Breast CancerNCT01722851
Circulating miRNAs.
An observational study of Breast Cancer and Newly Diagnosed Breast Cancer, run by Cancer Trials Ireland at 7 sites in Ireland.
Trial summary
To identify a panel of circulating miRNA markers which could help identify those breast cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy, and indeed serve as an overall prognostic factor and stratify patients into risk categories which would further guide their management. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Newly Diagnosed Breast Cancer, Recurrent Breast Cancer
- How many people
- 255 participants
- Where
- 7 sitesIreland
- Study dates
- May 2011to Dec 2021
- 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: Investigators aim to study two populations of breast cancer patients: 1. Patients undergoing neoadjuvant chemotherapy for breast cancer at tertiary referral breast cancer centres in Ireland. For GUH only: Additionally,investigators wish to evaluate miRNA expression levels in patients' diagnostic core biopsies. 2. Investigators also wish to study the same panel of miRNAs in patients who present with disease recurrence or disease progression, and who are commenced on systemic therapies (hormonal and/or chemotherapy).
Who may be able to join
- Patient must meet the criteria for either:
- Cohort 1: All patients with a new diagnosis of breast cancer, who are destined to undergo neoadjuvant chemotherapy.
- OR Cohort 2: All breast cancer patients who present with metastatic disease, disease recurrence or progression who will receive up-front chemotherapy ± hormonal therapy.
- OR Cohort 3: All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only.
- Patients must be aged 18 years or over.
- Patients must be able to give written informed consent.
Who cannot join
- All patients, who do not fulfil the inclusion criteria mentioned above.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Ireland7 sites
Bon Secours Hospital
Cork
Beaumont Hospital
Dublin
St James's Hospital
Dublin
University Hospital Galway
Galway
Letterkenny General Hospital
Letterkenny
Sligo General Hospital
Sligo
Midlands Regional Hospital Tullamore
Tullamore
About this study
Official title: Novel Breast Cancer Biomarkers and Their Use for Guiding and Monitoring Response to Chemotherapy
To identify a panel of circulating miRNA markers which could help identify those breast cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy, and indeed serve as an overall prognostic factor and stratify patients into risk categories which would further guide their management. Similarly, the investigators aim to identify a panel of circulating miRNA markers which could monitor patient's response to chemotherapy and hormonal therapies. Ideally a suitable panel of markers would show significant changes in expression level in good-responders whilst little or no change would be observed in miRNA expression in non-responders.
Read the detailed description
Primary Objectives:
- To identify a panel of miRNAs, detectable in the circulation, which are altered in breast cancer patients
- To identify specific combinations of miRNAs ('signatures') which associate with breast cancer intrinsic subtypes, and thereby could aid in prognostication and treatment planning on an individual patient basis.
Secondary Objective:
- To determine if systemic miRNA analysis can be used as a biomarker for monitoring response to chemotherapy, in the neoadjuvant setting and in patients who present with breast cancer recurrence and are treated with upfront chemotherapy and/or hormonal therapy. This is a prospective cohort studies, involving three study cohorts: Cohort 1: All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy. Cohort 2: All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy +/- hormonal therapy. Cohort 3: All breast cancer patients who present with metastatic disease who are commencing hormonal therapy only. Blood Sample Blood Sampling - Cohort 1:
- Blood sample 1: at presentation before commencing neoadjuvant treatment.
- Blood sample 2: midway through their chemotherapy treatment (after 2nd cycle if they are enrolled in a 4 cycle regimen, or after 4th cycle if they are prescribed an 8 week regimen).
- Blood sample 3: post-chemotherapy (before surgery as applicable).
- Blood sample 4: 2 to 4 weeks after surgery, or 2 to 4 weeks post 3rd blood sampling if patients do not undergo surgery.
- Blood sample 5: once during follow-up of 12 to 18 months after surgery or 12 to 18 months post 3rd blood sampling if patients do not undergo surgery. Blood Sampling - Cohort 2:
- Pre-treatment blood sample: at presentation before commencing treatment.
