BEBT-209, a primary CDK4 selective inhibitor, for the treatment of HR+/HER2- advanced breast cancer (BECTOP1): a phase 1, multicentre, open-label study.

ABSTRACT:

Purpose

Several cyclin-dependent kinase 4/6 (CDK4/6) inhibitors have been approved for the treatment of hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. Despite the side effects that affect patients' quality of life, most patients still opt for CDK4/6 inhibitors due to their significant benefits. However, to further enhance treatment efficacy and safety, new approaches are still needed.

Patients and methods

This multicentre, open-label, Phase 1 trial enrolled Chinese patients with HR+, HER2-advanced breast cancers. The primary endpoints were dose-limiting toxicity (DLT), maximum tolerated dose (MTD). Secondary endpoints included the objective response rate (ORR), clinical benefit rate (CBR), progression-fre

SUBMITTER: Hu ZY 

PROVIDER: S-EPMC12309592 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature