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临床试验/ACTRN12621000216819
ACTRN12621000216819尚未招募未知

A registry to prospectively describe real-world clinicopathologic presentation and treatment selection in patients with advanced HR+, HER2- breast cancer in Australia

The Walter and Eliza Hall Institute of Medical research (WEHI)0 个研究点目标入组 300 人开始时间: 2021年3月3日最近更新:
适应症

试验速览

阶段
未知
状态
尚未招募
发起方
入组人数
300

研究概览

简要总结

暂无简介。

研究设计

研究类型
Observational

入排标准

年龄范围
18 Years 至 o limit(—)
性别
All

入选标准

  • 1.Patients aged 18, of any gender and ECOG performance status diagnosed with advanced HR+, HER2- breast cancer (either de novo metastatic or relapsed), after 1st January 2020
  • 2.Histological or cytological confirmation of HR+, HER2- breast cancer from either primary archival tissue or from biopsy material obtained from a metastatic site
  • a) Hormone receptor positivity is defined as greater than 1% of oestrogen receptor expression and/or greater than 1% of progesterone receptor expression via immunohistochemistry (IHC) analysis
  • b) HER2 negativity by local laboratory assessment is defined as:
  • - In situ hybridisation (ISH) non-amplification (ratio of HER2 to CEP 17 < 2.0 or single probe average HER2 gene copy number < 4 signals/cell) OR
  • - IHC 0 or IHC 1+ (as per ASCO 2018 HER2 pathology classification guidelines)

排除标准

  • Patient's under 18 who have either HR-ve or HER2 +ve breast cancer
  • Patient's who have non metastatic breast cancer

研究者

发起方
The Walter and Eliza Hall Institute of Medical research (WEHI)

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