NCT04537286已完成2 期
A Prospective, Single-arm, Open-Label, Phase II Study of Nab-paclitaxel Plus Cisplatin Plus Camrelizumab as First-line Treatment in Patients With Metastatic Triple-negative Breast Cancer
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Adverse events
研究概览
简要总结
To evaluate the efficacy and safety of nab-paclitaxel plus cisplatin plus carilizumab as first-line treatment in patients with metastatic triple-negative breast cancer.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients aged 18-70 years who had
- •Metastatic TNBC. ER, PgR, and HER2 status were determined locally by immunohistochemistry (IHC) of patient primary or metastatic tumor sections. Metastatic disease was confirmed by clinical, imaging, histological or cytological measures.
- •Patients were required to receive no previous chemotherapy or targeted therapy for metastatic triple-negative breast cancer.
- •Patients who had received adjuvant/neoadjuvant therapy were required an interval for at least 6 months after stop of chemotherapy before the enrollment.
- •At least one measurable lesion according to RECIST 1.1,
- •ECOG performance status ≤ 1
- •Life expectancy of more than 12 weeks
- •Adequate organ and bone marrow function.
排除标准
- •Patient of childbearing potential but unwilling to receive contraception.
- •Radiation therapy of axial bone within 4 weeks before enrollment.
- •Previous treatment with PD-1 antibody, PD-L1 antibody and CTLA-4 antibody.
- •Patients have active autoimmune diseases.
- •Patients who need systemic corticosteroids (> 10 mg prednisone/d) or other immunosuppressive drugs within 14 days before enrollment or during the study period.
- •Symptomatic central nervous system (CNS) disease (patients with asymptomatic treated CNS metastases were permitted)
- •Other malignant diseases within the past 5 years (patients with basal cell skin carcinoma and cervical carcinoma in situ were permitted)
- •Uncontrolled infection.
结局指标
主要结局
Adverse events
时间窗: 6 weeks
Number of participants with treatment-related adverse events as assessed by Common Terminology Criteria for Adverse Events version 5.0 (CTCAE v5.0)
PFS
时间窗: 6 weeks
Progression free survival
次要结局
未报告次要终点
研究者
研究点 (1)
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