Overview

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:
Active, not recruiting

Trial end date:
2023-11-01

Target enrollment:

Participant gender:

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.

Phase:

Phase 3

Details

Lead Sponsor:

German Breast Group

Collaborators:

AGO Study Group
Breast International Group
NSABP Foundation Inc
Pfizer

Treatments:

Hormones
Palbociclib