Breast Cancer Proteomics and Molecular Heterogeneity

December 15, 2025 updated by: Cancer Trials Ireland

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

Study Overview

Status

Recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

1780

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Ireland
      • Cork, Ireland
        • Recruiting
        • Cork University Hospital
        • Contact:
          • Cancer Clinical Trials Unit
          • Phone Number: 021 4234816
        • Principal Investigator:
          • Paul Redmond
      • Dublin, Ireland
        • Recruiting
        • Beaumont Hospital
        • Contact:
          • Contact Person
          • Phone Number: 01- 809 3000
        • Principal Investigator:
          • Arnold Hill, Prof
        • Principal Investigator:
          • Bryan Hennessy, Prof
      • Dublin, Ireland
        • Recruiting
        • St. Vincent's University Hospital
        • Principal Investigator:
          • Janice Walshe
        • Contact:
          • CCRT
          • Phone Number: 01 221 4000
      • Dublin, Ireland
        • Completed
        • St James's Hospital
      • Limerick, Ireland
        • Active, not recruiting
        • University Hospital Limerick
      • Waterford, Ireland
        • Recruiting
        • University Hospital Waterford
        • Contact:
          • Cancer Clinical Trials Office
          • Phone Number: 051 848 000
        • Principal Investigator:
          • Gerry O'Donoghue

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All newly diagnosed breast cancer patients, recurrent and stage IV metastatic breast cancer patients.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Other

Cohorts and Interventions

Group / Cohort
Primary Breast Cancer
Recurrent/Metastatic Breast Cancer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
10 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer
Time Frame: 10 years
10 years
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
10 years
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
10 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cancer Trials Ireland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2013

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

January 1, 2038

Study Registration Dates

First Submitted

April 23, 2013

First Submitted That Met QC Criteria

April 23, 2013

First Posted (Estimated)

April 25, 2013

Study Record Updates

Last Update Posted (Estimated)

December 19, 2025

Last Update Submitted That Met QC Criteria

December 15, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ICORG 09-07

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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