Post Marketing Surveillance Study To Observe Safety And Efficacy Of Aromasin In The Patients With Early Or Advanced Breast Cancer
2015年10月6日 更新者：Pfizer
This non-interventional study is to monitor use in real practice in Korea including adverse events on Aromasin (Exemestane).
研究概览
详细说明
All cases at the participating institutions.
研究类型
观察性的
注册 (实际的)
206
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Busan、大韩民国、614-735
- Inje University Busan Paik Hospital
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Daegu、大韩民国、705-717
- Yeung Nam University Hospital
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Gyeonggi-do、大韩民国、463-707
- Seoul National University Bundang Hospital
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Incheon、大韩民国、400-711
- Inha University Hospital
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Seoul、大韩民国、110-744
- Seoul National University Hospital
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Seoul、大韩民国、156-707
- SMG-SNU Boramae Medical Center
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Seoul、大韩民国、136-705
- Korea University Anam Hospital
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Seoul、大韩民国、138-736
- Asan Medical Center, University of Ulsan
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Seoul、大韩民国、120-752
- Severance Hospital, Yonsei University Health System, Yonsei Cancer Center
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Seoul、大韩民国、158-710
- Ewha Womans University Mokdong Hospital
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Seoul、大韩民国、135 710
- Samsung Medical Center
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Seoul、大韩民国、110-744
- Seoul National University Hospital (SNUH)
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Seoul、大韩民国、100-380
- Cheil General Hospital & Women's Healthcare Center
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Seoul、大韩民国、152-703
- Korea University Medical Center (KUMC) - Korea University Guro Hospital
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Suwon、大韩民国、443-380
- Ajou University Hospital
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Chungcheongnam-do
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Cheonan、Chungcheongnam-do、大韩民国、330-721
- Soon Chun Hyang University Hospital Cheonan
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Gyeonggi-do
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Anyang、Gyeonggi-do、大韩民国、431-070
- Hallym University Sacred Heart Hospital
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Bucheon、Gyeonggi-do、大韩民国、420-767
- Soon Chun Hyang University Bucheon Hospital
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Goyang、Gyeonggi-do、大韩民国、412-270
- Myongji Hospital, Kwangdong Unversity College of Medicine
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Jeollabuk-do
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Iksan -si、Jeollabuk-do、大韩民国、570-749
- Wonkwang University School of Medicine and Hospital (WUH)
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Korea
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Seoul、Korea、大韩民国、138-736
- Asan Medical Center
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South Jeolla Province
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Cheonnam、South Jeolla Province、大韩民国、519-809
- Hwasun Hospital, Chonnam National University
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
女性
取样方法
非概率样本
研究人群
- Postmenopausal women diagnosed as estrogen-receptor positive early breast cancer, who have received two to three years of tamoxifen and are switched to AROMASIN for completion of a total of five consecutive years of adjuvant hormonal therapy OR postmenopausal women with breast cancer that has progressed following anti-estrogen therapy.
描述
Inclusion Criteria:
- - Postmenopausal women with breast cancer eligible for hormonal therapy.
Exclusion Criteria:
- Pregnant breast-feeding premenopausal.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
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ajuvant group
adjuvant setting after two to three years of tamoxifen
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25 mg table QD
其他名称：
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palliative group
palliative setting after progression of disease with anti-estrogen therapy
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25 mg table QD
其他名称：
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs)
大体时间：From the first dose of Aromasin through the end of the study for an average of 5.6 months
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All AEs reported after start of administration of Aromasin were considered as TEAEs and summarized.
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From the first dose of Aromasin through the end of the study for an average of 5.6 months
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Percentage of Participants Without Recurrence/Metastasis (Early Breast Cancer)
大体时间：At the end of the study, average of 5.6 months.
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The antitumor efficacy for early breast cancer was measured by recurrence/metastasis status (Yes or No) of the participant at the end of the study.
The investigator recorded the final evaluation date and the information of tumor recurrence or metastasis (Yes or No) in each participant's case report form (CRF).
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At the end of the study, average of 5.6 months.
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Time-to-Progression (Early Breast Cancer)
大体时间：At the end of the study, average of 5.6 months
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Time-to-Progression was defined as the duration from the date of first administration of Aromasin to the date of recurrence or contralateral breast cancer.
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At the end of the study, average of 5.6 months
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Percentage of Participants by Overall Tumor Response Assessed Using Response Evaluation Criteria in Solid Tumors (RECIST) (Advanced Breast Cancer)
大体时间：At the end of the study, average of 5.6 months
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The antitumor efficacy for advanced breast cancer was measured by objective tumor assessments according to the RECIST of uni-dimensional evaluation.
Complete response (CR) was defined as disappearance of all target and non-target lesions, and no new lesions.
Partial response (PR) was defined as disappearance of all target lesions, a persistence of ≥1 non-target lesions, no new lesions; or a ≥30% decrease in the sum of the longest dimensions of the target lesions, no unequivocal progression of existing non-target lesions, no new lesions.
Stable disease (SD) was defined as neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for progressive disease (PD), no unequivocal progression of existing non-target lesions, and no new lesions.
PD was defined as a ≥20% increase in the sum of the longest dimensions of the target lesions; or unequivocal progression of existing non-target lesions, or the appearance of ≥1 new lesions.
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At the end of the study, average of 5.6 months
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
赞助
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始
2010年6月1日
初级完成 (实际的)
2014年6月1日
研究完成 (实际的)
2014年6月1日
研究注册日期
首次提交
2009年12月24日
首先提交符合 QC 标准的
2010年1月8日
首次发布 (估计)
2010年1月12日
研究记录更新
最后更新发布 (估计)
2015年10月8日
上次提交的符合 QC 标准的更新
2015年10月6日
最后验证
2015年10月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.