Regulatory approval

Published by the Health Service Executive. Approved

The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab (subcutaneous - 21 days) in combination with adjuvant chemotherapy consisting of carboplatin and docetaxel for reimbursement as a treatment option for the treatment of HER2 positive early breast cancer. The European Medicines Agency product information for trastuzumab notes that trastuzumab should only be used in patients with metastatic or early breast cancer whose tumors have either HER2 overexpression or HER2 gene amplification as determined by an accurate and validated assay.

This is written in the approval document as:

HER2 positive early breast cancer (EBC) in combination with adjuvant chemotherapy consisting of DOCEtaxel and CARBOplatin.

Reimbursement

Hospital

Citation

Trastuzumab Subcutaneous 21 days - Early Breast Cancer, 2021, version number 4, NCCP National SACT Regimen, NCCP, viewed 26/03/2026, https://healthservice.hse.ie/documents/6700/285_v4_Trastuzumab_SC_21days_EBC.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	Carboplatin, Docetaxel, Trastuzumab
HSE (1)	ERBB2 amplification	Invasive Breast Carcinoma	Carboplatin, Docetaxel, 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.