Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that HER2-positive status confers therapeutic sensitivity to Doxorubicin, Paclitaxel, Trastuzumab in patients with Invasive Breast Carcinoma.
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.
This statement is based on a regulatory approval from the Health Service Executive:
HER2 positive early breast cancer (EBC) in combination with neoadjuvant chemotherapy followed by adjuvant trastuzumab therapy, for locally advanced (including inflammatory) disease or tumours >2cm in diameter.