Anrotinib in Combination With Capecitabine in the Single-arm, Open Phase II Treatment of Relapsed or Metastatic Triple-negative Breast Cancer Clinical Research
试验速览
- 阶段
- 2 期
- 入组人数
- 35
- 试验地点
- 2
- 主要终点
- Objective Response Rate
研究概览
简要总结
The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer
详细描述
It is a single-arm phase II clinical study of capecitabine combined with antinib in the treatment of recurrent or metastatic triple-negative breast cancer.
The hypothesis of this study is to discover if the capecitabine plus Anlotinib can shrink or slow the growth of pretreated advanced TNBC.
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 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female aged between 18 and 70;
- •Recurrence or metastasis OF TNBC confirmed by histological or cytological methods, TNBC definitions of ER, PR and HER-2 are negative, if there is metastasis pathology, the histological pathology of metastasis shall prevail.ER and PR negative were defined as ER < 10% positive and PR < 10% positive.
- •Disease progression after at least one prior systemic treatment and anthracycline and/or taxane use;Note: For neoadjuvant/adjuvant therapy, recurrence or disease progression during treatment or within 6 months of discontinuation of treatment should be counted as first-line systemic treatment failure;
- •There should be at least one measurable lesion according to the efficacy evaluation criteria for solid tumors (RECIST version 1.1)
排除标准
- •The number of previous treatment lines (including postoperative adjuvant therapy) >4 lines
- •symptomatic central system metastases.Patients with stable asymptomatic BMS who have received brain radiation and who have at least one other evaluable target in addition to the BMS can be enrolled (evaluable target should be at least 4 weeks away from the last radiotherapy).
- •New bisphosphonate or dinoselmer treatment for bone metastases was initiated within 28 days prior to study initiation.(Subjects are permitted if they have already been treated with bisphosphonate or dinoselmer for at least 4 weeks of optimal stable administration prior to study initiation.)Subjects already enrolled in this study may begin treatment with bisphosphonate or dinoselmer for bone metastases after the first post-treatment evaluation
研究组 & 干预措施
CA
Anlotinib 10mg Qd D1-14 Capecitabine 1G /m2 Bid D1-14 / Q21D
干预措施: Anlotinib (Drug)
CA
Anlotinib 10mg Qd D1-14 Capecitabine 1G /m2 Bid D1-14 / Q21D
干预措施: Capecitabine (Drug)
结局指标
主要结局
Objective Response Rate
时间窗: up to 1 year after the last patient enrolled
he ORR will be defined as the proportion of patients in the Efficacy Evaluable patient Set who achieve complete response (CR) and partial response (PR)
次要结局
- Progression-free survival(up to 1 year after the last patient enrolled)
- adverse events(approximately 1.5 years)
研究者
Peng Yuan
Chief of VIP department
Chinese Academy of Medical Sciences