Breast Cancer With Over-expression of erbB2 Study of the Treatment Paradigm in Metastasis to BRAIN (BRAINSTORM)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- To describe the treatment pattern of brain metastasis in ErbB2 over-expressing breast cancer in Asia Pacific countries.
研究概览
简要总结
This retrospective cohort study aims to improve our understanding of the current paradigm for treatment of brain metastases in erbB2+ breast cancer patients in the Asia Pacific region. We aim to identify approximately 300 erbB2+ breast cancer patients with brain metastases diagnosed between 2006-2008 in 6 countries. Medical records will be analyzed to determine the treatment pattern for brain metastases, including anti-erbB2 therapy. Additional objectives are to understand the impact of anti-erbB2 therapy on survival after brain metastases and to investigate the relationship between anti-erbB2 therapy for brain metastases and: 1) the time interval between diagnosis of erb2+ breast cancer and brain metastasis, and 2) the occurrence of brain metastasis as the first site of disease progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients diagnosed with erbB2+ breast cancer. ErbB2 positivity will be as determined by respective institutional standards, and will be based on medical history only.
- •Brain metastasis diagnosis made between January 2006 - December 2008.
排除标准
- •Women who have another primary cancer diagnosed between the time of breast cancer diagnosis and brain metastasis..
- •Patient has leptomeningeal metastases only without parenchymal brain involvement (since this pattern of the disease requires a different treatment approach.)
研究组 & 干预措施
Breast cancer patients with brain metastases
Female Erb2+ breast cancer patients with brain metastases diagnosed between January 2006 and December 2008 in 6 Asian countries (Indonesia, Korea, Malaysia, Philippines, Singapore, and Thailand).
干预措施: Anti-erbB2 therapy as part of a treatment regimen for either brain metastases or primary breast cancer (Drug)
结局指标
主要结局
To describe the treatment pattern of brain metastasis in ErbB2 over-expressing breast cancer in Asia Pacific countries.
时间窗: Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period
次要结局
- To describe the survival of ErbB2 over-expressing breast cancer patients with brain metastasis after diagnosis of brain metastasis in relation to the receipt of anti-erbB2 therapy.(Time (in months) from date of first diagnosis of brain metastasis through to death or end of study period)
- Describe association between usage of anti-erbB2 therapy (before brain metastasis) & 1) time interval from diagnosis of erbB2+ breast cancer to occurrence of brain metastasis and 2) occurrence of brain metastasis as the first site of disease progression(Time (in month) between the date of diagnosis of erbB2+ breast cancer and date of first diagnosis of brain metastasis)