CDK 4/6 Inhibitor Palbociclib (PD0332991) in Rb+ Advanced Breast Cancer: Phase II Activity, Safety, and Predictive Biomarker Assessment

DeMichele, Angela; Clark, Amy S.; Tan, Kay See; Heitjan, Daniel F.; Gramlich, Kristi; Gallagher, Maryann; Lal, Priti; Feldman, Michael; Zhang, Paul; Colameco, Christopher; Lewis, David; Langer, Melissa; Goodman, Noah; Domchek, Susan; Gogineni, Keerthi; Rosen, Mark; Fox, Kevin; O'Dwyer, Peter

doi:10.1158/1078-0432.ccr-14-2258

CDK 4/6 Inhibitor Palbociclib (PD0332991) in Rb+ Advanced Breast Cancer: Phase II Activity, Safety, and Predictive Biomarker Assessment

Purpose: The G1–S checkpoint of the cell cycle is frequently dysregulated in breast cancer. Palbociclib (PD0332991) is an oral inhibitor of CDK4/6. Based upon preclinical/phase I activity, we performed a phase II, single-arm trial of palbociclib in advanced breast cancer. Experimental Design: Eli…