NSABP B-54-I
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NSABP-B-54-I/GBG-78/BIG 1-13 (“PENELOPEB”)

Phase III study evaluating palbociclib (PD-0332991), aCyclin-Dependent Kinase (CDK) 4/6 Inhibitor in patients with hormone-receptor-positive, HER2-normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy

Primary Objective: To compare invasive disease free survival (iDFS) for palbociclib vs. placebo

in patients with residual invasive breast cancer and high CPS-EG score - after neoadjuvant chemotherapy receiving standard adjuvant endocrine therapy for HR-positive/HER2-normal primary breast cancer.

Patient Population: Hormone-receptor-positive / HER2-normal primary breast cancer patients without pathological complete response after neoadjuvant chemotherapy

Target Accrual: 1,100 patients

Status: Active, not recruiting

ClinicalTrials.gov IdentifierNCT01864746