Primary Breast CancerNCT01840293
Breast Cancer Proteomics and Molecular Heterogeneity
An observational study of Primary Breast Cancer and Recurrent/Metastatic Breast Cancer, run by Cancer Trials Ireland at 6 sites in Ireland.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Primary Breast Cancer, Recurrent/Metastatic Breast Cancer
- How many people
- 1,780 participants
- Where
- 6 sitesIreland
- Study dates
- Feb 2013to Jan 2038
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All newly diagnosed breast cancer patients, recurrent and stage IV metastatic breast cancer patients.
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Cancer Trials Ireland contact
6 sites in 1 country
Ireland6 sites, 4 recruiting
- Recruiting
Cork University Hospital
Cork
Cancer Clinical Trials Unit, 021 4234816
Paul Redmond
- Recruiting
Beaumont Hospital
Dublin
Contact Person, 01- 809 3000
Arnold Hill, Prof
- Completed
St James's Hospital
Dublin
- Recruiting
St. Vincent's University Hospital
Dublin
CCRT, 01 221 4000
Janice Walshe
- Active, not recruiting
University Hospital Limerick
Limerick
- Recruiting
University Hospital Waterford
Waterford
Cancer Clinical Trials Office, 051 848 000
Gerry O'Donoghue
About this study
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
Read the 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.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Primary Breast Cancer | Not described | |
| Recurrent/Metastatic Breast Cancer | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 years
Secondary outcomes (3)
Comparison of the molecular profile between primary and recurrent/metastatic lesions in breast cancer
Measured: 10 years
Identification of novel molecular mechanisms of breast cancer recurrence
Identification of novel molecular mechanisms of breast cancer recurrence, therapy resistance and/or metastasis
Measured: 10 years
Determination of novel potential molecular targets
Determination of novel potential molecular targets that can be used to develop future prevention and treatment advances in patients with breast cancer
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2013 (estimated)
- Study startFeb 2013
- Primary completionDec 2029 (estimated)
- Study completionJan 2038 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Primary Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 1,780 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840293
- Sponsor's protocol ID
- ICORG 09-07
- Status last verified
- Dec 2025
- First submitted
- 23 Apr 2013
- Last updated
- 19 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
Publications
Jagust P, Powell AM, Ola M, Watson L, de Pablos-Aragoneses A, Garcia-Gomez P, Fallon R, Bane F, Heiland M, Morris G, Cavanagh B, McGrath J, Ottaviani D, Hegarty A, Cocchiglia S, Sweeney KJ, MacNally S, Brett FM, Cryan J, Beausang A, Morris P, Valiente M, Hill ADK, Vareslija D, Young LS. RET overexpression leads to increased brain metastatic competency in luminal breast cancer. J Natl Cancer Inst. 2024 Oct 1;116(10):1632-1644. doi: 10.1093/jnci/djae091.
PubMed 38852945Charmsaz 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.
PubMed 33208158Charmsaz 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.
PubMed 28399921
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Breast Cancer Proteomics and Molecular Heterogeneity
- ClinicalTrials.gov ID
- NCT01840293
- Acronym / sponsor ID
- ICORG 09-07
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,780 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- Feb 2013 (actual)
- Primary completion
- Dec 2029 (estimated)
- Study completion
- Jan 2038 (estimated)
- First posted
- 25 Apr 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Primary Breast Cancer | – | – |
| Recurrent/Metastatic Breast Cancer | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All newly diagnosed breast cancer patients, recurrent and stage IV metastatic breast cancer patients.
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2025.
- Derived from this study: PubMed 38852945Jagust P, Powell AM, Ola M, Watson L, de Pablos-Aragoneses A, Garcia-Gomez P, Fallon R, Bane F, Heiland M, Morris G, Cavanagh B, McGrath J, Ottaviani D, Hegarty A, Cocchiglia S, Sweeney KJ, MacNally S, Brett FM, Cryan J, Beausang A, Morris P, Valiente M, Hill ADK, Vareslija D, Young LS. RET overexpression leads to increased brain metastatic competency in luminal breast cancer. J Natl Cancer Inst. 2024 Oct 1;116(10):1632-1644. doi: 10.1093/jnci/djae091.
- Derived from this study: PubMed 33208158Charmsaz 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.
- Derived from this study: PubMed 28399921Charmsaz 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Cancer Trials Ireland contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Primary Breast Cancer and Recurrent/Metastatic Breast Cancer, run by Cancer Trials Ireland at 6 sites in Ireland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Ireland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cancer Trials Ireland (info@cancertrials.ie), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Investigation of proteins and their pathways in primary breast cancer (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01840293, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Dec 2025.