Breast Cancer Proteomics and Molecular Heterogeneity
Study Details
Study Description
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:
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To expand our understanding of the complex molecular pathways dictating the progression of breast cancer and their response to different treatment regimes.
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To relate proteomic findings to survival data
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To identify potential serum markers of breast cancer progression
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
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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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Primary Breast Cancer
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| Recurrent/Metastatic Breast Cancer
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Outcome Measures
Primary Outcome Measures
- Investigation of proteins and their pathways in primary breast cancer [10 years]
Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.
Secondary Outcome Measures
- 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 [10 years]
Identification of novel molecular mechanisms of breast cancer recurrence, therapy resistance and/or metastasis
- Determination of novel potential molecular targets [10 years]
Determination of novel potential molecular targets that can be used to develop future prevention and treatment advances in patients with breast cancer
Eligibility Criteria
Criteria
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
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Patients receiving neoadjuvant treatment are also eligible (if applicable)
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Patients have to be ≥ 18 years of age
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Patients must be able to give informed consent
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | St. Vincent's University Hospital | Dublin 4 | Ireland | ||
| 2 | Beaumont Hospital | Dublin | Ireland |
Sponsors and Collaborators
- Cancer Trials Ireland
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- ICORG 09-07