Therapeutic Response Statement (Sensitivity)
This therapeutic response statement supports the relationship that AKT1 somatic variants, HER2-negative, PR positive status confers therapeutic sensitivity to Capivasertib, Fulvestrant in patients with Invasive Breast Carcinoma.
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.