Therapeutic Response

ER positive, HER2-negative, PIK3CA somatic variants, and PR positive status confers therapeutic sensitivity to Capivasertib in combination with Fulvestrant in patients with Invasive Breast Carcinoma.

Statements

Source and description

Truqap (capivasertib) [package insert]. FDA. The U.S. Food and Drug Administration granted approval to capivasertib in combination with fulvestrant for the treatment of adult patients 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 as detected by an FDA-approved test following progression on at least one endocrine-based regimen in the metastatic setting or recurrence on or within 12 months of completing adjuvant therapy. The efficacy of capivasertib in combination with fulvestrant was evaluated in CAPItello-291 (NCT04305496), which described biomarker eligibility as PIK3CA/AKT1 activating mutations or PTEN loss of function alterations.