Breast Cancer Proteomics and Molecular Heterogeneity
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Primary Breast Cancer, Recurrent/Metastatic Breast Cancer. Basic parameters: from 18 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Ireland
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Overview
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.
Primary outcome measures
- Investigation of proteins and their pathways in primary breast cancer [Time frame: 10 years]
Secondary outcome measures (3)
- Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer [Time frame: 10 years]
- Identification of novel molecular mechanisms of breast cancer recurrence [Time frame: 10 years]
- Determination of novel potential molecular targets [Time frame: 10 years]
Eligibility 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
- 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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Ireland · 6 centers
- Cork University Hospital — Cork
- Beaumont Hospital — Dublin
- St James's Hospital — Dublin
- St. Vincent's University Hospital — Dublin
- University Hospital Limerick — Limerick
- University Hospital Waterford — Waterford
Publications
- Charmsaz S, Doherty B, Cocchiglia S, Vareslija D, Marino A, Cosgrove N, Marques R, Priedigkeit N, Purcell S, Bane F, Bolger J, Byrne C, O'Halloran PJ, Brett F, Sheehan K, Brennan K, Hopkins AM, Keelan S, Jagust P, Madden S, Martinelli C, Battaglini M, Oesterreich S, Lee AV, Ciofani G, Hill ADK, Young LS. ADAM22/LGI1 complex as a new actionable target for breast cancer brain metastasis. BMC Med. 20 PMID 33208158
- Charmsaz S, Hughes E, Bane FT, Tibbitts P, McIlroy M, Byrne C, Cocchiglia S, McBryan J, Hennessy BT, Dwyer RM, Kerin MJ, Hill AD, Young LS. S100beta as a serum marker in endocrine resistant breast cancer. BMC Med. 2017 Apr 12;15(1):79. doi: 10.1186/s12916-017-0836-2. PMID 28399921
Identifiers
NCT: NCT01840293 · ICORG 09-07