Program for Assessment of Capecitabine (Xeloda) Plus Docetaxel First-line Therapies in HER2-negative Metastatic Breast Cancer (XEBRA Study)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 主要终点
- Progression-free Survival (PFS)
研究概览
简要总结
This multicenter observational study will evaluate the efficacy and safety of Xeloda (capecitabine) in combination with docetaxel in first-line therapy in participants with HER2-negative metastatic breast cancer. Participants will be followed for approximately 6 months of treatment.
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
- •Adult participants, >/= 18 years of age
- •HER2-negative metastatic breast cancer
- •Participants initiated on first-line therapy with Xeloda and docetaxel in accordance with the Summary of Product Characteristics; participants who started treatment with Xeloda and docetaxel no more than 3 months before enrollment in this study are also eligible
排除标准
- •Contraindications to Xeloda treatment according to the Summary of Product Characteristics
研究组 & 干预措施
Participants Receiving Capecitabine/Docetaxel
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
干预措施: capecitabine (Drug)
Participants Receiving Capecitabine/Docetaxel
Participants received capecitabine and docetaxel according to individualized physician-prescribed regimens.
干预措施: docetaxel (Drug)
结局指标
主要结局
Progression-free Survival (PFS)
时间窗: approximately 2 years
The time from enrollment until disease progression, assessed as the time to tumor progression, as evaluated by regular examinations per routine clinical practice, or death from any cause.
次要结局
- Time to Treatment Failure(approximately 2 years)
- Overall Response Rate(approximately 2 years)
- Clinical Benefit Rate(approximately 2 years)
- Duration of Treatment With Xeloda(approximately 2 years)
- Number of Participants With Adverse Events(approximately 2 years)
- Percentage of Capecitabine Dose Modifications(approximately 2 years)