NCT04350021已完成不适用
Effect of Low Dose Metronomic Chemotherapy in Metastatic Breast Cancer - a Two Step Study With a Retrospective Analyses Followed by a Translational Phase II Study
Vastra Gotaland Region1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2019年3月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Overall response rates
研究概览
简要总结
Low dose metronomic chemotherapy (LDMC) in patients with metastatic breast cancer (MBC) is used as a palliative regiment with the aim to prolong and improve quality of life. The effect of LDMC is not fully elucidated. The aim is to evaluate the effect of LDMC with Capecitabine and Cyclophosphamide (CX) and to discover new potential predictive markers and potential markers for monitoring treatment effect.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Written and informed consent
- •Breast cancer confirmed by histology
- •Recurrence (local or distant) not possible to cure
- •Measurable or evaluable disease
- •Life expectancy of more than tree months
- •ECOG (Eastern Cooperative Oncology Group) performance 0-2
- •No or any lines of previous therapies for recurrent disease.
- •Adequate contraception for patients of Child bearing age.
排除标准
- •Clinically significant cardiovascular disease
- •Non healing wound, Active peptic ulcer or bone fracture
- •Evidence of any other disease that puts the patient at high risk for treatment-related complications
结局指标
主要结局
Overall response rates
时间窗: From baseline until three months after last dose.
Radiological and Clinical evaluation
Clinical benefit defined as the proportion of patients with CR(complete respons) or PR(partial respons) and patients with stable disease for 24 weeks or more.
时间窗: 24 weeks
Complete response and Partial response
次要结局
- Progression free survival(From baseline until three months after last dose.)
- Overall survival(From baseline until death of any course assesed up to one year.)
- Tolerance and safety assessment(From baseline until three months after last dose.)
- Health-related quality of life(From baseline until three months after last dose.)
- Evaluation of molecular characteristics in ctDNA (circulating tumor) defined as mutational changes.(From baseline until the date of first documented progression or date of death from any cause, whichever came first.)
- Evaluation of CA (cancer associated antigen) 15-3 in relation to treatment effect(From baseline until the date of first documented progression or date of death from any cause, whichever came first.)
- Evaluation of immune deficiency panel markers defined as changes in immune cell composition(From baseline until the date of first documented progression or date of death from any cause, whichever came first.)
研究者
研究点 (1)
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