Dynamics of hyperglycemia of patients treated with alpelisib: exploratory interim analysis of ITACA trial.

ABSTRACT:

Background

Alpelisib and fulvestrant combination has improved outcomes in patients with phosphatidylinositol-4,5-bisphosphate 3-kinase catalytic subunit alpha (PIK3CA)-mutated, hormone receptor-positive (HR+), human epidermal growth factor receptor 2 negative (HER2-)- advanced breast cancer (BC) who relapsed or progressed on prior endocrine therapy. Hyperglycemia, on target toxicity, is a frequent adverse event occurring in over 60% of patients.

Objectives

The ITACA trial explores whether low carbohydrate dietary modifications and evening dosing of alpelisib to potentially mitigate impact of food on hyperglycemia. This exploratory interim analysis aimed to quantify the incidence and timing of hyperglycemia in the ITACA trial's pooled sample.

Methods

This exploratory i

SUBMITTER: Pancirov M 

PROVIDER: S-EPMC11950915 | biostudies-literature | 2025 Mar

REPOSITORIES: biostudies-literature