- On study blood samples: taken at monthly (± 1 week) intervals for a period of 6 months from date of pre-treatment blood sample, despite whether the patient is on treatment or completed treatment. On study blood sample 1: 1 month (± 1 week) from date of pre-treatment blood sample On study blood sample 2: 2 months (± 1 week) from date of pre- treatment blood sample On study blood sample 3: 3 months (± 1 week) from date of pre-treatment blood sample On study blood sample 4: 4 months (± 1 week) from date of pre-treatment blood sample On study blood sample 5: 5 months (± 1 week) from date of pre-treatment blood sample On study blood sample 6: 6 months (± 1 week) from date of pre-treatment blood sample
- End of study blood sample: once during follow-up of 12 to 18 months from date of pre-treatment blood sample or at the time of disease progression. Blood Sampling - Cohort 3:
- Pre-treatment blood sample: at presentation before commencing treatment.
- On study blood samples: taken at the following time points despite whether the patient is on treatment or completed treatment. On study blood sample 1: 3 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 2: 6 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 3: 12 months (± 2 weeks) from date of pre-treatment blood sample
- End of study blood sample: 18 months (± 2 weeks) from date of pre-treatment blood sample or at the time of disease progression. Blood samples will be processed for miRNA analysis, which involves:
- Lysis using Trizol 2. RNA isolation 3. Assessing concentration and integrity of RNA using Nanodrop spectrophotometry 4. cDNA synthesis (using miRNA specific stem loop primers) 5. PCR amplification and relative quantification (using miRNA specific probes)
- Keywords
- Breast Cancer, miRNAs, Newly diagnosed, Recurrent
- Medical subject headings
- Breast Neoplasms, Recurrence
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 |
|---|---|---|
| Cohort 1 | All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy | |
| Cohort 2 | All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy ± hormonal therapy | |
| Cohort 3 | All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Relationship between changes in a patients circulating miRNA expression levels over the course of their systemic therapy, and their response to that treatment.
For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses.
For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1." For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses.
For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1."
Measured: Up to week 66-92
Correlation of systemic miRNA levels with standard biomarkers of response
Standard bio markers of response include serum CEA and Ca15-3 levels
Measured: Up to week 66-92
Secondary outcomes (2)
Relationship between circulating miRNA profiles and patients' intrinsic subtype of breast cancer
Measured: Up to week 66-92
Relationship between miRNA expression levels and other existing clinicopathological parameters.
Other existing clinicopathological parameters include: ER, PR and HER2 status, stage of disease,histological grade and size of the tumour, and the Nottingham Prognostic Index.
Measured: Up to week 66-92
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2012 (estimated)
- Study startMay 2011
- Primary completion1 Apr 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 255 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01722851
- Sponsor's protocol ID
- ICORG 10-11
- Status last verified
- Jul 2025
- First submitted
- 24 Oct 2012
- Last updated
- 8 Jul 2025
- Results posted
- No
Publications
Davey MG, McGuire A, Casey MC, Waldron RM, Paganga M, Holian E, Newell J, Heneghan HM, McDermott AM, Keane MM, Lowery AJ, Miller N, Kerin MJ. Evaluating the Role of Circulating MicroRNAs in Predicting Long-Term Survival Outcomes in Breast Cancer: A Prospective, Multicenter Clinical Trial. J Am Coll Surg. 2023 Feb 1;236(2):317-327. doi: 10.1097/XCS.0000000000000465. Epub 2022 Nov 2.
PubMed 36648259Davey MG, Casey MC, McGuire A, Waldron RM, Paganga M, Holian E, Newell J, Heneghan HM, McDermott AM, Keane MM, Lowery AJ, Miller N, Kerin MJ. Evaluating the Role of Circulating MicroRNAs to Aid Therapeutic Decision Making for Neoadjuvant Chemotherapy in Breast Cancer: A Prospective, Multicenter Clinical Trial. Ann Surg. 2022 Nov 1;276(5):905-912. doi: 10.1097/SLA.0000000000005613. Epub 2022 Jul 25.
