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    Tumour profiling tests to guide adjuvant chemotherapy decisions in lymph node-positive early breast cancer

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    1 Recommendations

    1.1

    Use EndoPredict or Oncotype DX as options to guide adjuvant chemotherapy decisions for oestrogen receptor (ER)- or progesterone receptor (PR)-positive, human epidermal growth factor receptor 2 (HER2)‑negative early breast cancer with 1 to 3 positive lymph nodes. They can be used for women who have been through the menopause and men, only if:

    • information provided by the test would help them choose, with their healthcare professional, whether or not to have adjuvant chemotherapy

    • the companies provide the tests to the NHS with the discounts agreed in the access proposals.

      Use the test and results alongside NICE's guideline on shared decision making. Healthcare professionals should explain to the person the risks and benefits of treatment options based on their test result.

      Oncotype DX can only be used once it has appropriate regulatory approval.

    1.2

    Healthcare professionals should consider whether EndoPredict or Oncotype DX are suitable to guide adjuvant chemotherapy decisions for trans, non-binary or intersex people with ER- or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes depending on their hormonal profile.

    1.3

    EndoPredict and Oncotype DX should not be used to guide adjuvant chemotherapy decisions for ER- or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes in women who have not been through the menopause.

    1.4

    MammaPrint and Prosigna should not be used to guide adjuvant chemotherapy decisions for people with ER- or PR-positive, HER2-negative early breast cancer with 1 to 3 positive lymph nodes.

    More research

    1.5

    More research is needed:

    • to confirm whether tumour profiling tests have the same prognostic or predictive ability across different ethnic groups

    • on the types and formats of information that would help people with lymph node-positive breast cancer to understand all the factors that can support decisions on chemotherapy.

    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, risk of 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 cancer coming back in a different part of the body in women who have been through the menopause and men 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 the cancer will respond to chemotherapy, but this is uncertain.

    Clinical trial evidence suggests that chemotherapy is effective at reducing 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 postmenopausal women or did not distinguish by menopausal status, so it was unclear whether they would be useful in women who have not been through the menopause.

    Economic modelling suggests that EndoPredict and Oncotype DX are cost effective compared with standard care. Prosigna costs more than what is usually considered an acceptable use of NHS resources, even with confidential price reductions. MammaPrint is less clinically effective and costs more than standard care.

    There is no evidence on using tumour profiling tests for trans, non-binary or intersex people. But, healthcare professionals may offer testing if it is considered to be suitable depending 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.

    It is important that people with breast cancer are involved in decisions about their treatment, and are well informed about their options and the associated risks and benefits. Further research is needed on the best ways to communicate this information.