NCT01689610已完成不适用
Non-Interventional Study to Investigate Efficacy and Safety of Nab-Paclitaxel in Patients With Metastatic Breast Cancer
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- iOMEDICO AG
- 入组人数
- 705
- 试验地点
- 1
- 主要终点
- Time to Tumor Progression (TTP)
研究概览
简要总结
The purpose of this non-interventional study is to collect data on the efficacy and safety of Nab-Paclitaxel in the routine application.
详细描述
The main focus of this non-interventional study is set on answering the following questions:
- Can the results observed in controlled clinical trials regarding efficacy and safety be reproduced in the routine clinical setting?
- Are the side-effects of nab-paclitaxel therapy observed in this study comparable to the previously described safety-profile in terms of frequency and intensity?
- What are the main reasons for modification or termination of the nab-paclitaxel therapy?
- How does nab-paclitaxel therapy influence the patients' quality of life?
- What are the criteria for selecting nab-paclitaxel as therapy for metastatic breast cancer?
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
- Female
- 接受健康志愿者
- 否
入选标准
- •Female Patients with metastatic breast cancer, who are at least 18 years old (no upper age limit)
排除标准
- •Contraindication according to the summary of product characteristics of Abraxane®
- •No signed patient informed consent form available
- •pregnant or breastfeeding patients.
结局指标
主要结局
Time to Tumor Progression (TTP)
时间窗: 6 months after last-patient-in (LPI)
次要结局
- Overall survival (OS)(6 months after last-patient-in (LPI))
- Overall Response Rate (ORR)(6 months after last-patient-in (LPI))
- Time to treatment discontinuation(6 months after last-patient-in (LPI))
- Number of participants with Adverse Events as a measure of safety and tolerability(Until 30 days after discontinuation of Nab-paclitaxel)
- Relative dosage of Nab-Paclitaxel(Until discontinuation of Nab-Paclitaxel, up to 6 month)
- Intensity of peripheral neuropathy(Until discontinuation of Nab-Paclitaxel, up to 6 month)
- Necessity of supportive medication (e.g. haematopoetic growth factors, analgetics, antibiotics and antiemetics)(Until discontinuation of Nab-Paclitaxel, up to 6 month)
- Patient reported outcome on Quality of life and adverse events(At baseline, 3 and 6 months after start of treatment)
- Reasons for dose modifications or discontinuation of treatment(Until discontinuation of Nab-Paclitaxel, up to 6 month)
- Occurence of febrile neutropenia(Until discontinuation of Nab-Paclitaxel, up to 6 month)
- Occurence of peripheral neuropathy(Until discontinuation of Nab-Paclitaxel, up to 6 month)
- Occurence of neutropenia(Until discontinuation of Nab-Paclitaxel, up to 6 month)
研究者
研究点 (1)
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