Summary
The study is a randomized, double blind, placebo controlled, Phase 3 clinical trial with
the primary objective of demonstrating the superiority of palbociclib in combination with
fulvestrant (Faslodex®) over fulvestrant alone in prolonging PFS in women with HR+, HER2
negative metastatic breast cancer whose disease has progressed after prior endocrine
therapy. The safety between the two treatment arms will also be compared. During study
treatment, pre- and perimenopausal women must be receiving therapy with the LHRH agonist
goserelin (Zoladex® or generic).