This guidance is a partial review of NICE's diagnostics guidance on tumour profiling tests for guiding adjuvant chemotherapy decisions in early breast cancer (DG34) which made recommendations for lymph node-negative (including micrometastatic disease) early breast cancer. This partial review specifically considers tumour profiling tests for lymph node-positive early breast cancer. The recommendations from DG34 have been incorporated into this guidance. To see what NICE did for tumour profiling tests for lymph node-negative and micrometastatic early breast cancer, see the DG34 evidence review.
Oncotype DX is processed in the US and laboratories processing the test must be Clinical Laboratory Improvement Amendments (CLIA)-certified and be accredited to ISO15189 or ISO17025. Use of tests must be in compliance with UK General Data Protection Regulation (GDPR) and the Health and Social Care Act (2012).
Why the committee made these recommendations
People with early breast cancer may have further treatment (adjuvant treatment) after they have surgery. Decisions on adjuvant chemotherapy are made based on several factors relating to the clinical and pathological profile of the cancer, the risk of the cancer coming back (recurrence) and preference of the person with cancer. Additional information from tumour profiling tests may be helpful when making decisions about chemotherapy.
Evidence suggests that EndoPredict, MammaPrint, Oncotype DX and Prosigna can predict the risk of recurrence in a different part of the body in women who have been through the menopause who have ER- or PR-positive, HER2‑negative early breast cancer that has spread to 1 to 3 lymph nodes. There is some evidence that Oncotype DX can also predict whether chemotherapy is likely to prevent recurrence, but this is uncertain.
Clinical trial evidence suggests that chemotherapy is effective at reducing the risk of recurrence in women who have not been through the menopause, regardless of Oncotype DX recurrence score. So, the test should not be used in this population. Evidence for other tests was mostly in women who have been through the menopause or did not distinguish by menopausal status, so it was unclear whether they would be useful for women who have not been through the menopause.
Economic modelling suggests that EndoPredict, Oncotype DX and Prosigna are cost effective compared with standard care in women who have been through the menopause. MammaPrint is likely to be less clinically effective and costs more than standard care.
There is limited evidence on using tumour profiling tests for men, but healthcare professionals should offer testing if it is suitable for the person. There is no evidence for trans, non-binary or intersex people. But healthcare professionals should offer testing if it is suitable based on the person's individual hormonal profile. There is not enough evidence to say whether the ability of tumour profiling tests to predict risk may differ across ethnic groups. Further research is needed to establish the effectiveness of the tests in these populations (see the section on further research).
It is important that results from tumour profiling tests are considered alongside other clinical risk factors such as age and tumour size. People with breast cancer should be involved in decisions about their treatment, and should be well informed about what their test result means, their options, and the associated risks and benefits. Further research is needed on the best ways to communicate this information (see the section on further research). Oncologists should be aware of the limitations of the evidence for tumour profiling tests (see sections 3.7 to 3.10 and sections 3.14 to 3.15).