NCT06301438招募中不适用
Efficacy and Safety of Dalpiciclib in HR+/HER2- Advanced Breast Cancer: a Real-world Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 103
- 试验地点
- 1
- 主要终点
- Progression-Free Survival
研究概览
简要总结
To evaluate the efficacy and safety of dalpiciclib in patients with HR-positive/HER2-positive advanced breast cancer.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Histologically confirmed advanced breast cancer
- •Hormone receptor-positive and human epidermal growth factor receptor 2-negative
排除标准
- •Pregnant or breastfeeding
- •History of immunodeficiency
研究组 & 干预措施
dalpiciclib
dalpiciclib oral day 1-21, every 28 days
干预措施: dalpiciclib (Drug)
结局指标
主要结局
Progression-Free Survival
时间窗: From the date of starting dalpiciclib to the date of first documentation of progression or death (up to approximately 1 years)
The time from the date of starting dalpiciclib to the date of disease progression as per RECIST version 1.1 or death from any cause, whichever occurs first.
次要结局
- Adverse events(From the date of starting dalpiciclib to the end of the treatment (up to approximately 1 year))
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital
研究点 (1)
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