The Impact of the Gene Recurrence Score on Chemotherapy Prescribing in ER Positive, Lymph Node Positive Early Stage Breast Cancer

October 23, 2023 updated by: Cancer Trials Ireland

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.

Study Overview

Status

Active, not recruiting

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

Observational

Enrollment (Actual)

87

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Cork, Ireland
        • Cork University Hospital
      • Cork, Ireland
        • Bon Secour Cork
      • Dublin, Ireland
        • St James' Hospital
      • Galway, Ireland
        • University Hospital Galway
      • Limerick, Ireland, V94 F858
        • University Hospital Limerick
      • Waterford, Ireland
        • University Hospital Waterford
    • Co. Donegal
      • Letterkenny, Co. Donegal, Ireland
        • Letterkenny University Hospital
    • Dublin 4
      • Dublin, Dublin 4, Ireland
        • St Vincent's University Hospital
    • Dublin 7
      • Dublin, Dublin 7, Ireland
        • Mater Misericordiae University Hospital & Mater Private Hospital
    • Dublin 9
      • Dublin, Dublin 9, Ireland
        • Beaumont Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

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)

  1. Age 18 years of age or older
  2. ER Positive Tumours (≥1% positive cells or Allred score ≥ 2 (Appendix 1))
  3. Human Epidermal Growth Factor Receptor 2 (HER2) negative breast cancer (0-1 by IHC or FISH <2.0)
  4. No evidence of metastatic disease on CT, bone scan or other imaging
  5. Fit for consideration of chemotherapy as determined by the Investigator
  6. Adequate performance status (Eastern Cooperative Oncology Group (ECOG) 0 or 1 (Appendix 2))

Inclusion Criteria - Cohort 1 (Postoperative Patients): N= 75

  1. Adequate surgical excision of breast tumour (mastectomy or lumpectomy) and lymph nodes (sentinel lymph biopsy or axillary dissection)
  2. Any tumour size (T stage (Appendix 3))
  3. Involvement of 1-3 lymph nodes (N1, including micrometastases)

Inclusion Criteria - Cohort 2 (Preoperative Patients): N= 75

  1. Candidates for preoperative therapy for early breast cancer
  2. T2-T4 tumours
  3. Involvement of at least one lymph node, (including micrometastases) on biopsy
  4. Adequate tissue from core biopsy for 21 gene RS testing (approximate minimum 5mm)

Exclusion Criteria (All patients):

  1. ER negative tumour (Allred score 0-1)
  2. HER2 positive tumours as defined by IHC 3+ or FISH ≥ 2.0
  3. Node negative disease, including those with Isolated tumour cells only (node negative i+/i-)
  4. Known metastatic breast cancer
  5. Performance status ≥ 2
  6. Patients not considered by their treating physician to be fit to undergo chemotherapy.
  7. Men with breast cancer.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Impact of gene RS
Time Frame: 3 years
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.
3 years
Complete Response
Time Frame: 3 years
Investigate the correlation between the 21 gene RS and pathological complete response from preoperative therapy in operable breast cancer (cohort 2; n=75).
3 years
Radiological Response Rate
Time Frame: 3 years
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).
3 years
Economic Impact
Time Frame: 3 years
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
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dr Patrick Morris, Beaumont Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 16, 2017

Primary Completion (Actual)

April 30, 2021

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

October 11, 2018

First Submitted That Met QC Criteria

February 14, 2019

First Posted (Actual)

February 18, 2019

Study Record Updates

Last Update Posted (Actual)

October 24, 2023

Last Update Submitted That Met QC Criteria

October 23, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • CTRIAL-IE 15-34

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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