EUCTR2006-006619-64-GB进行中（未招募）1 期
Randomised Controlled Trial of Lapatinib (A Her1/2 Tyrosine Kinase Inhibitor) on Epithelial Proliferation and Apoptosis in Ductal Cancer in Situ. - Pre-operative study of Lapatanib in DCIS
niversity Hospital of South Manchester NHS Foundation Trust0 个研究点目标入组 80 人开始时间: 2008年2月22日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 80
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- Female
入选标准
- •Women with a core biopsy diagnosis of histologically proven Her2 positive DCIS or DCIS and invasive cancer.
- •All patients must give written informed consent for the use of core and excision biopsy prior to entering the trial.
- •Patients will undergo definitive surgical excision of their DCIS plus or minus invasive cancer within 14-21 days of the core biopsy.
- •Women undergoing re-excision of DCIS will be eligible provided residual DCIS is present in the re-excision specimen and 14-21 days of treatment are given between diagnostic biopsy and therapeutic excision.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Patients not undergoing definitive surgery for DCIS
- •Her2 negative DCIS
- •Patients unable to give informed consent
- •Primary chemotherapy as a neoadjuvant treatment
- •Patients with any serious systemic disease which precludes the use of Lapatinib or tyrosine kinase inhibitors
- •Patients using non-steroidal anti-inflammatory drugs
- •Allergy or aspirin allergy
- •Patients will not be on Lapatanib or a tyrosine kinase inhibitor prior to core biopsy. No previous invasive or in situ cancer will have been diagnosed within the same ipsilateral breast prior to diagnosis.
- •(a) Cardiovascular disease e.g. ischaemic heart disease
- •(b) Previous stroke/transient ischaemic attack or cerebrovascular disease
- •(c) Uncontrolled hypertension
- •Previous chemotherapy or radiotherapy in the past 12 months prior to study entry.
- •Pregnancy.
研究者
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