Neoadjuvant Treatment With Palbociclib and Exemestane Plus Trastuzumab and Pyrotinib in ER-positive, HER2-positive Breast Cancer (neoPEHP): an Exploratory, Open-label, Multi-center Phase 2 Study
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 57
- 主要终点
- pathological complete response(ypT0/is,ypN0, pCR)
研究概览
简要总结
neoPEHP is a multicohort, open-label, exploratory, phase 2 study. Patients were eligible if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive, ER-positive breast cancer and were suitable for neoadjuvant therapy. Patients were treated every 3 weeks with intravenous trastuzumab (8 mg/kg loading dose followed by 6 mg/kg) and oral pyrotinib (400 mg po QD) for six cycles plus oral palbociclib (125 mg once a day for 21 days in a 4-week cycle) and oral exemestane (25 mg po QD) every 4 weeks for 24 weeks. The primary endpoints was pathological complete response.
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
- •We judged patients eligible for the first study cohort if they had previously untreated, histologically confirmed, unilateral, invasive, HER2-positive (3+ on immunohistochemistry or neu-amplified) and ER-positive (>10% of cells in the tumour expressing ER) breast cancer. Other inclusion criteria were age 18 years or older, Eastern Cooperative Oncology Group (ECOG) performance status of 1 or less, and tumour classified between cT1c and cT4a-d.
排除标准
- •metastatic disease, bilateral breast cancer, other malignant disease, inadequate bone marrow or renal function, impaired liver function, impaired cardiac function, uncontrolled hypertension, pregnancy, and refusal to use contraception.
研究组 & 干预措施
Neoadjuvant treatment with palbociclib and exemestane plus trastuzumab and pyrotinib
干预措施: palbociclib and exemestane plus trastuzumab and pyrotinib (Drug)
结局指标
主要结局
pathological complete response(ypT0/is,ypN0, pCR)
时间窗: 24 weeks
defined as the absence of invasive tumor cells in breast and axilla, ypT0/is ypN0
次要结局
未报告次要终点