An open-label, single-arm, multicenter, phase II trial of bireociclib as monotherapy for heavily pretreated HR-positive, HER2-negative advanced breast cancer patients: BRIGHT-1 trial.

ABSTRACT:

Background

Bireociclib (XZP-3287) is a novel selective cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor, with a favorable safety profile demonstrated in preclinical and phase I studies. BRIGHT-1 aimed to further explore the efficacy and safety of bireociclib monotherapy in patients with locally advanced, recurrent or metastatic, hormone receptor-positive and human epidermal growth factor receptor 2-negative (HR⁺/HER2^-) breast cancer who had progressed on or after prior chemotherapy and endocrine therapy in advanced settings, without previous exposure to CDK4/6 inhibitors.

Methods

In this open-label phase II trial, eligible patients received bireociclib 480 mg twice daily (BID) until disease progression or intolerable toxicities. The primary endpoint w

SUBMITTER: Wang J 

PROVIDER: S-EPMC12187580 | biostudies-literature | 2025 Jun

REPOSITORIES: biostudies-literature