A Phase III,Multicenter,Randomized,Open-Label,Active-Controlled Trial of A166 Versus Trastuzumab Emtansine (T-DM1) in Patients With HER2-Positive Unresectable or Metastatic Breast Cancer Previously Treated With Trastuzumab and Taxane Therapy
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 365
- 试验地点
- 1
- 主要终点
- Progression-free survival (PFS)
研究概览
简要总结
Evaluation of the efficacy of A166 versus trastuzumab emtansine (T-DM1) in Patients with HER2-Positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy
详细描述
This study will evaluate the efficacy of A166 versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic breast cancer previously treated with trastuzumab and taxane therapy
To further evaluate the efficacy of A166 versus T-DM1 in patients with HER2-positive unresectable or metastatic breast cancer, based on effectiveness endpoints including:
Overall survival (OS)
Progression-free survival (PFS) as assessed by investigators
Objective response rate (ORR), disease control rate (DCR), duration of response (DOR), and clinical benefit rate (CBR) assessed by both blinded independent central review (BICR) and investigators.
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
- •Male or female patient ≥ 18 years and ≤ 75 years when signing the informed consent form.
- •Breast cancer patients by histopathology and/or cytology documented.
- •Disease progression after receiving a trastuzumab-based regimen (or a commercially available trastuzumab biosimilar or inetetamab) in the advanced or metastatic setting, or disease progression/recurrence within 12 months during or after (neo)adjuvant therapy (with a trastuzumab-based regimen or commercially available trastuzumab biosimilar).
- •Have previously received taxanes.
- •Patients must have experienced disease progression or intolerance during or after the most recent treatment prior to randomization.
- •At least one measurable lesion according to RECIST 1.1 criteria
排除标准
- •Previous treatment with A166 or any HER2-targeted antibody-drug conjugate (ADC) with a microtubule inhibitor payload.
- •Known history of severe hypersensitivity to other monoclonal antibodies, or allergy to A166 , T-DM1 (trastuzumab emtansine) or their components.
- •Permanent discontinuation of trastuzumab or its biosimilars due to any toxicity in prior treatments.
- •Presence of severe corneal epithelial disease at baseline; or inability to perform daily activities without contact lenses.
- •Presence of spinal cord compression or clinically active central nervous system (CNS) metastases.
- •Other conditions considered by the investigator to make the patient unsuitable for participation in the study
研究组 & 干预措施
A166
A166 is administered intravenously at a dose of 4.8 mg/kg every 21 (±3) days (q3w).
干预措施: A166 (Drug)
T-DM1
T-DM1 is administered intravenously at a dose of 3.6 mg/kg every 21 (±3) days (q3w).
干预措施: T-DM1 (Drug)
结局指标
主要结局
Progression-free survival (PFS)
时间窗: Randomization up to approximately 39 months
PFS as assessed by BICR according to RECIST v 1.1
次要结局
- Overall survival (OS)(Randomization up to approximately 48 months)
- Objective response rate(ORR)(Randomization up to approximately 39 months)
- Disease control rate(DCR)(Randomization up to approximately 39 months)
- Duration of response(DOR)(Randomization up to approximately 39 months)