Last updated on August 2020

An Epidemiologic Study on PD-L1 Expression Combined With Clinical Observation in the Chinese MIUBC Patients.


Brief description of study

The Primary Objective of this observational study is to investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients.

Detailed Study Description

The primary objective of this observational study is:

To investigate the prevalence of high PD-L1 expression in Chinese MIUBC patients. High PD-L1 expression is defined as 25% tumor cell membrane positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control OR 25% tumor associated immune cell positivity for PD-L1 at any intensity above background staining as noted on the corresponding negative control.

Note: PD-L1 High (>=25% tumor cell membrane positivity for PD-L1 or 1) IF IC area >1%: >=25% tumor associated immune cell positivity for PD-L1; 2) If IC area=1%: 100% tumor associated immune cell positivity for PD-L1). PD-L1 Low if criteria not met for PD-L1 High.

The second objectives of this observational study are:

  • To investigate the PD-L1 expression profile in TC or IC in Chinese MIUBC patients.
  • To assess the concordance of PD-L1 testing results generated from the hospital labs with those from the central lab.
  • To observe the initial treatment pattern for MIUBC patients in usual clinical practice in China.
  • To observe 2-year OS of the Chinese MIUBC patients.

The exploratory objectives of this observational study are:

  • To explore the relationship between the demographic characteristics and expression of PD-L1 and other exploratory biomarkers including immune cell (IC) subset CD8+ T cells and tumor mutation burden (TMB).
  • To explore the relationship between OS and the demographic characteristics as well as the expression of biomarkers.
  • To explore the relationship between PD-L1 and TMB, PD-L1 and CD8 positive T cell respectively.

Clinical Study Identifier: NCT03433924

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Recruitment Status: Open


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