Therapeutic Response

ERBB2 amplification status confers therapeutic sensitivity to Paclitaxel in combination with Trastuzumab in patients with Invasive Breast Carcinoma.

Statements

Source and description
Herceptin (trastuzumab) [product information]. EMA. The European Medicines Agency (EMA) has authorized trastuzumab in combination with paclitaxel for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) that have not received chemotherapy for their metastatic disease and for whom an anthracycline is not suitable. 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.
Herceptin (trastuzumab) [product information]. EMA. 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.