An observational study in Primary Breast Cancer and Recurrent/Metastatic Breast Cancer, sponsored by Cancer Trials Ireland. Recruiting at 6 sites in Ireland. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-12-19.
Sponsored by Cancer Trials Ireland · Observational
Primary objective:
The primary objective is to define the proteomic and molecular characteristics of primary and recurrent/ metastatic breast tumours with special focus on the expression of S100 protein and the estrogen receptor (ER), progesterone receptor (PR) and epidermal growth factor receptor 2 (HER2) genes
Secondary objective:
This is a translational study. Patient will undergo standard treatment and tissue and blood samples will be taken at various time points:
Tissue: Fresh frozen (FF) and Formalin fixed paraffin embedded tissue (FFPE) will be collected at time of surgery/biopsy of a primary or a recurrent/metastatic tumour tissue.
Blood: Two types of study bloods (non-heparinised and Ethylenediaminetetraacetic acid (EDTA)) will be taken pre-neoadjuvant treatment (if applicable), pre- and post-operatively of primary and recurrent/ metastatic breast cancer (if recurrent/metastatic diagnosis and no biopsy/surgery required then study bloods will be taken prior to starting treatment).
Additional blood samples will be taken annually at follow-up visits for 5 years from primary cases and for up to 2 years from recurrent/metastatic cases.
Non-heparinised blood will be processed to serum. Clinical data will be collected at all times of biological sampling.
All newly diagnosed breast cancer patients, recurrent and stage IV metastatic breast cancer patients.
Inclusion Criteria:
Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue
Or
-Patients with suspected or confirmed recurrent or metastatic breast cancer (Patient has a history of a biopsy- or surgically- (i.e. pathologically) confirmed primary breast cancer) attending hospital for the resection/biopsy and/or treatment of tumour tissue
Or
-Patient with suspected (but not necessarily biopsy confirmed) newly diagnosed stage 4 breast cancer attending hospital for the resection/biopsy and/or treatment of their tumour tissue
Investigation of proteins and their pathways in primary breast cancer
Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.
Time frame: 10 years
Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer
Time frame: 10 years
Identification of novel molecular mechanisms of breast cancer recurrence
Identification of novel molecular mechanisms of breast cancer recurrence, therapy resistance and/or metastasis
Time frame: 10 years
Determination of novel potential molecular targets
Determination of novel potential molecular targets that can be used to develop future prevention and treatment advances in patients with breast cancer
Time frame: 10 years
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Cancer Trials Ireland