A Multicenter Phase II Clinical Study of Pyrotinib Combined With Dalpiciclib Combined With Letrozole in the Treatment of ER-positive and HER2-positive Advanced Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 63
- 试验地点
- 1
- 主要终点
- Objective response rate
研究概览
简要总结
This is a a multicenter Phase II clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in ER-positive and HER2-positive advanced breast cancer patients. The sample size is 63.
详细描述
This is a a multicenter Phase II clinical study investigating efficacy of pyrotinib combined with dalpiciclib combined with letrozole in ER-positive and HER2-positive advanced breast cancer patients. Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d, d1-21, q28d. One cycle is 28d.
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
- •The subjects voluntarily joined the study, signed the informed consent, and had good compliance
- •Postmenopausal or premenopausal/perimenopausal women aged ≥18 years and ≤75 years
- •Patients with recurrent/metastatic breast cancer confirmed by histopathology with positive ER expression and positive HER2 expression
- •Have at least one extracranial measurable lesion that meets RECIST 1.1 criteria
- •At most one previous trastuzumab containing systemic therapy for recurrent metastatic breast cancer
排除标准
- •Subjects had untreated central nervous system metastasis
- •Bilateral breast cancer, inflammatory breast cancer, or latent breast cancer
- •Previous treatment with any CDK4/6 inhibitors
- •Inability to swallow, intestinal obstruction, or other factors affecting drug use and absorption
- •Subject has had other malignancies (except cured basal cell carcinoma of the skin and carcinoma in situ of the cervix) within 5 years or at the same time
研究组 & 干预措施
pyrotinib dalpiciclib letrozole
Patients receive pyrotinib 320mg/d, dalpiciclib 125mg/d and letrozole 2.5mg/d until disease progression, intolerated toxicity.
干预措施: pyrotinib dalpiciclib letrozole (Drug)
结局指标
主要结局
Objective response rate
时间窗: through study completion, an average of 2 year
the proportion of patients achieving complete response or partial response
次要结局
- Progression Free Survival(through study completion, an average of 2 year)
研究者
Chen Zhanhong
MD
Zhejiang Cancer Hospital