NCT01840293 Breast Cancer Proteomics and Molecular Heterogeneity
| NCT ID | NCT01840293 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Cancer Trials Ireland |
| Condition | Primary Breast Cancer |
| Study Type | OBSERVATIONAL |
| Enrollment | 1,780 participants |
| Start Date | 2013-02 |
| Primary Completion | 2029-12 |
Trial Parameters
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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
Eligibility Criteria
Inclusion Criteria: 1. 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 2. Patients receiving neoadjuvant treatment are also eligible (if applicable) 3. Patients have to be ≥ 18 years of age 4. Patients must be able to give informed consent
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