HS-10352 in hormone receptor-positive, HER2-negative advanced breast cancer: A phase 1 dose-escalation trial.

ABSTRACT:

Background

Approximately 40% of patients with hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer (ABC) exhibit PIK3CA mutations.

Aims

This study aims to evaluate the safety, tolerability, pharmacokinetics, and preliminary antitumor activity of HS-10352, a selective PI3Kα inhibitor, in this patient population.

Materials and methods

Conducted as a phase 1 dose-escalation trial, HS-10352 was administered orally once-daily (QD) at dose levels of 2, 4, 6, and 8 mg. The primary endpoints were dose-limiting toxicity (DLT) and the maximum tolerated dose (MTD). This study is registered at ClinicalTrials.gov (NCT04631835).

Results

Between August 2020 and March 2022, a total of 18 female patients were enrolle

SUBMITTER: Ouyang Q 

PROVIDER: S-EPMC10757118 | biostudies-literature | 2023 Dec

REPOSITORIES: biostudies-literature