Pertuzumab (in combination with trastuzumab and a taxane or capecitabine) [PER1]

The first line treatment of locally advanced or metastatic breast cancer where all the following criteria are met:

  1. This application for pertuzumab in combination with trastuzumab and a taxane or capecitabine is being made by and the first cycle will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has histologically documented breast cancer which is HER2 3+ by immunohistochemistry and/or has a HER2 ratio of ≥2.0 by in situ hybridisation.
  3. The patient has been diagnosed with locally advanced or metastatic breast cancer.
  4. The patient has an ECOG performance status of 0 or 1.
  5. The patient has a baseline LVEF of greater than or equal to 50%.
  6. Any adjuvant HER2 therapy was completed more than 12 months prior to the diagnosis of locally advanced or metastatic disease.
  7. The patient has had no prior treatment with chemotherapy or HER2 therapy for locally advanced or metastatic disease.
  8. The patient will receive pertuzumab and trastuzumab as first line treatment in combination with a taxane or capecitabine.
  9. The prescribing clinican understands that pertuzumab and trastuzumab are not to be used beyond first disease progression outside the CNS. Note: Treatment with pertuzumab and trastuzumab can continue if there is disease progression solely within the CNS.
  10. Treatment will be given using either intravenous pertuzumab and intravenous biosimilar trastuzumab or using the PHESGO® brand combination pertuzumab and trastuzumab subcutaneous injection. Please mark as to which mode of administration is to be used:
  • Intravenous pertuzumab and intravenous best value biosimilar trastuzumab or
  • PHESGO® subcutaneous pertuzumab and trastuzumab combination injection
  1. The prescribing clinician understands the differing dosages to be used for the different formulations of pertuzumab and trastuzumab in relation to the first (loading) cycle and then in subsequent cycles:
  • Intravenous pertuzumab is given at an initial loading dose of 840mg followed every 3 weeks thereafter by a maintenance dose of 420mg.
  • Intravenous trastuzumab is given as an initial loading dose of 8 mg/kg body weight followed every 3 weeks thereafter by a maintenance dose of 6 mg/kg body weight
  • Subcutaneous PHESGO® is given at an initial loading dose of 1,200mg pertuzumab and 600mg trastuzumab in 15 mL of solution in a single-dose vial followed every 3 weeks thereafter by a maintenance dose of 600mg pertuzumab and 600mg trastuzumab in a 10 mL of solution in a single-dose vial.
  1. When a treatment break of more than 6 weeks beyond the expected cycle length is needed, I will complete a treatment break form to restart treatment.
  2. Pertuzumab or PHESGO® will be otherwise used as set out in their respective Summary of Product Characteristics (SPC)

[NHS funded]{.badge .rounded-pill .bg-success} From: 05 June 2018

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CDF Managed Access: NA

NICE Technology Appraisal: TA509 (07 March 2018)

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