Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that AKT1 amplification, HER2-negative, PR positive status confers therapeutic sensitivity to Capivasertib, Fulvestrant in patients with Invasive Breast Carcinoma.
Health Canada approved capivasertib, in combination with fulvestrant, for the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.
This statement is based on a regulatory approval from the Health Canada:
TRUQAP (capivasertib tablets), in combination with fulvestrant, is indicated for the treatment of adult females with hormone receptor (HR) positive, human epidermal growth factor receptor 2 (HER2) negative locally advanced or metastatic breast cancer with one or more PIK3CA/AKT1/PTEN alterations following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy.