Regulatory approval
Published by the Health Service Executive.
The Republic of Ireland's Health Service Executive (HSE) has approved neoadjuvant chemotherapy followed by adjuvant trastuzumab for reimbursement as a treatment option for the treatment of HER2 positive early breast cancer for locally advanced (including inflammatory) disease or tumors > 2 cm in diameter. The corresponding European Medicines Agency approval for this indication cites the multicenter randomized trial MO16432, which used doxorubicin in combination with paclitaxel for the neoadjuvant chemotherapy, in the rationale for this approval.
This is written in the approval document as:
HER2 positive early breast cancer (EBC) in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab therapy, for locally advanced (including inflammatory) disease or tumours >2cm in diameter.
Citation
Trastuzumab Subcutaneous 21 days - Early Breast Cancer, 2021, version number 4, NCCP National SACT Regimen, NCCP, viewed 21/07/2024, https://www.hse.ie/eng/services/list/5/cancer/profinfo/chemoprotocols/breast/285.pdfTherapeutic response
Precision oncology relationships for therapeutic response derived from this regulatory approval.| Type | Biomarker(s) | Cancer type | Therapy(ies) | |
|---|---|---|---|---|
| Sensitivity (+) | HER2-positive | Invasive Breast Carcinoma | Doxorubicin, Paclitaxel, Trastuzumab |