Status:
COMPLETED
Estimation of the Prevalence of HER2 Low and Describe the SoC, Treatment Patterns, and Outcome in Real-world Practice Among Unresectable and/or Metastatic Breast Cancer Patients With HER2 Low Status
Lead Sponsor:
AstraZeneca
Collaborating Sponsors:
Daiichi Sankyo
Conditions:
Breast Cancer
Eligibility:
All Genders
18-130 years
Brief Summary
This is a worldwide, multicenter, non-interventional, retrospective study of patient medical records from metastatic breast cancer (mBC) patients previously identified as human epidermal growth factor...
Detailed Description
This is a worldwide, multicenter, non-interventional, retrospective study. The study will consist of 2 components. The first component involves local lab rescoring of qualified historical HER2 fixed t...
Eligibility Criteria
Inclusion
- Men or women:
- ≥ 18 years of age when consent provided for future sample and clinical data use - applicable for all countries participating in the study except Japan
- ≥ 20 years of age when consent provided for future sample and clinical data use - applicable for Japan only
- Must have a histological or cytological confirmed diagnosis of unresectable or/and mBC between 01 January 2015 and 31 December 2017
- Must have provided written consent allowing for data and samples to be used in the future and this study would be covered by the consent for future use. If the patient is deceased, a waiver may be accepted
- Diagnosed as HER2-neg (HER2 IHC 0, 1+, 2+/ISH-), regardless of hormone status
- Progressed on any systemic anti-cancer therapy (eg, endocrine therapy, chemotherapy, CDK4/6i, targeted therapies other than anti-HER2, or immunotherapy) in the metastatic setting
- Must have historical HER2 fixed tissue IHC stained slides (preferably stained using Ventana 4B5 assay) in acceptable quality for accurate rescoring.
Exclusion
- Have a history of other malignancies, other than basal cell carcinoma of the skin and squamous cell carcinoma of the skin
- Patients with historical HER2 status of IHC 2+/ISH+ or 3+, or HER2 amplified.
Key Trial Info
Start Date :
May 28 2021
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 26 2022
Estimated Enrollment :
798 Patients enrolled
Trial Details
Trial ID
NCT04807595
Start Date
May 28 2021
End Date
April 26 2022
Last Update
March 6 2023
Active Locations (13)
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1
Research Site
Pittsburgh, Pennsylvania, United States, 15213
2
Research Site
Melbourne, Australia
3
Research Site
Montreal, Quebec, Canada, H3T 1R2
4
Research Site
Clermont-Ferrand, France, 63011