Breast CancerNCT03843346
The Impact of the Gene Recurrence Score on Chemotherapy Prescribing in ER Positive, Lymph Node Positive Early Stage Breast Cancer
An observational study of Breast Cancer, run by Cancer Trials Ireland at 10 sites in Ireland.
Trial summary
This study examines the impact of an additional tumour test called the 21 gene Recurrence Score (OncotypeDx®), a commercially available test on a Medical Oncologist's decision to recommend chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- How many people
- 87 participants
- Where
- 10 sitesIreland
- Study dates
- 16 Mar 2017to 2 Feb 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: The study will examine 2 cohorts of patients; * 75 patients (cohort 1; "postoperative") who have undergone resection of their primary breast cancer and * 75 patients (cohort 2; "preoperative") who are referred to a Medical Oncologist for consideration of neoadjuvant (preoperative) treatment. Both cohorts will have ER positive, lymph node positive breast cancer and both cohorts will undergo testing with the 21 gene RS.
Who may be able to join
- General Inclusion Criteria (All Patients)
- Age 18 years of age or older
- ER Positive Tumours (≥1% positive cells or Allred score ≥ 2 (Appendix 1))
- Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer (0-1 by IHC or FISH <2.0)
- No evidence of metastatic disease on CT, bone scan or other imaging
- Fit for consideration of chemotherapy as determined by the Investigator
Show all 16Show fewer
- Adequate performance status (Eastern Cooperative Oncology Group (ECOG) 0 or 1 (Appendix 2))
- Inclusion Criteria - Cohort 1 (Postoperative Patients): N= 75
- Adequate surgical excision of breast tumour (mastectomy or lumpectomy) and lymph nodes (sentinel lymph biopsy or axillary dissection)
- Any tumour size (T stage (Appendix 3))
- Involvement of 1-3 lymph nodes (N1, including micrometastases)
- Inclusion Criteria - Cohort 2 (Preoperative Patients): N= 75
- Candidates for preoperative therapy for early breast cancer
- T2-T4 tumours
- Involvement of at least one lymph node, (including micrometastases) on biopsy
- Adequate tissue from core biopsy for 21 gene RS testing (approximate minimum 5mm)
Who cannot join
- ER negative tumour (Allred score 0-1)
- HER2 positive tumours as defined by IHC 3+ or FISH ≥ 2.0
- Node negative disease, including those with Isolated tumour cells only (node negative i+/i-)
- Known metastatic breast cancer
- Performance status ≥ 2
- Patients not considered by their treating physician to be fit to undergo chemotherapy.
- Men with breast cancer.
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Ireland10 sites
Bon Secour Cork
Cork
Cork University Hospital
Cork
St Vincent's University Hospital
Dublin, Dublin 4
Mater Misericordiae University Hospital & Mater Private Hospital
Dublin, Dublin 7
Beaumont Hospital
Dublin, Dublin 9
St James' Hospital
Dublin
University Hospital Galway
Galway
Letterkenny University Hospital
Letterkenny, Co. Donegal
University Hospital Limerick
Limerick, V94 F858
University Hospital Waterford
Waterford
About this study
Official title: The Impact of the 21 Gene Recurrence Score (RS) on Chemotherapy Prescribing in Estrogen Receptor Positive, Lymph Node Positive Early Stage Breast Cancer in Ireland
This study examines the impact of an additional tumour test called the 21 gene Recurrence Score (OncotypeDx®), a commercially available test on a Medical Oncologist's decision to recommend chemotherapy.
Read the detailed description
After a breast cancer and any lymph glands have been surgically removed, further (adjuvant) treatment is generally given to reduce the risk of cancer recurrence. For patients with estrogen receptor (ER) positive breast cancer, this treatment has traditionally been chemotherapy and hormone therapy. However, it is increasingly recognised that tumours which are ER positive and negative for the human epidermal growth factor receptor 2 (HER2), are relatively resistant to chemotherapy. It is likely that many more people are exposed to the risks for chemotherapy than ever benefit from it. In order to select patients who will get more benefit from chemotherapy and to spare those who get very little benefit from side effects, risk assessment tools are being developed.
The 21 Gene Recurrence Score is a test that examines the tumour genes to estimate the risk of the tumour relapsing and possible chemotherapy benefits. Currently, the 21 Gene Recurrence Score (OncotypeDx®) is used In Ireland for patients with no cancer in their lymph nodes. For these patients it can help in deciding who should get chemotherapy. Patients with low scores can sometimes avoid chemotherapy. In some countries, this test is offered to almost all patients with ER positive breast cancer, irrespective of whether the cancer has spread to lymph nodes or not. However, in Ireland this test is not standardly available for patients who have breast cancer involving lymph nodes.
- Conditions
- Breast Cancer
- 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 |
|---|---|---|
| Cohort 1: Postoperative group | Consists of 75 patients who have completed definite surgery for their primary breast cancer as determined by a Consultant Surgeon and have been referred to a Medical Oncologist for consideration of adjuvant chemotherapy. * Tumours of any size will be eligible * Between 1 and 3 lymph nodes involved by tumour as assessed by Consultant Pathologist * Micro metastases (<=0.2mm) will be eligibile * Isolated tumour cells only (node negative i+/i-) are excluded | |
| Cohort 2: Preoperative group | Consists of 75 patients who have been referred by a Consultant Surgeon to a Medical Oncologist for consideration of neoadjuvant (preoperative) chemotherapy. * Min tumour size 2.1mm (T2) * Histological proof of involvement of at 1 lymph node, including micrometastases (<=0.2mm) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recommended Chemotherapy
The percentage reduction in the number of patients for whom chemotherapy is recommended following resection of their primary breast cancer and testing with the 21 gene RS (cohort 1; n=75)
Measured: 3 years
Secondary outcomes (4)
Impact of gene RS
Examine the impact of the 21 gene RS on chemotherapy recommendations in operable breast cancer in the postoperative and preoperative setting (cohorts 1 and 2; n=150) using questionnaires completed by Medical Oncologists.
