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

NCT ID: NCT03843346

Last Updated: 2025-01-10

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-03-16
• Study Completion Date: 2021-02-02

Brief 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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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

No interventions assigned to this group

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)

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

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))

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)

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

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Cancer Trials Ireland

NETWORK

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr Patrick Morris

Role: PRINCIPAL_INVESTIGATOR

Beaumont Hospital

Locations

Letterkenny University Hospital

Letterkenny, Co. Donegal, Ireland

St Vincent's University Hospital

Dublin, Dublin 4, Ireland

Mater Misericordiae University Hospital & Mater Private Hospital

Dublin, Dublin 7, Ireland

Beaumont Hospital

Dublin, Dublin 9, Ireland

Bon Secour Cork

Cork, , Ireland

Cork University Hospital

Cork, , Ireland

St James' Hospital

Dublin, , Ireland

University Hospital Galway

Galway, , Ireland

University Hospital Limerick

Limerick, , Ireland

University Hospital Waterford

Waterford, , Ireland

Countries

Ireland

Other Identifiers

CTRIAL-IE 15-34

Identifier Type: -

Identifier Source: org_study_id