Therapeutic Response

HER2-positive status confers therapeutic sensitivity to Doxorubicin in combination with Paclitaxel and Trastuzumab in patients with Invasive Breast Carcinoma.

Statements

Source and description
Trastuzumab Subcutaneous 21 days - Early Breast Cancer. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved neoadjuvant chemotherapy followed by adjuvant trastuzumab for reimbursement as a treatment option for the treatment of HER2 positive early breast cancer for locally advanced (including inflammatory) disease or tumors > 2 cm in diameter. The corresponding European Medicines Agency approval for this indication cites the multicenter randomized trial MO16432, which used doxorubicin in combination with paclitaxel for the neoadjuvant chemotherapy, in the rationale for this approval.
Herceptin (trastuzumab) [product information]. EMA. The European Medicines Agency (EMA) has authorized trastuzumab in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab for the treatment of adult patients with HER2 positive early breast cancer (EBC) whose tumors are locally advanced (including inflammatory) disease or > 2 cm in diameter. This indication is based on the multicenter randomized trial MO16432 which used doxorubicin in combination with paclitaxel for the neoadjuvant chemotherapy. 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.