Neoadjuvant Dalpiciclib Plus Letrozole for HR+/HER2- Breast Cancer: A Single Arm, Open Label, Phase II Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 主要终点
- Complete cell-cycle arrest at C1D15, defined as ki67≤2.7%
研究概览
简要总结
In this single arm, open label, phase 2 trial, operable patients with stage IIB-III HR+/HER2- breast cancer will be enrolled and receive six cycles of adjuvant dalpiciclib plus letrozole. This study aims to assessed the biological effects and safety of dalpiciclib in combination with letrozole for HR+/HER2- breast cancer in the neoadjuvant setting.
详细描述
This is a single arm, open label, phase 2 trial aimed to investigate the biological effects and safety of neoadjuvant dalpiciclib in combination with letrozole for HR+/HER2- breast cancer. A total of 35 patients with stage IIB-III HR+/HER2- breast cancer will be enrolled. Six 4-week cycles of adjuvant therapy will be administrated. In each cycle, patients use dalpiciclib orally, 150mg, day 1-21, and letrozole orally, 2.5 mg, day 1-28. Premenopausal or perimenopausal patients should combine ovarian function suppression, including bilateral oophorectomy or treatment with gonadotropin-releasing hormone agonists. The primary endpoint is complete cell-cycle arrest at C1D15, defined as ki67≤2.7%. The secondary endpoints include residual cancer burden, overall response rate, change in Ki67 from baseline to 2 weeks of treatment, preoperative endocrine prognostic index, pathologic complete response, breast-conserving surgery rate and safety profile.
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 —（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
cohort 1
patients with stage IIB-III HR+/HER2- breast cancer
干预措施: dalpiciclib plus letrozole (Drug)
结局指标
主要结局
Complete cell-cycle arrest at C1D15, defined as ki67≤2.7%
时间窗: up 2 years
From the date into this study(signed ICF) to C1D15,defined as ki67≤2.7%
次要结局
- residual cancer burden(up 2 years)
- objective response rate(up 2 years)
- change in Ki67 from baseline to 2 weeks of treatment(up 2 years)
- preoperative endocrine prognostic index(up 2 years)
- pathologic complete response(up 2 years)
- breast-conserving surgery rate(up 2 years)
- safety profile(up 2 years)