Phase III Study Evaluating Palbociclib (PD-0332991), a Cycline-Dependent Kinase (CDK) 4/6 Inhibitor in Patients with Hormone-Receptor-Positive, HER2-Normal Primary Breast Cancer with High Relapse Risk after Neoadjuvant Chemotherapy "Penelope"


Location(s): United States


The PENELOPEB study is designed to demonstrate that in the background of standard anti-hormonal therapy palbociclib provides superior invasive disease-free survival (iDFS) compared to placebo in pre- and postmenopausal women with HR-positive/HER2-normal early breast cancer at high risk of relapse after showing less than pathological complete response to neoadjuvant taxane- containing chemotherapy. Considering the high risk of recurrence in patients after neoadjuvant chemotherapy and a high CPS-EG score, palbociclib appears to be an attractive option with a favourable safety profile for these patients.