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A trial looking at a test to predict who needs chemotherapy for breast cancer (OPTIMA)

This trial is looking at testing tissue samples to try and show whether a woman needs chemotherapy to treat her breast cancer.

Doctors often treat breast cancer with chemotherapy followed by hormone therapy. They decide who should have chemotherapy by looking at the size of the cancer and whether it has spread to lymph nodes. But some women may have chemotherapy when they don’t need to. So doctors are looking for better ways to decide who should and shouldn’t have chemotherapy.

Researchers have developed tests to predict who may benefit from having chemotherapy. Oncotype DX is one of these tests. The National Institute for Health and Care Excellence (NICE) has recently recommended Oncotype DX as an option to help make decisions about whether some people, with breast cancer that has not spread to lymph nodes, need chemotherapy after surgery. More research is needed to help decide how best to use tests like Oncotype DX, especially for people with cancers that have spread to lymph nodes.  

The aim of this trial is to see if it is safe to use a test like Oncotype DX to choose treatment.


Start 10/10/2012
End 30/04/2015



Who can enter

You may be able to enter this trial if you are a woman and

  • You have breast cancer that was growing into the surrounding healthy breast tissue (invasive breast cancer)
  • Your cancer has been removed with surgery
  • Your cancer is oestrogen receptor positive
  • You are able to have chemotherapy
  • You are at least 40 years old

You cannot enter this trial if

  • You have cancer that has spread to 10 or more lymph nodes under your arm
  • More than 2 lymph nodes were found to contain cancer when your surgeon removed a small number from under your arm (sampling or sentinel lymph node biopsy) and you haven’t had further surgery to remove the remaining lymph nodes
  • You have cancer that has spread to a lymph node in the middle of your chest
  • Your cancer has not spread to the lymph nodes and is smaller than 30 mm
  • You were taking hormone replacement therapy (HRT) when you had your surgery - you may take part if you stopped taking HRT before surgery
  • You have already had treatment for breast cancer

Trial design

This trial is in 2 stages. The first stage is the pilot trial. It will recruit between 300 and 500 women. If this stage goes well it will continue on to the second stage which is the main trial. The main trial will recruit between 3,720 and 5,580 women.

This is a randomised trial. The people taking part are put into 1 of 2 groups by a computer. Neither you nor your doctor will be able to decide which group you are in.

If you are in group 1, the Oncotype DX test won’t be used to decide your treatment. You will have chemotherapy followed by 5 years of hormone therapy.

If you are in group 2, the Oncotype DX test will be used to decide your treatment. You will have either chemotherapy followed by 5 years of hormone therapy or 5 years of hormone therapy only.

OPTIMA trial diagram

If you are having chemotherapy neither you nor your doctor will know if the Oncotype DX test was used to decide your treatment.

Your doctor will talk to you about which chemotherapy and hormone therapy is best for you. You have chemotherapy as a drip into a vein. Hormone therapy is a tablet you take daily.

The trial team will ask you to fill out a questionnaire before you start treatment, every 3 months for a year and then at year 2. The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

You see the doctor to have some tests before taking part in this trial. These tests may include

During treatment you see the doctor regularly. After treatment the doctor will talk to you about how often they want to see you.

Side effects

Your doctor will talk to you about the side effects of the chemotherapy and hormone treatment you have.

We have more information about the side effects of chemotherapy for breast cancer and side effects of hormone therapy for breast cancer in our treating breast cancer section.

Location of trial

For more information

Please note: we cannot help you to join a specific trial. Unless we state otherwise in this trial summary, you need to print this page and take it to your own doctor to discuss.

Find out how to join a trial or contact our cancer information nurses for other questions about cancer by phone (0808 800 4040), by email, or at

The Information Nurses
Cancer Research UK
Angel Building
407 St John Street

Chief Investigator

Dr Rob Stein

Supported by

Experimental Cancer Medicine Centre (ECMC)
Independent Cancer Patients Voice
NIHR Clinical Research Network: Cancer
NIHR Health Technology Assessment (HTA) programme
University College London (UCL)
Warwick Medical School Clinical Trials Unit
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Updated: 17 September 2014