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 either paclitaxel or docetaxel for reimbursement as a treatment option for the treatment of HER2 positive early breast cancer following adjuvant chemotherapy with doxorubicin and cyclophosphamide. 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 early breast cancer (EBC) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with PACLitaxel or DOCEtaxel.