Study on Xeloda® to Document Its Use in Routine Practice in Patients With Metastatic or Advanced Breast Cancer
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 274
- 主要终点
- Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
研究概览
简要总结
This observational study will evaluate the routine clinical use and the safety and efficacy of capecitabine (Xeloda®) in participants with metastatic or advanced breast cancer. Eligible participants will be followed for up to 24 months.
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
- •Adult female participants, >/= 18 years of age
- •Cytologic/histopathologic confirmed diagnosis of metastatic breast cancer
- •Prescribed capecitabine as in routine clinical practice
- •Informed consent signed
排除标准
- •Participation in any other clinical trial
- •History of severe and unexpected reactions to fluoropyrimidine therapy
- •Hypersensitivity to capecitabine or to any of the excipients of fluorouracil
- •Known dihydropyrimidine dehydrogenase (DPD) deficiency
- •Pregnant or lactating women
- •Severe leucopenia, neutropenia, or thrombocytopenia
- •Severe hepatic impairment
- •Severe renal impairment (creatinine clearance below 30 ml/min)
- •Treatment with sorivudine or its chemically related analogues, such as brivudine
- •Refusal to give consent
研究组 & 干预措施
Monotherapy
Capecitabine as monotherapy according to prescribing information and normal clinical practice.
干预措施: Capecitabine (Drug)
Combination Therapy
Capecitabine as part of combination therapy according to prescribing information and normal clinical practice.
干预措施: Capecitabine (Drug)
结局指标
主要结局
Percent of Participants With Capecitabine as a First Line, Second Line, or Third Line Therapy
时间窗: Up to approximately 4 years
To document use of Capecitabine regimen in the management of participants with metastatic breast cancer, the choice of Capecitabine monotherapy versus combination therapy was summarized according to whether the selection was for the participant's first, second, or third line of treatment.
Percentage of Participants Receiving Concomitant Medications During the Study
时间窗: Up to approximately 4 years
Percentage of participants receiving concomitant medications during the study along with their prescribed monotherapy or combination therapy were reported.
次要结局
- Percentage of Participants by Histopathology Grade Diagnosis Assessed at Baseline(Day 1)
- Mean Survival Time(Up to approximately 4 years)
- Percentage of Participants With Relevant Medical History Assessed at Baseline(Day 1)
- Percentage of Participants With Adverse Events(Up to approximately 4 years)