1.1 Neratinib is recommended as an option for the extended adjuvant treatment of hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)‑positive early stage breast cancer in adults who completed adjuvant trastuzumab-based therapy less than 1 year ago only if:
trastuzumab is the only HER2‑directed adjuvant treatment they have had, and
if they had neoadjuvant chemotherapy-based regimens, they still had residual invasive disease in the breast or axilla following the neoadjuvant treatment, and
the company provides neratinib according to the commercial arrangement.
1.2 This recommendation is not intended to affect treatment with neratinib that was started in the NHS before this guidance was published. People having treatment outside this recommendation may continue without change to the funding arrangements in place for them before this guidance was published, until they and their NHS clinician consider it appropriate to stop.
Why the committee made these recommendations
Trastuzumab is a HER2‑directed treatment. It can also be given in combination with another HER2‑directed treatment, pertuzumab, to reduce the risk of cancer returning after surgery in early stage cancer (adjuvant treatment). Neratinib is an option for extended adjuvant treatment in people who completed a standard course of HER2‑directed adjuvant treatment.
Clinical trial evidence shows that women who have treatment with neratinib have less risk of disease recurrence than women who have treatment with a placebo. We do not know if neratinib increases the length of time people live because the final trial results are not yet available.
The cost-effectiveness estimates are uncertain, but within the range that NICE normally considers an acceptable use of NHS resources. Therefore, neratinib is recommended if trastuzumab is the only HER2‑directed adjuvant treatment a person has had, and if they had chemotherapy-based treatment before surgery to reduce tumour size (neoadjuvant treatment) they still have signs of cancer (residual invasive disease) in tissue samples from the breast or armpit (axilla).
The clinical trial did not include people who had adjuvant pertuzumab. Also, it did not include people who had a pathological complete response (no sign of residual invasive disease in the breast or axilla) after chemotherapy-based neoadjuvant treatment, therefore these groups are not included in the recommendations.