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:

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.
The patient has unresectable locally advanced or metastatic breast cancer.
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.
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

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

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

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

The patient has previously been treated with trastuzumab emtansine and is now either resistant or refractory to trastuzumab emtansine or had to discontinue trastuzumab emtansine due to intolerance.
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 received two or more anti-HER2 treatment regimens which must have included a trastuzumab-containing regimen and a trastuzumab emtansine treatment regimen. 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):

The patient has not previously received treatment with tucatinib unless the patient has received tucatinib via a company early access scheme and the patient meets all the other criteria listed here.
The patient has not been previously treated with capecitabine in the locally advanced/metastatic disease setting.
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

The patient has an ECOG performance status of 0 or 1.
Confirmation of whether the treatment intent for all the treatment period is for this patient to receive trastuzumab via its subcutaneous or intravenous formulations. It is strongly recommended by NHS England that the patient is treated with subcutaneous trastuzumab from the start of treatment with tucatinib plus capecitabine. The subcutaneous administration of trastuzumab has obvious benefit for patients and significant service capacity advantages over intravenous administration for providers. Please mark below whether the treatment intent for all the treatment period with tucatinib in combination with trastuzumab and capecitabine is to use the subcutaneous or the intravenous formulations of trastuzumab:

Tucatinib will be given until disease progression or unacceptable toxicity or patient choice to stop treatment.
The prescribing clinician is aware that tucatinib has important drug interactions with the CYP2C8 and CYP3A systems, P-gp substrates and metformin as described in sections 4.2, 4.4 and 4.5 of tucatinib’s Summary of Product Characteristics and will take these interactions into consideration when prescribing all cycles of the tucatinib combination.
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, including as appropriate if the patient had an extended break on account of Covid-19.
Tucatinib, trastuzumab and capecitabine will be otherwise used as set out in their respective Summaries of Product Characteristics (SmPCs).

NHS funded From: 26 July 2022

Additional information

Form version:

CDF Managed Access: NA

NICE Technology Appraisal: TA786 (27 April 2022)

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