Published

June 27, 2025

Trastuzumab deruxtecan [TRAD2]

For treating over-expressed HER2 positive unresectable locally advanced or metastatic breast cancer in patients who have received 1 or more anti-HER2 therapies and who are treatment-naïve for trastuzumab emtansine in the advanced/metastatic disease setting where the following criteria have been met:

  1. This application for trastuzumab deruxtecan for the treatment of unresectable locally advanced or metastatic breast cancer is being made by and the first cycle of trastuzumab deruxtecan will be prescribed by a consultant specialist specifically trained and accredited in the use of systemic anti-cancer therapy.
  2. The patient has unresectable locally advanced or metastatic breast cancer.
  3. The patient has histologically documented breast cancer which is HER2 3+ by immunohistochemistry and/or has a HER2 amplification ratio of ≥2.0 by in situ hybridisation.
  4. If this patient received a HER2-targeted neoadjuvant regimen and if so its nature. Please tick which option applies to this patient:
  • the patient was not treated with a HER2-targeted neoadjuvant regimen or
  • the patient was treated with a HER2-targeted neoadjuvant regimen which contained both pertuzumab and trastuzumab or
  • the patient was treated with a HER2-targeted neoadjuvant regimen which contained trastuzumab as the sole HER2-targeted agent
  1. If the patient received a HER2-targeted adjuvant regimen and if so its nature. Please tick which option applies to this patient:
  • the patient was not treated with a HER2-targeted adjuvant regimen or
  • the patient was treated with a HER2-targeted adjuvant regimen which contained both pertuzumab and trastuzumab or
  • the patient was treated with a HER2-targeted adjuvant regimen which contained trastuzumab as the sole HER2-targeted agent or
  • the patient was treated with a HER2-targeted adjuvant regimen which contained trastuzumab emtansine
  1. If the patient received a HER2-targeted regimen for locally advanced/metastatic disease which included both pertuzumab and trastuzumab. Please tick which option applies to this patient:
  • the patient was not treated with a HER2-targeted regimen for locally advanced/metastatic disease which included both pertuzumab and trastuzumab or
  • the patient was treated with a HER2-targeted regimen for locally advanced/metastatic disease which included both pertuzumab and trastuzumab
  1. If the patient received a HER2-containing regimen for locally advanced/metastatic disease which included trastuzumab as the sole HER2-targeted agent. Please tick which option applies to this patient:
  • the patient was not treated with a HER2-targeted regimen for locally advanced/metastatic disease which included trastuzumab as the sole HER2-targeted agent or
  • the patient was treated with a HER2-targeted regimen for locally advanced/metastatic disease which contained trastuzumab as the sole HER2-targeted agent
  1. The patient has been treated with a prior regimen which contained at least trastuzumab and a taxane OR trastuzumab and capecitabine for advanced /metastatic breast cancer or developed disease recurrence during or within 6 months of completing an adjuvant or neoadjuvant treatment regimen which contained at least trastuzumab and a taxane or adjuvant treatment with trastuzumab emtansine. Please tick which option applies to this patient:
  • the patient was treated with a prior regimen for advanced/metastatic breast cancer which contained at least trastuzumab and a taxane OR trastuzumab and capecitabine
  • the patient has not yet been treated for advanced/metastatic breast cancer and has relapsed during or within 6 months of completing adjuvant or neoadjuvant therapy containing at least trastuzumab and a taxane
  • the patient has not yet been treated for advanced/metastatic breast cancer and has relapsed during or within 6 months of completing adjuvant therapy with trastuzumab emtansine
  1. The patient has received one or more anti-HER2 therapies which must have included trastuzumab. Please tick below how many anti-HER2 therapies this patient has received in all clinical settings (neoadjuvant, adjuvant and locally advanced/metastatic indications; e.g a treatment pathway of neoadjuvant pertuzumab plus trastuzumab regimen followed by adjuvant trastuzumab and then a 1st relapse treated with a pertuzumab plus trastuzumab regimen counts as 3 separate anti-HER2 therapies):
  • 1 anti-HER2 therapy
  • 2 anti-HER2 therapies
  • 3 anti-HER2 therapies
  • 4 anti-HER2 therapies
  1. The patient has NOT been previously treated with trastuzumab emtansine for advanced/metastatic breast cancer.
  2. Prior to consideration of treatment with trastuzumab deruxtecan the patient has a baseline left ventricular ejection fraction (LVEF) of at least 50%.
  3. The patient has an ECOG performance status of 0 or 1.
  4. The status as to the presence of brain metastases/leptomeningeal spread and its symptomatic and treatment status:
  • the patient has never had any known brain metastases or leptomeningeal spread
  • the patient has active brain metastases/leptomeningeal spread and has not received any active treatment for this CNS spread
  • the patient has been previously treated with CNS radiotherapy/stereotactic radiosurgery/intrathecal chemotherapy and the metastatic CNS disease is stable
  • the patient has been previously treated with CNS radiotherapy/stereotactic radiosurgery/intrathecal chemotherapy and the metastatic CNS disease is progressing
  1. The patient has had no prior treatment with trastuzumab deruxtecan unless it has been received as part of the Daiichi Sankyo early access scheme and the patient meets all the other criteria set out here.
  2. Trastuzumab deruxtecan will be used as monotherapy and will commence at a dose of 5.4 mg/Kg administered every 3 weeks.
  3. Trastuzumab deruxtecan will be given until disease progression or unacceptable toxicity or patient choice to stop treatment. Note: trastuzumab deruxtecan is not to be used beyond first disease progression outside the CNS. Note: it is advised that trastuzumab deruxtecan is not (at least initially) discontinued if disease progression is within the CNS alone.
  4. The prescribing clinician is aware that cases of interstitial lung disease/pneumonitis have been reported with trastuzumab deruxtecan and fatal outcomes have been observed. The prescribing clinician also confirms that an appropriate imaging schedule is being used to detect early interstitial lung disease and will ensure that all patients are aware of the need to immediately report cough, dyspnoea, fever, and/or any new or worsening respiratory symptoms. In addition, the prescribing clinician confirms that if a diagnosis is made of interstitial lung disease/pneumonitis, management will include dose interruptions and modifications of trastuzumab deruxtecan as described in sections 4.2 and 4.4 of the drug’s Summary of Product Characteristics (SmPC).
  5. When a treatment break of more than 6 weeks beyond the expected 3-weekly cycle length is needed, the prescribing clinician confirm that the prescribing clinician will complete a treatment break approval form to restart treatment.
  6. Trastuzumab deruxtecan will be otherwise used as set out in its Summary of Product Characteristics (SmPC).

CDF funded From: 20 December 2022

Form version:

CDF Managed Access: Yes

NICE Technology Appraisal: NA (NA)

Current Form Version

Note

The data on this page was produced using version 1.367 of the CDF list, downloaded from NHS England’s website on 27 June 2025 at 18:00.

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.