Retrospective Observational Study of Nab-paclitaxel (Abraxane®) Treatment in Patients With Metastatic Breast Cancer in Routine Clinical Practice
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 46
- 试验地点
- 19
- 主要终点
- Overall response rate (ORR)
研究概览
简要总结
This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. The study will be conducted by reviewing the medical records of patients up to the start of the study. In each case, only data from before the start of the study will be obtained in order to ensure they are retrospective in nature, thus reflecting the regular use of nab-paclitaxel in clinical practice and avoiding interference with the physician's clinical practice.
To ensure the observational nature of this study, these data will be collected whenever they are available in the patient's medical record, and so no diagnostic or therapeutic intervention outside regular clinical practice will be used.
详细描述
This is a national, multicenter, retrospective, observational post-authorization study (EPA-OD) study. Investigators will include all consecutive adult patients diagnosed with HER2-negative MBC who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease during the past 3 years (2012-2014). These patients must meet all the inclusion criteria and none of the exclusion criteria established in this protocol.
The primary objective is to describe the effectiveness of nab-paclitaxel in terms of response in early lines of chemotherapy for metastatic breast cancer in routine clinical practice.
This study plans to collect data retrospectively, provided they are available in the patient's medical record and according to routine clinical practice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
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
- •Women ≥18 years of age.
- •Confirmed diagnosis of MBC (stage IV).
- •Breast adenocarcinoma confirmed histologically.
- •HER2-negative according to the American Society of Clinical Oncology (ASCO) and Anatomical Pathology (CAP) criteria for the detection of HER2 in breast cancer.
- •Patients who have started treatment with nab-paclitaxel monotherapy no further than the third line of chemotherapy for metastatic disease in HER2-negative breast cancer during the period 2012-2014 (3 years) and who have received at least one cycle of treatment.
- •Ability to give informed consent, preferably in writing or orally in front of a witness, before the start of data collection (if it is able to be given).
排除标准
- •Patients with any medical or psychological disorder which in the investigator's opinion might compromise the ability of the patient to give their informed consent.
- •Patients who have received treatment with nab-paclitaxel combined with other chemotherapy agents or anti-angiogenic drugs or tumor-targeting drugs with anti-tumor activity.
- •Patients who have taken part in any clinical trial (interventional) during the study period.
结局指标
主要结局
Overall response rate (ORR)
时间窗: Up to approximately 8 months
The number of patients who achieve a complete response (CR) or partial response (PR) based on RECIST v1.1 criteria during treatment with nab-paclitaxel until disease progression, the end of treatment or the start of the study, whichever comes first.
次要结局
- Overall survival (OS)(Up to approximately 8 months)
- Disease control rate (DCR)(Up to approximately 8 months)
- Time to disease progression (TTP)(Up to approximately 8 months)
- Progression-free survival (PFS)(Up to approximately 8 months)
- Adverse Events (AEs)(Up to approximately 8 months)
- Overall Response Rate (ORR)(Up to approximately 8 months)