NL-OMON56528撤回3 期
Clinical Performance Study Plan for Ki-67 IHC MIB-1 pharmDx (Dako Omnis) on Early Breast Cancer Specimens used to identify subjects for enrolment in AstraZeneca*s Phase III CAMBRIA-1 trial (D8531C00002) - CPSP for Ki-67 IHC MIB-1 pharmDx (Dako Omnis)
Astra Zeneca0 个研究点目标入组 42 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 撤回
- 发起方
- 入组人数
- 42
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 18 至 99（—）
入选标准
- •Sample requirements for testing from patients with ER+/HER2- early breast
- •cancer and who have completed definitive locoregional therapy and at least 2
- •years of standard adjuvant endocrine-based therapy without disease recurrence.
- •Please note, overall patient inclusion/exclusion criteria for this study are
- •documented in Section 5.1 of the CAMBRIA-I CSP (D8531C00002) and summarised
- •All patients in this study must provide an archival FFPE tumour tissue sample.
- •If the patient has not received any neoadjuvant treatment, a tumour sample
- •collected during definitive surgery is preferable (although tumour sample
- •collected during initial diagnostic workup will be accepted). If the patient
- •has received neoadjuvant treatment, then a tumour sample collected during
- •initial diagnostic workup is required.
- •At least 200 viable tumour cells in invasive tumour component of the FFPE
- •FFPE tissue specimen cut into sections of 4-5 µm and stained within 4 months of
- •sectioning and stored at room temperature.
排除标准
- •Specimen Bone biopsies, fine needle aspirates, cell
- •pellets, or cytology samples. Specimens prepared using fixatives and/or
- •fixation times other than 6 to 72 hours in 10% Neutral Buffered Formalin.
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