Neratinib [NER1]
The extended adjuvant therapy for hormone receptor positive HER2-overexpressed early breast cancer after completion of adjuvant therapy with HER2 targeted monotherapy with trastuzumab where the following criteria have been met:
- This application for neratinib as extended adjuvant chemotherapy is made by and the first cycle of adjuvant neratinib will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- The patient has histologically documented breast cancer which is BOTH hormone receptor positive and HER2 overexpressed (HER2 3+ by immunohistochemistry and/or has a ratio of ≥2.0 by in situ hybridisation). Note: neratinib is not licensed for extended adjuvant therapy in hormone receptor negative patients.
- The patient has been diagnosed with early breast cancer and this has been adequately excised.
- That either the patient did not receive neoadjuvant therapy or the patient was treated with neoadjuvant therapy AND there was residual invasive carcinoma in the breast and/or the axilla. Please mark below which applies to this patient:
- patient did not receive neoadjuvant therapy or
- patient did receive neoadjuvant therapy and there was residual invasive disease in the breast and/or axillary nodes Note: neratinib is not recommended by NICE if any neoadjuvant therapy resulted in a pathological complete remission or if there was only residual carcinoma in situ disease in the breast and a pathological complete remission in the axillary nodes (if the axillary lymph node status was positive prior to neoadjuvant treatment).
- The patient has received chemotherapy in the management of the early breast cancer either as neoadjuvant treatment pre-definitive surgery or as adjuvant therapy post-surgery.
- The patient has completed adjuvant therapy with trastuzumab as HER2-targeted monotherapy and is within 1 year of completing such trastuzumab monotherapy. Note: NICE has not recommended use of neratinib if the patient received any pertuzumab as part of adjuvant therapy. Patients treated with neoadjuvant chemotherapy in combination with pertuzumab and trastuzumab are only eligible for neratinib therapy if the pertuzumab was solely used as part of neoadjuvant treatment and no pertuzumab was used as part of adjuvant therapy.
- The patient has an ECOG performance status of 0 or 1.
- The left ventricular ejection fraction prior to commencing extended adjuvant therapy with neratinib is ≥50%.
- Before commencing neratinib the patient will be instructed to initiate prophylactic treatment with anti-diarrhoeal medication with the first dose of neratinib and maintain regular dosing of the anti-diarrhoeal medication during the first 1-2 months of neratinib treatment, titrating the anti-diarrhoeal medication to a frequency of 1-2 bowel movements per day.
- A formal medical review as to whether extended adjuvant treatment with neratinib should continue and at what dose will be scheduled to occur at least by the start of the 2nd month of treatment.
- Treatment breaks of up to 3 weeks (as per SmPC recommendations) are allowed, but solely to allow toxicities to settle. Note the SmPC recommends that treatment is discontinued for patients who: • Fail to recover to Grade 0 to 1 from treatment-related toxicity, • have toxicities that result in a treatment delay > 3 weeks, or • For patients that are unable to tolerate 120 mg daily Where an unplanned treatment break of more than 6 weeks beyond the expected 4-weekly cycle length occurs and is unrelated to settling of treatment toxicities, I will complete a treatment break approval form to restart treatment
- Neratinib will be otherwise used as set out in its Summary of Product Characteristics (SPC)
NHS funded From: 18 February 2020
Additional information
Current Form Version
Note
The data on this page was produced using version 1.361 of the CDF list, downloaded from an archive of NHS England’s website on 08 May 2025 at 22:10.
If NHS England has published a new version of the CDF List but this site has not yet accessed that, this form may be out of date. Additionally, if any update has occurred without NHS England noting it as a change, this page will be out of date.