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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

NCT01864746 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1250

Last updated 2023-12-12

Study results available
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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.

Conditions

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

Interventions

DRUG

Palbociclib PD-0332991

palbociclib at a dose of 125 mg once daily, day 1 to day 21 followed by 7 days off treatment in a 28-day cycle

DRUG

Placebo

Arm B: Placebo of palbociclib once daily day 1 to day 21 followed by 7 days off treatment in a 28-day cycle for thirteen cycles

Sponsors & Collaborators

  • Pfizer

    collaborator INDUSTRY

  • AGO Study Group

    collaborator OTHER

  • NSABP Foundation Inc

    collaborator NETWORK

  • Breast International Group

    collaborator OTHER

  • GBG Forschungs GmbH

    lead OTHER

Principal Investigators

  • Sibylle Loibl, MD, Prof · ASCO, ESMO, EORTC-TRAFO, ESGO, DKG, AGO

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-10-30
Primary Completion
2020-08-24
Completion
2020-12-21

Countries

  • United States
  • Australia
  • Austria
  • Canada
  • France
  • Germany
  • Ireland
  • Japan
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01864746 on ClinicalTrials.gov