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

NCT03843346 | Completed

• 1 other identifier: CTRIAL-IE 15-34
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 10

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• 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)

  3 years

Secondary Outcomes (4)

• Impact of gene RS

  3 years

• Complete Response

  3 years

• Radiological Response Rate

  3 years

• Economic Impact

  3 years

Study Arms (2)

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)

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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))
• 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)
• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cancer Trials Ireland: lead

Study Sites (10)

Letterkenny University Hospital

Letterkenny, Co. Donegal, Ireland

Location

St Vincent's University Hospital

Dublin, Dublin 4, Ireland

Location

Mater Misericordiae University Hospital & Mater Private Hospital

Dublin, Dublin 7, Ireland

Location

Beaumont Hospital

Dublin, Dublin 9, Ireland

Location

Bon Secour Cork

Cork, Ireland

Location

Cork University Hospital

Cork, Ireland

Location

St James' Hospital

Dublin, Ireland

Location

University Hospital Galway

Galway, Ireland

Location

University Hospital Limerick

Limerick, V94 F858, Ireland

Location

University Hospital Waterford

Waterford, Ireland

Location

Biospecimen

Retention: SAMPLES WITH DNA

Tissue will be sent for 21 gene RS (OncotypeDx(r)) testing to Genomic Health as per standard clinical practice for patients with node negative tumours.

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Dr Patrick Morris

  Beaumont Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 11, 2018
• First Posted: February 18, 2019
• Study Start: March 16, 2017
• Primary Completion: February 2, 2021
• Study Completion: February 2, 2021
• Last Updated: April 13, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

IE (10)