A Phase II/III Study to Evaluate the Efficacy and Safety of B013 in Combination With Nab-Paclitaxel in First-line Treatment for Patients With Previously Untreated Locally Advanced or Metastatic Triple Negative Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 62
- 试验地点
- 13
- 主要终点
- Progression-free survival (PFS)(IRC) (phase Ⅲ)
研究概览
简要总结
This Phase II/III study assessed the efficacy, safety, pharmacokinetics, and immunogenicity of B013 administered with nab-paclitaxel in participants with locally advanced or metastatic triple negative breast cancer (TNBC) who have not received prior systemic therapy for metastatic breast cancer (mBC).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •Women or men aged 18 -75 years
- •Locally advanced or metastatic triple negative breast cancer (TNBC)
- •No prior chemotherapy or targeted systemic therapy for inoperable locally advanced or metastatic TNBC
- •ECOG performance status of 0 or 1
- •Patient must have measurable or evaluable disease as defined by RECIST v1.
- •Measurable lesions will be confirmed by radiographic imaging (CT or MRI)
排除标准
- •Previous treatment is eligible.
- •Spinal cord compression not definitively treated with surgery and/or radiation prior to study entry
- •Known central nervous system (CNS) disease
- •Uncontrolled pleural effusion, pericardial effusion, or ascites Patients
- •Uncontrolled tumor-related pain prior to study entry
- •The patient has a history of another malignancy within 5 years prior to study entry, except adequately treated non-melanotic skin cancer, carcinoma in situ of the cervix or Papillary carcinoma of the thyroid
- •Pregnancy or lactation
研究组 & 干预措施
B013+ Nab-Paclitaxel
B013 at a fixed dose of 600 milligrams via intravenous (IV) infusion on Days 1 and 15 of the first 28-day cycle, then on Day 1 of each subsequent 28-day cycle.
Nab-Paclitaxel 100 mg/m^2 is administered weekly on Days 1, 8, 15 of each 28-day cycle.
干预措施: B013+Nab-Paclitaxel (Drug)
结局指标
主要结局
Progression-free survival (PFS)(IRC) (phase Ⅲ)
时间窗: Baseline up to approximately 18 months
from the start date of study treatment to the date of progression disease or death , whichever occurred first.
Objective response rate (ORR)(phase Ⅱ)
时间窗: Baseline up to approximately 18 months
tumor response will be evaluated according to the Response Evaluation Criteria Solid Tumors (RECIST) criteria version 1.1.
次要结局
- Duration of remission (DOR)(18 months)
- Incidence of Treatment-Emergent Adverse Events(3years)
- Disease control rate (DCR)(18 months)
- Time to Response (TTR)(18 months)
- Overall Survival (OS)(3years)
- Drug concentration in plasma(18 months)