OncRef

Clinical Trial: NCT01864746

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

Status:

COMPLETED

Phase:

Phase 3

Lead Sponsor:GBG Forschungs GmbH
Information Provided By:GBG Forschungs GmbH
Last Update Posted:2023-12-12

Study Overview

Brief Summary

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.

Official Title

Phase III Study Evaluating Palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in Patients With Hormone-receptor-positive, HER2-normal Primary Breast Cancer With High Relapse Risk After Neoadjuvant Chemotherapy "PENELOPEB"

Conditions

Breast Cancer, Hormonreceptor Positive, Her2-normal, Postneoadjuvant Treatment With CDK 4/6 Inhibitor, CPS-EG Score

Intervention / Treatment

  • Drug: Palbociclib PD-0332991
  • Drug: Placebo

Other Study ID Numbers

  • GBG78/BIG 1-13/NSABP-B-54-I
  • 2013-001040-62

Start Date (Actual)

2013-10-30

Primary Completion Date (Actual)

2020-08-24

Study Completion Date (Actual)

2020-12-21

Enrollment (Actual)

1250

Study Type

Interventional

Phase

Phase 3