NCT07235618尚未招募2 期
A Phase II, Two-Stage Study Evaluating the Efficacy of Entinostat in Combined With Fulvestrant in Locally Advanced or Metastatic Breast Cancer With Recurrence or Progression After CDK4/6 Inhibitor Plus Endocrine Therapy
Sun Yat-sen University1 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2026年1月5日最近更新:
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Progression Free Survival (PFS)
研究概览
简要总结
This study aims to evaluate the efficacy of Entinostat combined with Fulvestrant in HR+/HER2- advanced breast cancer patients with recurrence/progression after endocrine therapy (primary endpoint: progression-free survival [PFS]), and explore the correlation between peripheral blood mononuclear cell (PBMC) acetylation levels and treatment response to determine the baseline acetylation threshold .
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
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Entinostat + Fulvestrant
Experimental
干预措施: Entinostat (Drug)
Entinostat + Fulvestrant
Experimental
干预措施: Fulvestrant (Drug)
结局指标
主要结局
Progression Free Survival (PFS)
时间窗: Up to 1 year
Progression-free survival(PFS) is defined as the time from treatment initiation to disease progression or death from any cause.
次要结局
- Overall Survival(OS)(Up to 3 years)
- Objective Response Rate(ORR)(Up to 3 years)
- Clinical Benefit Rate(CBR)(Up to 3 years)
- Duration of response(DOR)(Up to 3 years)
- Health-Related Quality of Life(Up to 3 years)
- Treatment compliance(Up to 3 years)
- Number of participants with adverse events(Up to 3 years)
研究者
wang shusen
Professor
Sun Yat-sen University
研究点 (1)
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