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Real-world progression-free survival 2 and tumor response with CDK4/6is + aromatase inhibitor in patients with HR+/HER2– metastatic breast cancer

Published

December 2025

Citation

Rugo H, Brufsky A, Layman R, et al. Real-world progression-free survival 2 and tumor response with CDK4/6is + aromatase inhibitor in patients with HR+/HER2– metastatic breast cancer. SABCS. 2025.

Overview

CDK4/6 inhibitors combined with endocrine therapy are the cornerstone of first-line treatment for hormone receptor-positive, HER2-negative metastatic breast cancer (HR+/HER2- MBC). This large-scale real-world study leverages the panoramic Flatiron Health Research Database to provide insights into real-world progression-free survival 2 (rwPFS2) and tumor response (rwTR) of three CDK4/6 inhibitors—palbociclib (PAL), ribociclib (RIB), and abemaciclib (ABE)—when combined with endocrine therapy. 

Using the Flatiron Health EHR-derived Panoramic database comprised of >940K patients with breast cancer to analyze data from over 9,000 patients, the study found no significant differences in rwPFS2, the time from 1L CDK4/6i + AI initiation to disease progression on 2L treatment or death, and rwTR among the three treatment options, supporting earlier findings that these drugs offer similar outcomes in terms of overall survival and progression-free survival.

Why this matters

This study offers valuable real-world evidence into the effectiveness of CDK4/6 inhibitors in a large, diverse patient population, building on prior real-world analyses. The findings also underscore the value of real-world evidence in guiding treatment strategies and complementing traditional clinical trials. Flatiron’s Panoramic datasets offer a scaled, comprehensive, disease-specific solution to answer questions not previously possible, unlocking critical information to improve care and outcomes for people with cancer. 

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