ABCSG 36 / PENELOPEB / ETERNITY
Status: Treatment Phase & Follow-up
Phase III trial to evaluate palbociclib (PD-0332991), a cyclin kinase 4/6 inhibitor, in patients with hormone receptor positive, HER2-negativ primary breast cancer and a high risk of relapse following neoadjuvant chemotherapy
ETERNITY: Registry for long-term follow-up of safety and efficacy parameters of GBG study participants
| Coordinating Investigator: | Michael Gnant (Vienna) |
| Start of study: | 11/2013 (global), 07/2015 (national) |
| Sample size: | 1.250 |
| Sponsor: | GBG |
Description and status:
PENELOPEB is an international phase III trial evaluating the effect of palbociclib combined with endocrine therapy on invasive disease-free survival (iDFS) in patients with hormone receptor (HR)-positive / human epidermal growth factor receptor 2 (HER2)-negative primary breast cancer and high relapse risk after neoadjuvant chemotherapy. The global enrollment goal was achieved by the end of 2017. Worldwide, 1.694 screenings were performed, followed by randomization of 1.250 patients. Overall, in this study in Austria, 19 sites were activated, 42 screenings were performed, and 25 patients were enrolled. Final analysis on the primary endpoint was completed in early autumn 2020 and revealed that the trial did not meet the primary endpoint of improved iDFS. The results were presented at the San Antonio Breast Cancer Symposium (SABCS) Virtual Meeting 2020. Following the recommendation of the trial´s Independent Data Monitoring Committee (IDMC), the long term-follow up will continue beyond the end of the PENELOPEB study. Moreover, translational research projects and subgroup analyses will be carried out. In Austria, the long term follow up continues within the ETERNITY register (GBG 107, Registry for long term follow-up of safety and efficacy parameters of GBG study participants).
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