Pertuzumab [PER4b]
Pertuzumab in combination with trastuzumab as adjuvant therapy for HER2- positive early breast cancer patients thought to be node negative or of unknown nodal status prior to neoadjuvant chemotherapy and found be axillary node positive AFTER completion of neoadjuvant pertuzumab/trastuzumab and surgery (PER4b) where the following criteria have been met: These patients must have completed form PER2b for the neoadjuvant portion of their therapy. PER2b patients (node negative or of unknown nodal status prior to neoadjuvant chemotherapy) who are node negative after surgery cannot have adjuvant pertuzumab as NICE has only recommended adjuvant pertuzumab in patients who are node positive. For patients known to be node positive prior commencing neoadjuvant therapy, forms PER2a (neoadjuvant portion of treatment) and PER4a (adjuvant portion of treatment) must be used. For node positive patients who did not receive neoadjuvant chemotherapy, applications for adjuvant pertuzumab should proceed directly adjuvant treatment in combination with pertuzumab and trastuzumab (form PER3).
- This application for pertuzumab in combination with trastuzumab as part of adjuvant chemotherapy is made by and the first cycle of adjuvant pertuzumab and trastzumab 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 confirm below the pathological status after 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
- pathological complete response in the breast but not in the axillary nodes after neoadjuvant chemotherapy in combination with pertuzumab and trastuzumab or
- residual invasive disease remaining in both breast and axillary nodes after neoadjuvant chemotherapy in combination with pertuzumab and trastuzumab
- One of the following scenarios applies to this patient in order to conclude that the patient had documented axillary lymph node involvement and is now eligible to receive pertuzumab in addition to trastuzumab. to
- the patient was concluded to be node negative or of unknown nodal status prior to neoadjuvant treatment and definitive surgery has since found residual invasive carcinoma in the axillary node(s) or
- was concluded to be node negative or of unknown nodal status prior to neoadjuvant treatment and definitive surgery has since found an absence of invasive carcinoma in the axillary nodes but there are histological changes (such as fibrosis) which the pathologist has interpreted as representing previous axillary nodal involvement
- 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 have received an additonal cycle of adjuvant pertuzumab and trastuzumab post-surgery (see form PER2b, question 8). 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 to - 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. to
- 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.