(PENELOPE-B) GBG-78 - BIG 1-13 - NSABP-B-54-I A Study of Palbociclib in Addition to Standard Endocrine Treatment in Hormone Receptor Positive Her2 Normal Patients With Residual Disease After Neoadjuvant Chemotherapy and Surgery

Investigator: Jenny Chang, MD

Study Coordinator: Lacey Burey

Status: Enrolling

ClinicalTrials.gov Number: NCT01864746

Phone: 713.441.1159

IRB Number: Pro00012210

Description

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.
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