Capivasertib, an AKT Kinase Inhibitor, as Monotherapy or in Combination with Fulvestrant in Patients with <i>AKT1</i> ^E17K-Mutant, ER-Positive Metastatic Breast Cancer.

ABSTRACT:

Purpose

The activating mutation AKT1 ^E17K occurs in approximately 7% of estrogen receptor-positive (ER⁺) metastatic breast cancer (MBC). We report, from a multipart, first-in-human, phase I study (NCT01226316), tolerability and activity of capivasertib, an oral AKT inhibitor, as monotherapy or combined with fulvestrant in expansion cohorts of patients with AKT1 ^E17K-mutant ER⁺ MBC.

Patients and methods

Patients with an AKT1 ^E17K mutation, detected by local (next-generation sequencing) or central (plasma-based BEAMing) testing, received capivasertib 480 mg twice daily, 4 days on, 3 days off, weekly or 400 mg twice daily combined with fulvestrant at the labeled dose. Study endpoints included safety, ob

SUBMITTER: Smyth LM 

PROVIDER: S-EPMC7415507 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature