Therapeutic Response Statement (Sensitivity)
This therapeutic response statement Supports the relationship that HER2-positive status confers therapeutic sensitivity to Trastuzumab in patients with Invasive Breast Carcinoma.
The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab (subcutaneous - 21 days) for reimbursement as a monotherapy treatment option for the treatment of HER2 positive metastatic breast cancer (MBC) in patients who have received at least two chemotherapy regimens for their metastatic disease. The indication further notes that prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments. 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 metastatic breast cancer (MBC) as monotherapy for the treatment of those patients who have received at least two chemotherapy regimens for their metastatic disease. Prior chemotherapy must have included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must also have failed hormonal therapy, unless patients are unsuitable for these treatments.