Breast CancerNCT01840306
Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
An observational study of Breast Cancer and HER2 Positive Breast Cancer, run by Cancer Trials Ireland at 11 sites in Ireland.
Trial summary
Primary Objective: (i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, HER2 Positive Breast Cancer, HER2 Negative Breast Cancer
- What is being tested?
- Biomarker Analysis
- How many people
- 330 participants
- Where
- 11 sitesIreland
- Study dates
- 12 Oct 2012to 24 May 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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: * HER2 positive breast cancer:Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer. * HER2 negative breast cancer:Female patients with newly diagnosed HER2 negative breast cancer.
Who may be able to join
- Patient with a newly diagnosed (including metastatic) HER2 positive breast cancer, who is to commence HER2 targeted treatment.
- OR
- Patient with a newly diagnosed HER2 negative breast cancer, who is to commence any type of treatment.
- Patient must be female and aged 18 years or over.
- Patient must provide written informed consent.
Who cannot join
- 1. Patients who do not fulfil the inclusion criteria mentioned above
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Ireland11 sites
Bon Secours Hospital
Cork
Cork University Hospital
Cork
Letterkenny General Hospital
Donegal
Our Lady of Lourdes Hospital
Drogheda
Beacon Hospital
Dublin
Beaumont Hospital
Dublin
St James's Hospital
Dublin
St Vincent's University Hospital
Dublin
The Adelaide & Meath Hospital, Dublin Incorporating the National Children's Hospital
Dublin
Sligo General Hospital
Sligo
University Hospital Waterford
Waterford
About this study
Primary Objective:
(i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii).
Read more
Secondary Objective:
To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.
Read the detailed description
This is a translational pilot study, involving two patient cohorts, designed to identify predictive biomarkers for HER2 targeted therapy, which will be validated in a larger future study.
Cohort 1: 300 newly diagnosed (including metastatic) HER2 positive breast cancer patients. Cohort 2: 30 newly diagnosed HER2 negative breast cancer patients.
Blood specimens will be taken:
- before starting treatment (cohort 1 and 2)
- after receiving chemotherapy and before starting HER2 targeted treatment (if applicable) (cohort 1)
- within one month following 1st treatment of HER2 targeted treatment (cohort 1)
- approximately every 3 months (coinciding with formal disease assessment) while on HER2 targeted treatment for a maximum of 5 years (cohort 1)
Blood will be processed to serum, which will be analysed for RNA and protein biomarkers.
- Being tested
- Biomarker Analysis
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biomarker AnalysisOther
| Study group | Role | What they receive |
|---|---|---|
| Cohort 1: HER2 positive breast cancer | Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer. Receives: Other: Biomarker Analysis | |
| Cohort 2: HER2 negative breast cancer | Female patients with newly diagnosed HER2 negative breast cancer Receives: Other: Biomarker Analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Identification of Extra Cellular RNAs/proteins in sera from cancer patients
Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment
Measured: 7 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 start12 Oct 2012
- Primary completion24 May 2023
- Study completion24 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Prospective
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01840306
- Sponsor's protocol ID
- ICORG 10-15
- Status last verified
- Jul 2025
- First submitted
- 23 Apr 2013
- Last updated
- 8 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exosomal and Free Extracellular RNAs and Proteins as Predictive Biomarkers for HER2 Therapies in Breast Cancer
- ClinicalTrials.gov ID
- NCT01840306
- Acronym / sponsor ID
- ICORG 10-15
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 12 Oct 2012 (actual)
- Primary completion
- 24 May 2023 (actual)
- Study completion
- 24 May 2023 (actual)
- 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:
(i) To identify panels of RNAs and proteins predictive of response to HER2 targeted agents, considering clinical responses. (ii) To investigate associations between presence vs. absence (or relative levels) of identified extracellular (EC) RNAs/proteins and patients' clinicopathological characteristics, including age at diagnosis, time to progression and overall survival, as well as correlations with serum protein biomarkers routinely analysed for these patients. (iii) To compare HER2 positive samples versus HER2 negative samples for the existence of RNAs/proteins identified in (i) and (ii).
Secondary Objective:
To develop a predictive model for use in the HER2 positive population based on the most accurate and sensitive combination of the identified biomarkers.
Detailed description
This is a translational pilot study, involving two patient cohorts, designed to identify predictive biomarkers for HER2 targeted therapy, which will be validated in a larger future study.
Cohort 1: 300 newly diagnosed (including metastatic) HER2 positive breast cancer patients. Cohort 2: 30 newly diagnosed HER2 negative breast cancer patients.
Blood specimens will be taken:
- before starting treatment (cohort 1 and 2)
- after receiving chemotherapy and before starting HER2 targeted treatment (if applicable) (cohort 1)
- within one month following 1st treatment of HER2 targeted treatment (cohort 1)
- approximately every 3 months (coinciding with formal disease assessment) while on HER2 targeted treatment for a maximum of 5 years (cohort 1)
Blood will be processed to serum, which will be analysed for RNA and protein biomarkers.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: HER2 positive breast cancer | – | Other: Biomarker AnalysisFemale patients with newly diagnosed (including metastatic) HER2 positive breast cancer. |
| Cohort 2: HER2 negative breast cancer | – | Other: Biomarker AnalysisFemale patients with newly diagnosed HER2 negative breast cancer |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- * HER2 positive breast cancer:Female patients with newly diagnosed (including metastatic) HER2 positive breast cancer. * HER2 negative breast cancer:Female patients with newly diagnosed HER2 negative breast cancer.
Key inclusion criteria (5 listed)
- Patient with a newly diagnosed (including metastatic) HER2 positive breast cancer, who is to commence HER2 targeted treatment.
- OR
- Patient must be female and aged 18 years or over.
- Patient must provide written informed consent.
Key exclusion criteria (1 listed)
- 1. Patients who do not fulfil the inclusion criteria mentioned above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biomarker Analysis | Other | Cohort 1: HER2 positive breast cancer, Cohort 2: HER2 negative breast cancer |
Primary outcome
Identification of Extra Cellular RNAs/proteins in sera from cancer patients
Time frame: 7 years
Identification of EC RNAs/proteins in sera from cancer patients, which correlate with their response to treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2025.
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and HER2 Positive Breast Cancer, run by Cancer Trials Ireland at 11 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 8 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Identification of Extra Cellular RNAs/proteins in sera from cancer patients (time frame: 7 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jul 2025; AzTrials last refreshed its copy on 7 Nov 2026.