Breast Cancer Proteomics and Molecular Heterogeneity

Study Overview
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Brief Summary
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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
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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.

Official Title
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Breast Cancer Proteomics and Molecular Heterogeneity

Conditions
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Primary Breast Cancer, Recurrent/Metastatic Breast Cancer

Participation Criteria
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Eligibility Criteria
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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 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Primary Breast Cancer<br> | |
| Recurrent/Metastatic Breast Cancer<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer |  | 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 | 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 | 10 years |