Penelope (GBG 78)

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. 

The recruitment goal of 1250 patients has been reached on 7-Dec-2017 and the treatment part of PENELOPE has been completed with the last patient visit on 25-Sep2020. Actual PENELOPE trial is in the follow-up phase, which will be finalized per protocol with the overall survival analysis in 3rd quarter of 2023.

Since long-term data on the safety and efficacy of a study treatment are of high scientific and medical interest, a new research project in the form of a register study is currently being in set-up at GBG. The aim is to include GBG study patients in this registry after completion of their study for a period of approximately 10 years.
The PENELOPE trial is intended to be the first study for this registry. In addition (or alternatively), it is also planned to include the study patients in our Patient Self-Assessment (PSA), which is currently only available in Germany.
Further information on this registry (GBG107) will be announced shortly.
[May 19, 2021]

We would like to thank the study centers for their great support!

In addition, we’d like to refer to tthe following publications of the PENELOPE study data:

Data on GBG study PenelopeB and several collaborative projects was presented at the SABCS Virtual Meeting 2020.

GS1-02 Oral presentation Wednesday, December 9, 2020. General Session 1
Moderator: Angela DeMichele, MD, MSCE, Time: 8:15-8-30 AM CT
Phase III study of palbociclib combined with endocrine therapy (ET) in patients with hormone-receptor-positive (HR+), HER2-negative primary breast cancerand with high relapse risk after neoadjuvant chemotherapy (NACT): First results from PENELOPE-B
Loibl S, Marmé F, Martin M, et al.

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

• 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.

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

• Calculator for CPS-EG-Score
  

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

Project Manager
Dr. Thomas Ballhausen
GBG Forschungs GmbH
Dornhofstrasse 10
63263 Neu-Isenburg
Germany

Fon: +49 6102 7480-0
Fax: +49 6102 7480-440
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Coordinating Investigator in Germany: Prof. Dr. Toralf Reimer
International Investigator: Prof. Dr. Gunter von Minckwitz