Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that HER2-positive status confers therapeutic sensitivity to Docetaxel, Trastuzumab in patients with Invasive Breast Carcinoma.
The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab (subcutaneous - 21 days) in combination with docetaxel as a treatment option for the treatment of HER2 positive metastatic breast cancer for patients who have not received chemotherapy for their metastatic disease. 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 statement is based on a regulatory approval from the Health Service Executive:
HER2 positive metastatic breast cancer (MBC) in combination with DOCEtaxel for the treatment of those patients who have not received chemotherapy for their metastatic disease.