Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer

Primary Objective: (i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii). Secondary Objective: To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.

Sex

Female

Minimum age

18 Years

Inclusion Criteria:

1. Patient with a newly diagnosed (including metastatic) HER2 positive breast cancer, who is to commence HER2 targeted treatment.

   OR

   \- Patient with a newly diagnosed HER2 negative breast cancer, who is to commence any type of treatment.
2. Patient must be female and aged 18 years or over.
3. Patient must provide written informed consent.

Exclusion Criteria:

1\. Patients who do not fulfil the inclusion criteria mentioned above