MO42921: PD-L1 AND ITS ROLE IN PATIENTS WITH TNBC (VANESSA)
Research type
Research Study
Full title
A MULTI-COUNTRY OBSERVATIONAL RETROSPECTIVE STUDY TO EVALUATE THE PREVALENCE OF PD-L1 AND ITS ROLE IN PATIENTS WITH TNBC TREATED WITH SYSTEMIC THERAPY (VANESSA)
IRAS ID
303428
Contact name
Head, EU/ROW Regulatory Affairs Pharmaceutical Division
Contact email
Sponsor organisation
F Hoffmann-La Roche Ltd
Duration of Study in the UK
0 years, 8 months, 28 days
Research summary
The purpose of this secondary data, non-interventional study is to evaluate the role of a protein called Programmed death-ligand 1 (PD-L1) in patients with triple negative breast cancer (TNBC). The PD-L1 protein is found in about 40% of tissue samples from patients with TNBC. PD-L1 positive tumours can partially resist or help the tumour evade the body’s natural immune response. Blocking the PD-L1 protein may help stop or reverse the growth of tumours.
The presence of PD-L1 protein in tumour tissue samples can be assessed with a laboratory test called the VENTANA anti-PD-L1 (SP142) assay.
This study will investigate how many patients with TNBC have tumours that are PD-L1 positive, and how being PD-L1 positive affects the behavior of the tumour. The study will also assess whether the PD-L1 test results are consistent when measured in different laboratories; a piece of tissue will be analysed in both the local site laboratory and a central laboratory. .
In the future, this study may help to understand TNBC better, as well as develop new products or improve the use of current products, such as tests and drugs for the treatment of breast cancer.
The data from approximately 2700 participants will be used for this study worldwide, approximately 180 from the UK.
Specific health information will be collected from existing participant medical records and be analysed as part of this study. Health information will be collected relating to the time period from initial TNBC diagnosis until June 2021. No additional assessments/tasks will be required of the participants.
Eligible participants will be those with a diagnosis of TNBC between 1st January 2014 and 31st December 2017. Given the nature of TNBC, some identified participants may be deceased.REC name
Yorkshire & The Humber - Leeds East Research Ethics Committee
REC reference
21/YH/0295
Date of REC Opinion
20 Jan 2022
REC opinion
Further Information Favourable Opinion