Intention CDKi study
Research type
Research Study
Full title
INTENTION: cyclIn depeNdenT kinasE immuNe acTIvatiOn sigNatures - clinical study
IRAS ID
336662
Contact name
Ellen Copson
Contact email
Sponsor organisation
University Hospital Southampton
Duration of Study in the UK
1 years, 11 months, 17 days
Research summary
Cyclin Dependent Kinase Inhibitors (CDKis) are a new class of anti-cancer drugs that have revolutionised the treatment of the most common subtype of metastatic breast cancer (breast cancer which has spread around the body). However, 20-30% of patients eligible for treatment with CDKi drugs do not respond to them. Currently there is no test available to predict in advance which patients are not going to respond well to CDKis and should instead receive an alternative treatment.
The technology company Proteotype Diagnostics has developed a new blood test called BEACON which measures immune system activity by analysing an “immune Activation Signature”. An initial study indicated that this test is effective at identifying which patients respond to CDKi therapy.
The aim of the Intention study is to test the effectiveness of the BEACON blood test in identifying patients with metastatic breast cancer who respond well to CDKi therapy, and those who do not, in a larger group of patients treated within the NHS. We will recruit 100 patients with metastatic oestrogen receptor positive, HER2 receptor negative breast cancer who have been recommended to have CDKi treatment. Patients will be recruited at University Hospital Southampton and two other cancer centres. All patients will receive standard of care treatment but they will be asked to provide an additional blood sample (10mls) before they start treatment with a CDKi drug and again after receiving this treatment for 3 months. These blood samples will be analysed using the BEACON test to determine the “Immune Activation Signature” of each patient.
We will collect clinical data on each patient, including response to treatment at 3 months on routine CT imaging, We will analyse these data and the Immune Activation Signature for each patient to confirm whether the BEACON test can accurately identify which patients respond to CDKis.
REC name
North East - Tyne & Wear South Research Ethics Committee
REC reference
24/NE/0060
Date of REC Opinion
28 Mar 2024
REC opinion
Favourable Opinion