The Efficacy and Safety of Chidamide Combined With Zimberelimab in the Treatment of Metastatic Triple-negative Breast Cancer Patients: A Single-armed, Phase II Trial
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Overall Response Rate (ORR)
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy.
详细描述
This is a phase II, single center, prospective, single arm clinical trial. The objective of the study is to evaluate the efficacy and safety of a new treatment regimen (Chidamide combined with Zimberelimab) in the treatment of patients with metastatic triple negative breast cancer after the second-line therapy. This study plans to recruit 47 subjects.
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
- •Histological confirmation of triple-negative breast cancer on primary tumour at diagnosis/on biopsy of metastasis.
- •At least 1 measurable lesion as defined by Response Evaluation Criteria in Solid Tumors (RECIST) criteria.
- •Fail first-line or above anti-tumor treatment.
- •Adequate organ function including bone marrow, renal function, hepatic function, and cardiac reserve.
- •Compliance with the study protocol.
- •Have provided written and signed informed consent.
- •Minimum life expectancy 16 weeks.
排除标准
- •Pregnant or breast feeding.
- •Uncontrolled medical problems.
- •Evidence of active acute or chronic infection.
- •Hepatic, renal, cardiac, or bone marrow dysfunction.
- •Concurrent malignancy or history of other malignancy within the last five years.
- •Known severe hypersensitivity to Chidamide or Zimberelimab
- •Patients were unable or unwilling to comply with program requirements.
研究组 & 干预措施
Treatment arm
Chidamide and Zimberelimab
干预措施: Chidamide combined with Zimberelimab (Drug)
结局指标
主要结局
Overall Response Rate (ORR)
时间窗: 18 months
The proportion of patients with measurable tumor size reduction of a predefined amount (complete response \[CR\], partial response \[PR\]) according to the response evaluation criteria in solid tumors (RECIST) version 1.1. Complete Response: Disappearance of all target lesions. Any pathological lymph nodes (whether target or non-target) must have reduction in short axis to \<10 mm (\<1 cm). Partial Response: At least a 30% decrease in the sum of the diameters of target lesions, taking as reference the baseline sum diameters.
次要结局
- Progression Free Survival (PFS)(24 months)
- Clinical benefit rate (CBR)(18 months)
- Occurrence and severity of AEs(30 months)
- Overall Survival (OS)(30 months)
研究者
Zhong-yu Yuan
Professor
Sun Yat-sen University