Tucatinib in combination with trastuzumab and capecitabine [TUC1]

For treating over-expressed HER2 positive unresectable locally advanced or metastatic breast cancer after 2 or more anti-HER2 treatment regimens where the following criteria have been met:

1. This application for tucatinib in combination with trastuzumab and capecitabine for the treatment of unresectable locally advanced or metastatic breast cancer is being made by and the first cycle of this tucatinib combination 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. Confirmation of whether 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
• the patient was treated with a HER2-targeted neoadjuvant regimen which contained both pertuzumab and trastuzumab
• the patient was treated with a HER2-targeted neoadjuvant regimen which contained trastuzumab as the sole HER2-targeted agent

5. Confirmation of whether 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
• the patient was treated with a HER2-targeted adjuvant regimen which contained both pertuzumab and trastuzumab
• the patient was treated with a HER2-targeted adjuvant regimen which contained trastuzumab as the sole HER2-targeted agent
• the patient was treated with a HER2-targeted adjuvant regimen which contained trastuzumab emtansine

6. Confirmation of whether 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
• the patient was treated with a HER2-targeted regimen for locally advanced/metastatic disease which included both pertuzumab and trastuzumab

7. Confirmation of whether 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 contained trastuzumab as the sole HER2-targeted agent
• the patient was treated with a HER2-targeted regimen for locally advanced/metastatic disease which contained trastuzumab as the sole HER2-targeted agent

8. The patient has previously been treated with an anti-HER-2 antibody drug conjugate (ADC) and is now either resistant or refractory to this ADC, or had to discontinue the drug due to intolerance/toxicity which was not able to be managed by dose reductions as outlined in the relevant summary of product characteristics.
9. The treatment status as to whether the patient has been treated with trastuzumab deruxtecan or not for locally advanced/metastatic breast cancer:

• the patient has been treated with trastuzumab deruxtecan
• the patient has not been treated with trastuzumab deruxtecan

10. The patient has received two or more anti-HER2 treatment regimens which must have included a trastuzumab-containing regimen and an anti-HER-2 antibody drug conjugate (ADC). Please tick below how many anti-HER2 therapies this patient has received in all clinical settings (neoadjuvant, adjuvant and locally advanced/metastatic indications; eg 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 and a 2nd relapse treated with trastuzumab emtansine counts as 4 anti-HER2 therapies):

• 2 anti-HER2 therapies
• 3 anti-HER2 therapies
• 4 anti-HER2 therapies
• 5 or more anti-HER2 therapies

11. The patient has not been previously treated with capecitabine in the locally advanced/metastatic disease setting.
12. 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

13. The patient has an ECOG performance status of 0 or 1.
14. Tucatinib will be given until disease progression or unacceptable toxicity or patient choice to stop treatment.
15. When a treatment break of more than 6 weeks beyond the expected 3-weekly cycle length is needed, I confirm that I will complete a treatment break approval form to restart treatment, which MUST be approved before treatment is re-commenced
16. Tucatinib, trastuzumab and capecitabine will be otherwise used as set out in their respective Summaries of Product Characteristics (SmPCs). Blueteq Approval Criteria

NHS funded From: 26 July 2022

Additional information

Form version: -

CDF Managed Access: NA

NICE Technology Appraisal: TA786 (27 April 2022)

Current Form Version

Note

The data on this page was produced using version 1.406 of the CDF list, downloaded from NHS England’s website on 09 September 2026 at 21:36.

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.

Older Form Versions

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

• TUC1_prior_to_cdf_1.361
• TUC1_prior_to_cdf_1.380