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.
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.
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.
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.
Registered centres can access further documents in the password-protected section of this website for internal use. Please log in here.
Dr. Christian Mäurer, Dr. Mathias Uhlig
GBG Forschungs GmbH
Martin Behaim Strasse 12
Fon: +49 6102 7480-0
Fax: +49 6102 7480-440
Coordinating Investigator in Germany: Prof. Dr. Toralf Reimer
International Investigator: Prof. Dr. Gunter von Minckwitz
GBG Forschungs GmbH
Martin-Behaim-Str. 12 | 63263 Neu-Isenburg | Fax +49 6102 7480-440