Pertuzumab [PER4a]
Pertuzumab in combination with trastuzumab as adjuvant therapy for patients with HER2-positive early breast cancer which was diagnosed as being NODE POSITIVE prior to neoadjuvant treatment and has now completed neoadjuvant pertuzumab in combination with trastuzumab and chemotherapy and surgery (PER4a) where the following criteria have been met: These patients must have had form PER2a completed for the neoadjuvant portion of their therapy. For patients who were node negative or of unknown nodal status prior to commencing neo- adjuvant therapy, form PER2b (neoadjuvant portion) should have been completed and form PER4b is for adjuvant pertuzumab in such PER2b patients who are found to be node positive after surgery. For node positive patients who did not receive neo-adjuvant chemotherapy with pertuzumab, form PER3 should be used for adjuvant treatment of pertuzumab + trastuzumab.
- This application for pertuzumab in combination with trastuzumab as part of adjuvant chemotherapy is made by and the first cycle of adjuvant pertuzumab and trastuzumab will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
- The patient has histologically documented breast cancer which is HER2 3+ by immunohistochemistry and/or has a ratio of ≥2.0 by in situ hybridisation.
- The patient has been diagnosed with early breast cancer and this has been adequately excised.
- The patient has received neoadjuvant chemotherapy in combination with pertuzumab and trastuzumab and has not had disease progression. Please indicate below whether or not the patient achieved a pathological complete response in terms of the invasive carcinoma to neoadjuvant chemotherapy in combination with pertuzumab and trastuzumab:
- pathological complete response in breast and axillary nodes after neoadjuvant chemotherapy in combination with pertuzumab and trastuzumab or
- residual invasive disease remaining in breast and/or axillary nodes after neoadjuvant chemotherapy in combination with pertuzumab and trastuzumab
- unknown (patient started on adjuvant pertuzumab plus trastuzumab post-surgery as they were known to be node positive before the pathology results were available to confirm the status as to pathological complete remission)
- The patient had confirmed node positive disease prior to neo-adjuvant treatment and surgery
- A maximum of 18 cycles of pertuzumab plus trastuzumab will be administered during the whole treatment period of neoadjuvant and adjuvant treatments added together e.g. if 4 cycles of neoadjuvant pertuzumab and trastuzumab are given in combination with neoadjuvant chemotherapy, then a maximum of 14 cycles of adjuvant pertuzumab and trastuzumab will be subsequently administered. It is acknowledged that patients may be started on adjuvant pertuzumab plus trastuzumab post-surgery as they were known to be node positive and before the pathology results have confirmed the status as to pathological complete remission. A maximum of 18 cycles of HER2-directed therapy (neoadjuvant plus adjuvant) are funded provided all other criteria are met.
- 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
- 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.
- The patient has an ECOG performance status of 0 or 1.
- The left ventricular ejection fraction prior to commencing adjuvant cycles of pertuzumab plus trastuzumab remains ≥50%.
- 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, including an indication as appropriate if the patient had an extended break because of COVID 19.
- Pertuzumab or PHESGO® will be otherwise used as set out in their respective Summary of Product Characteristics (SPC)
NHS funded From: 18 June 2019
Additional information
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.