Measured: 3 years
Complete Response
Investigate the correlation between the 21 gene RS and pathological complete response from preoperative therapy in operable breast cancer (cohort 2; n=75).
Measured: 3 years
Radiological Response Rate
Determine whether the 21 gene RS correlates with clinical, radiological response rate and the MD Anderson residual cancer burden score following preoperative therapy (cohort 2; n=75).
Measured: 3 years
Economic Impact
Determine the economic impact of the 21 gene RS testing on ER positive, node positive breast cancer patients (cohorts 1 and 2; n=150) using a simple budget impact model
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2019
- Study start16 Mar 2017
- Primary completion2 Feb 2021
- Study completion2 Feb 2021
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
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cancer Trials Ireland
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Dr Patrick Morris, Principal investigator, Beaumont Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03843346
- Sponsor's protocol ID
- CTRIAL-IE 15-34
- Status last verified
- Apr 2026
- First submitted
- 11 Oct 2018
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of the 21 Gene Recurrence Score (RS) on Chemotherapy Prescribing in Estrogen Receptor Positive, Lymph Node Positive Early Stage Breast Cancer in Ireland
- ClinicalTrials.gov ID
- NCT03843346
- Acronym / sponsor ID
- CTRIAL-IE 15-34
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Cancer Trials IrelandResearch network
- Study start
- 16 Mar 2017 (actual)
- Primary completion
- 2 Feb 2021 (actual)
- Study completion
- 2 Feb 2021 (actual)
- First posted
- 18 Feb 2019 (actual)
- 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.
This study examines the impact of an additional tumour test called the 21 gene Recurrence Score (OncotypeDx®), a commercially available test on a Medical Oncologist's decision to recommend chemotherapy.
Detailed description
After a breast cancer and any lymph glands have been surgically removed, further (adjuvant) treatment is generally given to reduce the risk of cancer recurrence. For patients with estrogen receptor (ER) positive breast cancer, this treatment has traditionally been chemotherapy and hormone therapy. However, it is increasingly recognised that tumours which are ER positive and negative for the human epidermal growth factor receptor 2 (HER2), are relatively resistant to chemotherapy. It is likely that many more people are exposed to the risks for chemotherapy than ever benefit from it. In order to select patients who will get more benefit from chemotherapy and to spare those who get very little benefit from side effects, risk assessment tools are being developed.
The 21 Gene Recurrence Score is a test that examines the tumour genes to estimate the risk of the tumour relapsing and possible chemotherapy benefits. Currently, the 21 Gene Recurrence Score (OncotypeDx®) is used In Ireland for patients with no cancer in their lymph nodes. For these patients it can help in deciding who should get chemotherapy. Patients with low scores can sometimes avoid chemotherapy. In some countries, this test is offered to almost all patients with ER positive breast cancer, irrespective of whether the cancer has spread to lymph nodes or not. However, in Ireland this test is not standardly available for patients who have breast cancer involving lymph nodes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1: Postoperative group | – | –Consists of 75 patients who have completed definite surgery for their primary breast cancer as determined by a Consultant Surgeon and have been referred to a Medical Oncologist for consideration of adjuvant chemotherapy. * Tumours of any size will be eligible * Between 1 and 3 lymph nodes involved by tumour as assessed by Consultant Pathologist * Micro metastases (<=0.2mm) will be eligibile * Isolated tumour cells only (node negative i+/i-) are excluded |
| Cohort 2: Preoperative group | – | –Consists of 75 patients who have been referred by a Consultant Surgeon to a Medical Oncologist for consideration of neoadjuvant (preoperative) chemotherapy. * Min tumour size 2.1mm (T2) * Histological proof of involvement of at 1 lymph node, including micrometastases (<=0.2mm) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The study will examine 2 cohorts of patients; * 75 patients (cohort 1; "postoperative") who have undergone resection of their primary breast cancer and * 75 patients (cohort 2; "preoperative") who are referred to a Medical Oncologist for consideration of neoadjuvant (preoperative) treatment. Both cohorts will have ER positive, lymph node positive breast cancer and both cohorts will undergo testing with the 21 gene RS.
Key inclusion criteria (16 listed)
- General Inclusion Criteria (All Patients)
- Age 18 years of age or older
- ER Positive Tumours (≥1% positive cells or Allred score ≥ 2 (Appendix 1))
- Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer (0-1 by IHC or FISH <2.0)
- No evidence of metastatic disease on CT, bone scan or other imaging
Key exclusion criteria (7 listed)
- ER negative tumour (Allred score 0-1)
- HER2 positive tumours as defined by IHC 3+ or FISH ≥ 2.0
- Node negative disease, including those with Isolated tumour cells only (node negative i+/i-)
- Known metastatic breast cancer
- Performance status ≥ 2
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
Recommended Chemotherapy
Time frame: 3 years
The percentage reduction in the number of patients for whom chemotherapy is recommended following resection of their primary breast cancer and testing with the 21 gene RS (cohort 1; n=75)
4 secondary outcomes
Impact of gene RS
Time frame: 3 years
Complete Response
Time frame: 3 years
Radiological Response Rate
Time frame: 3 years
Economic Impact
Time frame: 3 years
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 13 Apr 2026.
- Individual participant dataSharing planned: No
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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.
Dr Patrick Morris principal investigator
Beaumont Hospital
10 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, run by Cancer Trials Ireland at 10 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 16 inclusion and 7 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 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 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?
Recommended Chemotherapy (time frame: 3 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 13 Apr 2026.