UK HER2-Low Prevalence Study

• Research type

  Research Study

• Full title

  A Non-Interventional Multicenter Study to Estimate the Prevalence of HER2-low and Describe the Treatment Patterns, Resource Utilization, and Outcomes in Real-world Practice among Patients with Unresectable and/or Metastatic Breast Cancer with HR-positive, HER2-low Status in the UK - UK HER2Low Prevalence Study

• IRAS ID

  307975

• Contact name

  Emad Rakha

• Contact email

  emad.rakha@nuh.nhs.uk

• Sponsor organisation

  Astra Zeneca

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  0 years, 6 months, 30 days

• Research summary

  This is a non-interventional retrospective study. This study will be conducted in 3 to 5 NHS centres in the United Kingdom (UK). The study is a retrospective study of patients medical records and archived historical HER2 (human epidermal growth factor receptor) stained tumour biopsies / tissue specimens from patients with metastatic breast cancer (mBC) previously identified as HR-positive, HER2-negative.

  There will be no changes to patient management for the purposes of any part of the study and no additional tests, investigations or visits will be required.

  The population for this study is adult patients diagnosed with confirmed diagnosis of HR-positive HER2-negative, unresectable and/or mBC with a historical HER2 fixed tissue IHC stained slides (preferably stained using Ventana 4B5 assay) in acceptable quality for accurate rescoring. It is expected to recruit 500 patients in total.

• REC name

  North East - York Research Ethics Committee

• REC reference

  22/NE/0038

• Date of REC Opinion

  18 Feb 2022

• REC opinion

  Favourable Opinion