A Phase III, Randomized, Open-Label Clinical Trial Comparing Endocrine Therapy Combined With High-Dose Palbociclib and Hydroxychloroquine to Endocrine Therapy Combined With Standard-Dose Palbociclib for Hormone Receptor-Positive and HER2-Negative Advanced Breast Cancer
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 474
- 试验地点
- 1
- 主要终点
- Progression-Free Survival (PFS) as Assessed by the Investigator
研究概览
简要总结
This is a a phase III, randomized, open-label clinical trial comparing endocrine therapy combined with high-dose palbociclib and hydroxychloroquine to endocrine therapy combined with standard-dose palbociclib for hormone receptor-positive and her2-negative advanced breast cancer.
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 70 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
Control Group1
Standard-Dose Palbociclib + Endocrine therapy
干预措施: Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd (Drug)
Experimental Group 1
Standard-Dose Palbociclib + Endocrine Therapy + Hydroxychloroquine
干预措施: Palbociclib 125mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid (Drug)
Experimental Group 2
High-Dose Palbociclib + Endocrine Therapy + Hydroxychloroquine
干预措施: Palbociclib 200mg qd (3 weeks of treatment followed by 1 week off) + Anastrozole 1mg qd / Letrozole 2.5mg qd / Exemestane 25mg qd + Hydroxychloroquine 600mg bid (Drug)
结局指标
主要结局
Progression-Free Survival (PFS) as Assessed by the Investigator
时间窗: 3 years after random assignment
次要结局
- Progression-Free Survival (PFS) as Assessed by Blinded Independent Central Review (BICR)(3 years after random assignment)
- Overall Survival (OS)(3 years after random assignment)
- Objective Response Rate (ORR)(3 years after random assignment)
- Clinical Benefit Rate (CBR)(6 months after random assignment)
- Treatment Associated Adverse Effect(3 years after random assignment)
- Patient-Reported Outcomes (PRO)(3 years after random assignment)
研究者
Chang Gong
professor
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University