- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03843346
The Impact of the Gene Recurrence Score on Chemotherapy Prescribing in ER Positive, Lymph Node Positive Early Stage Breast Cancer
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
Study Overview
Status
Conditions
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 Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Cork, Ireland
- Cork University Hospital
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Cork, Ireland
- Bon Secour Cork
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Dublin, Ireland
- St James' Hospital
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Galway, Ireland
- University Hospital Galway
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Limerick, Ireland, V94 F858
- University Hospital Limerick
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Waterford, Ireland
- University Hospital Waterford
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Co. Donegal
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Letterkenny, Co. Donegal, Ireland
- Letterkenny University Hospital
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Dublin 4
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Dublin, Dublin 4, Ireland
- St Vincent's University Hospital
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Dublin 7
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Dublin, Dublin 7, Ireland
- Mater Misericordiae University Hospital & Mater Private Hospital
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Dublin 9
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Dublin, Dublin 9, Ireland
- Beaumont Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
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.
Description
Inclusion Criteria:
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
- 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)
Exclusion Criteria (All patients):
- 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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
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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.
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Recommended Chemotherapy
Time Frame: 3 years
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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)
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3 years
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Impact of gene RS
Time Frame: 3 years
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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.
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3 years
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Complete Response
Time Frame: 3 years
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Investigate the correlation between the 21 gene RS and pathological complete response from preoperative therapy in operable breast cancer (cohort 2; n=75).
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3 years
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Radiological Response Rate
Time Frame: 3 years
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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).
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3 years
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Economic Impact
Time Frame: 3 years
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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
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3 years
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Dr Patrick Morris, Beaumont Hospital
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CTRIAL-IE 15-34
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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