NCT05640778招募中2 期
Efficacy and Safety of Neoadjuvant Dalpiciclib Combined With Endocrine Therapy in Luminal B/HER2-negative Breast Cancer and Biomarker Analysis: a Single-arm, Open-label Trial
Second Affiliated Hospital, School of Medicine, Zhejiang University1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2022年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment
研究概览
简要总结
Evaluate the efficacy and safety of Dalpiciclib combined with aromatase inhibitors as a neoadjuvant therapy in Luminal B/HER2-negative breast cancer.
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
- •Patient is ≥ 18 years-old at the time of consent to participate this trial
- •Famale stage I-III breast cancer patients
- •HR-positive（ER≥10%）, HER2-negtive invasive breast cancer, either Ki67≥20% and/or PgR<20%
- •No prior anti-cancer treatment
排除标准
- •Known to have other aggressive malignant tumor in the past 5 years.
- •Bilateral breast cancer; Inflammatory breast cancer; Occult breast cancer; Distant metastasis confirmed by pathology.
- •There are other concomitant diseases that seriously threaten the patient's safety or affect the patient's completion of the study, such as serious infection, liver disease, cardiovascular disease, kidney disease, respiratory disease or uncontrolled diabetes or dyslipidemia.
- •Female patients during pregnancy or lactation.
- •The investigator determines that subjects are not appropriate to participate in the study due to other factors.
研究组 & 干预措施
neoadjuvant endocrine therapy
Experimental
CDK4/6 inhibitor combined with aromatase inhibitor
干预措施: Dalpiciclib combined with aromatase inhibitors (Drug)
结局指标
主要结局
Complete cell cycle arrest（CCCA, defined as ki67≤2.7%）rate at 2 weeks of treatment
时间窗: 3 years
Assess ki67 level through biopsy samples of patients
次要结局
- Objective response rate (ORR)(3 years)
研究者
研究点 (1)
Loading locations...
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