Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
This is a translational pilot study, involving two patient cohorts, designed to identify
predictive biomarkers for HER2 targeted therapy, which will be validated in a larger future
Cohort 1: 300 newly diagnosed (including metastatic) HER2 positive breast cancer patients.
Cohort 2: 30 newly diagnosed HER2 negative breast cancer patients.
Blood specimens will be taken:
- before starting treatment (cohort 1 and 2)
- after receiving chemotherapy and before starting HER2 targeted treatment (if
applicable) (cohort 1)
- within one month following 1st treatment of HER2 targeted treatment (cohort 1)
- approximately every 3 months (coinciding with formal disease assessment) while on HER2
targeted treatment for a maximum of 5 years (cohort 1)
Blood will be processed to serum, which will be analysed for RNA and protein biomarkers.
Observational Model: Cohort, Time Perspective: Prospective
Identification of Extra Cellular RNAs/proteins in sera from cancer patients
Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment
Ireland: Health Information and Quality Authority