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Breast cancer (early) - trastuzumab - NICE TAG TA107

CG80 Early and locally advanced breast cancer updates the recommendations contained in this appraisal.

For details, see 'About this guidance'.

1.1 Trastuzumab, given at 3-week intervals for 1 year or until disease recurrence (whichever is the shorter period), is recommended as a treatment option for women with early-stage HER2-positive breast cancer following surgery, chemotherapy (neoadjuvant or adjuvant) and radiotherapy (if applicable).

1.2 Cardiac function should be assessed prior to the commencement of therapy and trastuzumab treatment should not be offered to women who have a left ventricular ejection fraction (LVEF) of 55% or less, or who have any of the following:

  • a history of documented congestive heart failure

  • high-risk uncontrolled arrhythmias

  • angina pectoris requiring medication

  • clinically significant valvular disease

  • evidence of transmural infarction on electrocardiograph (ECG)

  • poorly controlled hypertension.

1.3 Cardiac functional assessments should be repeated every 3 months during trastuzumab treatment. If the LVEF drops by 10 percentage (ejection) points or more from baseline and to below 50% then trastuzumab treatment should be suspended. A decision to resume trastuzumab therapy should be based on a further cardiac assessment and a fully informed discussion of the risks and benefits between the individual patient and their clinician.


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