A Multicenter, Prospective Cohort Study to Provide Real-world Evidence on the Effect of Nab-paclitaxel (ABRAXANE®) Treatment on the Clinical Outcomes and Health-related Quality of Life in Patients With Metastatic Breast Cancer in Greece. The 'ABReast' Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 156
- 试验地点
- 1
- 主要终点
- Evaluation of the best objective response to nab-paclitaxel treatment in eligible MBC patients as measured from the start of therapy until disease progression, unacceptable toxicity, or termination of study participation
研究概览
简要总结
This non-interventional study aims at assessing the impact of nab-paclitaxel on the clinical outcomes and the health-related QoL (HRQoL) of this heavily burdened and difficult-to-treat population. Notably, the data generated in the context of this study will serve as complementary evidence to that of the tightly and strictly controlled pre-registration clinical trial setting, which is of essential importance especially in patient populations with diseases of complex and heterogeneous biology, such as 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
- •Patients eligible for inclusion in this study have to meet all of the following criteria:
- •Adult patients (18 years and older);
- •Patients with a histologically or cytologically confirmed diagnosis of MBC who have failed first-line treatment for metastatic disease and for whom standard, anthracycline containing therapy is not indicated;
- •Patients for whom the decision to prescribe therapy with nab-paclitaxel according to the locally approved product's summary of product characteristics (SmPC) has already been taken prior to their enrolment in the study; the assignment of the patient to this therapeutic strategy is not decided in advance by the study protocol but falls within current practice and the prescription of nab-paclitaxel is clearly separated from the physician's decision to include the patient in the current study;
- •Patients must be able and willing to provide written informed consent and to comply with the requirements of this study protocol;
- •Patients must have signed an informed consent document;
- •Patients must be able to read, understand and complete the study specific questionnaire
排除标准
- •A patient who meets any of the following criteria will be excluded from participation in this study:
- •Patients who have initiated treatment with nab-paclitaxel more than 7 days prior to their enrolment into the study;
- •Patients that meet any of the contraindications to the administration of the study drug according to the approved SmPC;
- •Receipt of any investigational agent within 30 days or 5 half-lives of the investigational agent (whichever is longer) before the commencement of therapy with nab-paclitaxel.
结局指标
主要结局
Evaluation of the best objective response to nab-paclitaxel treatment in eligible MBC patients as measured from the start of therapy until disease progression, unacceptable toxicity, or termination of study participation
时间窗: as measured by routine assessments from the start of nab-paclitaxel therapy (at least 6 months post-treatment onset and up to 12 months) until disease progression, occurrence of unacceptable toxicity, or study participation termination
The proportion of objective responders \[patients with either a complete response (CR) or a partial response (PR) as the best objective response\] as measured by routine assessments from the start of nab-paclitaxel therapy until disease progression, occurrence of unacceptable toxicity, or study participation termination whichever occurs sooner
次要结局
未报告次要终点