PubMed 35876391
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
- Novel Breast Cancer Biomarkers and Their Use for Guiding and Monitoring Response to Chemotherapy
- ClinicalTrials.gov ID
- NCT01722851
- Acronym / sponsor ID
- ICORG 10-11
- Keywords
- Breast Cancer, miRNAs, Newly diagnosed, Recurrent
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 255 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- May 2011 (actual)
- Primary completion
- 1 Apr 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 7 Nov 2012 (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.
To identify a panel of circulating miRNA markers which could help identify those breast cancer patients who are most likely to respond well to neoadjuvant and adjuvant chemotherapy, and indeed serve as an overall prognostic factor and stratify patients into risk categories which would further guide their management. Similarly, the investigators aim to identify a panel of circulating miRNA markers which could monitor patient's response to chemotherapy and hormonal therapies. Ideally a suitable panel of markers would show significant changes in expression level in good-responders whilst little or no change would be observed in miRNA expression in non-responders.
Detailed description
Primary Objectives:
- To identify a panel of miRNAs, detectable in the circulation, which are altered in breast cancer patients
- To identify specific combinations of miRNAs ('signatures') which associate with breast cancer intrinsic subtypes, and thereby could aid in prognostication and treatment planning on an individual patient basis.
Secondary Objective:
- To determine if systemic miRNA analysis can be used as a biomarker for monitoring response to chemotherapy, in the neoadjuvant setting and in patients who present with breast cancer recurrence and are treated with upfront chemotherapy and/or hormonal therapy. This is a prospective cohort studies, involving three study cohorts: Cohort 1: All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy. Cohort 2: All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy +/- hormonal therapy. Cohort 3: All breast cancer patients who present with metastatic disease who are commencing hormonal therapy only. Blood Sample Blood Sampling - Cohort 1:
- Blood sample 1: at presentation before commencing neoadjuvant treatment.
- Blood sample 2: midway through their chemotherapy treatment (after 2nd cycle if they are enrolled in a 4 cycle regimen, or after 4th cycle if they are prescribed an 8 week regimen).
- Blood sample 3: post-chemotherapy (before surgery as applicable).
- Blood sample 4: 2 to 4 weeks after surgery, or 2 to 4 weeks post 3rd blood sampling if patients do not undergo surgery.
- Blood sample 5: once during follow-up of 12 to 18 months after surgery or 12 to 18 months post 3rd blood sampling if patients do not undergo surgery. Blood Sampling - Cohort 2:
- Pre-treatment blood sample: at presentation before commencing treatment.
- On study blood samples: taken at monthly (± 1 week) intervals for a period of 6 months from date of pre-treatment blood sample, despite whether the patient is on treatment or completed treatment. On study blood sample 1: 1 month (± 1 week) from date of pre-treatment blood sample On study blood sample 2: 2 months (± 1 week) from date of pre- treatment blood sample On study blood sample 3: 3 months (± 1 week) from date of pre-treatment blood sample On study blood sample 4: 4 months (± 1 week) from date of pre-treatment blood sample On study blood sample 5: 5 months (± 1 week) from date of pre-treatment blood sample On study blood sample 6: 6 months (± 1 week) from date of pre-treatment blood sample
- End of study blood sample: once during follow-up of 12 to 18 months from date of pre-treatment blood sample or at the time of disease progression. Blood Sampling - Cohort 3:
- Pre-treatment blood sample: at presentation before commencing treatment.
