Breast Cancer Research Trust NZ, gaining knowledge and saving lives

The OPTIMA trial

Purpose

This international clinical trial aims to enrol 4800 participants and will find out if using a specialised laboratory gene test (called a Prosigna assay) on breast cancer tissue can help Medical Oncologists and their patients make safe and accurate decisions about whether or not chemotherapy treatment is needed.

The Prosigna assay is a means of identifying those patients with hormone receptor positive and HER2 negative high risk for recurrent breast cancer, who are likely to benefit from chemotherapy, while sparing those who are unlikely to do so from an unnecessary and unpleasant treatment. This trial is coordinated internationally by the University College London and coordinated in Australia and New Zealand by Breast Cancer Trials.

Scientific Title

Optimal personalised treatment of early breast cancer using multiparameter analysis: a randomised study (A multi-site partially blinded randomised international clinical trial with a non-inferiority endpoint and adaptive design) (BCT 2202 OPTIMA).

Background

The purpose of OPTIMA is to find out how well a test called “Prosigna” works to predict who will and will not benefit from chemotherapy.

People with ER-positive, HER2-negative breast cancer that is large, or has spread to the lymph nodes, are usually offered both chemotherapy and hormone (endocrine) treatment to reduce the risk of the cancer coming back in the breast or elsewhere in the body. Currently we don’t have a single test that can tell us whether or not someone might benefit from chemotherapy, so some people may receive chemotherapy when they don’t really need it. This is a problem because chemotherapy can have short- and long-term side-effects that can be quite serious.

There are now several tests which look at how active the genes are in breast cancer cells and give more accurate information about the risk of an individual’s breast cancer coming back. These tests use a sample of the cancer (tissue sample) already removed by the surgeon. We need to do more research into how best to use these tests. Some research that has already been done shows that the tests can be used to find patients who don’t need chemotherapy but will still have the cancer treated effectively with hormone treatment alone. Giving less treatment with the same or better results is called “de-escalation” or “de-intensification” (less intense treatment) and can personalise treatment to best suit each patient.

The test being used in OPTIMA is called Prosigna. Prosigna is currently used in Australia, New Zealand and other countries to help doctors advise patients about treating cancer that has not spread to the lymph nodes.

There is some evidence to suggest that the Prosigna test may also be effective at predicting which patients with breast cancer that is large or has spread to lymph nodes are likely to benefit from chemotherapy and which patients are unlikely to benefit. However, we need more evidence from larger numbers of people with cancer to make sure it is safe to use the Prosigna test to work out who really needs chemotherapy. This is why we are doing OPTIMA.