Published

May 11, 2025

Pertuzumab [PER2a]

Neoadjuvant pertuzumab plus trastuzumab in NODE POSITIVE patients for the neoadjuvant treatment of locally advanced, inflammatory or early breast cancer at high risk of recurrence (PER2a) where the following criteria have been met This form (introduced in November 2019) is for patients known to be pathologically node positive prior to commencing neo-adjuvant therapy. On commencing adjuvant treatment with pertuzumab, form PER4a (for node positive patients) must be completed. For patients with locally advanced, inflammatory or early breast cancer who are node negative of unknown nodal status when commencing neo- adjuvant pertuzumab, form PER2b must be used for the neoadjuvant part of treatment followed by form PER4b for the adjuvant part of treatment only if the histology post-surgery is node +ve.

  1. This application has been made by and the first cycle of systemic anti -cancer therapy with pertuzumab (in combination with chemotherapy and trastuzumab) will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy. NOTE: This application should be made immediately prior to commencing pertuzumab plus trastuzumab when given with single agent docetaxel/paclitaxel chemotherapy as part of sequential anthracycline/taxane regimen and not at the start of the anthracycline based component.
  2. Treatment is being initiated with neoadjuvant intent
  3. The patient has newly diagnosed locally advanced, inflammatory or early breast cancer at high risk of recurrence (i.e must have stage T2-T4b and M0 disease) and has pathologically-proven node positive disease
  4. The patient has HER2 3+ by IHC or FISH/CISH positive disease
  5. The patient has a baseline LVEF greater than or equal to 55% % or if anthracyclines were given that the LVEF was greater than or equal to 50% after completion of the anthracycline component of the neo-adjuvant chemotherapy.
  6. The patient has received no prior treatment with chemotherapy or HER2 therapy for this breast cancer
  7. Pertuzumab plus trastuzumab will be given in combination with docetaxel/paclitaxel-containing chemotherapy. The exceptions to this are for patients enrolled in the NIHR-approved ROSCO trial (UKCRN Study ID:19069 where neoadjuvant pertuzumab can be given with chemotherapy in either arm of the study) or potential participants in the NIHR-approved HER2 RADiCAL trial (UKCRN Study ID131362 where paclitaxel/nab-paclitaxel/docetaxel may be used). Please indicate below if the patient is enrolled in the NIHR-approved ROSCO neoadjuvant trial:
  • Patient NOT enrolled/eligible for either of the ROSCO or HER2 RADiCAL trials
  • Patient enrolled in the ROSCO neoadjuvant trial
  • Patient is a potential participant in the HER2 RADiCAL trial of tailored treatment for HER2 +ve early breast cancer
  1. The patient will receive a maximum of 4 cycles of pertuzumab plus trastuzumab if given with single agent docetaxel chemotherapy as part of sequential anthracycline/docetaxel regimen OR 4 cycles of pertuzumab plus trastuzumab if given with weekly paclitaxel chemotherapy as part of sequential anthracycline-paclitaxel regimen OR a maximum of 6 cycles of pertuzumab plus trastuzumab only if given with combination of docetaxel and carboplatin chemotherapy OR a maximum of 4 cycles of pertuzumab plus trastuzumab if given with the first 4 cycles of chemotherapy in either arm of the NIHR-approved ROSCO neoadjuvant trial OR a maximum of 6 cycles (minimum of 4) of pertuzumab plus trastuzumab with non-anthracycline taxane containing chemotherapy as part of the NIHR-approved HER2 RADiCAL trial of tailored treatment for HER2 positive early breast cancer. Please indicate below the maximum number of cycles of pertuzumab it is planned for the patient to receive:
  • 4 cycles OR
  • 6 cycles OR
  • Patient enrolled on the ROSCO neoadjuvant trial (4 cycles) OR or
  • Patient is a potential participant in on the HER2 RADICAL neoadjuvant trial (4-6 cycles) It is acknowledged that in patients who are node positive and whose blood counts have not recovered post neoadjuvant chemotherapy and there is a consequent delay to surgery, such patients may receive additional cycles of pertuzumab plus trastuzumab pre-surgery in order to ensure there is no break in anti-HER2 therapy. It is also acknowledged that such patients may continue with pertuzumab plus trastuzumab after surgery pending determination of status as to pathological complete remission or not.
  1. 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 9. 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 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. Pertuzumab or PHESGO® will be otherwise used as set out in their respective Summary of Product Characteristics (SPCs).

NHS funded From: 21 March 2017

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA424 (21 December 2016)

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.

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