NCT01840293

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

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,780

participants targeted

Target at P75+ for all trials

Timeline
142mo left

Started Feb 2013

Longer than P75 for all trials

Geographic Reach
1 country

6 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Feb 2013Jan 2038

Study Start

First participant enrolled

February 1, 2013

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

April 23, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

April 25, 2013

Completed
16.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2029

Expected
8.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2038

Last Updated

December 19, 2025

Status Verified

December 1, 2025

Enrollment Period

16.8 years

First QC Date

April 23, 2013

Last Update Submit

December 15, 2025

Conditions

Primary Breast CancerRecurrent/Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Investigation of proteins and their pathways in primary breast cancer

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

    10 years

Secondary Outcomes (3)

  • 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

  • Determination of novel potential molecular targets

    10 years

Study Arms (2)

Primary Breast Cancer

Recurrent/Metastatic Breast Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • Patients diagnosed with primary breast cancer attending hospital for the resection of their tumour tissue
  • 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
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (6)

Cork University Hospital

Cork, Ireland

RECRUITING

Beaumont Hospital

Dublin, Ireland

RECRUITING

St James's Hospital

Dublin, Ireland

COMPLETED

St. Vincent's University Hospital

Dublin, Ireland

RECRUITING

University Hospital Limerick

Limerick, Ireland

ACTIVE NOT RECRUITING

University Hospital Waterford

Waterford, Ireland

RECRUITING

Related Publications (2)

  • 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. 2020 Nov 19;18(1):349. doi: 10.1186/s12916-020-01806-4.

    PMID: 33208158DERIVED

  • 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: 28399921DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Central Study Contacts

Cancer Trials Ireland

CONTACT

info@cancertrials.ie

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
OTHER
Sponsor Type
NETWORK
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 23, 2013

First Posted

April 25, 2013

Study Start

February 1, 2013

Primary Completion (Estimated)

December 1, 2029

Study Completion (Estimated)

January 1, 2038

Last Updated

December 19, 2025

Record last verified: 2025-12

Locations

IE(6)