Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that ERBB2 amplification status confers therapeutic sensitivity to Docetaxel, Trastuzumab in patients with Invasive Breast Carcinoma.
The European Medicines Agency (EMA) has authorized trastuzumab in combination with paclitaxel or docetaxel for the treatment of adult patients with HER2 positive early breast cancer (EBC) following adjuvant chemotherapy with doxorubicin and cyclophosphamide. The production 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 European Medicines Agency:
Herceptin is indicated for the treatment of adult patients with HER2 positive early breast cancer (EBC) following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel.