The German Breast Group (GBG) and Pfizer Inc. (PFE) announced Friday that the collaborative Phase 3 PENELOPE-B trial of IBRANCE (palbociclib) in Early Breast Cancer did not meet the primary endpoint of improved invasive disease-free survival (iDFS) in women with hormone receptor-positive (HR+), human epidermal growth factor-negative (HER2-) early breast cancer (eBC) who have residual invasive disease after completing neoadjuvant chemotherapy. No unexpected safety signals were observed.
PENELOPE-B is a randomized, double-blind, placebo-controlled Phase 3 study comparing one year of palbociclib plus at least five years of standard adjuvant endocrine therapy to placebo plus at least five years of standard adjuvant endocrine therapy n 1,250 women with HR+, HER2- eBC at high risk of recurrence who have residual invasive disease after completing neoadjuvant chemotherapy.
The trial is sponsored by the GBG as part of a clinical research collaboration with Pfizer and other study groups.
IBRANCE is an oral inhibitor of CDKs 4 and 6, which are key regulators of the cell cycle that trigger cellular progression.
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