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

Cancer type:

Breast cancer

Status:

Open

Phase:

Phase 3

This trial is looking at testing tissue samples to try and find if you might benefit from having chemotherapy to treat your breast cancer.

More about this trial

Chemotherapy followed by hormone therapy is often used after surgery for breast cancer to help reduce the chances of it coming back.

Doctors decide who should have chemotherapy by looking at the size of the cancer and checking to see if it has spread to lymph nodes Open a glossary item. But some people might not benefit from having chemotherapy. It is possible that they will do as well with just hormone therapy. So doctors are looking for better ways to decide who should and shouldn’t have chemotherapy.

Researchers have developed tests to predict who might benefit from having chemotherapy. Prosigna is one of these tests.

The Prosigna test uses a specialist machine to look at a sample of cancer tissue that was removed during your surgery. It looks at 50 genes in the cancer cells and how they work.

The aim of this trial is to see if it is safe and effective to use a test like Prosigna to choose treatment.   

Who can enter

The following bullet points list the entry conditions for this trial. Talk to your doctor or the trial team if you are unsure about any of these. They will be able to advise you.

You may be able to enter this trial if your breast cancer:

  • Had grown into the surrounding healthy tissue (invasive breast cancer)
  • Has been removed with surgery

And you are in one of the following situations:

  • 1 to 9 lymph nodes under your arm have cancer in them. If your cancer has spread to only 1 to 3 lymph nodes, at least in 1 node the spread is greater than 2mm across
  • Your cancer measured more than 20mm, it has spread to 1 to 3 lymph nodes  and is less than 2mm across in each node
  • Your cancer measured 30mm or more but had not spread to the lymph nodes

And all of the following apply:

  • Your cancer is oestrogen receptor positive Open a glossary item
  • Your cancer is HER 2 negative Open a glossary item
  • You are able to have chemotherapy after your surgery
  • You are at least 40 years old

You cannot join this trial if any of these apply if:

  • Your cancer has spread to 10 or more lymph nodes under your arm
  • Your cancer has spread to another part of the body (metastatic)
  • You have already had treatment for breast cancer before surgery - you might be able to join the trial if you had hormone treatment before surgery and the treatment had stopped more than a year ago
  • You have already had further treatment after surgery apart from hormone treatment for a short time afterwards
  • It has been more than 8 weeks after your surgery
  • Your doctor has planned further breast cancer surgery unless it is an operation to remove the breast completely (mastectomy) or some more breast tissue after you have had chemotherapy
  • You were taking hormone replacement therapy (HRT) Open a glossary item when you had your surgery - you may take part if you stopped taking HRT before surgery
  • You have had another cancer apart from basal cell skin cancer Open a glossary item, cervical intraepithelial neoplasia (CIN Open a glossary item), lobular carcinoma in situ Open a glossary item (LCIS), lobular neoplasia of the breast, ductal carcinoma in situ (DCIS Open a glossary item) that has been removed by surgery or any other cancer that was removed with surgery and there has been no sign of it for at least 10 years
  • You have any other medical or mental health problem that your doctors think could affect you taking part in the trial 

Trial design

This trial was in 2 stages. The first stage was a pilot trial. 412 people took part in the pilot trial.

The 2nd stage is a phase 3 trial. For this stage the researchers need 4,500 people to join.

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. 

Group 1
The Prosigna test won’t be used to decide your treatment. You will have chemotherapy followed by 5 to 10 years of hormone therapy.

Group 2
The Prosigna test will be used to decide your treatment. You will have either chemotherapy followed by 5 to 10 years of hormone therapy or 5 to 10 years of hormone therapy only. 

OPTIMA trial diagram

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

Your doctor will talk to you about which chemotherapy and hormone therapy is best for you. This is the same as the usual treatment for breast cancer.

You have chemotherapy as a drip into the vein.

Hormone therapy is a tablet you take daily. If you have not had your menopause Open a glossary item you might be asked to have a monthly injection as part of your hormone therapy. These will stop your monthly periods. Research has shown that this helps to improve your hormone treatment.

Quality of life
The trial team will ask you to fill out a questionnaire when you agree to join the study then at:

  • 3 months
  • 6 months
  • 12 months
  • 24 months

The questionnaire will ask about side effects and how you’ve been feeling. This is called a quality of life study.

Hospital visits

Your doctor will see you regularly during and after treatment. They will tell you often this will be.

For some people their follow up might be longer. You then might find it better for your doctor to phone or email you. They will discuss this with you.

Most people will have a mammogram for at least 5 years. This is a part of the usual care. 

Side effects

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

We have information about the side effects of:

Location

Ayr
Bangor
Barnet
Basingstoke
Bedford
Birmingham
Blackpool
Bristol
Burton on Trent
Cambridge
Canterbury
Chester
Coventry
Dudley
Dumfries
East Kilbride
Edinburgh
Enfield
Epping
Exeter
Gateshead
Glasgow
Greenock
Hertfordshire
Huntingdon
Kilmarnock
Lancaster
Larbert
London
Luton
Macclesfield
Manchester
Newport (IOW)
North Shields
Northwood
Norwich
Nottingham
Paisley
Peterborough
Plymouth
Rhyl
Salisbury
Scarborough
Shrewsbury
Stevenage
Stockton-on-Tees
Stoke-on-Trent
Sunderland
Swansea
Torquay
Truro
Wigan
Winchester
Wishaw
Wolverhampton
Wrexham
York

Recruitment start:

Recruitment end:

How to join a clinical trial

Please note: In order to join a trial you will need to discuss it with your doctor, unless otherwise specified.

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

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
NIHR University College London Hospitals Biomedical Research Centre
University College London (UCL)
Warwick Clinical Trials Unit

Questions about cancer? Contact our information nurses

Freephone 0808 800 4040

Last review date

CRUK internal database number:

9754

Please note - unless we state otherwise in the summary, you need to talk to your doctor about joining a trial.

Harriet wanted to try new treatments

A picture of Harriet

“I was keen to go on a clinical trial. I wanted to try new cancer treatments and hopefully help future generations.”

Last reviewed:

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