Breast Cancer Proteomics and Molecular Heterogeneity
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Primary Breast Cancer
- Sponsor
- Cancer Trials Ireland
- Enrollment
- 1780
- Locations
- 6
- Primary Endpoint
- Investigation of proteins and their pathways in primary breast cancer
- Status
- Recruiting
- Last Updated
- 4 months ago
Overview
Brief Summary
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:
- To expand our understanding of the complex molecular pathways dictating the progression of breast cancer and their response to different treatment regimes.
- To relate proteomic findings to survival data
- To identify potential serum markers of breast cancer progression
Detailed Description
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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue
- •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
- •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
- •Patients receiving neoadjuvant treatment are also eligible (if applicable)
- •Patients have to be ≥ 18 years of age
- •Patients must be able to give informed consent
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
Investigation of proteins and their pathways in primary breast cancer
Time Frame: 10 years
Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.
Secondary Outcomes
- Identification of novel molecular mechanisms of breast cancer recurrence(10 years)
- Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer(10 years)
- Determination of novel potential molecular targets(10 years)