NCT03933982Unknown2 期
Pyrotinib Plus Vinorelbine in Patients With Brain Metastases From HER2-positive Metastatic Breast Cancer : a Prospective, Single-arm, Open-label Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Objective Response Rate (ORR) of CNS
研究概览
简要总结
Pyrotinib is an oral tyrosine kinase inhibitor targeting both HER1, HER2 and HER4 receptors. This study is a single-arm, prospective, open label clinical study of pyrotinib plus vinorelbine as the therapy of brain metastases from HER2-positive metastatic 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
- •Age18-75 years.
- •ECOG performance status ≤
- •Histologically confirmed HER2 positive advanced breast cancer.
- •Prior to anthracyclines and taxanes (neoadjuvant, adjuvant and metastatic setting). Received ≤4 regimes in metastatic setting. Prior to trastuzumab is allowed.
- •Not received whole brain radiotherapy (WBRT) or recurrence after WBRT.
- •Controlled CNS symptoms (headache, dizziness, lethargy, nausea etc.).
- •Patients with CNS metastasis; at least one CNS metastases with a longest diameter ≥1 cm and a diameter perpendicular to the longest diameter should be ≥0.5 cm;
- •Signed the informed consent form prior to patient entry.
排除标准
- •Participated in other drug clinical trials within 4 weeks before the start of the study;
- •Received radiotherapy, chemotherapy, surgery and target therapy within 4 weeks before the start of the study;
- •Received endocrine therapy within 7 days before the start of the study;
- •Suitable for surgical resection;
- •Accompanied by rapid progress of organ invasion;
- •Factors influencing the usage of oral administration (such as unable to swallow, gastrointestinal resection, chronic diarrhea and intestinal obstruction etc.).
- •Prior to pyrotinib or vinorelbine or anti-HER2 TKI drugs;
- •Allergies to any compounds of experimental drugs;
- •CNS disorders or mental disorders, history of clear neurological or mental disorders, including epilepsy or dementia;
- •Other malignancies within 5 years, except cured in-situ of uterine cervix carcinoma , skin basal cell carcinoma and squamous-cell carcinoma.
- •Any other situations judged by investigator as not suitable for participating in this study.
研究组 & 干预措施
Pyrotinib plus Vinorelbine
Experimental
干预措施: Pyrotinib Plus Vinorelbine (Drug)
结局指标
主要结局
Objective Response Rate (ORR) of CNS
时间窗: Estimated up to 1 year
ORR, defined as proportion of complete response and partial response according to RANO-Brain Metastases (RANO-BM) criteria.
次要结局
- Time to radiotherapy(Estimated up to 1 year)
- Time to progression (TTP)(Estimated up to 1 year)
- OS (overall survival)(Estimated up to 1 year)
研究者
Peng Yuan
Professor
Chinese Academy of Medical Sciences
研究点 (1)
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