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Penelope (GBG 78)

Penelope B

Phase III trial to evaluate palbociclib (PD-0332991), a cyclin kinase 4/6 inhibitor, in patients with HR+/HER2 normal primary breast cancer and a high risk of relapse following neoadjuvant chemotherapy.
GBG Forschungs GmbH is conducting this trial in cooperation with the AGO-B, the Breast International Group (BIG)  and the NSABP Foundation

 
 

Introduction

Detailed information about the trial is publicly accessible at Clinical Trials.gov u under NCT01864746:

The risk of relapse will be determined by means of the CPS-EG score (pre-treatment Clinical stage, post-treatment Pathologic Stage , Estrogen receptor status, nuclear Grade) in accordance with Mittendorf EA et al. 2011.

For recruitment to the PenelopeB trial, patients must have a score of 3 or 2 and ypN(+) status.

The score can be calculated in advance via the website of the MD Anderson Cancer Center

News

The Steering Committee of the PenelopeB trial followed the recommendation of the „Independent Data Monitoring Committee“ and enacted an increase of the global sample size to 1250 patients. This as well as administrative changes is addressed via the protocol amendment G. The status of the amendment implementation can be obtained via the local study group contact in each country.

On 31st May 2017 the 1000th patient was enrolled into the trial Ireland. Thereby 80% of the total enrollment – based on sample size of protocol G – was achieved. Currently, we estimate that the trial will stay open for enrollment until early 2018.

The PenelopeB trial has been initiated in 11 countries at more than 250 study sites so far. No new study sites are initiated at this time.

Design

  • Arm A: 1 year of placebo, 13 cycles (Cycle: 125mg once a day for 3 weeks, 1-week break)
  • Arm B: 1 year of palbociclib, 13 cycles (Cycle: 125mg once a day for 3 weeks, 1-week break)

By way of background therapy, all patients will receive endocrine treatment in accordance with standard guidelines.

Primary trial objective: comparison of invasive-disease-free survival (IDFS)

Inclusion and ecxlusion criteria and detailed information about trial design can be found in the protocol summary in the document section.

Documents

Registered centres can access further documents in the password-protected section of this website for internal use.

Registered centres can access further documents in the password-protected section of this website for internal use. Please log in here.

Contact

Project Managers
Dr. Christian Mäurer, Dr. Mathias Uhlig
GBG Forschungs GmbH
Martin Behaim Strasse 12
63263 Neu-Isenburg
Germany

Fon: +49 6102 7480-0
Fax: +49 6102 7480-440
pnlpgbgd

Coordinating Investigator in Germany: Prof. Dr. Toralf Reimer
International Investigator: Prof. Dr. Gunter von Minckwitz

Contact

pnlpgbgd
Fax: +4961027480440

Project Managers
Dr. Christian Mäurer, Dr. Mathias Uhlig

GBG Forschungs GmbH
Martin-Behaim-Str. 12 | 63263 Neu-Isenburg | Fax +49 6102 7480-440

+49 6102 7480-0 | nfGBGd