Why are we doing this study?


Breast cancer patients have asked us to do this research. They tell us that the single most important question in breast cancer is: “Can you improve the way you decide who needs chemotherapy, so that you treat fewer patients by intelligently choosing those who will definitely benefit, rather than giving chemotherapy to everyone”

For fifty years, doctors have made decisions about chemotherapy based on simple factors: the size of the cancer, if it has spread to nearby lymph nodes and what it looks under a microscope. But this is old technology, and we know that it has serious limitations. Many patients receive chemotherapy who do not need it. 

Chemotherapy carries risks and can lead to a number of short and long term side effects. Some patients will do just as well with hormone tablets alone. They may benefit by getting on to hormones quickly and not wasting time with chemotherapy. 

Over the past few years, laboratory scientists across the world have developed new tests which probe the deep biology of the breast cancer, far beyond what can be seen with a microscope. 

This new technology is transforming the way we think about this disease and the evidence is stacking up to suggest that it can pick out patients who need chemotherapy (and also identify those patients who would get no benefit from this treatment). 

If we can bring these tests into the clinic, we may be able to reduce our use of chemotherapy by up to 80% without having any effect on rates of successful treatment, which would spare many patients from going through the ordeal of this treatment. 

Any time a new technology appears in medicine, it always has to be tested in a large trial to ensure that it can safely and effectively be used in everyday care – the reason for OPTIMA.

What is the Prosigna test?

The Prosigna test uses a specialist machine to look at a sample of breast cancer tissue. The sample is taken from tissue removed when you had a biopsy or surgery. The test looks at 50 genes in the cancer cells and how they work.

Can I have the Prosigna test without joining the OPTIMA study?

It depends:

  • Tests like Prosigna are routinely used by the NHS for all patients whose cancer has not spread to lymph nodes.
  • These tests are also available on the NHS for some patients where the cancer is just beginning to appear in lymph nodes under the arm.

But doctors do not yet know how reliable the test is for younger patients, more active looking tumours, or if there is more spread into the lymph nodes. For these patients, the test is not available on the NHS, because more research is necessary before it can be confidently used. This is why the NIHR has set up and funded the OPTIMA study.

    Why do we need to test the Prosigna test? (I’ve been told it works, so why test it?)

    Whilst available evidence looks promising, we need a large scale study to collect more evidence about the effectiveness of the test for patients where the cancer has spread to the lymph nodes.