Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that ERBB2 amplification status confers therapeutic sensitivity to Carboplatin, 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 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 statement is based on a regulatory approval from the Health Service Executive:
HER2 positive early breast cancer (EBC) in combination with adjuvant chemotherapy consisting of DOCEtaxel and CARBOplatin.