Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Gene test may spare some breast cancer patients from chemo

NCT ID NCT03843346

Knowledge-focused Sponsor: Cancer Trials Ireland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at whether a tumor gene test called the 21 gene Recurrence Score (OncotypeDx) changes doctors' recommendations for chemotherapy in women with early-stage, hormone receptor-positive breast cancer that has spread to lymph nodes. Researchers tracked how often chemotherapy was recommended before and after the test results were known. The goal was to see if the test helps avoid unnecessary chemotherapy.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

What this could lead to
If successful, this could help doctors better decide which patients need chemotherapy, avoiding unnecessary treatment.
What could go wrong
This is a small, completed observational study in Ireland, so results may not apply to all populations. The test itself is already commercially available, so the main question is about its real-world impact.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

87 people

The number who actually took part.

Started

Mar 2017

Finished

Feb 2021

Lead sponsor

A research network

The lead sponsor is a research network or cooperative group.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Female participants only

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Breast cancer are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • Beaumont Hospital

    Dublin, Dublin 9, Ireland

  • Bon Secour Cork

    Cork, Ireland

  • Cork University Hospital

    Cork, Ireland

  • Letterkenny University Hospital

    Letterkenny, Co. Donegal, Ireland

  • Mater Misericordiae University Hospital & Mater Private Hospital

    Dublin, Dublin 7, Ireland

  • St James' Hospital

    Dublin, Ireland

  • St Vincent's University Hospital

    Dublin, Dublin 4, Ireland

  • University Hospital Galway

    Galway, Ireland

  • University Hospital Limerick

    Limerick, V94 F858, Ireland

  • University Hospital Waterford

    Waterford, Ireland

More trials for these conditions

Other studies related to the condition(s) this trial covers.