Regulatory approval

Published by the Health Service Executive. Approved

HER2 positive metastatic breast cancer (MBC) in combination with an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab.

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

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Therapeutic response

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

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