Therapeutic Response

ER positive and HER2-positive status confers therapeutic sensitivity to Anastrozole 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 an aromatase inhibitor for the treatment of postmenopausal patients with hormone-receptor positive MBC, not previously treated with trastuzumab. 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.
Trastuzumab Subcutaneous 21 days - Metastatic Breast Cancer. NCCP National SACT Regimen. HSE. The Republic of Ireland's Health Service Executive (HSE) has approved trastuzumab (subcutaneous - 21 days) in combination with an aromatase inhibitor as a treatment option for the treatment of HER2 positive, hormone-receptor positive metastatic breast cancer not previously treated with trastuzumab for patients who are postmenopausal. The corresponding European Medicines Agency (EMA) approval for this indication cites the clinical trial BO16216 as rationale for the approval where Herceptin (trastuzumab) and anastrozole were administered. The EMA product information for trastuzumab also 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.