A phase IV prospective study of efficacy and safety of ribociclib and letrozole as first-line therapy in older women (≥70 years) with hormone receptor-positive HER2-negative advanced breast cancer: the RibOB study.

ABSTRACT:

Background

Cyclin-dependent kinase 4/6 inhibitors with endocrine therapy are standard first-line therapy for patients with hormone receptor-positive metastatic breast cancer. Older patients, especially the frailer subpopulation, are underrepresented in clinical trials, limiting data on treatment and safety outcomes in this population.

Patients and methods

The RibOB study was an open-label, single-arm phase IV prospective trial evaluating first-line ribociclib 600 mg 3 weeks out of 4 with letrozole in women ≥70 years with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer. Primary endpoint was progression-free survival (PFS). Secondary endpoints were safety, functional evolution and quality of life (QoL), and outcomes in relati

SUBMITTER: Van Houdt M 

PROVIDER: S-EPMC12816914 | biostudies-literature | 2026 Jan

REPOSITORIES: biostudies-literature