Therapeutic Response

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

Statements

Source and description
Herceptin (trastuzumab) [product information]. EMA. The European Medicines Agency (EMA) has authorized trastuzumab as a monotherapy for the treatment of adult patients with HER2 positive metastatic breast cancer (MBC) that have received at least two chemotherapy regimes for their metastatic disease. Prior chemotherapy must have been included at least an anthracycline and a taxane unless patients are unsuitable for these treatments. Hormone receptor positive patients must have also failed hormonal therapy, unless a patient is unsuitable for those treatments. 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 for the treatment of adult patients with HER2 positive early breast cancer (EBC) following surgery, chemotherapy (neoadjuvant or adjuvant), and radiotherapy (if applicable). 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) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to trastuzumab for the treatment of patients with HER2-overexpressing breast cancer. The product label specifies to select patients for therapy based on an FDA-approved companion diagnostic for herceptin.