Primary Breast Cancer, Recurrent/Metastatic Breast Cancer
Conditions
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.
Interventions
None listed
Sponsors
Cancer Trials Ireland
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Ireland
Contacts
Primary ContactCancer Trials Ireland
Outcome results
None listed