugTQB2102 Injection is a Human Epidermal Growth Factor Receptor 2 (HER2) bispecific antibody-drug conjugate.
Trastuzumab Emtansine for Injection
DrugTrastuzumab Emtansine for Injection is HER2-targeting antibody-drug conjugate (ADC).
The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC)
The PFS evaluation of TQB2102 for injection compared with Trastuzumab Emtansine for injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the Independent Imaging Review Committee (IRC).
The PFS evaluated by the researchers
The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine in evaluating the progression-free survival (PFS) in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was assessed by the researchers.
The Overall Survival (OS) evaluated by the researchers
The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine, as evaluated by the researchers, in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs.
The Duration of Response (DOR) evaluated by the researchers
The efficacy of injectable TQB2102 compared to injectable Trastuzumab Emtansine as evaluated by the researchers in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was studied.
The Partial Response (PR) evaluated by the researchers
The efficacy of PR-assessed TQB2102 injection compared with Trastuzumab Emtansine injection in HER2-positive, unresectable locally advanced or metastatic breast cancer patients who had previously received anti-HER2 monoclonal antibodies and taxane drugs was evaluated by the researchers.
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