CompletedInterventional

PRE-DX – the impact of earlier genomic testing in the treatment of breast cancer

When someone is diagnosed with early-stage breast cancer, doctors often use a special test called Oncotype DX. This test looks at cancer genes to help decide whether treatments like chemotherapy are needed after surgery. Normally, this test is carried out on tissue removed during the cancer operation. The PRE-DX study is looking at what happens if the test is done much sooner, using the small sample (biopsy) taken when the cancer was first diagnosed. Researchers want to see if having the results earlier helps doctors plan follow-up treatments faster, reduces delays, and eases stress for patients. Two out of every three participants will have the test done early on their initial biopsy sample, while one in three will have it done after surgery as usual. Taking part does not change the actual cancer treatments you receive.

At a glance

Status

Completed

Sponsor

Newcastle upon Tyne Hospitals NHS Foundation Trust

Enrolment target

330

Start

10 Oct 2022

Estimated completion

01 Dec 2023

Breast cancer

What is this study about?

When planning treatment for early breast cancer, doctors need as much clear information as possible. A common test called Oncotype DX looks closely at the genes inside cancer cells. The result gives doctors a score showing how likely the cancer is to come back and helps them decide whether extra treatments, such as chemotherapy or radiotherapy, are necessary after surgery.

In standard NHS care, this test is usually done on the cancer tissue removed during your main operation. This means you and your care team often have to wait several weeks after surgery to get the score and agree on the next steps. Waiting for these decisions can be an anxious time for patients and their families.

The PRE-DX trial is exploring whether doing the test earlier makes a helpful difference. Instead of waiting for surgery, researchers want to run the test on the small sample of tissue (the diagnostic core biopsy) taken when your cancer was first found.

By getting the score before surgery takes place, doctors hope to speed up the whole treatment pathway. If successful, this approach could help people start any needed follow-up therapies sooner, save hospital resources, and reduce the worry that comes with long waiting periods.

Key takeaways

The PRE-DX trial tests whether running the Oncotype DX test before surgery speeds up breast cancer care.
The study uses tissue samples that have already been taken, so no extra biopsies are needed.
Two out of three participants have the test done on their initial biopsy; one out of three receives standard testing after surgery.
Participants complete three short questionnaires about their mood and wellbeing during their treatment journey.
Your planned cancer treatments and surgery dates will not be changed by joining the study.

Who may be eligible?

This study is open to adults aged 18 and over who have recently been diagnosed with early-stage, invasive breast cancer. It includes both men and women whose cancer is oestrogen-receptor positive (ER-positive) and HER2-negative. To join, having surgery as your first main treatment must be the plan, and you must be generally well enough to have chemotherapy if your test results suggest you need it.

You will not be able to join if your cancer is HER2-positive or ER-negative, or if the cancer has spread more widely into nearby areas. People who need chemotherapy or hormone treatment before surgery to shrink the tumour are also not eligible.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

I am aged 18 or older.
I have been newly diagnosed with early-stage, invasive breast cancer.
My cancer is oestrogen-receptor positive (ER+) and HER2-negative.
Surgery is planned as my first main treatment.
I am fit enough to have chemotherapy if my test results show I need it.

Answer every question to see your result.

What does participation involve?

If you agree to take part, a computer will place you at random into one of two groups. Two out of three people will have the Oncotype DX test performed early on the biopsy tissue already collected at diagnosis. One out of three people will have the test done on the tissue removed during surgery, which is standard practice. You will not need any extra operations or extra biopsy procedures for this study.

You will be asked to fill in brief questionnaires about your emotional wellbeing, anxiety, and your use of healthcare services. You will complete these surveys at three specific points: when you join the study, at your clinic check-up after surgery, and after your doctors discuss your follow-up treatment plan. The study fits alongside your normal hospital visits and does not require additional travel.

Potential risks and benefits

Taking part does not involve new drugs or extra invasive procedures, as the test uses tissue samples that have already been collected. Because your actual treatments will remain the same, the physical risks are no different from standard NHS care. While joining may not directly change your personal treatment result, you will be helping doctors discover whether earlier testing can shorten delays and improve cancer care for others in the future. You are free to leave the study at any point, and choosing to stop will never affect the standard of care you receive.

Locations (17)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

The Newcastle upon Tyne Hospitals NHS Foundation Trust
City only
Newcastle upon Tyne, England
Royal Liverpool University Hospital NHS Trust
City only
Liverpool, England
Oxford University Hospitals NHS Foundation Trust
City only
Oxford, England
Gateshead Health NHS Foundation Trust
City only
Gateshead, England
Aneurin Bevan University Lhb
City only
Newport, Wales
The Shrewsbury and Telford Hospital NHS Trust
Unverified
Shrewsbury, England
Hywel Dda University Lhb
Unverified
Carmarthen, Wales
NHS Grampian
Unverified
Aberdeen, Scotland
Hull University Teaching Hospitals NHS Trust
Unverified
Hull, England
Chesterfield Royal Hospital NHS Foundation Trust
Unverified
Chesterfield, England
Wirral University Teaching Hospital NHS Foundation Trust
Unverified
Wirral, England
Mid and South Essex NHS Foundation Trust
Unverified
Westcliff-on-sea, England

Common questions

Will taking part delay my cancer surgery?

No. Your surgery will go ahead as planned by your healthcare team. The study only changes the timing of when your tissue sample is tested.

Do I need to have another biopsy taken?

No. The test uses the tissue sample that was already collected when your breast cancer was first diagnosed.

Can I choose whether my test is done early or after surgery?

No. A computer allocates participants at random to ensure the study produces fair and reliable results. You have a two-in-three chance of having the test done early.

What is the Oncotype DX test looking for?

It looks at a group of genes in the cancer cells to help work out the risk of the cancer returning and whether chemotherapy will be helpful for you.

What happens if I change my mind about taking part?

You can leave the study at any time without giving a reason. Your doctors will continue to give you the best standard care available.

How to find out more

Matthew Northgraves

Matthew.northgraves@hyms.ac.uk +44 (0)1482 463373 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.