NCT07008976招募中3 期
A Randomized, Open-label, Parallel-controlled Phase III Clinical Trial to Evaluate the Efficacy and Safety of TQB2102 for Injection Versus Trastuzumab Emtansine for Injection in Patients With HER2-positive Advanced Breast Cancer
Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.30 个研究点 分布在 1 个国家目标入组 246 人开始时间: 2025年7月7日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 246
- 试验地点
- 30
- 主要终点
- The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC)
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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;
- •The hormone receptor (HR) status has been clearly determined:
- •a) According to the 2020 version of the ASCO/CAP guidelines, HR positive includes ER positive and/or PR positive, that is, the proportion of tumor cells with positive staining among all tumor cells is ≥ 1%.
- •Received anti-HER2 monoclonal antibody and taxane drugs during the recurrence/metastasis stage.
- •Disease progression occurred during or after the most recent treatment or intolerance.
- •At least 1 line of treatment has been received in the recurrence/metastasis stage.
- •According to the Response Evaluation Criteria In Solid Tumors (RECIST) 1.1 standard, at least one measurable lesion exists.
排除标准
- •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 ≤
- •Patients with poorly controlled blood pressure (systolic blood pressure ≥150 mmHg or diastolic blood pressure ≥100 mmHg).
- •Patients with major cardiovascular diseases
- •Patients with a history of interstitial lung disease/pneumonia (non-infectious type) requiring steroid intervention treatment, or currently having interstitial lung disease/pneumonia, or those with suspected interstitial lung disease/pneumonia indicated by screening period imaging and cannot be excluded.
研究组 & 干预措施
TQB2102 Injection
Experimental
The drug is administered by intravenous infusion, at a dose of 6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle.
干预措施: TQB2102 Injection (Drug)
Trastuzumab Emtansine for Injection
Active Comparator
The drug is administered by intravenous infusion, at a dose of 3.6mg/kg each time. It is given once every 3 weeks, and each 3-week period constitutes one treatment cycle.
干预措施: Trastuzumab Emtansine for Injection (Drug)
结局指标
主要结局
The Progression-Free Survival (PFS) evaluated by Independent Review Committee (IRC)
时间窗: Up 30 months
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).
次要结局
- The PFS evaluated by the researchers(Up 30 months)
- The Overall Survival (OS) evaluated by the researchers(Up to 5 years)
- The Duration of Response (DOR) evaluated by the researchers(Up to 5 years)
- The Partial Response (PR) evaluated by the researchers(Up to 5 years)
- The Objective Response Rate (ORR)evaluated by the researchers(Up to 5 years)
- The Clinical Benefit Rate (CBR) evaluated by the researchers(Up to 5 years)
- The incidence and severity of adverse events(Sign the informed consent form, and until 28 days after the last medication administration / before starting a new anti-tumor treatment (which ever occurs first)))
- Antibody-drug conjugate (ADC)(Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks))
- Total antibodies(Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks))
- The small molecule toxin TO22723(Cycle 2, Cycle 4, Cycle 8, Cycle 16 (Each cycle is 3 weeks))
- The incidence rate of Anti-Drug Antibody (ADA)(Cycle 1, Cycle 2, Cycle 4, Cycle 8, Cycle 16, 28 days (±7 days) after the last administration (Each cycle is 3 weeks))
研究者
研究点 (30)
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