MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PHASE 3 TRIAL OF FULVESTRANT (FASLODEX (REGISTERED)). WITH OR WITHOUT PD-0332991 (PALBOCICLIB) +/- GOSERELIN IN WOMEN WITH HORMONE RECEPTOR-POSITIVE, HER2-NEGATIVE METASTATIC BREAST CANCER WHOSE DISEASE PROGRESSED AFTER PRIOR ENDOCRINE THERAPY

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).