Efficacy and Safety of Adjuvant CDK4/6 Inhibitors in Patients With Hormone Receptor-positive/Human Epidermal Growth Factor Receptor 2-negative Breast Cancer: a Real-world Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 229
- 试验地点
- 1
- 主要终点
- Invasive Disease-free Survival (iDFS)
研究概览
简要总结
To evaluate the efficacy and safety of adjuvant CDK4/6 inhibitors in patients with hormone receptor-positive/human epidermal growth factor receptor 2-negative 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
- •Aged ≥18 and older
- •Patients with pathologically confirmed breast cancer without distant metastasis or local recurrence
- •HR+/HER2-
- •Subjects meeting current guideline recommendations and planning to receive adjuvant CDK4/6 inhibitors
排除标准
- •During pregnancy or lactation
- •Subjects that are unable to swallow tablets, or dysfunction of gastrointestinal absorption
研究组 & 干预措施
Adjuvant CDK4/6 inhibitor
CDK4/6 inhibitors are drugs that block cell division in cancer cells. They are used with hormonal therapy for hormone receptor-positive breast cancer and may improve survival.
干预措施: CDK4/6 inhibitor (Drug)
结局指标
主要结局
Invasive Disease-free Survival (iDFS)
时间窗: From the date of surgery until time of event up to 2 years.
Invasive disease-free survival time is defined as the time from date of randomization until the first invasive disease recurrence of the following events: invasive ipsilateral breast tumor recurrence, invasive contralateral breast cancer, local/regional invasive recurrence, distant recurrence and death from any cause.
次要结局
- Disease-free Survival (DFS)(From the date of surgery until time of event up to 2 years)
- Overall Survival (OS)(From the date of surgery until time of event up to 2 years)
- Adverse events(From the date of starting CDK4/6 inhibitor to the end of the treatment (up to approximately 3 years))
研究者
Wenjin Yin
Deputy Chief of Breast Surgery Department
RenJi Hospital