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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:

News

Data on GBG study PenelopeB and several collaborative projects will be 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.

Recruiting was closed at December 2017.

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 Manager
Dr. Thomas Ballhausen
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 Manager
Dr. Thomas Ballhausen

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

+49 6102 7480-0 | nfGBGd