- On study blood samples: taken at the following time points despite whether the patient is on treatment or completed treatment. On study blood sample 1: 3 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 2: 6 months (± 2 weeks) from date of pre-treatment blood sample On study blood sample 3: 12 months (± 2 weeks) from date of pre-treatment blood sample
- End of study blood sample: 18 months (± 2 weeks) from date of pre-treatment blood sample or at the time of disease progression. Blood samples will be processed for miRNA analysis, which involves:
- Lysis using Trizol 2. RNA isolation 3. Assessing concentration and integrity of RNA using Nanodrop spectrophotometry 4. cDNA synthesis (using miRNA specific stem loop primers) 5. PCR amplification and relative quantification (using miRNA specific probes)
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –All newly diagnosed breast cancer patients who are scheduled to undergo neoadjuvant chemotherapy |
| Cohort 2 | – | –All breast cancer patients who present with metastatic disease, disease recurrence or progression, who are commencing up-front chemotherapy ± hormonal therapy |
| Cohort 3 | – | –All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Investigators aim to study two populations of breast cancer patients: 1. Patients undergoing neoadjuvant chemotherapy for breast cancer at tertiary referral breast cancer centres in Ireland. For GUH only: Additionally,investigators wish to evaluate miRNA expression levels in patients' diagnostic core biopsies. 2. Investigators also wish to study the same panel of miRNAs in patients who present with disease recurrence or disease progression, and who are commenced on systemic therapies (hormonal and/or chemotherapy).
Key inclusion criteria (6 listed)
- Patient must meet the criteria for either:
- Cohort 1: All patients with a new diagnosis of breast cancer, who are destined to undergo neoadjuvant chemotherapy.
- OR Cohort 2: All breast cancer patients who present with metastatic disease, disease recurrence or progression who will receive up-front chemotherapy ± hormonal therapy.
- OR Cohort 3: All breast cancer patient who present with metastatic disease who are commencing hormonal therapy only.
- Patients must be aged 18 years or over.
Key exclusion criteria (1 listed)
- All 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.
Primary outcome
Relationship between changes in a patients circulating miRNA expression levels over the course of their systemic therapy, and their response to that treatment.
Time frame: Up to week 66-92
For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses. For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1." For cohort 1, a patient's response to treatment will be determined using 3 standard parameters: clinical, radiological and pathological responses. For cohort 2 and 3, a patient's response to treatment will be evaluated using RECIST criteria version 1.1."
Correlation of systemic miRNA levels with standard biomarkers of response
Time frame: Up to week 66-92
Standard bio markers of response include serum CEA and Ca15-3 levels
2 secondary outcomes
Relationship between circulating miRNA profiles and patients' intrinsic subtype of breast cancer
Time frame: Up to week 66-92
Relationship between miRNA expression levels and other existing clinicopathological parameters.
Time frame: Up to week 66-92
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.
- Derived from this study: PubMed 36648259Davey MG, McGuire A, Casey MC, Waldron RM, Paganga M, Holian E, Newell J, Heneghan HM, McDermott AM, Keane MM, Lowery AJ, Miller N, Kerin MJ. Evaluating the Role of Circulating MicroRNAs in Predicting Long-Term Survival Outcomes in Breast Cancer: A Prospective, Multicenter Clinical Trial. J Am Coll Surg. 2023 Feb 1;236(2):317-327. doi: 10.1097/XCS.0000000000000465. Epub 2022 Nov 2.
- Derived from this study: PubMed 35876391Davey MG, Casey MC, McGuire A, Waldron RM, Paganga M, Holian E, Newell J, Heneghan HM, McDermott AM, Keane MM, Lowery AJ, Miller N, Kerin MJ. Evaluating the Role of Circulating MicroRNAs to Aid Therapeutic Decision Making for Neoadjuvant Chemotherapy in Breast Cancer: A Prospective, Multicenter Clinical Trial. Ann Surg. 2022 Nov 1;276(5):905-912. doi: 10.1097/SLA.0000000000005613. Epub 2022 Jul 25.
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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.
7 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 Newly Diagnosed Breast Cancer, run by Cancer Trials Ireland at 7 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 6 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 7 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?
Relationship between changes in a patients circulating miRNA expression levels over the course of their systemic therapy, and their response to that treatment. (time frame: Up to week 66-92). The study lists 2 primary outcomes in all. 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 NCT01722851, which also lists 2 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 8 Jul 2025.