Tibremciclib or Placebo Plus Fulvestrant in Hormone Receptor-Positive and ERBB2-Negative Advanced Breast Cancer After Endocrine Therapy: A Randomized Clinical Trial.

ABSTRACT:

Importance

Cyclin-dependent kinase (CDK) 4/6 inhibitors combined with endocrine therapy (ET) are now considered the standard treatment regimen for hormone receptor-positive (HR+) and ERBB2 (formerly HER2)-negative (ERBB2-) advanced breast cancer (ABC). Tibremciclib (BPI-16350), a novel CDK4/6 inhibitor, has demonstrated favorable tolerability and promising antitumor activity as a monotherapy or combined with fulvestrant among patients with HR+/ERBB2- ABC in a phase 1 trial. Further investigations are necessary to assess the efficacy and safety of tibremciclib.

Objective

To compare tibremciclib plus fulvestrant and placebo plus fulvestrant in terms of efficacy and safety among patients with HR+/ERBB2- ABC who exhibited disease progression after ET.

Design, setting, and par

SUBMITTER: Tao Z 

PROVIDER: S-EPMC12314770 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature