Pertuzumab [PER2b]

Neoadjuvant pertuzumab plus trastuzumab in patients who are NODE NEGATIVE or of UNKNOWN NODAL STATUS for the neoadjuvant treatment locally advanced, inflammatory or early breast cancer at high risk of recurrence (PER2b) where the following criteria have been met: This form (introduced November 2019) is for patients who are node negative or of unknown nodal status prior to commencing neo-adjuvant therapy. If a biopsy post-surgery shows that the patients are found to be node positive, then for them to commence adjuvant treatment with pertuzumab and trastuzumab, form PER4b must be completed. For patients with locally advanced, inflammatory or early breast cancer who are node positive when commencing neo-adjuvant chemotherapy in combination with pertuzumab and trastuzumab, form PER2a must be used followed by form PER4b when commencing adjuvant treatment with pertuzumab and trastuzumab

  1. An 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 is either node negative or is of unknown nodal status prior to surgery.
  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: of
  • 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
  • Patient is a potential participant in on the HER2 RADICAL neoadjuvant trial (4-6 cycles) It is acknowledged that in patients 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 axillary nodal involvement or not and 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
  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 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.
  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: 21 March 2017

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA424 (21 December 2016)

Current Form Version

Important

This is an older version of the form. To view the most up to date form follow this link

Older Form Versions

There are previous versions of this form. These may not all be available on this site.