Regulatory approval

Published by the Health Service Executive. Approved

HER2 positive metastatic breast cancer (MBC) in combination with PACLitaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable.

This is written in the approval document.

Reimbursement

Hospital

Citation

Trastuzumab Subcutaneous 21 days - Metastatic Breast Cancer, 2021, version number 4, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6694/272_v4_Trastuzumab_SC_21days_MBC.pdf

Therapeutic response

Precision oncology relationships for therapeutic response derived from this regulatory approval.

Organizations	Biomarkers	Cancer types	Therapies
HSE (1)	HER2-positive	Invasive Breast Carcinoma	Paclitaxel, Trastuzumab
HSE (1)	ERBB2 amplification	Invasive Breast Carcinoma	Paclitaxel, Trastuzumab