Regulatory approval

Published by the Health Service Executive. Approved

HER2 positive metastatic breast cancer (MBC) as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.

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	Trastuzumab
HSE (1)	ERBB2 amplification	Invasive Breast Carcinoma	Trastuzumab

Contributions

Date	Contributor	Description
2026-08-02	Van Allen lab	Initial curation of into moalmanac-db
2024-01-16	Van Allen lab	Adding HSE approvals for reimbursement to database
2015-09-15	Health Service Executive	Indication approved for reimbursement.