Phase III study evaluating palbociclib (PD-0332991), a Cyclin-Dependent Kinase (CDK) 4/6 Inhibitor in patients with hormone-receptor-positive, HER2-normal primary breast cancer with high relapse risk after neoadjuvant chemotherapy.
GBG Forschungs GmbH is conducting the study in cooperation with the AGO-B, the Breast International Group (BIG) and the NSABP Foundation.
News
The recruitment target of 1250 patients was reached on Dec. 7, 2017 and the treatment part of the study was completed with the last patient visit on Sep. 25, 2020. This is followed by the current follow-up phase (Overall Survival Follow-Up, MedCODES: FU OS), which will be completed per protocol with the Overall Survival evaluation in Q3 2023.
Long-term data is of great scientific and medical interest. We therefore ask you to discuss with the patients the inclusion in the GBG Patient Self-Assessment (PSA), which would then extend beyond 2023. You can obtain more information on this from the PM team and here as well.
For Germany, the close-out visits of the trial centers will start in September 2021 and will be conducted primarily by telephone. The follow-up phase will continue unaffected by the close-out visits until Q3-2023, as described above.
We would like to thank the PENELOPE trial centers for their great support!
Of course, we would also like to thank the patients! We have prepared a Thank you Letter, which also contains an overview of the study results. This has already been provided to the trial centers and is also available on this page for download.
Design
- Arm A: 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 for thirteen cycles;
- 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.
Patients in both arms shall receive standard endocrine treatment for at least 5 years.
Primary Objective: Comparison of invasive disease-free survival (IDFS).
Detailed information on the study is publicly available on Clinical Trials.gov: NCT01864746.
The risk of relapse is determined using the CPS-EG score (pretreatment clinical stage, post-treatment pathologic stage, estrogen receptor status, nuclear grade) according to Mittendorf EA et al. 2011.
Patients with a score of 3 or 2 with ypN(+) status can be included in the PenelopeB study.
The calculation can be performed online in advance on the website of the MD Anderson Cancer Center.
Contact
Dr. Thomas Ballhausen
