A Phase IB Study of Binimetinib and Palbociclib in Molecularly Selected Advanced Triple-Negative Breast Cancer.

ABSTRACT:

Purpose

Advanced, pretreated triple-negative breast cancer (TNBC) has a dismal prognosis and lacks effective options beyond standard cytotoxics. We previously showed, via phosphoproteomic screening, that cyclin-dependent kinase 6 (CDK6) and ERK hyperactivation are linked to adverse outcomes and represent actionable targets. This prompted us to evaluate palbociclib and binimetinib in advanced TNBC after one or two prior therapies.

Patients and methods

Patients with increased ERK and/or CDK6 activity were eligible. Treatment consisted in daily binimetinib (45 mg twice a day) plus palbociclib (100 mg daily, days 1-21) in 28-day cycles. Palbociclib escalation to 125 mg was allowed in cycle 2. The primary objective was to demonstrate a 2.5 month-long progression-free survival (PF

SUBMITTER: Manso L 

PROVIDER: S-EPMC12477833 | biostudies-literature | 2025 Sep

REPOSITORIES: biostudies-literature