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Real-world effectiveness of palbociclib in combination with an aromatase inhibitor in HR+/HER2− bone-only metastatic breast cancer

Published

February 2026

Citation

Brufsky A, Layman RM, Liu X, et al. Real-world effectiveness of palbociclib in combination with an aromatase inhibitor in HR+/HER2− bone-only metastatic breast cancer. Breast. 2026. https://www.thebreastonline.com/article/S0960-9776(26)00054-8/fulltext

Overview

While cyclin-dependent kinase 4/6 inhibitors combined with endocrine therapy are a standard treatment for HR+/HER2− metastatic breast cancer (MBC), evidence regarding their real-world effectiveness specifically for patients with bone-only disease has been limited. This study used the US nationwide Flatiron Health Research database to compare clinical outcomes for 974 patients receiving either palbociclib plus an aromatase inhibitor (AI) or AI alone as a first-line treatment.

Using the Flatiron Health EHR-derived Panoramic database comprised of >980K patients, researchers found that patients receiving the combination therapy experienced significantly improved outcomes across all measured areas. Specifically, the median overall survival was over a year longer for those receiving palbociclib plus AI (63.4 months) compared to those receiving AI alone (51.3 months). The combination therapy also significantly extended real-world progression-free survival and delayed the time before patients needed to initiate chemotherapy.

Why this matters

Patients with bone-only metastatic breast cancer represent a specific subgroup that may have different needs or outcomes than the broader MBC population. This research provides critical real-world evidence confirming that adding palbociclib to standard hormone therapy provides substantial survival benefits in a routine clinical setting. These findings help clinicians and patients make more informed, data-driven treatment decisions, ultimately aiming to optimize care and improve long-term survival for patients with this specific form of breast cancer.

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