HERdi PREDICT - Pilot Biomarker Study
Research type
Research Study
Full title
A pilot study to measure the expression of the HER2-HER3 dimer in samples from patients with HER2 positive breast cancer receiving HER2 targeted therapies.
IRAS ID
216170
Contact name
Gargi Patel
Contact email
Sponsor organisation
King's College, London
Duration of Study in the UK
0 years, 11 months, 30 days
Research summary
The treatment of breast cancer is determined by its ‘receptor (or signal) status’. Receptors are signals present on all cells and if abnormal can drive cancer growth. One of the signals that can drive breast cancer growth is the HER2 receptor/signal. One quarter of all breast cancers are found to have too many HER2 signals i.e. HER2-positive breast cancer.
HER2 is a member of the HER-family which constitutes HER1,HER2,HER3,and HER4 signals. Currently, tests can identify breast cancers with too much HER2, from a biopsy, so a cancer doctor can prescribe anti-HER2 treatment to block these signals. These drugs have improved survival rates in HER2-positive breast cancer. Members of the HER family can also ‘pair’ with each other to activate signals that encourage cancer growth. For example, HER3 naturally ‘pairs’ with HER2. Though anti-cancer drugs have been developed to target this pairing, the current method of patient selection is not developed to detect pairing of signals in tissue biopsies. A specialist imaging technique called FLIM-FRET can identify signal pairing on cancer cells from tissue, and potentially, from blood samples.
This study involves having blood tests while participants receive anti-HER2 treatment. We will also seek permission to take samples of cancer tissue from the biopsies that were already carried out, e.g. at diagnosis. Some participants may need an additional biopsy, which will be discussed with participants prior to consent. This study will use the specialist FLIM-FRET technique to measure the signal pairing in tumour samples and blood samples. We will measure if the levels of signal pairing from blood are the same as that from tissue, which could lead to bloods tests being used to select patients for anti-HER2 treatments, instead of invasive tissue biopsies. Changes in signal pairing may also help to predict if a cancer is becoming resistant to treatment.
REC name
London - Riverside Research Ethics Committee
REC reference
19/LO/1366
Date of REC Opinion
5 Sep 2019
REC opinion
Favourable Opinion