Safety of Abemaciclib in Indian Patients with Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative Locally Advanced and/or Metastatic Breast Cancer: A Multicenter, Nonrandomized, Open-Label, Single-Arm, Phase 4 Study.

ABSTRACT:

Background

Global phase III trials demonstrated efficacy of abemaciclib in patients with HR +/HER2- metastatic breast cancer (BC) as a first-line therapy in combination with a nonsteroidal aromatase inhibitor (MONARCH-3) or with fulvestrant following progression after endocrine therapy (ET) (MONARCH-2). However, there is limited data on safety and tolerability of abemaciclib plus ET in the metastatic BC setting among Indian patients, which the present study aims to address.

Materials and methods

An open-label, single-arm, phase IV study was conducted across 16 centers in India to assess the safety and tolerability of abemaciclib in patients with HR +/HER2- locally advanced or metastatic BC. Patients were assigned to either cohort A, ET-naive patients (abemaciclib + anastrozo

SUBMITTER: Doval DC 

PROVIDER: S-EPMC12727028 | biostudies-literature | 2025 Jul

REPOSITORIES: biostudies-literature