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NCT Number: NCT01840293

Breast Cancer Proteomics and Molecular Heterogeneity

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

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Cork University Hospital, Cork, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Investigation of proteins and their pathways in primary breast cancer

    Time frame: 10 years

    Investigation of proteins and their pathways in primary breast cancer, which are associated with patient outcome.

Secondary outcomes

  1. Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer

    Time frame: 10 years

  2. Identification of novel molecular mechanisms of breast cancer recurrence

    Time frame: 10 years

    Identification of novel molecular mechanisms of breast cancer recurrence, therapy resistance and/or metastasis

  3. Determination of novel potential molecular targets

    Time frame: 10 years

    Determination of novel potential molecular targets that can be used to develop future prevention and treatment advances in patients with breast cancer

Study contacts

Contact information is provided by the study sponsor or research team.

Cancer Trials Ireland

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Cancer Trials Ireland

Network

Registry information

Important dates

Study start
2013
Primary completion
2029
Study completion
2038
First posted
Apr 25, 2013
Registry last updated
Dec 19, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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