Abemaciclib in combination with endocrine therapy [ABEM3]

As adjuvant treatment for high risk hormone receptor-positive and HER2- negative early breast cancer where the following criteria have been met:

  1. This application for abemaciclib in combination with endocrine therapy is being made by and the first cycle of abemaciclib plus endocrine therapy will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has early breast cancer.
  3. The patient has histologically or cytologically documented hormone receptor-positive and HER-2 negative breast cancer.
  4. The patient has high risk early breast cancer as defined by having either 4 or more positive axillary lymph nodes or 1-3 positive axillary lymph nodes and a primary tumour size of ≥5cm and/or histologically grade 3 disease. Please mark in the box below which category applies to this patient:
  • ≥4 positive axillary lymph nodes or
  • 1-3 positive axillary lymph nodes and a primary tumour size ≥5cm or
  • 1-3 positive axillary lymph nodes and histological grade 3 disease or
  • 1-3 positive axillary lymph nodes and a primary tumour size ≥5cm and histological grade 3 disease
  1. The patient has completed definitive locoregional therapy (surgery with or without radiotherapy).
  2. The patient has completed any adjuvant or neoadjuvant chemotherapy. Please mark in the box below the relevant treatment that the patient did or did not receive:
  • the patient did not receive any adjuvant or neoadjuvant chemotherapy or
  • the patient received adjuvant chemotherapy only or
  • the patient received neoadjuvant chemotherapy
  1. The patient has received no more than 12 weeks of adjuvant endocrine therapy after completion of the last non-endocrine therapy (surgery or chemotherapy or radiotherapy).
  2. The patient is male or female and if female, pre- or peri-menopausal and having adjuvant aromatase inhibitor therapy that the patient has undergone ovarian ablation or suppression with LHRH agonist treatment. Please mark in the box below which category applies to this patient:
  3. The patient has an ECOG performance status of 0 or 1.
  4. Abemaciclib is being given in combination with standard endocrine therapy.
  5. The patient has had no prior treatment with a CDK 4/6 inhibitor.
  6. Treatment with abemaciclib will continue until there is progressive disease or excessive toxicity or until the patient chooses to discontinue treatment or for a maximum of 2 calendar years, whichever is the sooner.
  7. The prescribing clinician is aware of abemaciclib’s interactions with CYP3A4 inhibitors and inducers as outlined in abemaciclib’s Summary of Product Characteristics.
  8. The prescribing clinician is aware of the necessary abemaciclib dose adjustments for diarrhoea, increased aminotransferases, interstitial lung disease and venous thromboembolic events as outlined in abemaciclib’s Summary of Product Characteristics.
  9. When a treatment break of more than 6 weeks beyond the expected 4-weekly cycle length is needed, the prescribing clinician will complete a treatment break approval form to restart treatment, including as appropriate if the patient had an extended break on account of Covid-19.
  10. Abemaciclib will be otherwise used as set out in its Summary of Product Characteristics (SPC).

[NHS funded]{.badge .rounded-pill .bg-success} From: 18 October 2022

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CDF Managed Access: NA

NICE Technology Appraisal: TA810 (20 July 2022)

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