The five-year follow-up of the PALLAS trial did not show improved invasive disease-free survival with the addition of palbociclib to endocrine therapy in patients with early-stage hormone receptor-positive, HER2-negative breast cancer. The overall survival was similar between the two arms.
Study
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Randomized, open-label, international, multicenter, phase III study [PALLAS] \nEarly-stage hormone receptor-positive/HER2-negative breast cancer \nPalbociclib+ET (n=2883) vs ET (n=2870)
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Efficacy
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5-yr iDFS: 84.2% vs 82.4% (HR 0.88 [0.77-1.01])\n5-yr OS: 92.6% vs 93.2% (HR 1.09 [0.89-1.33])
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Safety
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Grade >=3 AEs: Serious adverse events were not significantly different.\nHigher chemotherapy after recurrence: 52.5% vs 41%\nHigher CDK4/6 inhibitor use in ET alone arm: 65.7% vs 33.0%
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Ann Oncol. Published online 2025.
Mayer EL, Hlauschek D, Gnant M New Reference: Adjuvant Palbociclib for HR+ Breast Cancer
http://doi.org/10.1016/j.annonc.2025.10.003
Reviewed by Ulas D. Bayraktar, MD on Oct 18, 2025
